Core Faculty Biographical Sketches 2017

THE UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE TUCSON DEPARTMENT OF SURGERY

I. DIVISION OF CARDIOTHORACIC SURGERY

• David Bull, MD (Professor of Surgery, with tenure; new Division Chief of CT Surgery) • Mary Jane Barth, MD (Clinical Associate Professor of Surgery) • Kenneth Fox, MD, (Clinical Assistant Professor of Surgery, clinical track) • Toshinobu Kazui, MD, PhD (Assistant Professor of Surgery, clinical track) • Zain Khalpey, MD, PhD (Associate Professor of Surgery, tenure track) • Samuel Kim, MD (Assistant Professor of Surgery, tenure track) • Scott Lick, MD (Professor of Surgery, with tenure) • Young-Wook Won, PhD (Assistant Professor of Surgery, tenure track)

II. DIVISION OF GENERAL SURGERY

• Taylor S. Riall, MD, PhD, FACS (Acting Chair and Division Chief - Professor - Tenured) • Amanda Arrington, MD, FACS (Assistant Professor – Non-Tenure Clinical Scholar Track) • Iman Ghaderi, MD, MSc, FRCSC, FACS (Assistant Professor - Non-Tenure Clinical Scholar Track) • Vinod Gollapalli MD (Clinical Instructor) • Marlon A. Guerrero, MD, FACS (Section Chief, Associate Professor - Tenured) • Robert C. Harland, MD, FACS (Professor - Tenured) • Tun Jie, MD, MS, FACS (Associate Professor - Non-Tenure Clinical Scholar Track) • Ethan E. Larson, MD (Assistant Professor - Non-Tenure Clinical Scholar Track) • James H. McClenathan, MD, FACS (Professor - Non-Tenure Clinical Scholar Track) • Lilah F. Morris-Wiseman, MD, FACS (Assistant Professor – Non-Tenure Clinical Scholar Track) • David D. Neal, MD, FACS (Associate Professor - Non-Tenure Clinical Scholar Track) • Leigh A. Neumayer, MD, MS, FACS (Professor - Tenured) • Valentine N. Nfonsam, MD, MS, FACS (Associate Professor - Tenured) • Rebecca K. Viscusi, MD, FACS (Assistant Professor - Non-Tenure Educator Scholar Track) • Amy L. Waer, MD, FACS (Professor - Non-Tenure Educator Scholar Track) • James A. Warneke, MD, FACS (Associate Professor - Tenure)

III. DIVISION OF NEUROSURGERY

• G. Michael Lemole Jr., MD (Division Chief – Professor, Surgery - Tenured) • Travis M. Dumont MD (Assistant Professor, Surgery - Tenure Track) • R. John Hurlbert MD (Professor, Surgery - Tenure Track) • Willard S. Kasoff MD (Assistant Professor, Surgery - Tenure Track) • Martin E. Weinand MD (Professor, Surgery - Tenured)

Core Faculty Biographical Sketches (cont.) 2017

IV. DIVISION OF TRUAMA, CRITICAL CARE, BURN AND EMERGENCY SURGERY

• Terence O’Keeffe MB, ChB, MSPH, FACS (Interim Chief - Associate Professor - Tenured) • Randall S. Friese MD, FACS, FCCM (Professor - Tenured) • Lynn M. Gries MD (Assistant Professor - Non-Tenure Clinical Scholar Track) • Arpana Jain MD (Assistant Professor - Non-Tenure Clinical Scholar Track) • Bellal A. Joseph MD, FACS (Associate Professor - Tenured) • Narong Kulvatunyou MD, FACS (Associate Professor - Non-Tenured Clinical Scholar Track) • Andrew L. Tang MD, FACS (Associate Professor - Tenured) • Gary A. Vercruysse MD, FACS (Associate Professor - Tenure Track) • El Rasheid Zakaria PhD (Research Assistant Professor)

V. DIVISION OF UROLOGY

• Benjamin R. Lee, MD (Division Chief - Professor - Tenured) • Ken Batai, PhD (Research Assistant Professor – Non-tenure track) • Joel T. Funk, MD, FACS (Assistant Professor - Non-Tenure Clinical Scholar Track) • Matthew B. Gretzer, MD, FACS (Associate Professor - Non-Tenure Clinical Scholar Track) • Marty Schiff, MD (Professor Emeritus) • Christian O. Twiss, MD, FACS (Associate Professor - Non-Tenure Clinical Scholar Track)

VI. DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY

• Wei Zhou, MD, FACS (Chief - Professor - Tenured) • Eric Espensen DPM, DABMSP (Assistant Professor - Non-Tenure Clinical Scholar Track) • Kay R. Goshima MD, FACS (Associate Professor - Non-Tenure Clinical Scholar Track) • Jennifer L. Pappalardo DPM (Assistant Professor - Non-Tenure Clinical Scholar Track) • Tze-Woei Tan MBBS (Assistant Professor - Tenure Track) • Craig Weinkauf, MD (Assistant Professor – Tenure Track, starting Fall 2017) • Marlys H. Witte MD (Professor - Tenured)

VII. RESEARCH & EDUCATION

• Allan Hamilton MD, FACS (Professor) • Ronald Heimark PhD (Professor) • Robert Johnson PhD (Research Professor) • Klearchos Papas PhD (Professor) • Wiliams Adamas-Rappaport MD, FACS (Professor)

I. DIVISION OF CARDIOTHORACIC SURGERY DAVID BULL

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Bull, David A. eRA COMMONS USER NAME: DAVID_BULL POSITION TITLE: Professor of Surgery, Division of Cardio-Thoracic Surgery, University of Arizona School of Medicine

DEGREE INSTITUTION AND LOCATION Date FIELD OF STUDY (if applicable) University of California Berkeley, Berkeley, CA B.A. 1981 Biochemistry University of California San Francisco, San Francisco, CA M.D. 1985 Medicine University of California San Francisco, San Francisco, CA Intern 1986 General Surgery University of California San Francisco, San Francisco, CA Resident 1987 General Surgery University of Arizona Health Science Center, Tucson, AZ Resident 1989 General Surgery University of Arizona Health Science Center, Tucson, AZ Chief Resident 1990 General Surgery University of Arizona Health Science Center, Tucson, AZ Fellow 1992 Vascular Surgery University of Utah School of Medicine, Salt Lake City, UT Fellow 1994 Cardiothoracic Surgery

A. Personal Statement

With this application, we propose to develop a biological affinity-driven rapamycin delivery vehicle for T-cells- targeted immunosuppression. We will have developed a bi-functional recombinant fusion protein containing a CD80 domain that targets CTLA4 expressed on activated T-cells and the rapamycin-binding domain (RBD) derived from FKBP12. In this CD80-RBD fusion protein, the RBD incorporates rapamycin analogues through biological affinity binding that does not require the creation of chemical bonds. This targeted delivery of rapamycin by the CD80-RBD fusion protein provides a means for the recipient’s T-cell-focused combined immunosuppression to effectively reduce the incidence of grafts rejection and minimize the adverse effects of the immunosuppressive agents. As a Cardio-Thoracic surgeon with a history of published research and prior NIH funding in the fields of drug delivery systems, I have the skill set and experience to conduct and oversee the proposed studies as the principle investigator. Perhaps more importantly, having been intimately involved in developing and bringing together all of the elements that this project requires, I have the ability and the expertise in navigating through any unexpected challenges or unforeseen problems which may occur during the course of our project. The successful completion of our proposed Specific Aims will advance the development of a new platform for targeted delivery of immunosuppressive agents.

DAVID BULL

B. Positions and Honors

Positions and Employment 1994 – 2001 Assistant Professor of Surgery, University of Utah Division of Cardiothoracic Surgery, Salt Lake City, UT 1994 – Present Chief, Salt Lake City VA Medical Center, Cardiac Transplantation, Salt Lake City, UT 1994 – Present Surgical Co-Director, Salt Lake VA Medical Center, UTAH Cardiac Transplant Program, Salt Lake City, UT 2001 – Present Chief, Salt Lake VA Medical Center, Cardiothoracic Surgery, Salt Lake City, UT 2001 – 2006 Associate Professor of Surgery, University of Utah Division of Cardiothoracic Surgery, Salt Lake City, UT 2006 – 2016 Professor of Surgery, University of Utah Division of Cardiothoracic Surgery, Salt Lake City, UT 2009 – 2016 Division Chief, University of Utah Division of Cardiothoracic Surgery, Salt Lake City, UT

2017-Present Professor of Surgery, University of Arizona Division of Cardiothoracic Surgery, Tucson, AZ 2017-Present Division Chief, University of Arizona Division of Cardiothoracic Surgery, Tucson, AZ

Honors 1980 Frank Gerbode Research Scholar 1981 Phi Beta Kappa, Achievement Award for College Scientists 1991 Who's Who Among Rising Young Americans 2002 J. Maxwell Chamberlain Memorial Paper, Society for Thoracic Surgery 2003 – 2017 America's Top Physicians, Consumers' Research Council of America 2003 – 2017 America's Top Surgeons, Consumers' Research Council of America 2004 – 2017 Good Housekeeping's Top Heart Specialists 2004 – 2017 America's Top Doctors 2009 – 2017 America’s Top Doctors for Cancer

DAVID BULL

C. Contributions to Science My publications have been focused on clinically translatable research in the fields of cell therapy, stem cell biology, gene therapy for cancer, biopolymer carriers, and ischemia-inducible gene therapy systems.

1. Clinical Transplantation a. Kumpati GS, Patel AN, Bull DA. Thrombosis of a descending thoracic aortic endovascular stent graft in a patient with factor V Leiden: case report. Journal of cardiothoracic surgery. 2014; 9:47. PubMed [journal]PMID: 24618347 PMCID: PMC3984718 b. Wozniak CJ, Baird BC, Stehlik J, Drakos SG, Bull DA, Patel AN, Selzman CH. Improved survival in heart transplant patients living at high altitude. The Journal of thoracic and cardiovascular surgery. 2012; 143(3):735-741.e1. PubMed [journal]PMID: 22169457 c. Healy AH, Mason NO, Hammond ME, Reid BB, Clayson SE, Drakos SG, Kfoury AG, Patel AN, Bull DA, Budge D, Alharethi RA, Bader FM, Gilbert EM, Stehlik J, Selzman CH. Allograft rejection in patients supported with continuous-flow left ventricular assist devices. The Annals of thoracic surgery. 2011; 92(5):1601-7; discussion 1607. PubMed [journal]PMID: 21944258 d. Bull DA, Reid BB, Selzman CH, Mesley R, Drakos S, Clayson S, Stoddard G, Gilbert E, Stehlik J, Bader F, Kfoury A, Budge D, Eckels DD, Fuller A, Renlund D, Patel AN.The impact of bridge-to-transplant ventricular assist device support on survival after cardiac transplantation. The Journal of thoracic and cardiovascular surgery. 2010; 140(1):169-73. PubMed [journal]PMID: 20451930 e. Stehlik J, Islam N, Hurst D, Kfoury AG, Movsesian MA, Fuller A, Delgado JC, Hammond ME, Gilbert EM, Renlund DG, Bader F, Fisher PW, Bull DA, Singhal AK, Eckels DD. Utility of virtual crossmatch in sensitized patients awaiting heart transplantation. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation. 2009; 28(11):1129-34. PubMed [journal]PMID: 19782589

2. Development of Cell Therapies. The cell surface engineering technology developed in our group provides for the non-covalent introduction of antibodies or recombinant proteins on the surface of any type of cell. Unlike other methods utilizing chemical conjugation, viral-gene transfer, or electrostatic interaction, our method of cell surface modification does not alter the activity or metabolism of the cells. We have demonstrated the potential of this technology by placing CXCR4 on the surface of mesenchymal stem cells to enhance their migration towards an SDF-1 gradient (a). This cell surface engineering technology represents a novel platform for the development of targeted cell delivery systems. I have led our research group’s efforts to isolate metabolically active human brown adipose tissue derived stem cells from human donors (b), as a potential therapy for the treatment of patients with metabolic syndrome, obesity and diabetes mellitus. We have also developed skeletal myoblasts generated by non-viral gene transfer that can protect and regenerate the heart after myocardial infarction, demonstrating the potential of genetically engineered myoblasts for the treatment of patients with ischemic heart disease (c). I have been a lead investigator on a phase II clinical trial of ixmyelocel-T in patients with ischemic or non- ischemic dilated cardiomyopathy (DCM). The intramyocardial injection of ixmyelocel-T reduced major adverse cardiovascular events and improved symptoms in patients with ischemic DCM but not in patients with non- ischemic DCM (d).

DAVID BULL

As both a laboratory and clinical investigator, I have extensive experience in a wide variety of settings navigating through the unexpected challenges and unforeseen problems which can occur during a research project.

a. Won YW, Patel AN, Bull DA. Cell surface engineering to enhance mesenchymal stem cell migration toward an SDF-1 gradient. Biomaterials. 2014 Jul;35(21):5627-5635. Epub 2014/04/16. doi: 10.1016/j.biomaterials.2014.03.070. b. Silva FJ, Holt DJ, Vargas V, Yockman J, Boudina S, Atkinson D, Grainger DW, Revelo MP, Sherman W, Bull DA, Patel AN. Metabolically active human brown adipose tissue derived stem cells. Stem Cells. 2014 Feb;32(2):572-581. doi: 10.1002/stem.1595.

c. McGinn AN, Nam HY, Ou M, Hu N, Straub CM, Yockman JW, Bull DA, Kim SW. Bioreducible polymer- transfected skeletal myoblasts for VEGF delivery to acutely ischemic myocardium. Biomaterials. 2011 Jan;32(3):942-949. doi: 10.1016/j.biomaterials.2010.09.061. PMCID: PMC2998412 d. Henry TD, Traverse JH, Hammon BL, East CA, Bruckner B, Remmers AE, Recker D, Bull DA, Patel AN. Safety and efficacy of ixmyelocel-T: an expanded, autologous multi-cellular therapy, in dilated cardiomyopathy. Circ Res. 2014 Sep 26;115(8):730-737. doi: 10.1161/CIRCRESAHA.115.304554.

3. Translational Research. The papers listed below highlight my work to develop ischemia-inducible gene therapies and the targeted delivery of these gene therapies for the treatment of ischemic heart disease. My work has demonstrated the feasibility of ischemia-inducible gene therapies as a novel treatment for patients with ischemic heart disease.

a. Won YW, Lee M, Kim HA, Nam K, Bull DA, Kim SW. Synergistically combined gene delivery for enhanced VEGF secretion and antiapoptosis. Mol Pharm. 2013 Oct 7;10(10):3676-3683. Epub 2013/09/07. doi: 10.1021/mp400178m. PMCID: PMC3818911 b. Won YW, McGinn AN, Lee M, Nam K, Bull DA, Kim SW. Post-translational regulation of a hypoxia- responsive VEGF plasmid for the treatment of myocardial ischemia. Biomaterials. 2013 Aug;34(26):6229-6238. Epub 2013/05/30. doi: 10.1016/j.biomaterials.2013.04.061. PMCID: PMC3679269 c. Won YW, Lee M, Kim HA, Bull DA, Kim SW. Hypoxia-inducible plasmid expressing both miSHP-1 and HO-1 for the treatment of ischemic disease. J Control Release. 2013 Jan 10;165(1):22-28. Epub 2012/10/31. doi: 10.1016/j.jconrel.2012.10.014. PMCID: PMC3883575 d. Won YW, McGinn AN, Lee M, Bull DA, Kim SW. Targeted gene delivery to ischemic myocardium by homing peptide-guided polymeric carrier. Mol Pharm. 2013 Jan 7;10(1):378-385. doi: 10.1021/mp300500y. PMCID: PMC3542830

DAVID BULL

4. Development of Therapies for the Treatment of Cancer. I have contributed to the development of cationic polymers to deliver anti-cancer genes into cancer cells. My publications have demonstrated that these polymers are capable of either the ubiquitous delivery or the targeted delivery of siRNAs or pDNA to silence cancer-related genes or to express genes that suppress cancer a. Kim SH, Jeong JH, Kim TI, Kim SW, Bull DA. VEGF siRNA delivery system using arginine-grafted bioreducible poly(disulfide amine). Mol Pharm. 2009 May-Jun;6(3):718-726. Epub 2008/12/06. doi: 10.1021/mp800161e. PMCID: PMC2754713

Full list of publications http://www.ncbi.nlm.nih.gov/sites/myncbi/1DkizYWd2BYQF/bibliograpahy/47877945/public/?sort=date&directio n=ascending

Completed Research Support

1R01DK065739 Kim (PI) 12/31/2003-12/30/2014 National Institutes of Health Genetic Modification of Stem Cells Role: Co-Investigator

5R01HL065477 Kim (PI) 07/01/2009- 06/30/2014 NIH NHLBI Polymer Carrier For Ischemic Disease Role: Co-Investigator

5R01HL071541 Bull (PI) 07/01/2003-06/30/2008 NIH NHLBI Hypoxia-Regulated Gene Therapy for Myocardial Ischemia. Role: Principal Investigator

1U01HL084889 Bull (PI) 9/30/2006-07/30/2011 NIH NHLBI Heart Failure Network Gene and Cell Based Therapies for LVAD Patients Role: Principal Investigator

ABI-55-0712-1 Bull (PI) 08/15/2008-08/31/2012 Aastrom Biosciences, Inc. Cell Therapy For Dilated Cardiomyopathy Role: Principal Investigator

DAVID BULL

Bull; Patel; Selzman (PIs) 02/01/2010-04/30/2014 Harvest Technologies Corp Bec Cell Therapy for Heart Failure Role: Co-Principal Investigator

135872 Bull (PI) 09/01/2006-09/30/2014 Duke Clinical Research Institute Hf Network Role: Principal Investigator

ABI-55-0712-1 Bull (PI) 08/15/2008-08/31/2012 Aastrom Biosciences, Inc. Crc For Dilated Cardiomyopathy Role: Principal Investigator

I. DIVISION OF CARDIOTHORACIC SURGERY MARY JANE BARTH

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Mary-Jane Theresa Barth, MD eRA COMMONS USER NAME (credential, e.g., agency login): ---- POSITION TITLE: Pediatric Cardiac Surgeon EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

DEGREE Completion Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of Saint Thomas, Houston, TX BA 06/1978 Biology/PreMed

University of Texas Southwestern, Dallas, TX MD 06/1985 Medical Degree

University of Texas Southwestern, Dallas, TX Residency 06/1991 General Surgery

University of Texas Southwestern, Dallas, TX Residency 06/1993 Cardiothoracic Surgery

Birmingham Children’s Hosp. Birmingham, UK Fellowship 12/1994 Pediatric Cardiac Surgery

Heart Institute for Children, Oak Lawn, IL Fellowship 12/1996 Pediatric Cardiac Surgery

A. Personal Statement

I am a board certified pediatric cardiac surgeon with over 20 years’ experience in this field. My experience has been weighted in the realms of neonatal cardiac surgery, typical congenital heart disease and ECMO.

MARY JANE BARTH

B. Positions and Honors

Positions and Employment 1/97 – 12/08 Pediatric Cardiac Surgery, The Heart Institute for Children, Christ Hospital, Oak Lawn, IL 1/09 – 3/2016 Site Director for Pediatric Cardiac Surgery, University of Oklahoma, Tulsa, OK 1/09 – 3/2016 Adjunct Clinical Associate Professor of Pediatrics, Oklahoma State Univ Ctr Health, Tulsa, OK 1/09 – 3/2016 Pediatric Cardiac Surgery, Children’s Hospital of Saint Francis, Tulsa, OK 4/16 – present Banner University Medical Center, Tucson, AZ

Honors Alpha Omega Alpha 1985 Top Doctors 2015 (Oklahoma) Castle Connolly Top Doctors 2017 Castle Connolly Exceptional Women in Medicine Award 2017

C. Contributions to Science

Because I have been primarily in private practice medicine for the first 20 years since finishing my training, papers have not been focused on any particular topic but rather bringing to light some of the newer innovations that our group brought forward based on our practice. Typical papers are as follows:

1) Experience with an alternative technique for the management of anomalous left coronary artery from the pulmonary artery. Barth MJ, Allen BS, Gulecyuz M, Chiemmongtoltip P, Cuneo B, llbawi MN. Ann Thorac Surg 2003: Nov 76(5):1429-34 2) Alternative approach to the surgical management of congenital tracheal stenosis. Hasaniya N, elZein CF, Mara S, Barth MJ, llbawi, MN. Ann Thorac Surg 2006 Dec 82(6):2305-7 3) Pericardial leaflet extension for aortic valve repair: Techniques and late results. Smith PC, Barth MJ, llbawi, MN. Pediatric Cardiac Surg Annual fo the Seminars in Thorac and Cardiovasc Surgery 1999;2:83-93 4) Poincare Plot of heart rate variability after Norwood surgery in hypoplastic left heart syndrome (HLHS). Gordon D, Gulecuzy M, Barth MJ, Roberson D, Husayni T, Arcilla R, llbawi MN. Second World Congress of Pediatric Cardiology and Cardiac surgery 1997

D. Additional Information: Research Support and/or Scholastic Performance

My focus within this institution involves training and education of PICU attendings and PICU nursing staff.

I. DIVISION OF CARDIOTHORACIC SURGERY KENNETH FOX

Please see the following faculty profile link: http://medicine.arizona.edu/person/kenneth-fox

I. DIVISION OF CARDIOTHORACIC SURGERY TOSHINOBU KAZUI

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Toshinobu Kazui MD PhD eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Assistant Professor of Surgery EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Sapporo Medical University (Japan) MD 03/1999 Medicine

Iwate Medical University (Japan) PhD 06/2006 Medicine, Medical imaging

Memorial Heart Center, Iwate Medical University (Japan) 04/1999- Resident - General 03/2006 Surgery Fellow – Cardiovascular Surgery Washington University School of Medicine 11/2010- Research Fellow – 06/2014 Cardiothoracic Surgery Advanced fellow - Heart transplant/ Mechanical Circulatory Support

A. Personal Statement

I have been a faculty member at the University of Arizona for over 2 years. Presently, clinical scholar track Assistant Professor in Surgery. My passion is to deliver the best surgical treatment to patients with heart disease. I believe being an academic surgeon is important to accomplish this goal. In order to achieve this goal, I have been actively involved with clinical activities, research, and education. Clinically I have been performing variety of procedures such as coronary artery bypass grafting, valve surgery, arrhythmia surgery, aortic surgery, transcatheter aortic valve replacement (TAVR), mechanical circulatory support (MCS) surgery, and thoracic (heart/lung) transplant surgeries. My research interests are focused on how to improve surgical techniques, how to minimize surgical insult and improve clinical outcomes. I am especially interested in valve repair techniques, surgical procedures for atrial fibrillation, and MCS surgery.

TOSHINOBU KAZUI

More particularly, I have done investigative work on the relationship between clinical outcome and imaging data in the past such as aortic root physiology after aortic root repair, cardiac function after mitral valve repair. Also proposed meticulous left ventricular assist device implantation technique reviewing chest x-ray and CT scan. Secondly, I have experience in conducting physiological assessment such as pressure volume loop utilizing large animal. This was performed during my research fellowship at Washington University School of Medicine. We investigated cardiac function and performed validation study of multiple surgical ablation devices utilizing acute and chronic porcine model. I have been helping students and residents to accomplish their academic goal. We have published manuscripts and abstracts. There are some ongoing projects as well. Currently I am working on developing a simulation model to have better surgical planning and education purpose and clinical research. Ideally this will enhance our understanding of our procedures also bringing higher quality of surgery locally, nationwide and beyond.

B. Positions and Honors Positions and Employment 1999 - 2001 Resident General Surgery, Cardiovascular Surgery Memorial Heart Center, Iwate Medical University, Japan 2001 - 2006 Fellow Cardiovascular Surgery, Memorial Heart Center, Iwate Medical University, Japan 2006 - 2009 Assistant professor Cardiovascular surgery, Memorial Heart Center, Iwate Medical University, Japan 2009 – 2010 Staff surgeon Cardiovascular surgery, Heart Center, St. Luke`s international hospital, Japan 2009 – 2011 Research Staff Cardiovascular surgery, Memorial Heart Center, Iwate Medical University, Japan 2010 – 2013 Research Fellow Cardiothoracic Surgery Research Laboratory, Washington University School of Medicine, St. Louis, MO 2013 – 2014 Cardiac surgery Transplant/VAD Fellow Cardiothoracic Surgery, Washington University School of Medicine / Barnes-Jewish Hospital, St. Louis, MO 2014 –2016 Clinical Instructor Department of Surgery The University of Arizona/ Banner University Medical Center Tucson, Tucson, AZ 2016-Present Assistant Professor Department of Surgery The University of Arizona/ Banner University Medical Center Tucson, Tucson, AZ

TOSHINOBU KAZUI

Honors and Professional Memberships 2012 The Uehara Memorial Foundation Research Fellowship, surgical treatment of atrial fibrillation 2010-2011 St. Lukes life science institute “Young investigator`s award”, the impact of atrial fibrillation on cardiac function 1999-Present Member, Japan Surgical Society 1999-Present Member, The Japanese Association for Thoracic Surgery 1999-Present Member, The Japanese Society for Cardiovascular Surgery 2002-Present Member, The Japanese Society for Vascular Surgery 2006-Present Member, The Japanese Circulation Society 2014-Present Member, The International Society for Heart and Lung Transplantation 2014-Present Member, American Heart Association 2014-Present Member, Society of Thoracic Surgeons

C. Contributions to Science 1. Assessing cardiac function pre and post cardiac surgery My research focus has been to investigate the cardiac function after cardiac surgery. The surgical procedures have been refined by feedback from imaging studies such as echocardiography, CT scan and MRI. With these feedbacks, cardiac surgical procedures were able to provide better cardiac function and more reliable and durable outcome. For example, aortic root repair techniques were gaining attention as promising alternative approach due to its ability to preserve native aortic valve and create the shape of sinus of Valsalva, while aortic root replacement which consists of aortic root graft replacement and aortic valve replacement was standard therapy. I was able to demonstrate that the motion of aortic root during cardiac cycle after aortic root remodeling surgery (Ph. D thesis). Another research topic was why mitral valve repair provides better cardiac function than mitral valve replacement. This leaded to refinement of mitral valve replacement that was to preserve subvalvular apparatus as much as possible to preserve left ventricular integrity. Recently, our group looked into patients who developed left ventricular assist device (LVAD) thrombosis. Narrow angle between the LVAD inflow cannula and LVAD pump body on chest x ray had impact on developing LVAD thrombosis. This helped us to improve our surgical technique in implanting the device. 1. Kazui T, Zhang A, Greenberg J, Itoh A, Tran P, Keith MS, Ewald G, Damiano R, Silvestry S.: Left ventricular assist device inflow angle and pump positional change over time adversely impact on left ventricular assist device function. Ann Thorac Surg. 2016 Dec;102(6):1933-1940 2. Kazui T, Tsuboi J, Niinuma H, Okabayashi H: Changes in the left ventricular twist after mitral valve repair. J Thorac Cardiovasc Surg 2011 Mar; 141(3): 714-24. 3. Kazui T, Kin H, Tsuboi J, Yoshioka K, Okabayashi H, Kawazoe K: Perioperative dynamic morphologic changes of the aortic annulus during aortic root remodeling with aortic annuloplasty at systole and diastole phases. J Heart Valve Dis 2008; 17: 366-370. 4. Kazui T, Izumoto H, Nasu M, Kawazoe K: Perioperative changes in dynamic aortic root morphology after Yacoub's root remodeling and concomitant aortic annuloplasty. Interactive CardioVascular and Thoracic Surgery 2004; 3: 465 - 69.

TOSHINOBU KAZUI

2. Surgical treatment of atrial fibrillation I joined Dr. Damiano’s (Chief of Cardiothoracic surgery, Washington University School of Medicine) research lab as a research fellow to contribute improvement of surgical treatment of atrial fibrillation (AF). Dr. Damiano’s lab was funded by NIH (RO1 HL32257). I participated in a variety of projects on surgical treatment of AF utilizing large animal such as the impact of AF on atrial and ventricular function, effectiveness of ablation devices, and electrophysiology. 1. Watanabe Y, Schill M, Kazui T, Melby S, Schuessler R, Damiano R.: Strategies to improve the efficacy of epicardial linear ablation on the beating heart. Innovation. 2016 Dec7. 2. Kazui T, Henn M, Watanabe Y, Kovacs S, Lawrance C, Greenberg J, Moon M, Schussler R, Damiano R.: The impact of six weeks of atrial fibrillation on left atrial and ventricular structure and function. J Thorac Cardiovasc Surg. 2015 Sep 5. 3. Watanabe Y, Weimar T, Kazui T, Lee U, Schuessler RB, Damiano RJ Jr.: Epicardial ablation performance of a novel radiofrequency device on the beating heart in pigs. Ann Thorac Surg. 2014 Feb;97(2):673-8 4. Weimar T, Watanabe Y, Kazui T, Lee US, Montecalvo A, Schuessler RB, Moon MR: Impact of differential right-to-left shunting on systemic perfusion in pulmonary arterial hypertension. Catheter Cardiovasc Interv. 2012 Apr 18 5. Weimar T, Watanabe Y, Kazui T, Lee US, Schuessler RB, Moon MR, Damiano RJ JR.: Differential impact of short periods of rapid atrial pacing on left and right atrial mechanical function. Am J Physiol Heart Circ Physiol 2012 Jun;302(12): H2583-91. Epub 2012 Apr 13.

I. DIVISION OF CARDIOTHORACIC SURGERY ZAIN KHALPEY

eRA COMMONS USER NAME (credential, e.g., agency login): ZKHALPEY

POSITION TITLE: Associate Professor of Surgery

DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

University of London, England B.S. 06/1995 Pathology: Haematology and Basic Medical Sciences University of London, London, England M.B.B.S. 06/1998 Medicine Imperial College, London, England Ph.D. 06/2012 Cardiothoracic Surgery, Bioenergetics and Cardiac Transplantation Brigham & Women's Hospital, Harvard Fellow 06/2012 Integrated ACGME General & Medical School, Boston, MA Cardiothoracic Surgery Joint Training Program New York Presbyterian, Columbia Fellow 12/2012 Advanced Mechanical Circulatory Support University, New York, NY

A. Personal Statement

I am a surgeon scientist whose work is focused on metabolic aspects of cellular and whole organ transplant and on the salvage of marginal organs for transplant. My past basic science research experience in bioenergetics, metabolism, and cell survival excited my interest in translational tissue regeneration. I was recently awarded a Fulbright Fellowship to study nucleotide metabolism in a rat model of heart failure. The experimental strategy employed during my Fulbright studies are directly applicable to my role in the current application. My laboratory performs basic and translational research in organogenesis, organ preservation, metabolic studies and tissue regeneration. I am actively engaged in ex vivo reconditioning of marginal human hearts and lungs; generation of functional heart and lung tissue that can ultimately be used for transplantation by using human decellularized bioscaffolds and re-seeding them with stem cells. I have established an extensive collaborative and multidisciplinary network with colleagues in thoracic surgery, biochemistry, immunology, cell and computational biology, bioengineering, and transplant surgery with potential for translation to the clinical bedside. I am currently the Director of The Mechanical Circulatory Support and Robotic Mitral Valve Programs and Co-Director of Heart Transplant and Perfusion Sciences at the University of Arizona.

B. Positions and Honors Positions and Employment 2001 - 2005 PhD Fellow in Cardiac Surgery, Imperial College of Science, Technology & Medicine, London 2002 - 2003 Honorary Research Registrar, Cardiothoracic Surgery, Royal Brompton Hospital, London 2003 - 2004 Research Fellow in Transplantation Biology, Mayo Clinic, Rochester, MN

ZAIN KHALPEY

2004 - 2005 Research Fellow in Surgery, Transplantation Biology Research Center, Massachusetts General Hospital, Boston, MA 2013 - Co-Director, Heart Transplant Program, University of Arizona College of Medicine, Tucson, AZ 2012 - 2012 Assistant Attending, Cardiothoracic Surgery, Columbia University, New York, NY 2012 - Associate Professor of Surgery, University of Arizona College of Medicine, Tucson, AZ

Other Experience and Professional Memberships 1998 - Member, General Medical Council, UK 2001 - Associate Fellow, Royal College of Surgeons of Ireland 2001 - Member, American Heart Association 2001 - Member, International Society of Heart and Lung Transplantation 2001 - Member, International Society of Surgeons 2002 - Member, Royal College of Surgeons of England 2002 - Fellow, Royal Society of Medicine 2003 - 2003 Cardiology and Cardiac Surgery Advisor, British Medical Journal 2005 - Member, American College of Surgeons 2013 - Early Career Reviewer, NIH Center for Scientific Review 2014 - Member, Region 5 Heart Review Board, UNOS 2014 - Member, ISHLT Basic Science and Translational Research Council 2014 - Member, Junior Faculty and Trainee Committee, International Society for Cardiovascular Translational Research (ISCTR) 2015 - Diplomat, American Academy and Board of Regenerative Medicine 2015 - Society of Thoracic surgeons- 261441 2016 - Fulbright Association: Lifetime Member 2016 - Member, American Association of Thoracic Surgeons- 124236 2016 - Fellow of the American College of Surgeons- 03268059 2016 - Member, American society for Artificial Organs- 15951

Honors 1998 Solly Medal and Prize for Surgery, University of London 2003 Young Investigators Award, European Society for the Study of Purine and Pyrimidine Metabolism in Man 2003 The International Lancet Award, The Lancet, London, UK 2004 John Parker International Fellowship, British Cardiac Society, University of London 2005 Hunterian Professor of Surgery, Royal College of Surgeons of England 2010 Hunterian Medal for Surgery, Society of Cardiothoracic Surgeons of Great Britain, Royal College of Surgeons of England 2010 Excellence in Teaching Award-Best Resident/Fellow in Teaching, Harvard Medical School 2012 Sarver Heart Center Award, Sarver Heart Center- University of Arizona 2013 - Tony S. Marnell Sr. Endowed Chair in Cardiothoracic Surgery, University of Arizona, Tucson, AZ 2014 International Society for Cardiovascular Translational Scholar Award, American College of Cardiology 2015 Fulbright Distinguished Chair in Medical Sciences

C. Contribution to Science 1. Metabolomics, nucleotide metabolism Due to the shortage of human organs available for transplant I explored the option of xenotransplantation for my PhD. Acute humoral rejection (AHR) was a major limit in the clinical application of animal organs for xenotransplantation. I investigated the contribution of mammalian disparities in nucleotide metabolism to the microvascular component in AHR, which at the time was not well defined. To analyze these disparities HPLC was performed on blood and heart and kidney biopsies from wild type mice, rats, pigs, baboons, and human donors. We found Ecto-5’-nucleotidase 17

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(E5’N) activities were 4-fold lower in pigs and baboon hearts compared to human and mice hearts while rat activity was highest. Similar differences between pigs and humans were also observed with kidneys and endothelial cells. More than 10-fold differences were observed with other purine enzymes. AMP deaminase (AMPD) activity was exceptionally high in mice but very low in pig and baboon hearts. Adenosine deaminase (ADA) activity was highest in baboons. Adenosine kinase (AK) activity was more consistent across different species. Pig blood had the highest levels of hypoxanthine, inosine and adenine. Human blood uric acid concentration was almost 100 times higher than in other species studied. Because of the importance of endothelial cells in transplantation we specifically investigated confrontation of pig heart and endothelial cells with human blood changes the activity of E5’N. We demonstrate a specific decrease in E5’N activity in pig hearts following exposure to human blood which impairs adenosine production resulting in a loss of a cytoprotective phenotype, contributing to xenograft rejection. This effect is triggered by human humoral immune responses, and complement contributes but does not fully mediate E5’N depletion. a. Khalpey, Z., Yuen, A.H., Kalsi, K.K., Kochan, Z., Karbowska, J., Slominska, E.M., & et al. (2005). Loss of ecto-5′nucleotidase from porcine endothelial cells after exposure to human blood: Implications for xenotransplantation. Biochimica Et Biophysica Acta (BBA) - Molecular Basis of Disease, 1741(1-2), 191–198. PMID: 15955461 b. Khalpey, Z., Kalsi, K., Yuen, A., Karbowska, J., Kochan, Z., Slominska, E.M., & et al. (2005). Exposure to Human Blood Inactivates Swine Endothelial Ecto-5′-Nucleotidase. Nucleosides, Nucleotides & Nucleic Acids, 24(4), 271–274. PMID: 16021914 c. Kutryb-Zajac B, Yuen AH, Khalpey, Z., Zukowska P, Slominska EM, Taylor PM, Goldstein S, Heacox AE, Lavitrano M, Chester AH, Yacoub MH, Smolenski RT. Nucleotide Catabolism on the Surface of Aortic Valve Xenografts; Effects of Different Decellularization Strategies. J Cardiovasc Transl Res. 2016 Apr;9(2):119-26. doi: 10.1007/s12265-016-9672-6. Epub 2016 Feb 1. d. Khalpey, Z., Yuen, A.H.Y., Lavitrano, M., McGregor, C.G.A., Kalsi, K.K., Yacoub, M.H., & Smolenski, R.T. (2007). Mammalian mismatches in nucleotide metabolism: implications for xenotransplantation. Molecular and Cellular Biochemistry, 304(1-2), 109–117. PMID: 17657591

2. “First in man” Translational Clinical Work- As a physician scientist I actively seek out advances in science that can be applied to my clinical practice. Consequently, I have been on the leading edge of clinical application of stem cells resulting in four “first in man” publications. Specifically, I have implemented and investigated adipose-derived stromal vascular fraction cells and cardiac function restoration; amniotic membrane patches and postoperative inflammation; and amniotic stem cell injections for wound healing and scar remodeling. a. Khalpey, Z., Janardanan R., Konhilas J., & Hemphill, C. (2014). First in Man: Adipose-derived Stromal Vascular Fraction Cells May Promote Restorative Cardiac Function. The American Journal of Medicine, 127(5), e11–e12. PMID: 24758874 b. Hemphill, C., Stavoe, K., & Khalpey, Z. (2014). First in man: Amniotic stem cell injection promotes scar remodeling and healing processes in late-stage fibrosis. International Journal of Cardiology, 174(2), 442–443. PMID: 24768371 c. Iwanski J, Knapp SM, Avery R, Oliva I, Wong RK, Runyan RB, Khalpey, Z. (2017). Clinical outcomes meta-analysis: measuring subendocardial perfusion and efficacy of transmyocardial laser revascularization with nuclear imaging.. J Cardiothorac Surg. 2017 May 19;12(1):37. doi: 10.1186/s13019-017-0602-8. d. Khalpey, Z., Marsh, K.M., Ferng, A., Riaz, I.B., Hemphill, C., Penick, K., et al. (2015). First in Man: Sternal Reconstruction with Autologous Stem Cells. ASAIO Journal, 1–9. PMID: 25914951

3. Organ Transplantation - In 2005 I co-authored a paper, which studied the novel application of Sirolimus (SRL), a kidney transplant drug, in cardiac transplant. The conclusion of this initial study was that substitution of calcineurin inhibitors (CNIs) with SRL in cardiac transplant recipients is safe and effective and leads to an improvement in renal function, without compromise in cardiac function and rejection. In subsequent studies we found that graduated substitution of CNI with SRL in cardiac transplant recipients is safe and improves renal function, without cardiac compromise, and substituting CNI with SRL as primary immunosuppression attenuates cardiac allograft vasculopathy progression. Finally, I was able to personally 18

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apply these findings to a patient as reported in the case report “Long-Term Maintenance Therapy for Post– Cardiac Transplant Monoclonal Lymphoproliferative Disorder: Caveat Mammalian Target of Rapamycin”. a. Kushwaha, S.S., Khalpey, Z., Frantz, R.P., Rodeheffer, R.J., Clavell, A.L., Daly, R.C., et al. (2005). Sirolimus in Cardiac Transplantation: Use as a Primary Immunosuppressant in Calcineurin Inhibitor– induced Nephrotoxicity. The Journal of Heart and Lung Transplantation, 24(12), 2129–2136. PMID: 16364861 b. Raichlin, E., Khalpey, Z., Kremers, W., Frantz, R.P., Rodeheffer, R.J., Clavell, A.L., et al. (2007). Replacement of Calcineurin-Inhibitors With Sirolimus as Primary Immunosuppression in Stable Cardiac Transplant Recipients. Transplantation, 84(4), 467–474. PMID: 17713429 c. Raichlin, E., Bae, J-H., Khalpey, Z., Edwards, B.S., Kremers, W.K., Clavell, A. L., et al. (2007). Conversion to sirolimus as primary immunosuppression attenuates the progression of allograft vasculopathy after cardiac transplantation. Circulation, 116(23), 2726–2733. PMID: 18025531 d. Khalpey, Z., Miller, D.V., Schmitto, J.D., & Kushwaha, S.S. (2011). Long-Term Maintenance Therapy for Post–Cardiac Transplant Monoclonal Lymphoproliferative Disorder: Caveat Mammalian Target of Rapamycin. Tps, 43(5), 1893–1899. PMID: 21693296

4. Surgical Innovation - Mechanical Circulatory Support – I have built my surgical career on implementing innovative and novel strategies to optimize mechanical circulatory support. I run the Total Artificail Heart and Transplant Program and regularly execute robotic2 Left Ventricular Assist Device surgery. I am one of the first surgeons to successfully implement Extracorporeal Membrane Oxygenation (ECMO) in the Southwest. We have further modified the procedure to match patient needs on a case-base-basis.

a. Khalpey, Z., Bin Riaz I, Marsh KM, Ansari MZ, Bilal J, Cooper A, Paidy S, Schmitto JD, Smith R, Friedman M, Slepian MJ, Poston R. Robotic Left Ventricular Assist Device Implantation Using Left Thoracotomy Approach in Patients with Previous Sternotomies. ASAIO J. 2015 Nov-Dec;61(6):e44- 6. doi: 10.1097/MAT.0000000000000251. a. Iwanski J, Wong RK, Larson DF, Ferng AS, Runyan RB, Goldstein S, Khalpey, Z. Remodeling an infarcted heart: novel hybrid treatment with transmyocardial revascularization and stem cell therapy. Iwanski J, Wong RK, Larson DF, Ferng AS, Runyan RB, Goldstein S, Khalpey, Z. Springerplus. 2016 Jun 16;5(1):738. doi: 10.1186/s40064-016-2355-6. eCollection 2016. Review.

Complete List of Published Work in MyBibliography: http://www.ncbi.nlm.nih.gov/myncbi/browse/collection/47967133/?sort=date&direction=+descending

D. Research Support Ongoing Research Support 5U01HL125208-02 Rischard, F. (PI) 09/01/14 - 08/31/19 National Heart, Lung, and Blood Institute Phenomic and Genomic Study to Subphenotype Hispanics with Pulmonary Hypertension This grant will redefine pulmonary hypertension classification by employing a combination of physiological, genomic and epigenetic strategies to sub-phenotype Latino and non-Latino pulmonary hypertension patients across the 5 Groups of PH categories with the goal of enhancing our understanding of disease pathophysiology, progression and prognosis. Role: Co-I

5R01HL066012-13 Yuan, J. (PI) 06/01/14 - 05/31/17 National Heart, Lung, and Blood Institute Calcium Signaling in Pulmonary Arterial Hypertension: Role of CaSR and TRPC6 The major goals of this project are to investigate the molecular mechanisms involved in the calcium-sensing receptor-mediated intracellular signaling and trpc6 gene function in the development of pulmonary arterial hypertension. Role: Co-I 19

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7R01HL115014-03 Yuan, J. (PI) 06/01/14 - 05/31/17 National Heart, Lung, and Blood Institute Molecular mechanisms of downregulated Kv channels in IPAH: Role of microRNA The major goals of this project are to investigate the molecular mechanisms involved in the posttranscriptional regulation of Kv channels by microRNAs in pulmonary artery smooth muscle cells isolated from patients with pulmonary hypertension. Role: Co-I

Department of Surgery Faculty Seed Grant, University of Arizona 01/03/17 – 12/31/18 The goal of the proposed research project is to explore the mechanistic basis for our observation that injection of human amniotic stem cells and/or transmyocardial revascularization (TMR) provides an improvement in cardiac function. Role: PI

UO1 HL131014 National Heart, Lung, and Blood Institute Khalpey (Co-I) Evaluation of the Safety and Efficacy of Angiotensin 1-7 to Enhance Cognitive Function in Participants Undergoing Coronary Artery Bypass Graft (CABG Surgery) Budget Period: 3/1/17-2/28/18 (DC $540,944; F&A $204,121) Project Period: 3/1/17-2/28/21 (DC $2,000,753; F&A $611,186) PIs: Andrew Arai, Meredith Hay, Lee Ryan, Nancy Sweitzer

Clinical Trials: NCT02326402 Khalpey (PI) 07/15/16 - 06/30/17 Sponsor: Cardiac Assist, Inc. The purpose of this registry is to collect information about disease defining characteristics resulting in the clinical decision to use TandemHeart for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal. The progression of the illness prior to, during and following TandemHeart support will be collected. Role: Investigator

NCT02459054 Khalpey (PI) 07/15/16 - 03/21/20 Sponsor: SynCardia Systems Inc. SynCardia 50cc TAH-T as a Bridge to Transplant. The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible patients at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits. Role: Investigator

NCT02232659 Khalpey (PI) 04/5/16 - 02/21/20 Sponsor: SynCardia Systems Inc. SynCardia 70cc Temporary TAH-T for Destination Therapy. The purpose of this research study is to evaluate whether the TAH-t can support patients with life-threatening irreversible biventricular heart failure who are not eligible for transplantation. The TAH-t, when used for patients who are not eligible for transplant, is considered to be an investigational (not approved by FDA) use. This use is called destination therapy (DT). Role: Investigator

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Completed Research Support NCT02073331 Khalpey (PI) 02/05/15 - 11/23/16 Sponsor: CorMatrix Cardiovascular Incorporated A Post Market Observational Study To Obtain Additional Information on the Use Of CorMatrix ECM For Pericaridial Reconstruction. The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction. Role: PI

NCT02268942 Khalpey (PI) 12/31/15 - 11/14/16 Sponsor: HeartWare, Incorporated A Prospective, Single Arm, Multi-Center Clinical Study in Collaboration with the InterAgency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) to Evaluate the Thoracotomy Implant Technique of the HeartWare HVAD® System in Patients with Advanced Heart Failure. This study will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD®. Role: PI

Arizona State University Khalpey (PI) 07/01/13 - 06/30/16 14-375/NNX13AM01G RNA Deep Sequencing and Metabolomic Profiling of Microgravity-Induced Regulation of the Host-Pathogen Role: PI

Fulbright Distinguished Chair in Medical Sciences-Poland Khalpey (PI) 10/01/15 - 06/30/16 The goal of this study will be to investigate mitochondrial metabolism and stem cell characterization. Work will be performed jointly at the University of Arizona, Tucson, Arizona, USA and the Medical University of Gdansk, Gdansk, Poland. Role: PI

NCT02073331 Green (PI) 03/01/14 - 12/16/15 CorMatrix Post Market Observational Study of CorMatrix ECM (Extracellular matrix) for Pericardial Reconstruction (CorMatrix RECON), The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction. Role: CPI

NCT01810679 Suri (PI) 04/01/13 - 12/01/15 Sorin Group Perceval S Aortic Heart Valve Study- North America The major goal of this clinical trial is to demonstrate the safety and effectiveness of the Perceval S sutureless heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis. Role: CPI

NCT01827319 Capps (PI) 05/01/13 - 07/20/15 Cardiogenesis Corp. Cardiogenesis Transmyocardial Revascularization Registry (ANGINA RELIEF) The major goal of this study is to evaluate a registry to Track "real world" performance outcomes and physician experience using the Cardiogenesis Laser System and further define the disease characteristics of the population being treated. Role: CPI

NCT01963780 Ardehali (PI) 11/01/13 - 12/01/14 21

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TransMedics International EXPAND Lung Pivotal Trial (EXPANDLung) The major of this clinical trial is to test the use of the TransMedics OCS™ to preserve and assess lungs donated after cardiac death (DCD) lungs ex vivo. Role: OP

NCT00733447 Garippa (PI) 03/01/10 - 08/01/13 SynCardia Systems SynCardia Freedom Driver System Study for Bi-ventricular Failure The major goal of this study was to evaluate the safety, efficacy and durability of a portable driver system for the 70cc Total Artificial Heart. Role: CPI

I. DIVISION OF CARDIOTHORACIC SURGERY SAMUEL KIM

BIOGRAPHICAL SKETCH a) Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAME Samuel Kim, M.D. eRA COMMONS USER NAME (credential, e.g., agency login) NA EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.) DEGREE INSTITUTION AND LOCATION MM/YY FIELD OF STUDY (if applicable) Johns Hopkins University, Baltimore, MD BA 06/1997 Biophysics Tufts University School of Medicine, Boston, MA MD 06/2002 Medicine University of Pennsylvania Hospital, Philadelphia Residency 07/2009 General Surgery Massachusetts General Hospital, Boston, MA Fellowship 12/2011 Thoracic Surgery

A. Personal Statement I am currently working as an Assistant professor of Surgery at an academic institution. My clinical and research interest is in thoracic oncology, both in clinical outcomes research and translational research. Since joining staff, I have worked tirelessly to forge collaboration amongst physicians and scientists to identify key clinical needs for our patients in Southern Arizona, formulate and test clinical ideas through scientific research, develop personalized medicine that fits the patient’s needs, and forge a bond and relationship with the community though improvement of communication and education. I currently have a robust clinical practice with full commitment and supports (both financial and mentorship) for research from the department of Cardiothoracic Surgery as well as collaborators from the Arizona Cancer Center. Through current project, I have built a multidisciplinary team of collaborators and contributors from various departments including Thoracic Surgery, Pathology, Radiology, Medical Oncology, Radiation Oncology Basic Cell Biology, Bioinformatics and Statistics. This group has worked successfully on several grants that resulted in peer-reviewed publications. I have both participated and published in clinical, translational and basic science projects. I received a Research Fellowship Award from the Thoracic Surgery Foundation for Research and Education as a resident and, with the support of the award, I was able to publish two first author papers in Cancer Research and Journal of Immunotherapy. My collaborator and I currently have institutional grant to support translational research projects.

a) B. Positions and Honors

Positions and Employment 07/2009-12/2011 – Fellowship – Cardiothoracic Surgery (thoracic track) – Massachusetts General Hospital, Boston, MA 7/2010-10/2010 – Fellow Rotation – Minimally Invasive Esophageal Surgery under Dr. Luketich, University of Pittsburg, PA 10/2010-12/2010 – Fellowship Rotation – Thoracic Surgery Residency under Dr. Claude Deschamps, Mayo Clinic, Rochester, MN 2/2012-Current – Assistant Professor Surgery – University of Arizona, Cardiothoracic Surgery, Tucson, AZ 23

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Other Experience and Professional Memberships 2002 – National Alpha Omega Alpha Society 2006-2007 – Communications Officer for Housestaff Committee at University of Pennsylvania Hospital 2007 – American Thoracic Society 2010 – Society of Thoracic Surgery 2011 – General Thoracic Surgery Club 2015- Western Thoracic Surgical Society

Honors 1993-1997 – Dean’s List, National Honor Society 1997 – Graduate Phi Beta Kappa 2001 – Student/Resident Research Award – Specialty of Pulmonary – American Society for Laser Medicine and Surgery 2002 – Alpha Omega Alpha 2006 – Research Fellowship Award – The Thoracic Surgery Foundation for Research and Education 2006-2007 – Penn Center of Surgical Excellence Scholar Award

b) C. Selected Peer-reviewed Publications 1. Wilderman M., Kim S., Gillespie C.T., Sun J., Kapoor V., Vachani A., Sterman D., Kaiser L., Albelda S.M. Blockade of TNFa Decreases Both Inflammation and Efficacy of Intrapulmonary Ad.IFN Beta Immunotherapy in an Orthotopic Model of Bronchogenic Lung Cancer. Molecular Therapy,13:910-917, 2006. PMID:16488193

2. Suzuki E, Kim S, Cheung HK, Corbley M, Zhang X, Sun L, Shan F, Singh J., Lee WC, Albelda SM, Ling. A Novel Small Molecule Inhibitor of TGF-beta type I Receptor Kinase (SM16) Inhibits Murine Mesothelioma Tumor Growth in vivo and Prevents the Extent of Tumor Recurrence After Surgical Resection. Cancer Research, 67:2351-2359, 2007. PMID:17332368

3. Kim S, Fridlender ZG, Dunn R, Kehry MR., Kapoor V, Blouin A, Kaiser LR., Albelda SM. B-cell Depletion Using an Anti-CD20 Antibody Augments Antitumor Immune Responses and Immunotherapy in Nonhematopoetic Murine Tumor Models. Journal of Immunotherapy. 31(5):446-457, June 2008. PMID:18463540

4. Kim S, Buchlis G, Fridlender ZV, Sun J, Kapoor V, Cheng G, Haas A, Cheung HK, Zhang X Corbley M. Kaiser LR, Ling L, Albelda SM. Systemic Blockade of Transforming Growth Factor-β (TGF-β) Signaling Augments the Efficacy of Immunogene Therapy. Cancer Res 2008;68(24):10247–56. PMID:19074893

5. Fridlender ZG, Sun J, Kim S, Kapoor V, Cheng G, Ling L, Worthen GS, Albelda SM. Polarization of tumor- associated neutrophil phenotype by TGF-beta: "N1" versus "N2" TAN. Cancer Cell. 2009 Sep 8;16(3):183-94 PMID: 20395632

SAMUEL KIM

6. Kim S, Fridlender ZG, Jassar AS, Blouin A, Kapoor V, Albelda SM, Singhal S. The role of neoadjuvant transforming growth factor beta inhibition to prevent local recurrence and distant metastasis in advanced thoracic malignancies. Journal of American College of Surgeon 9/2009:209(3):S32

7. Kim S, Ott HC, Wain J, Wright C, Donahue D, Gaissert H, Mathisen D and Lanuti M. Pulmonary Resection of Metastatic Sarcoma: Prognostic Factors Associated with Improved Survival and Outcomes. Ann Thorac Surg 2011;92:1780-1787 PMID: 22051274

8. Song JJ, Kim S, Joren C ZL, Madsen J, Mathisen DJ, Vacanti JP, Ott HC. Enhanced in vivo Function of Bioartificial Lungs in Rats. Ann Thorac Surg. 2011 Sep;92(3);998-1005. PMID:21871290

9. Nielsen VG, Kim S, Zelman EA, Steinbrenner EB. Lung Tumor Effects on Plasmatic Coagulation: Role of Hemeoxygenase-1. Lung Cancer. 2014 Feb;83(2):288-91 PMID:24553061

10. Nielsen VG, Matika RW, Ley MB, Waer A, Gharagozloo F, Kim S, Nfonsam V, Ong E, Jie T, Warneke JA, Steinbrenner E. Tissue-type plasminogen activator-induced fibrinolysis is enhanced in patients with breast, lung, pancreas and colon cancer. Blood coagulation & fibrinolysis: an international journal in haemostasis and thrombosis. 4/2014; 25(3):248-53 PubMedID: 24674880

11. Poston R, Gharagozloo F, Khalpey Z, Kim S. Robotic Training in Cardiothoracic Surgery. Annals of Thoracic Surgery. 2014; vol97, 378 PMID:24384203

12. Rawashdeh B,, Meyer M, Gill J, Moslemi M, Kim S. Unusual presentation of a giant benign inflammatory polyp in the upper esophagus. International Journal of Surgery Case Reports vol 6, 2015 :206-209 PMID:25544491

13. Rawashdeh B, Meyer M, Moslemi M, Kim S. Unicenteric Castleman’s Disease Presenting As Pulmonary Mass; A Diagnostic Dilemma. Am J Case Rep. 2015 Apr 30;16:259-61. PMID:25928278

14. Avila MJ, Skoch J, Fennell VS, Palejwala S, Walter CM, Kim S, Baaj AA. Combined posterior hemiosteotomies and stabilization with lateral thoracotomy for en bloc resection of thoracic paraspinal primary bone tumors. J of Neurosurg Spine 2015 Oct 9:1-5 PMID: 26451666

15. Kim S, Khalpey Z, Daugherty S , Torabi M , Little AG. Factors in Selection and Management of Chest Tubes after Pulmonary Lobectomy: Results of a National Survey of Thoracic Surgeons. Ann Thorac Surg. 2016 Mar;101(3):1082-8. PMID: 26680313 16.Kim, S. Is there a need for a new staging system in early lung cancer? J Thorac Cardiovasc Surg. 2016 Jun;151(6):1569-70. PMID: 26971385

SAMUEL KIM

17. Kim, S, Yoo B, Baaj A, Little AG. Resection of a posterior mediastinal mass: Lessons learned from a failed exploration for presumed schwannoma. The J of Thorac Cardiovasc Surg. 2016 April 16. PMID: 27174512

18. Kim S. 3D printing: the next big thing in surgery? J Thorac Cardiovasc Surg. 2016 Jul;152(1):e9 PMID:27130301

19. Kim S. Role of metformin in lung cancer treatment and prevention; are we any closer to the answer? J Thorac Cardiovasc Surg. 2016 Jul;152(1):62-3 PMID: 27343906

20. Kazui T, Tran PL, Echeverria A, Jerman CF, Iwanski J, Kim S, Smith RG, Khalpey ZI. Minimally invasive approach for percutaneous CentriMag right ventricular assist devise support using a single PROTEKDuo Cannula. J Cardiothorac Surg. 2016 Aug 4;11(1):123. PMID:27487837

21. Kim S. The IASLC lung cancer staging project proposal for the classification of lung cancers with multiple pulmonary sites of involvement: the first step toward finding optimal treatment. J Thorac Dis. 2016 Sep;8(9):2313-2314. PMID:27746963

22. Kazui T, Sydow N, Friedman M, Kim S, Lick S, Khalpey Z. A Modified Park Stitch to Correct Aortic Insufficiency at Time of Ventricular Assist Device Implant: report of a case. J of Cardiothorac Surg. 2016 Nov 30:11(1):161 PMID: 27955681

23. Natt B, Hem D, Kim S, Bime C. Decreased In-hospital Mortality after Lobectomy using Video-Assisted Thoracoscopic Surgery compared to Open Thoracotomy. Annals of the American Thoracic Society, October 25, 2016 PMID: 27779897

24. Kim S, Khalpey Z, Hsu C, Kasui T, Little AG The Changing Spectrum of Tracheostomy related and Post Intubation Tracheal Stenosis: Implications for Surgical Treatment. Accepted abstract and oral presentation for Society of Southern Thoracic Surgery

25. Lin FC, Lin SJ, Kim S, Walker JR. A rare diaphragmatic ureteral herniation case report: endoscopic and open reconstructive management. BMC Urol. 2017 Apr 5;17(1):26. PMID:28381270

SAMUEL KIM Other Publications and Presentations 1. Kim S. Role of 425nm Pulse dye laser in the treatment of the Squamous cancer of the neck. Oral presentation at the 2001 Annual American Society for Laser Medicine and Surgery meeting, New Orleans, LA.

2. Kim S, Kapoor V, Sun J, Workman A, Kaiser L, Albelda S. TGF- B inhibition Augments Ad-INF B Gene Therapy in the Murine Mesothlioma Model. Poster presentation at 2006 International Mesothelioma Interest Group, Chicago, 2006.

3. Kim S, Workman A, Kapoor V, Sun J, Ling L, Kaiser L, Albelda S. TGF- β Inhibition Using a Type I Receptor Kinase Inhibitor (SM16) Causes Tumor Suppression by Changing the Tumor Microenvironment. Oral presentation at 2007 ATS International Conference in San Francisco, California.

4. Kim S, Ott H, Wain J, Wright C, Donahue D, Gaissert H, Mathisen D, Lanuti M. Pulmonary Resection of Metastatic Sarcoma: Prognostic Factors Associated with Improved Survival and Outcomes. Oral presentation at STS 47th annual meeting in San Diego, CA 2011.

5. Kim S, Meyer M. Robot Assisted Ivor-Lewis Esophagectomy Oral presentation at 2012 Society of Laparoscopic Surgeon Minimally Invasive Week in Boston.

6. Kim S, Meyer M. Robotic Assited Extrapleural Pneumonectomy Poster at 2013 Society of Robotic Surgery Annual Meeting in Orlando, Florida.

7. Kim S, Meyer M. Robotic Highly Selective Dorsal Sympathectomy for Hyperhidrosis. Poster at 2013 Society of Robotic Surgery Annual Meeting in Orlando, Florida.

8. Centouri S, Kim S, Gomes C, Putnam C, Mount D, Garland L, Martinez J. Tumor-infiltrating B cells are predictive of human squamous cell survival. AACR 106th Annual Meeting 2015; April 18-22, 2015; Philadelphia, PA

9. Kim S, Yoo B. Robotic Heller Myotomy for Symptomatic Achalsia. Oral Presentation at 2015 Minimally Invasive Week, Society of Laparoscopic Surgeon. New York, New York.

10. Yoo B, Kim S. Surgical Management of Pulmonary Coccidiomycosis using Video-Assisted Thoracoscopic Surgery. Oral Presentation at 2015 Minimally Invasive Week, Society of Laparoscopic Surgeon. New York, New York.

11. Kim S, Khalpey Z, Hsu C, Kasui T, Little AG The Changing Spectrum of Tracheostomy related and Post Intubation Tracheal Stenosis: Implications for Surgical Treatment. Oral presentation for Society of Southern Thoracic Surgery, Naples Florida 2016.

SAMUEL KIM

Ongoing Research Support

4/2016-4/2018 (Co- PI, 20%) PI: Charles Hsu Co-PIs: Linda Garland, Phil Kuo, Marty Pagel Imaging-based Biomarker of Tumor Acidity to Assess Response to Chemoradiation Therapy of Locally Advanced Lung Tumor Followed by Resection, Phase II. University of Arizona Cancer Center Clinical Research Oversight Council Grant. $14,800.

8/2016-8/2018 (Co-PI, 20%) PI: Charles Hsu, Co-PIs: Linda Garland, Paul Okunieff Pilot Study of Novel Assay of Tumor Cell Free DNA (cfDNA) From Plasma As Biomarker of Treatment Response in Patients with Newly Diagnosed Non-Small Cell Lung Cancer. University of Arizona Health Science Clinical Research Pilot Program Award ( UAHS-CRPS)- $20,000

Completed Research Support

6/2006-6/2008 (PI, 100%) Co- PI: Steven Albelda The Role of B-Cell Depletion in Augmenting the Immunotherapy. The Thoracic Surgery Foundation for Research and Education Research Fellowship Award, $60,000

I. DIVISION OF CARDIOTHORACIC SURGERY SCOTT LICK

Please see the following faculty profile link: http://surgery.arizona.edu/profile/scott-d-lick-md-facs

I. DIVISION OF CARDIOTHORACIC SURGERY YOUNG-WOOK WON

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Won, Young-Wook eRA COMMONS USER NAME: YOUNGWOOKWON POSITION TITLE: Assistant Professor of Surgery, University of Arizona College of Medicine EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) Completion DEGREE INSTITUTION AND LOCATION Date FIELD OF STUDY (if applicable) MM/YYYY Hanyang University, Korea BS 02/2005 Biochemistry and Molecular Biology Hanyang University, Korea MS 02/2008 Bioengineering Hanyang University, Korea PhD 08/2011 Bioengineering University of Utah, Salt Lake City, UT Post-doctoral 06/2013 Gene Delivery Fellow University of Utah School of Medicine, Salt Lake City, Post-doctoral 06/2014 Gene and Cell Therapy UT Fellow

A. Personal Statement With a history of published research in the fields of drug delivery systems such as drug delivery, recombinant proteins, cancer nano-therapeutics, cancer gene therapy, and biopolymer carriers, my research focuses on the development of innovative strategies to improve the targeted delivery of small molecule drugs, genes, and stem cells by using naturally derived materials, including recombinant fusion proteins. My long-term research goal is the development of clinically translatable, biologically based systems to enhance the efficacy of bioactive molecules without the need for synthetic materials. I have a broad background in biomaterials science including recombinant protein technology, polymer chemistry, gene delivery/therapy, and small molecule drug delivery. My previous work with synthetic materials for drug delivery led me to question why the field of drug delivery has, to the present time, focused on the development of artificial materials rather than naturally derived biomaterials. The recombinant fusion protein, a key component of this research, is one such example of a naturally derived biomaterial for drug delivery.

I have previously explored the development of two recombinant fusion proteins: the PTD-heat shock protein 27 and the PTD-metallothionein. Skills that I acquired from that research work include DNA cloning, protein expression, purification, analysis, and structural/functional assays, all of which are required to pursue the proposed Aims in this project. In particular, I learned how to successfully clone plasmid DNAs that encode two functional domains into a fusion protein. This prior experience is crucial to the synthesis of the recombinant fusion proteins that will be prepared in this project. In addition, my experience in screening a homing peptide by phage

YOUNG-WOOK WON display will help us to build our own library of scFv domains. As our laboratory has significant expertise in the production of recombinant scFv antibodies in mammalian cells, we can then insert the discovered sequences into an expression vector. The function and antigen-specificity of the scFv antibody will be verified, followed by its fusion with the anti-cancer agent-binding domain. Throughout this process, my expertise in DNA cloning will be critical to the construction of the plasmid DNA expressing the scFv-GBD fusion protein.

I also have experience in the production of nanoparticles and hydrogels as delivery systems for anti-cancer agents including geldanamycin. During this previous work, creating nanoparticles for the delivery of an anti- cancer drug, I realized that a certain type of recombinant protein could serve as a drug carrier. This realization led to the design of a recombinant protein that could serve as a binding domain for an anti-cancer drug. My prior experience with anti-cancer drug delivery has fueled my interest in cancer biology, the mechanism of action of anti-cancer drugs, and animal models of cancer. The knowledge that I have gained from my prior work will contribute to the successful completion of this proposed research, which is challenging and highly innovative.

Selected Publications 1. Won Y-W, Yoon S-M, Lim KS, Kim Y-H. Self-Assembled Nanoparticles with Dual Effects of Passive Tumor Targeting and Cancer-Selective Anticancer Effects. Advanced Functional Materials. 2012;22(6):1199-1208. doi: 10.1002/adfm.201101979. 2. Won YW, Kim KM, An SS, Lee M, Ha Y, Kim YH. Suicide gene therapy using reducible poly (oligo-D-arginine) for the treatment of spinal cord tumors. Biomaterials. 2011 Dec;32(36):9766-9775. Epub 2011/09/20. doi: 10.1016/j.biomaterials.2011.08.089. 3. Won YW, Yoon SM, Sonn CH, Lee KM, Kim YH. Nano self-assembly of recombinant human gelatin conjugated with alpha-tocopheryl succinate for Hsp90 inhibitor, 17-AAG, delivery. ACS Nano. 2011 May 24;5(5):3839-3848. Epub 2011/04/27. doi: 10.1021/nn200173u. 4. Lim KS, Lee DY, Valencia GM, Won Y-W, Bull DA. Nano-Self-Assembly of Nucleic Acids Capable of Transfection without a Gene Carrier. Advanced Functional Materials. 2015;25(34):5445-5451. doi: 10.1002/adfm.201502067.

B. Positions and Honors Positions and Employment 2013.03 – 2013.06 Visiting Scientist, University of Twente, Department of Controlled Drug Delivery, Enschede Netherlands 2014.07 – 2017.03 Assistant Professor of Surgery, University of Utah School of Medicine, Salt Lake City, UT 2014.11 – 2017.03 Adjunct Assistant Professor, Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah, Salt Lake City, UT 2015.10 – 2017.02 Director, Recombinant Protein Service/Recharge Center, University of Utah Health Sciences Center, Salt Lake City, UT 2017.03 – present Assistant Professor of Surgery, University of Arizona College of Medicine, Tucson, AZ

YOUNG-WOOK WON

Awards and Honors 2006-2008 Hanyang Fusion Materials Program, Ministry of Education, Science, and Technology, Hanyang University, Korea 2008-2010 Seoul Fellowship, Seoul Metropolitan Government, Korea 2011 Best Ph.D Thesis Award, Hanyang University, Korea 2011-2012 Post-Doctoral Fellowship, National Research Foundation of Korea, Korea

C. Contribution to Science

1. Anti-cancer drug delivery. My previous publications described the development of nanoparticles or injectable thermo-reversible hydrogels as carriers for the delivery of anti-cancer agents by using naturally derived biomaterials instead of synthetic materials. Some of the most frequently used natural biomaterials in drug delivery systems are polysaccharides. Polysaccharides, however, are difficult to digest and to eliminate from the body after systemic administration due to their high molecular weight and the absence of degrading enzymes. Therefore, the development of degradable natural biomaterials that can be easily eliminated is critical to the development of successful in vivo applications. These publications utilized a recombinant human gelatin or a degradable low molecular weight methylcellulose as a backbone polymer in order to formulate self- assembled nanoparticles or hydrogels. This body of work has proven that these naturally derived biomaterials can serve as alternatives to the synthetic polymers currently widely used in the field of drug delivery. As the first author, my role was designing the overall research, performing the experiments and preparing the manuscript for all of these studies. a. Won YW, Yoon SM, Sonn CH, Lee KM, Kim YH. Nano self-assembly of recombinant human gelatin conjugated with alpha-tocopheryl succinate for Hsp90 inhibitor, 17-AAG, delivery. ACS Nano. 2011 May 24;5(5):3839-3848. Epub 2011/04/27. doi: 10.1021/nn200173u. b. Won Y-W, Yoon S-M, Lim KS, Kim Y-H. Self-Assembled Nanoparticles with Dual Effects of Passive Tumor Targeting and Cancer-Selective Anticancer Effects. Advanced Functional Materials. 2012;22(6):1199-1208. doi: 10.1002/adfm.201101979. c. Kim JK, Won YW, Lim KS, Kim YH. Low-molecular-weight methylcellulose-based thermo-reversible gel/pluronic micelle combination system for local and sustained docetaxel delivery. Pharm Res. 2012 Feb;29(2):525-534. Epub 2011/09/10. doi: 10.1007/s11095-011-0581-8.

2. Recombinant protein drug delivery. In addition to the contributions described above, I have been a core contributor to the development of nanoparticles and injectable thermo-reversible hydrogels for protein drug delivery. Protein delivery remains one of the major challenges in the field of drug delivery. The studies listed below demonstrated that naturally derived polymers, including recombinant proteins and polysaccharides, are suitable as biomaterials to construct nanoparticles or hydrogels for the delivery of protein drugs. As the first author, my role was designing the overall research, performing the experiments and preparing the manuscript for all of these projects. a. Won YW, Kim YH. Recombinant human gelatin nanoparticles as a protein drug carrier. J Control Release. 2008 Apr 21;127(2):154-161. Epub 2008/03/11. doi: 10.1016/j.jconrel.2008.01.010.

YOUNG-WOOK WON

b. Won Y-W, Kim Y-H. Preparation and cytotoxicity comparison of type a gelatin nanoparticles with recombinant human gelatin nanoparticles. Macromolecular Research. 2009;17(7):464-468. doi: 10.1007/bf03218893.

c. Won YW, Kim JK, Cha MJ, Hwang KC, Choi D, Kim YH. Prolongation and enhancement of the anti-apoptotic effects of PTD-Hsp27 fusion proteins using an injectable thermo-reversible gel in a rat myocardial infarction model. J Control Release. 2010 Jun 1;144(2):181-189. Epub 2010/02/16. doi: 10.1016/j.jconrel.2010.02.014. 3. Gene delivery. Cationic polymers have been used to deliver DNAs or RNAs for over 20 years but my research has shown that cationic peptide-based gene carriers have advantages over synthetic polymers in terms of safety and the lack of the need for additional modification for targeted delivery. In the most recent publication, I demonstrated that the ATS-9R/shFABP4 oligopeptide complex is capable of targeted delivery of shRNA against FABP4 in obese adipocytes and is a safe therapeutic approach to treat obesity as well as obesity-induced metabolic syndromes. As the first author, my role was designing the overall research, performing the experiments and preparing the manuscript. a. Won YW, Yoon SM, Lee KM, Kim YH. Poly(oligo-D-arginine) with internal disulfide linkages as a cytoplasm-sensitive carrier for siRNA delivery. Mol Ther. 2011 Feb;19(2):372-380. Epub 2010/11/18. doi: 10.1038/mt.2010.242. PMCID: PMC3034849

b. Won YW, Kim KM, An SS, Lee M, Ha Y, Kim YH. Suicide gene therapy using reducible poly (oligo-D- arginine) for the treatment of spinal cord tumors. Biomaterials. 2011 Dec;32(36):9766-9775. Epub 2011/09/20. doi: 10.1016/j.biomaterials.2011.08.089.

c. Won Y-W, Adhikary PP, Lim KS, Kim HJ, Kim JK, Kim Y-H. Oligopeptide complex for targeted non-viral gene delivery to adipocytes. Nat Mater. 2014 12//print;13(12):1157-1164. doi: 10.1038/nmat4092

d. Lim KS, Lee DY, Valencia GM, Won Y-W, Bull DA. Nano-Self-Assembly of Nucleic Acids Capable of Transfection without a Gene Carrier. Advanced Functional Materials. 2015;25(34):5445-5451. doi: 10.1002/adfm.201502067.

4. Cell delivery. My recent publication reported the development of a practical method of cell surface engineering to introduce recombinant CXCR4 on the surface of mesenchymal stem cells. Other methods that have been developed to engineer cell surfaces utilize chemical conjugation, viral-gene transfer, or electrostatic interaction, which can alter the activity or metabolism of cells after cell surface modification and limit their clinical utility. The development of a non-invasive and practical method of cell surface engineering is critical for successful cell therapies. The surface engineering technique that we have developed can serve as a platform to re-direct cytotoxic T cells to become cancer-specific T cells for the treatment of primary and advanced stage breast cancer. As the first author, I designed the overall research, performed the experiments and prepared the manuscript under the guidance and mentorship of Dr. David Bull. a. Won YW, Patel AN, Bull DA. Cell surface engineering to enhance mesenchymal stem cell migration toward an SDF-1 gradient. Biomaterials. 2014 Jul;35(21):5627-5635. Epub 2014/04/16. doi: 10.1016/j.biomaterials.2014.03.070.

Full list of publications http://www.ncbi.nlm.nih.gov/sites/myncbi/1nmb_Ol0Q7bAH/bibliography/47509516/public/?sort=date&direction =ascending

II. DIVISION OF GENERAL SURGERY TAYLOR RIALL

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Riall, Taylor Sohn (maiden name: Taylor Ashli Sohn) eRA COMMONS USER NAME (credential, e.g., agency login): tsriall

POSITION TITLE: Professor, Department of Surgery; Acting Chair and Chief, Division of General Surgery and Surgical Oncology

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Rutgers University, Douglass College, New BA 05/1992 Chemistry Brunswick, NJ The Johns Hopkins University School of Medicine, MD 05/1996 Doctor of Medicine Baltimore, MD The University of Texas Medical Branch, Galveston, PHD 08/2007 Clinical Science TX Institute for Professional Excellence in Coaching, CPC 11/2015 Executive Coaching Shrewsbury, NJ

A. Personal Statement

I am currently Professor and Acting Chair in the Department of Surgery. I also serve as Chief of the Division of General Surgery and Surgical Oncology. I obtained my PhD in the Clinical Sciences Graduate Program (health services research track) at UTMB in 2007 and served as the Director of the Center for Comparative Effectiveness and Cancer Outcomes at the University of Texas Medical Branch in Galveston from 2009-2015. I am an active clinical surgeon, doing approximately 150 cases per year, including complex pancreaticobiliary and gastrointestinal operations as well as general surgical cases. My research background is in health services/comparative effectiveness research. My research over the past 10 years has primarily involved analysis of administrative data (Surveillance, Epidemiology, and End Results (SEER), SEER-Medicare, Texas Cancer Registry and Linked Medicare claims, Medicare, NSQIP). I have studied methods for controlling for selection bias using observational data, overuse and underuse of various surgical procedures and tests (CT scans, echocardiograms, cholecystectomy, colonoscopy, pancreatic surgery) in specific clinical situations, geographic and provider variation in care delivery, and disparities in cancer treatment and treatment of gallbladder

TAYLOR RIALL disease in older patients. I am also a certified professional coach with an interest in physician wellbeing and optimal performance. As Division Chief and Department Chair I am committed to building a well-rounded department providing the highest quality patient-centered care, driven by discovery and evidence-based medicine. My goal is to train the next generation of surgeons and develop future surgeon-leaders by enabling each member of my department achieve their highest potential.

B. Positions and Honors

Positions and Employment 2004 – 2005 Instructor, Department of Surgery, The Johns Hopkins Medical Institutions, Dept. of Surgery, Baltimore, MD 2005 – 2008 Assistant Professor, Department of Surgery, The University of Texas Medical Branch, Dept. of Surgery, Galveston, TX 2008 – 2013 Associate Professor, Department of Surgery, The University of Texas Medical Branch, Dept. of Surgery, Galveston, TX 2008 – 2015 John Sealy Distinguished Chair in Clinical Research, The University of Texas Medical Branch, Dept. of Surgery, Galveston, TX 2009 – 2010 Assistant Director, General Surgery Residency Program, The University of Texas Medical Branch, Galveston, TX 2009 – 2015 Director, Center for Comparative Effectiveness and Cancer Outcomes, The University of Texas Medical Branch, Galveston, TX 2013 – 2015 Professor, Department of Surgery, The University of Texas Medical Branch, Dept. of Surgery, Galveston, TX 2013 – 2015 Associate Director, Clinical Sciences Graduate Program, The University of Texas Medical Branch, Galveston, TX 2015 - Professor, Department of Surgery; Chief, Division of General Surgery and Surgical Oncology; Vice Chair of Quality and Performance, University of Arizona, Tucson, AZ

Professional Memberships 2000 - Member, Society for Surgery of the Alimentary Tract, (elected) 2005 - Member, Association for Academic Surgery (elected) 2006 - Member, Fellow, American College of Surgeons, (elected) 2007 - Member, Americas Hepato-Pancreato-Biliary Association, (elected) 2007 - Editorial Board, Journal of Gastrointestinal Surgery 2007 - 2012 Editorial Board, Journal of Surgical Research 2008 - Member, Society of University Surgeons, (elected) 2009 - Member, Southern Surgical Association, (elected) 2009 - Member, Surgical Biology Club II, (elected) 2012 - Editorial Board, Annals of Surgery 2012 - Member, Texas Surgical Society, (elected) 2012 - Section Editor, Scientific American Surgery (formerly American College of Surgeons Surgery) 2013 - Member, American Surgical Association, (elected) 2013 - Editorial Board, Surgery 2015 - 2016 Study Section. NIH Grants for Early Medical/Surgical Specialists' Transition to Aging Research (GEMSSTAR) 2016 - Member, Society of Clinical Surgery, (elected) 2016- Western Surgical Society

TAYLOR RIALL

Honors 1989 – 1992 Douglass Scholar, Academic Scholarship 1989 – 1992 New Jersey Distinguished Scholar 1991 – 1992 Barry M. Goldwater Scholarship 1992 Highest Honors, B.A., Rutgers University 1992 Phi Beta Kappa, Rutgers University 1996 William Stewart Halsted Award, General Surgery 1998 – 2000 SSAT/Ross Resident’s Research Competition 1998 – 2000 Upjohn Award for Clinical Research 1999 – 2002 Niarchos Foundation Research Grant 2000 American Hepato-Pancreato-Biliary Association/Ethicon Research Award 2002 The A. McGehee Harvey Research Award, Young Investigators’ Day 2004 Alpha Omega Alpha 2006 Resident Teaching Award, UTMB 2006 Sealy Center for Vaccine Development Graduate Student Award, UTMB 2007 AAMC Early Career Women’s Professional Development Conference 2007 Best paper in Journal of Gastrointestinal Surgery 2007 Phi Kappa Phi Graduate School Honor Society 2008 - John Sealy Distinguished Chair in Clinical Research 2009 Arthur M. Shipley Award, Southern Surgical Association 2012 The Douglass Society Award (recognizes alumnae who have distinguished themselves in their career or through community service) 2014 Executive Leadership in Academic Medicine (ELAM), Fellow

C. Contribution to Science

1. The Treatment of Older Patients with Gallstone Disease Current guidelines recommend cholecystectomy for elective patients with gallstone disease. Using Medicare data, we demonstrated that fewer than 25% of older patients presenting with an initial symptomatic episode actually undergo elective cholecystectomy; of those that do not 13% go on to require emergent gallstone-related hospitalizations, at which point their mortality (6%) and morbidity (>50%) are significant. Based on these data, we developed a model that accurately predicts the 2year risk of developing gallstone-related complications. Furthermore, we demonstrated that the decision to perform cholecystectomy in these patients is paradoxically unrelated to risk. We continue to examine the trajectory of care to determine why patients are not appropriately treated. We are translating this work into clinical practice by educating primary care physicians and surgeons and using the risk prediction model to increase elective cholecystectomy rates in the patients at highest risk of developing gallstone-related complications. a. Dimou FM, Adhikari D, Mehta HB, Riall TS. Trends in Follow-Up of Patients Presenting to the Emergency Department with Symptomatic Cholelithiasis. J Am Coll Surg. 2016 Apr;222(4):377-84. PubMed PMID: 26837281; PubMed Central PMCID: PMC4818112. b. Parmar AD, Sheffield KM, Adhikari D, Davee RA, Vargas GM, Tamirisa NP, Kuo YF, Goodwin JS, Riall TS. PREOP-Gallstones: A Prognostic Nomogram for the Management of Symptomatic Cholelithiasis in Older Patients. Ann Surg. 2015 Jun;261(6):1184-90. PubMed PMID: 25072449; PubMed Central PMCID: PMC4309752. c. Riall TS, Adhikari D, Parmar AD, Linder SK, Dimou FM, Crowell W, Tamirisa NP, Townsend CM Jr, Goodwin JS. The risk paradox: use of elective cholecystectomy in older patients is independent of their risk of developing complications. J Am Coll Surg. 2015 Apr;220(4):682-90. PubMed PMID: 25660731; PubMed Central PMCID: PMC4372464.

2. TAYLOR RIALL

d. Parmar AD, Coutin MD, Vargas GM, Tamirisa NP, Sheffield KM, Riall TS. Cost-effectiveness of elective laparoscopic cholecystectomy versus observation in older patients presenting with mild biliary disease. J Gastrointest Surg. 2014 Sep;18(9):1616-22. PubMed PMID: 24919433; PubMed Central PMCID: PMC4140946.

2. The Quality of Post-treatment Surveillance of Cancer Care in Texas This work focused on the quality of posttreatment surveillance across cancer types in Texas. Using Texas Cancer Registry and linked Medicare claims data we were able to demonstrate both overuse and underuse of guideline-appropriate post-treatment surveillance in patients with breast and colorectal cancer. In addition, we examined current patterns in posttreatment surveillance for both pancreatic and lung cancers, two cancers were guidelines are less clear. This work demonstrates that appropriate testing would potentially improve outcomes and decrease cost and has implications for cancer care delivery in Texas. a. Sharma G, Nishi SP, Lin YL, Kuo YF, Goodwin JS, Riall TS. Pattern of Imaging Following Lung Cancer Resection: 1992-2005. Ann Am Thorac Soc. 2016 May 31;PubMed PMID: 27243464. b. Vargas GM, Sheffield KM, Parmar AD, Han Y, Brown KM, Riall TS. Physician follow-up and observation of guidelines in the post treatment surveillance of colorectal cancer. Surgery. 2013 Aug;154(2):244-55. PubMed PMID: 23889952; PubMed Central PMCID: PMC3839939. c. Parmar AD, Sheffield KM, Vargas GM, Han Y, Chao C, Riall TS. Quality of post-treatment surveillance of early stage breast cancer in Texas. Surgery. 2013 Aug;154(2):214-25. PubMed PMID: 23889950; PubMed Central PMCID: PMC3728715. d. Sheffield KM, Crowell KT, Lin YL, Djukom C, Goodwin JS, Riall TS. Surveillance of pancreatic cancer patients after surgical resection. Ann Surg Oncol. 2012 May;19(5):1670-7. PubMed PMID: 22143577; PubMed Central PMCID: PMC3360943.

3. Controlling for Selection Bias in Observational Studies Observational, population-based data such as Medicare claims data can provide study populations with sufficient statistical power to study rare events such as bile duct injury. However, administrative data lack clinical information regarding the indications for treatment and are subject to unmeasured confounding (selection bias and bias by indication). We have two landmark papers that demonstrate this selection bias. Significant controversy exists regarding the role of intraoperative cholangiography (IOC) in the prevention of common bile duct injury during cholecystectomy. Previous population-based studies using data from Medicare claims, hospital discharge records, and national inpatient registries report nearly 2-fold higher rates of injury in cholecystectomies done without IOC. We used Texas Medicare claims data, the association between IOC and bile duct injury was highly sensitive to the analytic method used. Results from standard risk-adjustment methods indicated that not using an IOC during cholecystectomy was significantly associated with an increase in bile duct injury, even after controlling for patient, surgeon, and hospital characteristics. When we employed instrumental variable methods, the relative increase in injury was attenuated and the association was no longer statistically significant. Similarly, while a previous study documented improved survival in pancreatic cancer patients receiving EUS, there is little biologic plausibility for an effect of EUS on survival, especially in patients who did not receive pancreatic resection. In evaluating the association between EUS and survival, risk-adjustment using standard regression and propensity score methods appears to be subject to unmeasured confounding or bias, with patients who underwent EUS were healthier, had

TAYLOR RIALL

better functional status, and less extensive disease than patients who did not undergo EUS. An association between EUS and survival was observed in both standard (Cox regression models) and propensity score (matching and risk-adjustment) risk-adjustment models. Only when we used IV methods was the survival benefit eliminated a. Parmar AD, Sheffield KM, Han Y, Vargas GM, Guturu P, Kuo YF, Goodwin JS, Riall TS. Evaluating comparative effectiveness with observational data: endoscopic ultrasound and survival in pancreatic cancer. Cancer. 2013 Nov 1;119(21):3861-9. PubMed PMID: 23922148; PubMed Central PMCID: PMC3811156. b. Sheffield KM, Han Y, Kuo YF, Townsend CM Jr, Goodwin JS, Riall TS. Variation in the use of intraoperative cholangiography during cholecystectomy. J Am Coll Surg. 2012 Apr;214(4):668-79; discussion 679-81. PubMed PMID: 22366491; PubMed Central PMCID: PMC3319194.

4. The Treatment of Patients with Pancreatic Cancer Throughout the course of my career, my research has focused on the management of pancreatic cancer. As a surgical resident, I compiled the largest pancreatic surgery database in the world and published papers defining the treatment of patients with pancreatic and periampullary neoplasms. Subsequently, I used population-based data to study the quality of pancreatic cancer care in the US, evaluating the underuse of surgical resection in early stage disease, the underuse of multimodality therapy, the quality of end-of-life care, outcomes in the elderly, the effect of depression on pancreatic cancer, hospital days and medical care days in patients with pancreatic cancer and many other topics. I am a recognized expert in pancreatic disease, with more than 50 publications in this area. a. Parmar AD, Vargas GM, Tamirisa NP, Sheffield KM, Riall TS. Trajectory of care and use of multimodality therapy in older patients with pancreatic adenocarcinoma. Surgery. 2014 Aug;156(2):280-9. PubMed PMID: 24851723; PubMed Central PMCID: PMC4099282. b. Sheffield KM, Boyd CA, Benarroch-Gampel J, Kuo YF, Cooksley CD, Riall TS. End-of-life care in Medicare beneficiaries dying with pancreatic cancer. Cancer. 2011 Nov 1;117(21):5003-12. PubMed PMID: 21495020; PubMed Central PMCID: PMC3139734. c. Riall TS, Sheffield KM, Kuo YF, Townsend CM Jr, Goodwin JS. Resection benefits older adults with locoregional pancreatic cancer despite greater short-term morbidity and mortality. J Am Geriatr Soc. 2011 Apr;59(4):647-54. PubMed PMID: 21453378; PubMed Central PMCID: PMC3156667. d. Sohn TA, Yeo CJ, Cameron JL, Koniaris L, Kaushal S, Abrams RA, Sauter PK, Coleman J, Hruban RH, Lillemoe KD. Resected adenocarcinoma of the pancreas-616 patients: results, outcomes, and prognostic indicators. J Gastrointest Surg. 2000 Nov-Dec;4(6):567-79. PubMed PMID: 11307091.

5. Minimally Invasive Breast Biopsy in Patients with Breast Cancer Minimally invasive breast biopsy (MIBB) is the recommended diagnostic modality in women found to have a breast mass. We examined MIBB rates in Texas and to describe associated geographic patterns that will enable us to better understand the barriers to achieving the 2009 consensus statement target of >90% MIBB rates for patients presenting with palpable breast masses and/or suspicious mammographic abnormalities. Between 2001 and 2008, only 65.8% of all initial biopsies for new breast lesions were MIBB. Despite the increase in MIBB over time, in 2008 only 79% women underwent MIBB as the initial biopsy procedure for newly diagnosed breast mass or mammographic abnormality. Racial/socioeconomic disparities persisted, with Hispanics and patients with lower socioeconomic status being less likely to undergo a MIBB. Even in the later time period, only

TAYLOR RIALL

4.8% of 208 HSAs in Texas met the 90% MIBB target rate. We then used multilevel hierarchical models to evaluate surgeon- and facility-level variation in the use of MIBB as the initial diagnostic modality in a woman presenting with a palpable breast mass or mammographic abnormality. We identified only 7.0% of facilities and 13% of surgeons performing MIBB in >90% of their breast cancer cases. We observed wide variation in the use of MIBB across surgeons (8.8% to 86.2%) and facilities (8.4% to 95.8%). In our multilevel models, over 22% of the variance in MIBB use was attributable to the facility and 16% attributable to the surgeon. Finally, we also identified specific surgeon and facility characteristics associated with a low use of MIBB. This study provided clear targets for intervention to improve MIBB rates. a. Tamirisa NP, Sheffield KM, Parmar AD, Zimmermann CJ, Adhikari D, Vargas GM, Kuo YF, Goodwin JS, Riall TS. Surgeon and Facility Variation in the Use of Minimally Invasive Breast Biopsy in Texas. Ann Surg. 2015 Jul;262(1):171-8. PubMed PMID: 25185475; PubMed Central PMCID: PMC4345162. b. Zimmermann CJ, Sheffield KM, Duncan CB, Han Y, Cooksley CD, Townsend CM Jr, Riall TS. Time trends and geographic variation in use of minimally invasive breast biopsy. J Am Coll Surg. 2013 Apr;216(4):81424; discussion 824-7. PubMed PMID: 23376029; PubMed Central PMCID: PMC3608736.

Complete List of Published Work in MyBibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/taylor.riall.2/bibliography/40870266/public/?sort=date&direction=ascending

D. Research Support

Completed Research Support

K07 CA130983-01A1 Riall, Taylor Sohn (PI) 09/15/08-08/31/13 Underutilization of Surgical Resection in Patients with Pancreatic Cancer Project Title: Underutilization of Surgical Resection in Patients with Pancreatic Cancer The goal of this research is to describe the evaluation process of patients with locoregional and metastatic pancreatic cancer including specialist visits and key diagnostic tests and to describe the patient, tumor, surgeon, hospital volume, and medical system characteristics which predict the receipt of surgical evaluation and surgery in patients with locoregional pancreatic cancer. This grant also evaluates the extent of and trends in regionalization of care to high-volume centers (>10 pancreatic resections per year) among Medicare patients with locoregional and metastatic pancreatic cancer and assesses variability in care among Medicare providers performing pancreatic resection Role: PI

TAYLOR RIALL

1R24HS022134-01, Agency for Healthcare Research and Quality Goodwin (PI) 06/01/13-07/31/15 Patient Centered Outcomes Research in the Elderly The goal of this research was to transform UTMB into a center of rigorous high quality comparative effectiveness research (CER) and patient-centered outcomes research (PCOR), focused on healthcare decision-making facing older individuals, their providers, and the health systems providing their care. Dr. Riall served a Co-Director and CoInvestigator on this proposal until she left UTMB in 2015. Her particular projects focused on shared-decision making in gallbladder disease and cancer. Role: Co-Investigator

RP101207, CPRIT (Cancer Prevention Research Institute of Texas) (Project 3 PI: Riall; overall grant PI: Goodwin) (PI) 08/01/10-07/31/15 Comparative Effectiveness of Cancer Care in Texas (CERCIT) Project 3: Quality of Post Treatment Surveillance of Cancer Patients in Texas" This is a five-year grant from the Cancer Prevention and Research Institute of Texas to a consortium of institutions, including UTMB, MD Anderson, UT School of Public Health, Rice University and Baylor College of Medicine. The grant supported the linkage of Texas Cancer Registry (TCR) data to Medicare and Medicaid data, in order to support population-based analyses of screening for, and diagnosis, treatment, and post-treatment surveillance of cancer patients in Texas, with a particular emphasis on disparities in cancer care associated with race/ethnicity and rural residence. Project 3 use the TCR and linked Medicare claims data to evaluate the quality of post-treatment surveillance across cancer types in Texas. Role: Co-Investigator

T32 DK007639-17 (PI: Hellmich) 07/01/13 - 07/31/18 NIH Project Title: Surgical Research Training in Gastrointestinal Disease The training program is specifically focused on the research training of young academic surgeons interested in surgical problems of the alimentary tract. Our program represents an intensive and integrated two-year research experience which offers the individual trainee a highly structured research experience in fundamental aspects of outcomes research, biostatistics, molecular biology, physiology, biochemistry, endocrinology, pharmacology, and immunology and cell biology as they pertain to diseases of the digestive tract. The primary goal of our program is to prepare young academic surgeons to be independent scientists and to incorporate \t techniques learned during their training period in their research and ultimate care of the surgical patient with diseases of the GI tract.

Role: Associate Director until she left UTMB in 2015. Trained 3 T32 fellows from 2012-2015.

II. DIVISION OF GENERAL SURGERY AMANDA ARRINGTON

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Arrington. Amanda K eRA COMMONS USER NAME (credential, e.g., agency login): ARRINGTONA POSITION TITLE: Assistant Professor EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completio (if n Date FIELD OF STUDY INSTITUTION AND LOCATION applicable MM/YYYY )

West Virginia University, Morgantown, WV BS 05/1999 Chemistry West Virginia University, Morgantown, WV MD 05/2003 MD University of Minnesota, Minneapolis, MN Residency 06/2011 General Surgery City of Hope Cancer Center, Duarte, CA Fellowship 06/2013 Surgical Oncology

A. Personal Statement As surgical oncologist, I have a broad background in cancer treatment, cancer surgeries, and cancer- related outcomes research. As a clinician, I bring the expertise of cancer treatment strategies and guidelines. Further, my background of being intimately involved with clinical outcomes research will serve the project well. I have previously researched the timeliness of chemotherapy in the setting of resectable gastric and colorectal cancer using a large national database system. Therefore, I bring not only surgical and clinical expertise, but also strength in performing studies on the effect of timing of treatment and procedures on cancer survivals and providing a key link in the translation of this vital clinical research directly to patient care.

B. Positions and Honors Employment

2003 – 2011 General Surgery Resident University of Minnesota Department of Surgery Minneapolis, MN

2006-2009 Surgical Research Fellow University of Minnesota Department of Surgery Minneapolis, MN

AMANDA ARRINGTON

2006-2009 Surgical Infectious Disease Fellow Univ. of Minnesota Dept. of Surgery Minneapolis, MN

2011-2013 Surgical Oncology Fellow City of Hope Cancer Center Department of Surgery Duarte, CA

2013-2014 Assistant Professor Univ. of South Carolina Department of Surgery Columbia, SC

2014-present Adjunct Assistant Professor Univ. of South Carolina School of Public Health Columbia, SC

2014-2017 Assistant Professor Marshall University Department of Surgery Huntington, WV

2017-present Assistant Professor University of Arizona Department of Surgery Tucson, AZ BOARD CERTIFICATION

June 2012 American Board of Surgery 057075 January 2017 Complex General Surgical Oncology 000126

Abbreviated Professional Memberships: 2005-present Member of the American Medical Association 2013-present Member of the American Society of Clinical Oncology 2009-present Member of the Association for Academic Surgery 2011-present Member of Surgical Outcomes Club 2011-present Member of the American Society of Breast Surgeons 2013-present Member of the American Medical Women’s Association 2011-present Fellow of the Society of Surgical Oncology 2011-present Member of the Society for Surgery of Alimentary Tract 2016-present Fellow of the American College of Surgeons 2009-present Member of Association of Women Surgeons 2016-present Member of the Association of Program Directors in Surgery

AMANDA ARRINGTON

Honors: 2013 Society of Surgical Oncology 2013 Poster Contest Finalist, Basic Science Category for “Baicalein Induces Tumor Suppression in Triple Negative Breast Cancer while increasing DDIT4 Expression in an Orthotopic Breast Cancer in vivo model “. National Harbor, MD. March 6-9, 2013 2013 Society of Surgical Oncology 2013 Poster Contest Finalist, Clinical Research Category for “Lymph Node Evaluation in Early Stage Breast Cancer: Epidemiology and Survival”. National Harbor, MD. March 6-9, 2013 2012 City of Hope 2012 Annual Poster Session Second Place Clinical Fellow/Resident category for “The Decision To Undergo Prophylactic Mastectomy”. 2012 ASCO Conquer Cancer Foundation Merit Award for ASCO Breast Cancer Symposium. San Francisco, CA September 13-15, 2012 2012 ASCO Conquer Cancer Foundation Merit Award for ASCO Gastrointestinal Cancers Symposium. San Francisco, CA January 19-21, 2012

C. Contributions to Science C.1. From my earliest experiences, my work focused on basic science and translational cancer research. Esophageal cancer (adenocarcinoma) continues to be a little understood disease process. My initial research focused on downregulation of HER2-Neu (ERBB2) in esophageal adenocarcinoma. This basic science research has expanded to breast cancer as well, looking particularly at DDIT4 expression.

1. Wang Y, Han E, Xing W, Yan J, Arrington A, Wang C, Tully D, Kowolik CM, Lu DM, Horne D, Yip R, Yim JH. Baicalein upregulates DDIT4 expression which mediates mTOR inhibition and growth inhibition in cancer cells. Cancer Lett. 2014 Dec 25. S0304- 3835(14)00788-5 [Epub ahead of print] 2. Heinrich EL, Arrington AK, Ko ME, Luu C, Lee W, Lu J, Kim J. Paracrine Activation of Chemokine Receptor CCR9 Enhances the Invasiveness of Pancreatic Cancer Cells. Cancer Microenviron. 2013 Feb 1 [Epub ahead of print]. 3. Arrington AK, Davydova J, Vickers SM, Yamamoto M.Anti-ERBB2 sh-RNA Suppress Both Cell Growth and Tumor Growth in ERBB2-Overexpressing. J Gastrointestin Surg. 2009 Oct 13 (10): 1754-1761. 4. Arrington AK, Dahlberg PS, Davydova J, Vickers SM, Yamamoto M. ERBB2 suppression decreases cell growth via apoptosis in gastrointestinal adenocarcinomas, Surgery 2009 Aug: 14(2):213-219.

C.2. The majority of my research is focused on clinical and surgical cancer outcomes. My most cited work looked at patient factors associated with the choice of contralateral prophylactic mastectomy. This work resulted in multiple publications and presentations for breast cancer outcomes.

AMANDA ARRINGTON

Arrington AK, Voci A, Reparaz L, Fry W. Factors Associated with Surgical Treatment of Contralateral Breast Cancers. Am J Surg. 2014 Oct; 208(4): 524-30. Tuttle TM, Arrington A, Reuth N. Increasing Contralateral Mastectomy Use at Diagnosis: Surgical Prevention of Contralateral Breast Cancer. Current Breast Cancer Reports 2009, 1:162–166 Arrington AK, Jarosek SL, Virnig BA, Habermann EB, Tuttle TM. Patient and Surgeon Characteristics Associated with Increased Use of Contralateral Prophylactic Mastectomy in Patients with Breast Cancer. Ann Surg Oncol 2009 Aug 4. Tuttle TM, Arrington AK, Reuth NR. Increasing contralateral mastectomy use at diagnosis: Surgical prevention of contralateral breast cancer. Current Breast Cancer Reports, Vol 1, No 3, Sept 2009: 162-166 Tuttle TM, Jarosek S, Habermann EB, Arrington A, Abraham A, Morris TJ, Virnig BA. Increasing rates of contralateral prophylactic mastectomy among patients with ductal carcinoma in situ. J Clin Oncol. 2009 Mar 20;27(9):1362-7. Epub 2009 Feb 17

C.3. My later work expanded to health care disparities in relation to cancer outcomes and cancer care. This work also demonstrates my growing expertise in utilizing clinical and population data sources using various modalities and collaborating with a number of researchers.

1. Bullard, JT, Eberth JM, Arrington AK, Adams SA, Cheng X, Salloum RG. Timeliness of Treatment Initiation and Associated Survival Following Diagnosis of Non-Small-Cell Lung Cancer in South Carolina. South Med J. 2017 Feb; 110 (2): 107-113. PMID 28158880 2. Bell N, Arrington A, Adams SA. Census-based socioeconomic indicators for monitoring injury causes in the USA: a review. Inj Prev. 2015 Aug: 21(4)278-84 PMID 25678685 3. Kim J, Ko ME, Nelson R, Arrington A, Luu C, Falor A, Nissen N, Colquhuon S, Hurria A, Singh G. An Investigation of Increasing Age and Survival after Orthotopic Liver Transplantation for Patients with Hepatocellular Cancer. J Am Coll Surg. 2014 Mar;218(3):431-8. 4. Arrington AK, Nelson R, Patel S, Luu C, Ko M, Chen SL, Garcia-Aguilar J, Kim J. Timing of Chemotherapy and Survival in Patients with Resectable Gastric Adenocarcinoma. Word J GI Surg. 2013 December 27; 5(12) 321-8. 5. Arrington AK, Kruper L, Vito C, Yim J, Kim J, Chen SL. Rural and urban disparities in the evolution of sentinel lymph node utilization in breast cancer. Am J Surg. 2013 Sep 12. pii: S0002- 9610(13)00404-2. 6. Nelson R, Ko EB, Arrington A, Lee W, Kim J, Garcia-Aguilar J, Kim J. The Extent of Lymphadenectomy and Improved Survival of Korean-American Patients with Gastric Cancer. J Gastrointest Surg. 2013 Mar;17(3):471-81.

II. DIVISION OF GENERAL SURGERY IMAN GHADERI

Please see the following faculty profile link: http://surgery.arizona.edu/profile/iman-ghaderi- md-msc-frcsc-facs

II. DIVISION OF GENERAL SURGERY VINOD GOLLAPALLI

Please see the following faculty profile link: http://surgery.arizona.edu/profile/vinod-gollapalli- md-mrcs-frcs

II. DIVISION OF GENERAL SURGERY MARLON GUERRERO

BIOGRAPHICAL SKETCH

NAME: Marlon Guerrero, MD, FACS eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Associate Professor of Surgery EDUCATION/TRAINING DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

California State University, Hayward, CA BS 1993-1997 Biology Meharry Medical College, Nashville, TN MD 1999-2003 Doctor of Medicine Baylor Medical College, Houston, TX Residency 2003-2008 General Surgery University of California, San Francisco Fellowship 2008-2009 Endocrine Surgery

A. Personal Statement

Marlon Guerrero, MD, FACS is an Associate Professor with the University of Arizona Department of Surgery, Division of General Surgery, Section of Surgical Oncology. Dr. Guerrero became interested in treating endocrine tumors and disorders after his training at the MD Anderson Cancer Center. He entered a prestigious Endocrine Surgery Fellowship at the University of California, San Francisco under the mentorship of the legendary Dr. Orlo H. Clark. He joined the department of surgery at the University of Arizona in July 2009 as Director of Endocrine Surgery. In 2017, he was appointed Vice Chair of Quality and Performance with The Department of Surgery. He holds an adjunct faculty position with The Department of Otolaryngology.

B. Positions and Honors

Positions

2008 – 2009 Clinical Instructor, University of California - San Francisco, San Francisco, CA 2009 – 2014 Assistant Professor, Department of Surgery, The University of Arizona, Tucson, AZ 2009 – Present Director, Endocrine Surgery Center, The University of Arizona, Tucson, AZ 2009 – 2010 Director, Resident Laparoscopy Training, ASTEC lab, The University of Arizona, Tucson, AZ 2011 – Present Medical Student Mentor, Societies Doctor Patient Program, The University of Arizona, Tucson, AZ

MARLON GUERRERO

2012 – 2014 Assistant Program Director, General Surgery Residency Program, The University of Arizona, Tucson, AZ 2014 – Present Associate Program Director, General Surgery Residency Program, The University of Arizona, Tucson, AZ 2017 – Present Vice Chair of Quality and Performance, Department of Surgery, The University of Arizona, Tucson, AZ

Honors and Awards

1994 – 1997 NIH Funded Biomedical Research Support Scholar 1996 Air Force ROTC Academic Excellence Award 1996 Retired Officers Society Outstanding Leadership Award 1996 Arnold Air Academic Society 1997 Golden Key National Honor Society 2000 Hears Endowed Scholarship 2000 Jonathon Wayne House Memorial Scholarship 2002 Henry Nehemiah Cooper, M.D. Memorial Scholarship 2003 Alpha Omega Alpha Honor Medical Society 2005 St. Luke's Elvin L. Shelton Resident of the Year 2006 Society of Vascular Surgery Travel Scholarship 2007 International Association of Endocrine Surgery, Presentation Award (oral presentation) 2008 Outstanding Resident Teaching Award 2011 Leader in Patient Satisfaction, 5 East, University of Arizona Medical Center 2012 American Association of Clinical Endocrinologist, 3rd Place Poster Presentation Award 2014 Medical Student Teaching Award, Surgery Clerkship 2015 College of Medicine Award for Dean’s List for Excellence in Teaching

C. Contributions to Science

My primary interest and focus as an endocrine surgeon is thyroid research and education.

1. Campbell MJ, McCoy KL, Shen WT, Carty SE, Lubitz CC, Moalem J, Nehs M, Holm T, Greenblatt DY, Press D, Feng X, Siperstein AE, Mitmaker E, Benay C, Tabah R, Oltmann SC, Chen H, Sippel RS, Brekke A, Vriens MR, Lodewijk L, Stephen AE, Nagar S, Angelos P, Ghanem M, Prescott JD, Zeiger MA, Aragon Han P, Sturgeon C, Elaraj DM, Nixon IJ, Patel SG, Bayles SW, Heneghan R, Ochieng P, Guerrero MA, Ruan DT. A multi-institutional international study of risk factors for hematoma after thyroidectomy. Surgery. 2013: 154(6):1283-89.

2. Nielsen VG, Garol BD, Zelman EA, Guerrero MA. Hemeoxygenase-1 mediated hypercoagulability in a patient with thyroid cancer. Blood Coagul Fibrinolysis. 2013: 24(6):663-5.

MARLON GUERRERO

3. Rose J, Wertheim BC, Guerrero MA. Regional differences in thyroid cancer presentation and survival: a SEER study. Endocr Pract. 2013: 19(6):998-1006.

I am passionate about patient care and treatment of thyroid disease.

4. Vriens MR, Weng J, Suh I, Huynh N, Guerrero MA, Shen WT, Duh QY, Clark OH, Kebebew E. MicroRNA expression profiling is a potential diagnostic tool for thyroid cancer. Cancer. 2012: 118(13):3426-32.

5. Schreinemakers JM, Vriens MR, Munoz-Perez N, Guerrero MA, et al. Fluorodeoxyglucose-positron emission tomography scan positive recurrent papillary thyroid cancer and the prognosis and implications for surgical management. World J Surg Onc. 2012:10:192.

6. Rose J, Wertheim BC, Guerrero MA. Radiation treatment of patients with primary pediatric malignancies: risk of developing thyroid cancer as a secondary malignancy. Am J Surg. 2012: 204(6):881-6.

D. Additional Information: Research Support and/or Scholastic Performance Ongoing Research Support

Nielsen VG, Garol BD, Zelman EA, Guerrero MA. Hemeoxygenase-1 mediated hypercoagulability in a patient with thyroid cancer. Blood Coagul Fibrinolysis. 2013: 24(6):663-5. - Project goal was to identify factors involved in hypercoagulability in patients with thyroid cancer. My primary role was tissue acquisition for analysis.

Rose J, Wertheim BC, Guerrero MA. Regional differences in thyroid cancer presentation and survival: a SEER study. Endocr Pract. 2013: 19(6):998-1006. - Project goal was to identify factors that contribute to survival in thyroid cancer. My primary role was evaluation of SEER data.

II. DIVISION OF GENERAL SURGERY ROBERT HARLAND

OMB No. 0925-0001 and 0925-0002 (Rev. 10/15 Approved Through 10/31/2018) BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Harland, Robert Carl eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Professor of Surgery, Vice Chair of Academic Affairs EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Whitworth College, Spokane, WA B.S. 05/1979 Biology, Chemistry Duke University School of Medicine, M.D. 05/1983 Medicine Durham, NC Duke University Medical Center Residency 12/1986 Internal Medicine Duke University Medical Center Research Fellowship 12/1988 Transplant Immunology Duke University Medical Center Residency 06/1992 General Surgery Duke University Medical Center Fellowship 06/1994 Transplant Surgery

A. Personal Statement My primary area of interest is the management of patients with end organ disease, including liver and kidney disease. I have worked at several institutions in leadership roles developing multi-disciplinary teams that seek to improve the care of patients, many of whom require organ transplantation to restore them to health. I have been actively involved in basic and clinical research efforts to improve our understanding of rejection and to develop and test better ways of managing patients who have undergone transplantation. I came to the University of Arizona in 2015 as the Surgical Director of Solid Organ Transplantation in order to continue collaborative clinical and scientific work related to patients with end organ disease.

I have a keen interest as well in broad clinical and basic science training in the field of transplantation. My career has focused on identifying mechanisms of rejection and other forms of organ injury. On the clinical side, I have sought to identify methods of maximally utilizing the available organs that we have to transplant and study the methods of improving the function and longevity of transplanted organs. I have been funded through the NIH as well as through industry to study clinical applications of new modalities for treating patients undergoing kidney, pancreas or liver transplantation. I have focused on projects that demand a comprehensive knowledge of the process and potential pitfalls in the clinical transplant process where my

ROBERT HARLAND

training and experience in Internal Medicine and complex Surgery provides a unique insight for program management as well as application of novel treatments.

I have had significant experience in managing a team of clinicians as well as support personnel in accomplishing efficient evaluation and management of patients throughout the transplant process. This includes significant experience with maintaining compliance with various regulatory bodies. I have balanced an academic career bridging both clinical transplantation and its basic science aspects over the past 25 years and am equipped to contribute regularly and consistently to this effort.

B. Positions and Honors

Positions and Employment 1992-1999 Assistant Professor of Surgery, Duke University School of Medicine, Durham, NC 1993-1999 Assistant Clinical Professor of Surgery, University of North Carolina School of Medicine, Durham, NC 1999- 2001 Professor of Surgery and Chief, Division of Organ Transplantation, Department of Surgery, University of Massachusetts School of Medicine, Worcester, MA 1999-2001 General Surgery Residency Program Director, University of Massachusetts School of Medicine, Worcester, MA 2000-2001 Associate Professor of Medicine, University of Massachusetts Medical School, Worcestor, MA 2001-2009 Associate Professor of Surgery and Medicine, University of Chicago/Pritzker School of Medicine, Chicago, IL 2010-2015 Professor of Surgery and Medicine, Chief, Division of Surgical Immunology and Transplantation, East Carolina University/Brody School of Medicine, Greenville, NC 2015 - Professor and Vice Chair, Academic Affairs, Surgical Director of Solid Organ Transplantation, Department of Surgery, University of Arizona, Tucson, AZ

Other Experience and Professional Memberships 1990- Member, Transplantation Society 1992- Member, International Pancreas and Islet Transplantation Association 1992- Member, American Society of Transplant Surgeons 1994- Member, International Xenotransplant Society 1998-2001 Invited Reviewer, Xenotransplantation 2001-2004 Invited Reviewer, Journal of Urology 2003-2007 Member, Patient Education Committee, American Society of Transplantation 2003-2005 Merit Review-Surgery, Department of Veteran’s Affairs Chairman: 2004 2005-2007 Team Leader, Gift 4 Hope, National Organ Transplant Breakthrough Collaborative, UNOS and HHS 2010- Fellow, American College of Surgeons 2010-2015 Carolina Donor Service Medical Advisory Board 2010- Invited Reviewer, American Journal of Transplantation 2011-2014 Invited Reviewer, Journal of Cardiovascular Translational Research 2017 Member, UNOS Regional Review Board-Liver transplant, Region 5 2017 Region 5 Representative, UNOS Pancreas Transplant Committee

ROBERT HARLAND

Honors 1981 Alpha Omega Alpha 1992 Golden Apple Teaching Award 1997 Davison Society Excellence in Teaching Award (Medical Students) 1997 David C. Sabiston, Jr. Award for Excellence in Resident Education 2003-2015 Best Doctors in America, Best Doctors, Inc. 2005 Robert Baker Golden Apple Teaching Award 2016 Charles F. Zukoski Outstanding Role Model in Surgery Award 2017 Charles F. Zukoski Outstanding Role Model in Surgery Award

C. Contributions to Science My interest in rejection of solid organ transplants dates back to my research training in medical school and during my residency training. This has further been focused to antibody-mediated rejection, both from antibodies to major histocompatibility antigens as well as in xenotransplantation. I explored several different treatment modalities to prolong survival of organ transplants in various animal models. I developed experience with several animal models of allo and xenotransplantation. I was the first to demonstrate the improvement of cardiac xenograft survival in a model of xenotransplantation by utilizing transgenically modified donors expressing human complement regulatory proteins1. Later work identified mechanisms of antibody mediated rejection of pig cardiac transplants in baboons.2 The application of xenotransplantation in a clinical model was achieved with the successful treatment of patient with hepatic failure with ex-vivo porcine liver perfusion as a bridge to liver transplantation.3 reported in a case report. This subsequently led to a multi-center trial of porcine liver perfusion in which I served as the PI.

More recently I have been involved in efforts to determine the role of antibodies against HLA antigens in solid organ transplant rejection. This is most prevalent among kidney transplant recipients and we have characterized the incidence of alloantibody formation, the impact on graft survival as well as methods of controlling the antibody and subsequent rejection.4

At the University of Arizona I have pursued collaborations in cellular transplantation as well as optimizing organ preservation. This has led to specific focus on working to improve the delivery of oxygen to organs during preservation and assessing the impact on the health of the organ or cells derived from them.5 I am serving as the primary bridge for bringing the clinically applicable aspects of this work to the bedside.

1. Harland RC, Logan JS, Kooyman D, Bryne GW, Platt JL. (1995). Ex vivo perfusion of mouse hearts expressing the human complement regulatory protein CD59. Transplantation Proceedings, 26(3):1245. 2. Lin SS, Weidner BC, Byrne GW, Diamond LE, Lawson JH, Hoopes CW, Daniels LJ, Daggett CW, Parker W, Harland RC, Davis RD, Bollinger RR, Logan JS, Platt JL. (1998). The role of antibodies in acute vascular rejection of pig-to-baboon cardiac transplants. J Clinical Investigation, 101(8): 1745-1756. 3. Chari RS, Collins BH, Magee JC, DiMaio JM, Kirk AD, Harland RC, McCann RL, Platt JL, Meyers WC. (1994). Brief report: treatment of hepatic failure with ex vivo pig-liver perfusion followed by liver transplantation. N Engl J Med, 331(4):268-9.

ROBERT HARLAND

4. Everly MJ, Rebellato LM; Haisch CE, Ozawa M, Parker K, Briley KP, Catrou PG, Bolin P, Kendrick WT, Kendrick SA, Harland RC, Terasaki PI. (2013). Incidence and Impact of De Novo Donor-Specific Alloantibody in Primary Renal Allografts. Transplantation, 95(3): 410-417. 5. Min C, Steyn L, Pandey A, Harland R, Galons J-P, Papas K. (2016). Persufflation Improves Viability and Function of Porcine Kidneys Relative to Static Cold Storage. American Journal of Transplantation, 16:634.

D. Research Support

Ongoing Research Support Humacyte, Inc. Harland (PI) 2016-present An Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison with ePTFE Grafts as Conduits for Hemodialysis (HUMANITY) Role: PI

Completed Research Support Shire Regenerative Medicine, Inc. Bolin (PI) 2013-2015 A Phase 2, Single-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy and Safety ofSRM003 (Vascugel®) in Improving the Rate of Arteriovenous Fistula Maturation and Use in Subjects Undergoing Surgery for Creation of an Arteriovenous Fistula for Hemodialysis Access Role: Sub-Investigator

Astellas Pharmaceuticals Harland (PI) 2012-2015 A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de novo Kidney Transplant Recipients Role: PI

Humacyte, Inc. Harland (PI) 2012-2015 Off-the-Shelf Urinary Conduit Study in Non-Human Primate Model Role: PI

Astellas Pharmaceuticals Harland (PI) 2011-2013 A Phase 2/3, Double-Blind, Placebo-Controlled, Two-Part Study to Assess the Safety, Efficacy and Pharmacokinetics of Single Intravenous Doses of ASP8597 (Diannexin) in de novo Kidney Transplant Recipients Role: PI

II. DIVISION OF GENERAL SURGERY TUN JIE

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Tun Jie, MD, MS, FACS eRA COMMONS USER NAME: TUNJIE POSITION TITLE: Associate Professor of Surgery EDUCATION/TRAINING: Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

State University of New York (SUNY), B.S. 05/1993 Computer Science and Stony Brook, NY Biochemistry

State University of New York (SUNY), M.D. 05/1999 Medicine SUNY Downstate Medical Center, Brooklyn, NY

University of Minnesota Medical School, Minneapolis, MN M.S. 04/2006 Health Informatics

A. Personal Statement I am an associate professor in department of surgery. I am the OPTN/UNOS Region V Representative of BUMC transplant program, UNOS surgical director of transplantation – kidney/pancreas/liver, and section chief of abdominal transplant and HPB in the department of surgery. I am a board-certified general surgeon with additional certifications from fellowships in liver, pancreas, and kidney transplantation; surgical infectious disease; and da Vinci robotic surgery. My academic focus has been on abdominal organ transplant, and HepatoPancreatico and Biliary (HPB) surgery. In particular, I have been involving in pancreatic endocrine and exocrine disorders for over a decade. I have received funding on works related to organ (kidney and pancreas) preservation, kidney donor outcomes, and immunosuppressive regiments for prevention of organ rejection. The proposed study is part of my ongoing interests in the pathogenesis of pancreatic islet cell, and its manifestation in malignant transformation (neuroendocrine tumor of pancreas).

TUN JIE

B. Positions and Honors Positions and Employment

7/2007-6/2009 Instructor, Department of Surgery, University of Minnesota Medical School, Minneapolis, MN 7/2009- Assistant Professor, Department of Surgery, The University of Arizona, Tucson, AZ 9/2013- UNOS Surgical Director of Transplantation- Kidney/Liver/Pancreas, Department of Surgery, The University of Arizona, Tucson, AZ 9/2013- Section Chief, Division of Abdominal Transplant Surgery, Department of Surgery, The University of Arizona,Tucson, AZ 7/2016- Associate Professor, Department of Surgery, The University of Arizona, Tucson, AZ

Other Experience and Professional Memberships

1996- Member, The American Medical Association 2000- Member, The American College of Surgeons 2007- Member, The United Network for Organ Sharing (UNOS) 2008- Member, The American Society of Transplant Surgeons 2010- Member, The Donor Network of Arizona Medical Executive Committee 2012- Member, The Arizona Medical Association 2012- Member, The Arizona Chapter, American College of Surgeons 2012- Member, Americas Hepato Pancreato Biliary Association 2013- Member, Southwest Nephrology Conference Planning Committee 2013- Member, The Association for Academic Surgery 2013- Representative, OPTN/UNOS Region V

Honors

2003 The Minnesota Surgical Society Resident Award, St Paul, MN 2004 Young Investigator Award, International Congress of the Transplantation Society, Vienna, Austria 2005 The Rozica and Sifra Yussim Award, Minnesota Medical Foundation, Minneapolis, MN 2005 The Minnesota Surgical Society Resident Award, Minneapolis, MN 2006 The Earl Young Award, Department of Surgery, University of Minnesota 2006 The David Gaviser Surgical Research Award, Department of Surgery, University of Minnesota 2007 The Distinguished Teaching Award, School of Medicine, University of Minnesota 2011 Leader in Patient Satisfaction, University Medical Center 2013 The Charles F. Zukoski Award, Outstanding Role Model in Surgery 2013 Dean’s List: Excellence in Teaching-Years III and IV, University of Arizona

TUN JIE

C. Contribution to Science 1. My research interests has been focusing on pancreas/islet transplant. Pancreatic islet transplant is an emerging treatment for patients with type I diabetes. Compared to pancreas transplant, islet cell transplant has significantly less surgical risks. However, the efficacy of islet transplant remains controversial due to the challenges in selection of sites for transplantation, monitoring function after transplant, and monitoring rejections. To explore different source of organ donor, we studied the feasibility of xeno-transplantation in non-human primary model. To understand the functionality of transplanted islets, we studied patients received auto-islet transplant after total pancreatectomy for pancreatitis.

a. Gruessner RW, Sutherland DER, Dunn DL, Najarian JS, Jie T, Hering BJ, Gruessner AC: Transplant options for patients undergoing total pancreatectomy for chronic pancreatitis; Journal of American College of Surgeons; 2004;198(4):559-67. [PMID: 15051008] b. Hering BJ, Wijkstrom M, Graham ML, Hardstedt M, Aasheim TC, Jie T, Ansite JD, Nakano M, Cheng J, Lei W, Moran K, Christians U, Finnegan C, Mills CD, Sutherland DER, Bansal-Pakala P, Murtaugh MP, Kirchhof N, Schuurman HJ; Prolonged diabetes reversal after intraportal xenotransplantation of wild- type porcine islets in immunosuppressed on human primates; Nature Medicine; 2006;12(3):301-3. [PMID: 16491083] c. Blondet JJ, Carlson AM, Kobayashi T, Jie T, Bellin M, Hering BJ, Freeman ML, Beilman GJ, Sutherland DER; The role of total pancreatectomy and islet autotransplantation for chronic pancreatitis; Surgical Clinics of North America; 2007;87(6):1477-1501. [PMID: 18053843] d. Khan KM, Desai CS, Kalb B, Patel C, Grigsby BM, Jie T, Gruessner RW, Rodriguez-Rilo H; MRI Prediction of Islet Yield for Autologous Transplantation After Total Pancreatectomy for Chronic Pancreatitis; Digestive Diseases and Sciences; 2013;58(4):1116-24. [PMID: 23086123]

2. Abdominal Transplantation:

a. Gruessner AC, Jie T, Papas KK, Porubsky M, Rana A, Smith MC, Yost S, Dunn DL, Gruessner RW; Transplantation; pp 321-363; Schwartz’s Principles of Surgery; The McGraw-Hill Companies, Inc, New York, NY; 2015; 10th Edition. [No PMID] b. Thai JN, Abidov A, Jie T, Krupinski EA, Kuo PH; Nuclear Myocardial Perfusion Imaging Versus Stress Echocardiography in the Preoperative Evaluation of Patients for Kidney Transplantation; Journal of Nuclear Medicine Technology; 2015 Sept;43(3):201-5. [PMID: 26111705]

TUN JIE

3. Transplant immunology:

a. Kaplan B, Jie T, Diana R, Renz J, Whinery A, Stubbs N, Bracamonte E, Spier C, Schubart P, Rilo H, Gruessner RW; Histopathology and Immunophenotype of the Spleen During Acute Antibody- Mediated Rejection; American Journal Transplantation; 2010;10(5):1316-20. [PMID: 20346068] b. Gruessner RW, Pugliese A, Reijonen HK, Gruessner S, Jie T, Desai CS, Sutherland DER, Burke GW; Development of diabetes mellitus in living pancreas donors and recipients; Expert Review of Clinical Immunology; 2011;7(4):543-551. [PMID: 21790295] c. Jie T, Dunn DL, Gruessner RW; Diagnosis and Management of Rejection, Infection, and Malignancy in Transplant Recipients; pp 1903-1920; Irwin & Rippe’s Intensive Care Medicine; Wolters Kluwer/Lippincott Williams & Wilkins, Philadelphia, PA; 2012; 7th Edition. [No PMID] d. Cieza NE, Porubsky M, Jie T; Transplantation: Advances in Immunosuppressive Therapy; pp 545- 559;Technological Advances in Surgery, Trauma, and Critical Care; Springer Science+Business Media, New York, NY; 2016; 1st Edition. [No PMID]

4. HepatoPancreatico and Biliary (HPB) surgery:

a. Glazer ES, Amini A, Jie T, Gruessner RW, Krouse RS, Ong ES; Recognition of Complications After Pancreaticoduodenectomy for Cancer Determines Inpatient Mortality; Journal of the Pancreas; 2013;14(6):626-31. [PMID: 24216548] b. Cucher D, Kulvatunyou N, Green DJ, Jie T, Ong ES; Gallstone Pancreatitis: A Review; The Surgical Clinics of North America; 2014 Apr;94(2):257-80. Epub 2014 Feb 20. [PMID: 24679420] c. Cardenas A, Abrams A, Ong ES, Jie T; Robotic-Assisted Cystgastostomy for a Patient with a Pancreatic Pseudocyst; Journal of Robotic Surgery; 2014 June;8(2):181-4. [No PMID]

5. Organ preservation:

a. Scott WE 3rd, Weegman BP, Balamurugan AN, Ferrer-Fabrega J, Anazawa T, Karatzas T, Jie T, Hammer BE, Matsumoto S,Avgoustiniatos ES, Maynard KS, Sutherland DE, Hering BJ, Papas KK; Magnetic resonance imaging: a tool to monitor and optimize enzyme distribution during porcine pancreas distention for islet isolation; Xenotransplantation; 2014 Sept-Oct;21(5):473-9. [PMCID: PMC4174958] b. Weegman BP, Suszynski TM, Scott WE, Ferrer J, Avgoustiniatos ES, Takayuki A, O’Brien TD, Rizzari MD, Karatzas T, Jie T, Sutherland DER, Hering BJ, Papas KK; Temperature Profiles of Different Cooling Methods in Porcine Pancreas Procurement; Xenotransplantation; 2014 Nov;21(6):574-81. [PMCID: PMC4262706]

Full List of Published Works: http://www.ncbi.nlm.nih.gov/pubmed/?term=Jie+T%5BAuthor%5D

TUN JIE

D. Research Support Ongoing Research Support

I2-0427-01 Jie (PI) 05/21/12-04/01/18 Evaluating Nulojix Long-Term Safety in Transplant, ENLiST Registry The main goal of this study is to estimate the incidence rates of PTLD, CNS PTLD and PML in EBV seropositive adult kidney transplant patients treated with belatacept as part of standard clinical practice. Role: PI

2R44DK070400-05A1 Papas (PI) 09/25/14-08/31/16 Portable Gas Perfusion System for Pancreas Preservation Phase II B The goal of this project is to study the clinical implementation of portable gas perfusion system for pancreas preservation and potential application for islet transplantation. Role: Site PI

5R01DK085185-04 Jie (PI) 03/10/11-02/28/15 Kidney Donor Outcomes Cohort (KDOC) Study The main goal is to establish a multisite prospective cohort of living kidney donors, their recipients, and a healthy comparison group to assess donor outcomes and their predictors across multiple domains (surgical, medical, functional, psychological, and financial). Role: PI

Completed Research Support

R44DK070400-01A1 Jie (PI) 08/01/10-07/31/2012 Portable Gas Perfusion System for Pancreas Preservation The goal of this project is to study the feasibility of gas perfusion (persufflation) as a method for pancreas graft preservation. Role: PI

II. DIVISION OF GENERAL SURGERY ETHAN LARSON

Please see the following faculty profile link: http://surgery.arizona.edu/profile/ethan-e-larson- md

II. DIVISION OF GENERAL SURGERY JAMES MCCLENATHAN

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: McClenathan, James Horner eRA COMMONS USER NAME (credential, e.g., agency login): jmcclenathan POSITION TITLE: Professor of Surgery EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Carnegie Mellon University, Pittsburgh, PA B.S. 06/1968 Pre Medical Sciences George Washington University School of Medicine, M.D. 06/1972 Medicine / Surgery Washington, DC University of Michigan, Ann Arbor, MI Internship 06/1974 General Surgery Intern National Health Institute, Heart & Lunch Institute, Fellowship 06/1976 Cardiology / Heart / Lung Bethesda, MD Stanford University Hospital, Stanford, CA Residency 06/1979 General Surgery Residency

A. Personal Statement

My academic rank is Professor of Clinical Surgery at the University of Arizona, Department of Surgery at Banner University Medical Center. I have practiced as a clinical surgeon for the past 38 years. My first 28 years of practice was in Silicon Valley for the Kaiser Permanente Medical Group. For the past nine years, I have been the senior general surgeon for the University of Arizona. In addition to having excellent clinical outcomes for my patients, I believe I serve as an outstanding role model of a passionate surgeon with a lifelong commitment to teaching and education.

B. Positions and Honors

07/1979-08/2007 Staff Surgeon / Clinical Professor of Surgery, Stanford University Hospital, Stanford, CA 07/1991-08/2007 Staff Surgeon, Kaiser Permanente Hospitals, Santa Clara, CA 07/1991-06/1996 Chief of Surgery, Clinical Professor of Surgery, Kaiser Permanents Hospitals, Santa Clara, CA

JAMES MCCLENATHAN

03/2008-06/2016 Associate Professor of Surgery, Department of Surgery, College of Medicine, University of Arizona, Tucson, AZ 07/2016 - Professor of Clinical Medicine/Surgery, Department of Surgery, College of Medicine, Banner University Medicine Center South Campus Hospital, Tucson, AZ Honors

1999 Golden Apple Award, Kaiser Permanente Hospital, Santa Clara, CA 2002 John Collins Memorial Teaching Award, Stanford University, Stanford, CA 2003-2006 Best Faculty Teaching Award, Stanford University Clerkship Program, Stanford, CA 2004 Kaiser Permanente Physician of the Year, Kaiser Permanente, Santa Clara, CA 2005 Golden Apple Award, Kaiser Permanente Hospital, Santa Clara, CA 2011 Charles Zukowski Memorial Teaching Award, Department of Surgery, General Surgery Residency Program Teaching Award, University of Arizona, Tucson, AZ 11/2015 - Site Program Director – General Surgery Residency Program Department of Surgery, College of Medicine at Banner University Medical Center, Tucson, AZ

Memberships/Certifications

American College of Surgeons Arizona Medical Board License American Board of Surgery Diplomat

C. Contributions to Science

I do not do basic research and have never applied for grants. I am a clinical surgeon like most surgeons in the country.

Most of my publications are in the form of case reports resulting from care of fascinating patients. My major contributions relate to care of patients with visceral aneurysms, Burkitt’s Lymphoma, Adenoid Cystic Breast Cancer and most recently, perforated ulcer disease.

1. Biswas S, Keddington J, McClenathan JH. Large B-cell lymphoma presenting as acute abdominal pain and spontaneous splenic rupture; a case report and review of relevant literature. World Journal Emergency Surgery. 2006 Nov 28: 1:35.

2. Rose J, Khoubyari R, McClenathan JH. Diverticulitis as a cause of septic thrombophlebitis; A literature review. International Journal of Case Reports. 2012, 2(12):28-33.

3. McClenathan JH. Surgical Treatment of Pseudoaneurysm of the Breast. Internet Scientific Publication. 2013, Volume 30, Number 4.

JAMES MCCLENATHAN 4. McClenathan JH, Vijayasekaren A. Brazilian Butt Lift Gone Bad; Necrotizing Soft tissue Infection After Gluteal Augmentation: Review. Internet Scientific Publication. 2014, Volume 31, Number 1.

5. McClenathan JH, Kraemer CK. Perianal basal Cell Carcinoma. Internet Scientific Publication. 2015, Volume 32, Number 1.

6. Rankin T, Echeverria A, Green JD, McClenathan J. Wunderlich syndrome: the role of the general surgeon. American Surgery. 2015 Mar;81(3):E113-4.

7. McClenathan JH. Benign Piloimatricoma of the Breast. Journal Applied Radiology. 2015 Apr, 4(4):24-26.

8. Korovin LN, Raoof M, Kettelle JB, McClenathan JH, Patel JA. Concurrent Factor V Leiden and Protein C Deficiency Presenting as Mesenteric Venous Thrombosis. American Surgery. 2016 Apr;82(4):96-8.

9. Tieman JT, McClenathan JH. Congenital Absence of Falciform Ligament. Internet Scientific Publication. 2016, Volume 33, Number 1.

D. Additional Information: Research Support and/or Scholastic Performance

Again, I do not do basic research and have never applied for grants. I am a clinical surgeon like most surgeons in the country.

With my commitment as an outstanding role model as a passionate surgeon with a lifelong commitment to teaching and education, I invite a review of student and resident evaluations of my teaching contributions since I have been in Arizona. My most recent faculty evaluation rated my effort as “truly exceptional.”

II. DIVISION OF GENERAL SURGERY LILAH MORRIS-WISEMAN

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Lilah Morris-Wiseman, MD eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Assistant Professor of Surgery EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of California, Berkeley, CA BA 1991-1995 English University of California (UCLA); Los Angeles, CA -- 1997-1999 Science Certificate Tulane University School of Medicine, New Orleans, LA MD 2000-2004 Doctorate of Medicine University of California (UCLA), Los Angeles, CA -- 2003-2008 General Surgery Residency MD Anderson Cancer Center, Houston, TX -- 2011-2013 Endocrine Surgery Fellowship

A. Personal Statement

I am a fellowship trained endocrine surgeon who has recently joined the University of Arizona, Tucson, in order to pursue a more complex, multidisciplinary clinical surgical practice; reengage in research interests; and work with students and residents to expand surgical knowledge and technique. After completing fellowship and relocating to Tucson, Arizona with my family, I joined a community (hospital-owned) practice that offered a broad general surgery experience (elective hernia, colon, gallbladder, and skin/soft tissue procedures and emergency general surgery procedures). I built a community endocrine surgery practice focused on evaluation and surgical management of thyroid and parathyroid disease. I joined the University of Arizona in March 2017 in a position of combined endocrine and general surgery.

I am working to create a clinical program for optimal multidisciplinary treatment of patients with functional and nonfunctional neuroendocrine tumors, including genetic evaluation. Both multidisciplinary treatment of patients with neuroendocrine tumors and clinical genetic evaluation for these patients have been largely unavailable in Tucson. Much of this work will involve care coordination between endocrinologists (for those with functional tumors or genetic syndromes), oncologists, pancreatic and hepatobiliary surgeons, clinical geneticists, and endocrine surgeons. In addition, I enjoy practicing and teaching general surgical techniques and will continue to work in this area on the South Campus.

LILAH MORRIS-WISEMAN

B. Positions and Honors

2001 Student Fellowship Award, Society of Nuclear Medicine “Radioactive ablation (131I) for thyroid cancer” 2001 Boris Catz Fellowship in Nuclear Medicine, “Radioactive ablation (131I) for thyroid cancer,” Cedars-Sinai Medical Center, Los Angeles, California 2003 Arnold P. Gold Foundation Humanism in Medicine Honor Society 2004 Richard Freeman Leadership Prize, Tulane University School of Medicine 2004 Harold Cummins Senior Award, Tulane University Scholl of Medicine 2006 – 2008 UCLA Cancer Gene Medicine Training Grant, T32 CA 75956, “Immunotherapy of cancer” 2007 – 2008 Outstanding Student Teaching Award, UCLA School of Medicine 2010 – 2011 Longmire Administrative Chief Resident, University of California (UCLA), Los Angeles, CA 2011 Wilma Miley Morton Award for research performed during residency 2012 Travel Award Recipient, American Association of Clinical Endocrinologists ( (AACE) 2012 Board-certified in Surgery. Certificate #057265. 2013 American Association of Endocrine Surgeons-Accredited Fellowship Certificate 2013 Cancer Survivorship Poster Competition Winner, MD Anderson Trainee Research Day 2013 The Jesse H. Jones Fellowship in Cancer Education, MD Anderson Cancer Center Multidisciplinary Endocrine Surgery Educational Videoconference 2013 – 2017 Endocrine and General Surgeon, Northwest Allied Physicians, Tucson, AZ 2016 – Member, American Association of Endocrine Surgeons Fellowship Committee 2016 – 2017 Section Head, General Surgery, Northwest Medical Center, Tucson, AZ 2016 – 2017 Associate Medical Director, Northwest Allied Physicians 2017 – Clinical Assistant Professor, Banner-University Medical Center, University of Arizona, Tucson

C. Contributions to Science

Much of my research has focused on thyroid disease and thyroid cancer. At MD Anderson Cancer Center I developed a robust thyroid cancer database to evaluate trends in treatment and outcomes at a multidisciplinary cancer center. Research findings produced through this project have been used to help change thyroid cancer staging guidelines. This work culminated in my participation as an author on the 8th Edition AJCC Staging Guidelines for Differentiated Thyroid Center. We accomplished several important changes in these new criteria. We increased the age delineation of “high risk” differentiated thyroid cancer from 45 to 55 years old. In addition, we eliminated “minimal extrathyroidal extension” as a criterion that previously upstaged what we now believe to be lower risk thyroid cancers.

1. Morris LF, Waguespack SG, Warneke CL, Ryu H, Ying AK, Anderson BJ, Sturgis EM, Clayman GL, Lee JE, Evans DB, Grubbs EG, Perrier ND. Long-Term Follow-Up Data May Help Manage Patient and Parent Expectations for Pediatric Patients Undergoing Thyroidectomy. Surgery. 2012 Dec;152(6):1165-71.

LILAH MORRIS-WISEMAN

2. Nixon IJ, Wang LY, Migliacci JC, Eskander A, Campbell MJ, Aniss A, Morris L, Vaisman F, Corbo R, Momesso D, Vaisman M, Carvalho A, Learoyd D, Leslie WD, Nason RW, Kuk D, Wreesmann V, Morris L, Palmer FL, Ganly I, Patel SG, Singh B, Tuttle RM, Shaha AR, Gönen M, Pathak KA, Shen WT, Sywak M, Kowalski L, Freeman J, Perrier N, Shah JP. An international multi-institutional validation of age 55 years as a cutoff for risk stratification in the AJCC/UICC staging system for well-differentiated thyroid cancer. Thyroid. 2016 Mar;26(3):373-80. 3. Tuttle RM, Morris LF, Haugen BR, Shah JP, Sosa JA, Rohren E, Subramaniam RM, Hunt JL, Perrier ND. “Thyroid – Differentiated and Anaplastic Carcinoma.” In: AJCC Cancer Staging Manual, Eighth Edition. Eds: MB Amin, et al. American Joint Committee on Cancer 2017. pp. 873-890.

Surgical technique and peri- and intraoperative testing when performing parathyroidectomy for sporadic primary hyperparathyroidism has been subject to much debate. My research in this area has focused on streamlining performance of parathyroidectomy to provide optimal surgical outcomes (biochemical cure) while appropriately and efficiently limiting resource overutilization and operative complications. These data have led to more selective use of intraoperative PTH hormone, better understanding of operative failures, and optimal treatment for persistent or recurrent primary hyperparathyroidism.

1. Morris LF, Zannoco K, Ituarte P, Ro K, Duh QY, Sturgeon C, Yeh MW. The value of intra-operative PTH monitoring in localized primary hyperparathyroidism: A cost analysis. Ann Surg Onc. 2010 Mar;17(3):679-85. 2. Hwang RS, Morris LF, Ro K, Park S, Ituarte PH, Hong JC, and Yeh MW. A selective, Bayesian approach to intraoperative PTH monitoring. Ann Surg. 2010 Jun;251(6):1122-6. 3. Lee S, Ryu H, Morris LF, Grubbs EG, Lee JE, Harun N, Feng L, Perrier ND. Operative failure in minimally invasive parathyroidectomy utilizing an intraoperative parathyroid hormone assay. Ann Surg Onc. 2014 Jun;21(6):1878-83. 4. Morris LF, Lee S, Warneke CL, Abadin SS, Suliburk JW, Romero Arenas MA, Lee JE, Grubbs EG, Perrier ND. Fewer adverse events after reoperative parathyroidectomy associated with initial minimally invasive parathyroidectomy. Am J Surg. 2014 Nov;208(5):850-5.

II. DIVISION OF GENERAL SURGERY DAVID NEAL

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Neal, David D. eRA COMMONS USER NAME (credential, e.g., agency login): dneal321 POSITION TITLE: Associate Professor of Surgery EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of California, Riverside, CA B.S. 06/1979 Biomedical Sciences David Geffen School of Medicine, UCLA, Los Angeles, M.D. 06/1982 Medicine / Surgery CA University of Arizona, College of Medicine, Tucson, AZ Internship 06/1983 General Surgery Internship University of Arizona, College of Medicine, Tucson, AZ Residency 06/1987 General Surgery Residency

A. Personal Statement

I recently ended a very successful private practice (30 years) in the summer of 2016 and have transferred over to a new surgical practice with Banner University Medical Group at the University of Arizona College of Medicine with the Department of Surgery. As I transition into my new academic/surgical practice, I have made my 2016 goals in contacting new providers in letting them know of my new practice and have been actively involved with the organization in adopting the Crimson Medical Referrals, an internet based medical referral system which quite of number of Tucson area physicians use. This has increased the number of referrals not only for my practice but also for my General Surgery colleagues as well.

After being in the private practice arena for over 30 years, I am also meeting another of my goals in becoming more involved with the academic process in mentoring and teaching more with the surgery residents and clerkship students.

DAVID NEAL

B. Positions and Honors

1989-1992 Assistant Clinical Lecturer, Department of Surgery, University of Arizona, Tucson, AZ 1992-1998 Assistant Professor of Surgery, Department of Surgery, University of Arizona, Tucson, AZ 1998-2016 Associate Professor of Surgery, Department of Surgery, University of Arizona, Tucson, AZ 1983-1986 CIGNA Healthcare, URGENT Care Physician, Tucson, AZ 1987-1992 CIGNA Healthcare, Staff Surgeon, Tucson, AZ 1992-1997 Department of Veterans Affairs Medical Center – SAVAHCS Chief, General Surgery, Department of Surgery, Tucson, AZ 1995-1996 Department of Veterans Affairs Medical Center – SAVAHCS Assistant Chief of Surgery, Department of Surgery, Tucson, AZ 1997-1998 Thomas-David Medical Center, Staff Surgeon, Tucson, AZ 1998-2016 President – Palo Verde Surgical Associates, Tucson, AZ 2016 - Associate Professor of Surgery, Chief, Division of General Surgery, Department of Surgery, University of Arizona, Tucson, AZ

Honors

American Medical Association – Physician Recognition Award

Memberships / Certifications

1989- Tucson Surgical Society 1989- American College of Surgeons – Fellow 1993- Southwestern Surgical Congress 1993- Society of American Gastrointestinal Endoscopic Surgeons (SAGES) 1994-1997 National Association of VA Physicians and Dentists 1994- Society of Laparoendoscopic Surgeons 1995- American College of Surgeons – AZ Chapter

Arizona Medical License 1988 American Board of Surgery 1996 Re-certification American Board of Surgery 2007 Re-certification American Board of Surgery

C. Contributions to Science

Being in private practice, I have not been involved with basic research and generally do not apply for grants. I am a clinical surgeon like most surgeons in the country.

DAVID NEAL

Following is record of my research endeavors and publications from early on in my career:

Books / Chapters

1. Neal D, Moritz M, Jarrell B: “Liver, Portal Hypertension and Biliary Tract.” In: Jarrell B, Carabasi R, eds. Surgery 3rd Ed., Chapter 14. Harvard Publications, 1996.

2. Carter WB, Neal D, et al.: “Laparoscopic Surgery.” In: Jarrell B, Carabasi R, eds. Surgery, 3rd ed., Chapter 30. Harvard Publications, 1996.

Journal Articles

1. Villar H, Neal D, el al.: Gastrointestinal Complications after Human “Transplantation and Mechanical Heart Replacement.” The American Journal of Surgery 157:1989.

2. Sreekantaiah C, Leong S, Karakousis C, McGee D, Rappaport W, Villar H, Neal D, et al.: “Cytogenic Profile of 109 Lipomas.” Cancer Research 51, 422-433, January 1, 1991.

3. Rappaport W, Valente J, Hunter G, Rance N, Lick S, Lewis T, Neal D: “Clinical Utilization and Complications of Sural Nerve Biopsy.” The American Journal of Surgery 166:3, 252-256, 1994.

4. Rappaport W, Warneke J, Neal D, et al.: “Contraindications and Complications of Laparoscopic Cholecystectomy.” American Family Physician 50:8, 1707-1711, December 1994.

5. Balserak JC, Neal D: “Intraoperative Endoscopy as an Adjunct to Surgical Ligation of Multiple AVM’s.” Surgical Laparoscopy and Endoscopy 6:1, 68-70, February 1996.

DAVID NEAL

Abstracts / Posters

1. Walters A, Neal D, et al.: “Unusual Complications of Laparoscopic Cholecystectomy.” Southwestern Surgical Congress, Tucson, AZ April 19, 1994.

Research Funding / Grants

Title: “Prospective, Controlled, Double-Blind Randomized, Multi-Center Comparison of the Safety, Efficacy, and Economic Impact of Sequential (IV to PO), Ciprofloxacin plus Metronidazole with Piperacillin/Tazobactam for the Treatment of Patients with Complicated Intra-Abdominal Infections.” Source: Bayer Study 094-028-13 Role: Co-Investigator Total Amount: $71,720 Years of Grant: 1995-1997 Effort: 65%

D. Additional Information: Research Support and/or Scholastic Performance

Again, I have done very little basic research throughout my career and am a clinical surgeon like most surgeons in the country.

I do have a commitment as an outstanding role model as a passionate surgeon with a commitment to teaching and education. One of my 2017 goals is to become even more involved in the resident and medical student teaching by becoming an assigned mentor to both and to continue with individual teaching in the cadaver lab. Possibly become more involved in some clinical research projects within the Department.

II. DIVISION OF GENERAL SURGERY LEIGH NEUMAYER

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Leigh A. Neumayer eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Professor and Chair, Department of Surgery, University of Arizona College of Medicine Tucson EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Colorado State University B.S. 05/1981 Biomedical Engineering Baylor College of Medicine M.D. 05/1985 Medicine University of California at San Francisco Intern/Resident 06/1987 General Surgery University of Arizona Health Science Center Chief Resident 06/1990 General Surgery University of Arizona Resident 06/1990 General Surgery University of Michigan M.S. 05/1993 Clinical Research Design and Statistical Analysis Drexel College of Medicine Fellow 05/2014 Executive Leadership in Academic Medicine

A. Personal Statement I am Professor and Chair in the Department of Surgery at the University of Arizona College of Medicine in Tucson. I have focused my scholarly activity in four main themes: surgical education, clinical trials, quality and outcomes, and mentoring/faculty development. My masters degree in clinical research design and statistical analysis laid a strong foundation for not only designing and conducting prospective trials, but also a deeper understanding of statistical analyses and other methodologies such as survey design and health related quality of life measurements. Combining the skills and knowledge gained from my masters program I

LEIGH NEUMAYER

successfully have led investigations in hernia repair techniques, breast cancer treatment, surgical quality and outcomes as well as surgical education techniques. My work has also involved mentoring others in these and other pursuits. More recently I have focused my energy in the diagnosis and treatment of breast cancer via innovative technology and clinical trials.

B. Positions and Honors Positions and Employment 1990-1996 Assistant Professor, University of Arizona, Department of General Surgery/Critical Care, Tucson, AZ 1992-2010 Staff Physician, Veteran's Administration Health Care System, Salt Lake City, UT 1993-1996 Assistant Professor, University of Utah School of Medicine, Department of General Surgery, Salt Lake City, UT 1996-2004 Associate Professor, University of Utah Health Sciences Center, Department of Surgery, Salt Lake City, Utah 2001-2005 Adjunct Associate Professor, University of Utah School of Medicine, Department of Family & Preventive Health, Salt Lake City, UT 2004-present Professor, University of Utah Health Sciences Center, Department of Surgery, Salt Lake City, Utah 2009-2014 Jon and Karen Huntsman Presidential Professor, University of Utah/ Hunstman Cancer Institute, Salt Lake City, UT 2012-2014 Vice Chair for Academic Affairs, University of Utah, Department of Surgery, Salt Lake City, UT 2014-present Margaret and Fenton Maynard Endowed Chair in Breast Cancer Research, University of Arizona College of Medicine, Tucson, AZ 2014-present Professor and Chair, University of Arizona College of Medicine, Tucson, AZ Other Experience and Professional Memberships 2003-present Grant Review Committee/Study Section, VA Research & Development, Blue Ribbon Panel for Clinical Research, Washington DC 2004-2006 Grant Review Committee/Study Section, Reviewer VA Clinical Research Center of Excellence Grants Honors 2006-2007 Association of Women Surgeons Olga Jonasson Distinguished Member Award 2012 Best Doctors 2012 Dr. Clark Lowe Rich Distinguished Surgeon Award 2012-2013 Association for Surgical Education Distinguished Educator Award

C. Contribution to Science 1. Surgical Education: Having won multiple teaching awards as a resident and early faculty member and having the opportunity to lead the surgery clerkship, I saw gaps in evidence to support some of our teaching methodology. Using the Medical student research program at the University of Arizona and a resident in my “education laboratory” I studied multiple aspects of the clerkship and the impact and influence it had on students. I have also been interested throughout my career on how mentors and mentoring influence career choices.

LEIGH NEUMAYER

a. Neumayer LA, Sachdeva AK, Hebert JC, Lang NP. Who should teach medical students surgery? Am J Surg. 1997 Mar;173(3):218-9. PubMed PMID: 9124630. b. Neumayer L, McNamara RM, Dayton M, Kim B. Does volume of patients seen in an outpatient setting impact test scores? Am J Surg. 1998 Jun;175(6):511-4. PubMed PMID: 9645784 c. Cochran A, Paukert JL, Neumayer LA. Does a general surgery clerkship influence student perceptions of surgeons and surgical careers? Surgery. 2003 Aug;134(2):153-7. PubMed PMID: 12947312. d. McMullin J, Greenband R, Price R, Neumayer L. Overnight activities of medical students on call: is it really educational? Am J Surg. 2006 Feb;191(2):268-71. PubMed PMID: 16442958.

2. Clinical Trials: As a formally trained clinical trialist I have designed and conducted several large multicenter trials and some single center trials. I have mentored other surgeons in the design and conduct of these trials. In an effort to determine the best technique to repair hernias (inguinal and incisional) or whether to repair at all (inguinal), we designed and conducted three large multicenter trials. The VA hernia trial is still the world’s largest trial for inguinal hernia repair comparing open and laparoscopic hernia repair. The watchful waiting trial was performed in the private sector as a “sister” trial to the VA trial. After successfully conducting these, I mentored a surgical investigator and we designed and conducted a multicenter randomized trial comparing open and laparoscopic ventral hernia repair. As my clinical interests narrowed to breast cancer, I helped design the BREAST trial, a single center randomize trial comparing two types of biologic sling materials for breast reconstruction. a. Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350(18):1819-27. Epub 2004 Apr 25. PubMed PMID: 15107485. b. Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, Dunlop DD, Reda DJ, McCarthy M Jr, Neumayer LA, Barkun JS, Hoehn JL, Murphy JT, Sarosi GA Jr, Syme WC, Thompson JS, Wang J, Jonasson O. Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA. 2006 Jan 18;295(3):285-92. Erratum in: JAMA. 2006 Jun 21;295(23):2726. PubMed PMID: 16418463. c. Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L; Veterans Affairs Ventral Incisional Hernia Investigators.Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg. 2010 Apr;145(4):322-8; discussion 328. doi: 10.1001/archsurg.2010.18. PubMed PMID: 20404280. d. Agarwal JP, Mendenhall SD, Anderson LA, Ying J, Boucher KM, Liu T, Neumayer LA. The breast reconstruction evaluation of acellular dermal matrix as a sling trial (BREASTrial): design and methods of a prospective randomized trial. Plast Reconstr Surg. 2015 Jan;135(1):20e-8e. doi: 10.1097/PRS.0000000000000809. PubMed PMID: 25539330.

3. Quality and Outcomes: I have spent a large portion of my career working to improve the outcomes of surgery (patient and surgeon centered). My involvement in the VA National Quality Surgery Improvement Program led to participation in the Patient Safety in Surgery Trial where we rolled the VA NSQIP out to 14 academic medical centers. In the VA hernia trial noted above, we validated a hernia specific pain score and an activities score.

LEIGH NEUMAYER

a. Khuri SF, Najjar SF, Daley J, Krasnicka B, Hossain M, Henderson WG, Aust JB, Bass B, Bishop MJ, Demakis J, DePalma R, Fabri PJ, Fink A, Gibbs J, Grover F, Hammermeister K, McDonald G, Neumayer L, Roswell RH, Spencer J, Turnage RH; VA National Surgical Quality Improvement Program. Comparison of surgical outcomes between teaching and nonteaching hospitals in the Department of Veterans Affairs. Ann Surg. 2001 Sep;234(3):370-82; discussion 382-3. PubMed PMID: 11524590; PubMed Central PMCID: PMC1422028. b. Neumayer L, Hosokawa P, Itani K, El-Tamer M, Henderson WG, Khuri SF. Multivariable predictors of postoperative surgical site infection after general and vascular surgery: results from the patient safety in surgery study. J Am Coll Surg. 2007 Jun;204(6):1178-87. PubMed PMID: 17544076. c. Khuri SF, Henderson WG, Daley J, Jonasson O, Jones RS, Campbell DA Jr, Fink AS, Mentzer RM Jr, Neumayer L, Hammermeister K, Mosca C, Healey N; Principal Investigators of the Patient Safety in Surgery Study. Successful implementation of the Department of Veterans Affairs' National Surgical Quality Improvement Program in the private sector: the Patient Safety in Surgery study. Ann Surg. 2008 Aug;248(2):329-36. doi: 10.1097/SLA.0b013e3181823485. PubMed PMID: 18650645. d. McCarthy M Jr, Chang CH, Pickard AS, Giobbie-Hurder A, Price DD, Jonasson O, Gibbs J, Fitzgibbons R, Neumayer L. Visual analog scales for assessing surgical pain. J Am Coll Surg. 2005 Aug;201(2):245-52. Erratum in: J Am Coll Surg. 2005 Nov;201(5):826. PubMed PMID: 16038823.

4. Mentoring: I have throughout my career studied the impact of mentoring on career choice and career satisfaction and have served as a mentor for surgeons who now hold positions including Chair of the Department of Surgery at Stanford (Hawn), Professor of Surgery at Harvard (Itani), Associate and Assistant Professor of Surgery at the University of Utah (Cochran and Matsen respectively). a. Hawn MT, Itani KM, Giobbie-Hurder A, McCarthy M Jr, Jonasson O, Neumayer LA. Patient-reported outcomes after inguinal herniorrhaphy. Surgery. 2006 Aug;140(2):198-205. PubMed PMID: 16904970. b. Itani KM, Neumayer L, Reda D, Kim L, Anthony T. Repair of ventral incisional hernia: the design of a randomized trial to compare open and laparoscopic surgical techniques. Am J Surg. 2004 Dec;188(6A Suppl):22S-29S. PubMed PMID: 15610889. c. Cochran A, Hauschild T, Elder WB, Neumayer LA, Brasel KJ, Crandall ML. Perceived gender-based barriers to careers in academic surgery. Am J Surg. 2013 Aug;206(2):263-8. doi: 10.1016/j.amjsurg.2012.07.044. Epub 2013 Feb 12. PubMed PMID: 23414631. d. Matsen CB, Luther SL, Stewart AK, Henderson WG, Kim H, Neumayer LA. A match made in heaven? Trying to combine ACS-NSQIP and NCDB databases. J Surg Res. 2012 Jun 1;175(1):6-11. doi: 10.1016/j.jss.2011.06.065. Epub 2011 Jul 23. PubMed PMID: 21924740.

5. Breast Cancer: Since 2008, I have focused my clinical practice in the treatment of breast disease and my research focus has also followed. I have strong collaborative ties with several other investigators that have led to successful pursuits. I have provided the clinical input and clinical trial expertise for these projects.

LEIGH NEUMAYER

a. Schabel MC, Morrell GR, Oh KY, Walczak CA, Barlow RB, Neumayer LA. Pharmacokinetic mapping for lesion classification in dynamic breast MRI. J Magn Reson Imaging. 2010 Jun;31(6):1371-8. doi: 10.1002/jmri.22179. PubMed PMID: 20512889. b. Liu X, Zhao L, Derose YS, Lin YC, Bieniasz M, Eyob H, Buys SS, Neumayer L, Welm AL. Short-Form Ron Promotes Spontaneous Breast Cancer Metastasis through Interaction with Phosphoinositide 3- Kinase. Genes Cancer. 2011 Jul;2(7):753-62. doi: 10.1177/1947601911421924. PubMed PMID: 22207901; PubMed Central PMCID: PMC3218405. c. Doyle TE, Factor RE, Ellefson CL, Sorensen KM, Ambrose BJ, Goodrich JB, Hart VP, Jensen SC, Patel H, Neumayer LA. High-frequency ultrasound for intraoperative margin assessments in breast conservation surgery: a feasibility study. BMC Cancer. 2011 Oct 12;11:444. doi: 10.1186/1471-2407- 11-444. PubMed PMID: 21992187; PubMed Central PMCID: PMC3209468. d. DeRose YS, Wang G, Lin YC, Bernard PS, Buys SS, Ebbert MT, Factor R, Matsen C, Milash BA, Nelson E, Neumayer L, Randall RL, Stijleman IJ, Welm BE, Welm AL. Tumor grafts derived from women with breast cancer authentically reflect tumor pathology, growth, metastasis and disease outcomes. Nat Med. 2011 Oct 23;17(11):1514-20. doi: 10.1038/nm.2454. PubMed PMID: 22019887; PubMed Central PMCID: PMC3553601.

Complete list of published work in MyBibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/1rYfwyPE_9Ykh/bibliography/48855760/public/?sort=date&direction= ascending.

D. Research Support Ongoing 5R01 CA172787 (Parker, PI) 08/21/13-05/31/18 NIH/NCI Non-Invasive MRI-Guided HIFU for Breast Cancer Therapy The goal of this project is to develop missing crucial capabilities to enable the application of MRI-guided high intensity focused ultrasound therapy to the heterogeneous human breast and perform preclinical studies of system safety and efficacy. Role: Co-Investigator

Completed Research Support No Grant # (Neumayer, PI) 08/01/08-03/31/12 QCMetrix, Inc. Decision Support for Safer Surgery (DS3) The goal of this project was to determine if a system that was previously used for retrospective risk adjustment at the hospital level could be used for prospective risk prediction at the patient level. Role: Site Principal Investigator

LEIGH NEUMAYER

5R01 CA134599 (Parker, PI) 09/01/08-08/31/12 NIH/NCI Non-invasive Image Guided HIFU for Breast Cancer Therapy The goal of this project is to develop missing crucial capabilities to enable the application of MRI-guided high intensity focused ultrasound therapy to the heterogeneous human breast and perform preclinical studies of system safety and efficacy. Role: Co- Investigator

No Grant # (Neumayer, PI) 11/01/12-05/31/13 Mayo Clinic Rochester Acosog Ccop Sub With Mayo Title: Cancer patient reported outcomes in the perioperative period The goal of this project was to understand the levels of anxiety and fear in cancer patients in the perioperative period and whether informing the provider of this improves patient satisfaction. Role: Principal Investigator

II. DIVISION OF GENERAL SURGERY VALENTINE NFONSAM

BIOGRAPHICAL SKETCH

NAME: Valentine Nfonsam, MD, MS, FACS eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Associate Professor of Surgery EDUCATION/TRAINING Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of Calabar, Nigeria B.S. 06/1994 Biology/Zoology Michigan State University M.S. 08/1998 Molecular Parasitology University of Illinois M.D. 05/2003 Doctor of Medicine University of Texas Residency 06/2005 General Surgery Cleveland Clinic Fellow 06/2006 Research Fellow North Shore/LIJ Health System Residency 06/2009 General Surgery University of South Florida Fellow 06/2011 Colon and Rectal Surgery

A. Personal Statement

B. Positions and Honors

Positions

2008 – 2009 Clinical Instructor, University of California - San Francisco, San Francisco, CA 2009 – 2014 Assistant Professor, Department of Surgery, The University of Arizona, Tucson, AZ 2009 – Present Director, Endocrine Surgery Center, The University of Arizona, Tucson, AZ 2011 – Present Medical Student Mentor, Societies Doctor Patient Program, The University of Arizona, Tucson, AZ

VALENTINE NFONSAM

Honors and Awards

1984 Best Graduating Student, University of Calabar, Nigeria 1999 MIRT – Student Scholars NIH-Fogaty Center Grant, Institute of International Health, Philippines 2011 Leader in Patient Satisfaction, University Medical Center, Tucson, AZ 2013 Caregiver of the Month, University Medical Center, Tucson, AZ 2015 Endless Possibilities Award, Banner University Medical Center, Tucson, AZ

C. Contributions to Science

My key publications related to proposed research address directly the fact that incidence of colorectal cancer is alarmingly rising among young individuals with age below 50 with the most significant increase in patients of age group 40 - 44 with a high possibility of many of these cancers being missed by sigmoidoscopy. This publication and new data that are a part of manuscripts in preparation document that consideration should be given for age-based colonoscopic screening beginning at age 40, an age at which the incidence mirrors other accepted screened cancers. By providing evidence and simple clinical approaches, this body of work could change the standards for colorectal cancer screening especially for younger populations. I serve as the primary investigator or co-investigator in all of these studies.

7. Davis DM, Marcet JE, Frattini JC, Prather AD, Mateka JJ, Nfonsam VN; Is it time to lower the recommended screening age for colorectal cancer; Journal of the American College of Surgeons; 2011 Sep; 213(3): 352-61. doi: 10.1016/j.jamcollsurg. 2011.04.033.

8. Aziz H, DiGiovanni RM, Ohlson E, Gruessner A, Nfonsam V. Increased Incidence of Early Onset Colorectal Cancer in Arizona (Submitted to Journal of Surgical Research)

9. Aziz H, DiGiovanni RM, Ohlson E, Gruessner AC, Nfonsam VN. Increased Incidence of Early Onset Colorectal Cancer in Arizona: A Comprehensive 15-year Analysis of the Arizona Cancer Registry (Submitted to The American Journal of Surgery)

10. Aziz H, Vera E, Ohlson E, DiGiovanni RM, Gruessner AC, Nfonsam VN. Patients Diagnosed With Colorectal Cancer in Rural Areas in Arizona Typically Present With Higher Stage Disease (Submitted to Diseases of the Colon and Rectum)

11. Jandova J, Gluck C, Nelson M and Nfonsam V. Early-Onset Colorectal Cancer: A review of clinical features, histopathology, and molecular mechanisms (Submitted to the European Journal of Cancer)

VALENTINE NFONSAM

12. Jandova J, Ohlson E, DiGiovanni R, Rocio-Torres M and Nfonsam V. Socioeconomic Status and Racial Disparities in Incidence of Colorectal Cancer in Arizona (Submitted to the American Journal of Surgery)

13. Nfonsam V, Ohlson E, DiGiovanni R, Rocio-Torres M and Jandova J. Gender Inequalities in Incidence of Colorectal Cancer in Arizona (Submitted to the Journal of Surgical Research)

14. Facista A, Nguyen H, Lewis C, Prasad AR, Ramsey L, Zaitlin B, Nfonsam V, Krouse RS, Bernstein H, Payne CM, Stern S, Oatman N, Banerjee B, Bernstein C; Deficient expression of DNA repair enzymes in early progression to sporadic colon cancer; Genome Integ; 2012 Apr 11; 3(1):3. PMID: 22494821

15. Bernstein C, Nfonsam V, Prasad A, Bernstein H; Epigenetic field defects in progression to cancer; World J Gastrointest Oncol; 2013 Mar 15; 5(3):43-9. PMID: 23671730

D. Additional Information: Research Support and/or Scholastic Performance

Ongoing Research Support

SWOG S0713 01/01/2012 – Present A phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer Role: Site Principal Investigator, University of Arizona Cancer Center

SWOG S1008 01/01/2012 - Present Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention in Breast and Colorectal Cancer Participants, phase II Role: Site Principal Investigator, University of Arizona Cancer Center

CALGB 80702 10/01/2012 - Present A Phase III Trial of 6 versus 12 Treatments of Adjuvant Folfox plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer Role: Site Co-Principal Investigator, University of Arizona Cancer Center

SWOG S0820 01/01/2013 - Present A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in patients with Stage 0-III Colon Cancer, phase III Role: Site Principal Investigator, University of Arizona Cancer Center

II. DIVISION OF GENERAL SURGERY REBECCA VISCUSI

Please see the following faculty profile link: http://surgery.arizona.edu/profile/rebecca-k- viscusi-md-facs

II. DIVISION OF GENERAL SURGERY AMY WAER

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Waer, Amy L. eRA COMMONS USER NAME (credential, e.g., agency login): N/A

POSITION TITLE: Professor, Department of Surgery Associate Dean, Curricular Affairs Medical Director, Arizona Telemedicine Program EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of Arizona B.S. 5/1988 Microbiology/Biochemistry University of Arizona M.D. 5/1992 Medicine

A. Personal Statement

I have been a general surgeon since 1997 and am currently a Professor in the Department of Surgery on the Educator Scholar Track at the University of Arizona College of Medicine in Tucson. I completed my medical school training at the University of Arizona College of Medicine in 1992 and my general surgery residency training also at the University of Arizona. I then went to Virginia Beach, Virginia where I practiced general surgery in a private group practice for seven years. I returned to Tucson and the University of Arizona in 2004 to develop the general surgery department at the University of Arizona Medical Center at South Campus. I then served five years as the surgery Clerkship Director, followed by two years as the surgery residency Associate Program Director, and then five years as the surgery residency Program Director. In July 2010, I was invited to serve as the Interim Assistant Dean for Medical Student Education. In July 2013, I began the full-time position of Associate Dean for Medical Student Education. As Associate Dean, I oversee our Rural Health Professions Program and throughout each academic year I travel throughout Arizona doing site visits, appreciation dinners, and recruitment for our rural faculty preceptors. As of June 2016, I was fortunate to become the Medical Director for the Arizona Telemedicine Program and look forward to this new role particularly as it pertains to access to healthcare in rural Arizona. My main research efforts have focused on medical education particularly as it relates to the learning environment, professionalism, and inter-professional activities.

AMY WAER

B. Positions and Honors

Positions and Employment 1997 – 2004 Private Practice General Surgery, Southeastern Surgical Associates, Virginia Beach, VA 2004 – Assistant Professor of Clinical Surgery, University of Arizona Health Sciences Center, Tucson, AZ 2004 – 2009 Director, Surgery Clerkship, University of Arizona, Tucson, AZ 2004 – 2009 Associate Director, Perioperative Services, University Physicians Healthcare Hospital Tucson, AZ 2004 – 2009 Director, Multispecialty Surgical Clinic, University Physicians Healthcare Hospital Tucson, AZ 2004 – 2009 Chief of Surgery, University Physicians Healthcare Hospital, Tucson, AZ 2005 – Clinical Advisor, Second Year Medical Students, University of Arizona College of Medicine Tucson, AZ 2005 – 2009 Chief of General Surgery, University Medical Center, Tucson, AZ 2006 – 2010 Societies Mentor, University of Arizona College of Medicine, Tucson, AZ 2007 – 2009 Associate Program Director, General Surgery Residency Program University of Arizona, Tucson, AZ 2006 – 2008 Chief of Staff Elect, University Physicians Healthcare Hospital, Tucson, AZ 2008 – 2009 Chief of Staff, University Physicians Healthcare Hospital, Tucson, AZ 2008 - Block Director, Advanced Topics, University of Arizona College of Medicine, Tucson, AZ 2009 – 2013 Program Director, General Surgery Residency, University of Arizona, Tucson, AZ 2010 – 2013 Interim Assistant Dean for Medical Student Education, University of Arizona College of Medicine, Tucson, AZ 2012 – 2016 Associate Professor, Department of Surgery, University of Arizona Health Sciences Center Tucson, AZ 2013 – 2017 Associate Dean for Medical Student Education, University of Arizona College of Medicine Tucson, AZ 2014 - Director of Clinical Translational Sciences Degree Program University of Arizona Graduate College, Tucson, AZ 2016 - Medical Director, Arizona Telemedicine Program, University of Arizona Health Sciences Center, Tucson, AZ 2016 - Professor, Department of Surgery, University of Arizona Health Sciences Center, Tucson, AZ 2017 – Associate Dean, Curricular Affairs (formerly Office of Medical Student Education), University of Arizona College of Medicine, Tucson, AZ

Other Experience and Professional Memberships 2005 - Member, Association for Surgical Education 2007 - Member, Association of Women Surgeons 2007 - Member, Association for Academic Surgery 2009 - Committee member, Graduate Surgical Education Committee for The Association for Surgical Education 2011 - Voted member, Association for Academic Surgery Ethics Committee 2012 Associate Examiner for the American Board of Surgery Certifying Examination, Salt Lake City, October 21-24, 2012.

AMY WAER

2014 - Member, USMLE Ambulatory Care Test Material Development Committee, Philadelphia, PA 2015 - Voted Co-Chair, WGEA Undergraduate Medical Education Committee 2015 - Co-Chair Undergraduate Medical Education, Western Group on Educational Affairs (WGEA) 2016- Associate Examiner for the American Board of Surgery Certifying Examination, Dallas, TX, January 24-27, 2016 2016- Program Chair, WGEA Annual Spring Conference, Hosted by University of Arizona College of Medicine, Tucson, AZ 2016- Committee Member, WGEA By-Law Revision Committee

Honors 1988 Cum Laude Graduate, University of Arizona, Tucson, AZ 1997 The Charles W. Putnam Teaching Award, Surgical Chief Resident of the Year, University of Arizona, Tucson, AZ 1998 Fellow, American College of Surgeons 2006 Department of Surgery Outstanding Teaching Award Voted by the Class of 2006, University of Arizona, Tucson, AZ 2006 Outstanding Achievement in Teaching by a Clerkship or Elective in the Clinical Sciences Award, 2005/2006, Accepted as Surgical Clerkship Director, University of Arizona College of Medicine, Tucson, AZ 2007 Fellowship Award to attend the Women’s Health 2007: Clinical Insights and Best Practices Conference, Williamsburg, Virginia 2007 Department of Surgery Outstanding Teaching Award, Voted by the Class of 2007, College of Medicine, University of Arizona, Tucson, AZ 2007 Faculty Development Fellowship Program, 2006/2007 University of Arizona College of Medicine – Phoenix Campus, Department of Family and Community Medicine 2007 The Charles F. Zukoski Award for Outstanding Role Model In Surgery, Department of Surgery, University of Arizona, Tucson, AZ 2007 Outstanding Achievement in Teaching by a Clerkship or Elective in the Clinical Sciences Award, 2006/2007, Accepted as Surgical Clerkship Director, University of Arizona College of Medicine, Tucson, AZ 2009 Award for Excellence in Clinical Science Teaching for Medical Students, University of Arizona College of Medicine, Tucson, AZ 2010 Award for Excellence in Clinical Science Teaching for Medical Students Second Year for Advanced Topics Block, University of Arizona College of Medicine, Tucson, AZ 2011 Dean’s List for Excellence in Teaching Yr II, Awarded by the medical students to faculty members for excellent in teaching in the basic science curriculum, College of Medicine, University of Arizona, Tucson, AZ 2012 Excellence in Graduate Medical Education, University of Arizona College of Medicine, Tucson, AZ 2013 University of Arizona Department of Surgery Achievement Award in recognition of your fine leadership, extra determination and continuous contribution to the success of the General Surgery Residency Program August 2013, University of Arizona, College of Medicine, Tucson, AZ (Received 10-23-13)

AMY WAER

2013 Outstanding Achievement in Teaching by a Block-Year II Advanced Topics, November 2013, University of Arizona, College of Medicine, Tucson, AZ (Received 11-14-13) 2013 Dean’s List for Excellence in Teaching-Department of Surgery, November 2013, University of Arizona, College of Medicine, Tucson, AZ (Received 11-14-13) 2015 Outstanding Achievement in Teaching by a Block- Advanced Topics, November 2015, University of Arizona, College of Medicine, Tucson, AZ (Received 11-19-15)

C. Contributions to Science

1. Rising chief residents in any specialty rarely receive enough orientation and introduction to their upcoming roles within any institutional graduate medical education program. Since geriatrics touches almost every specialty except for perhaps Pediatrics, we thought that it was critical to better prepare our rising chief residents for their leadership role while tying in education around geriatrics. With our national IP-CRIT grant, we have been able to put on a two day CRIT (chief resident immersion training) process for our rising chief residents in the early summer for the past five years. We have found through our evaluation process of the program, that it develops a mechanism to introduce the different specialty rising chief residents to each other, provides an educational format around the topic of geriatrics, and fosters growing relationships amongst the specialties particularly with regards to safety and quality projects. These findings assist with documenting the importance of the IP-CRIT for ongoing professional development and interprofessionalism. I was one of the first University of Arizona College of Medicine grant recipient providers and have maintained my key role in the program over the past five years with ongoing involvement.

a. Mohler J, D’Huyvetter K, O’Neill L, Clemens C, Waer A, Began V, Wendel C, Fain, M; Development of an enhanced interprofessional chief resident immersion training (IP-CRIT) program; Gerontology & Geriatrics Education; 2014 Jan 6: 1-15 [Epub ahead of print] b. Mohler MJ; Clemens C; Waer A; Began V; O’Neill LM; D’Huyvetter K; Spear Ellinwood, K; Fain MJ; Interprofessional (IP) chief resident immersion training (IP-CRIT): supporting the triple aim; Poster; Gerontological Society of America 65th Annual Scientific Meeting; 2012 November 14-18; San Diego, CA. c. Mohler MJ; Clemens C; Waer A; Began V; O’Neill LM; D’Huyvetter K; Spear Ellinwood, K; Fain MJ; Interprofessional (IP) chief resident immersion training (IP-CRIT): supporting the triple aim; Poster; University of Arizona Frontiers in Biomedical Research Forum; 2012 November 7; Tucson, AZ.

2. The learning environment of medical colleges particularly as it pertains to professionalism continues to remain an area of ongoing need for development across the nation. Prior to our University of Arizona College of Medicine Tucson Liaison Committee for Medical Education (LCME) visit in January of 2014 it was clear that the new accreditation standards emphasized the development and implementation of robust reporting and monitoring systems around the learning environment of the medical college. In a relatively short time prior to our site visit, we developed and implemented a

AMY WAER

Professionalism Committee with a Professional Conduct Comment form electronic reporting mechanism for both exemplary acts of professionalism as well as acts of unprofessional behavior. Our initiatives and our successful site visit, demonstrated one method of implementing these programs to the benefit of any medical college. I had the central oversight of the development of these programs and continue to be the main contact at our medical school for all of our learning environment and professionalism activities and programs. a. Dutcher C, Koch B, Poskus D, Waer A; Responding to an LCME recommendation: start-up of an institution-wide professionalism quality improvement program; Small Group Session; 2015 WGEA Conference; San Diego, CA; April 25, 2015.

3. Medical student surgical skill preparation for the surgery clerkship as well as other specialties such as obstetrics and gynecology along with some primary care practice is critical to the success of our students and our future practitioners. It was clear from our surgical faculty and surgical residents that our medical students could benefit from better surgical skill training prior to entering their third year core clerkships where surgical skills were necessary. At the beginning of each of our Surgery clerkships we utilized unembalmed fresh cadavers with our surgery faculty and surgery residents to teach the incoming medical students key surgical skills such as suturing and knot tying. Through the utilization of pre and post-tests, we were able to determine that additional exposure to these skills provided for better preparation and confidence in our medical students as they entered their surgery clerkships. I participated in the development and evaluation of this curriculum. a. Benjamin M, Waer A, Ong E, Poskus D, Adamas-Rappaport WJ; Preparing medical students for subinternship and beyond: refining surgical skills through an unembalmed cadaver laboratory course; Presentation; Association for Surgical Education Out of the Box Lunch; San Diego, CA; March 22, 2012.

4. Many medical schools within the United States over the past five plus years have switched from standard lecture formats to more interactive learning modalities. Our medical school at the University of Arizona in Tucson, underwent a major curriculum reorganization in 2006 with the introduction of Case Based Instruction (CBI) as a new learning modality for our pre-clinical medical school curriculum. CBI can be either faculty facilitated or student small group lead. While CBI in our pre-clinical medical school curriculum was received and evaluated well, the use of CBI in our core clinical clerkships had not been explored. We initiated CBI in our surgery clerkship and studied the benefit of unguided versus guided faculty facilitation. We determined that faculty guided facilitation proved to be of more educational benefit through the utilization of pre and post-tests. I assisted with the CBI faculty guided surgery clerkship CBIs as well as the evaluation of the process and post data. a) Waer A, Glazer E, Copeland H, Ong E, Sozanski J, Doskocil B, Poskus D, Adamas-Rappaport WJ; A comparison of unguided versus guided case-based instruction on the surgery clerkship; Podium Presentation; The Association for Surgical Education; Boston, MA; March 2011.

AMY WAER

b) Adamas-Rappaport, WJ, Waer A, Teeple M, Benjamin M, Glazer E, Sozanski, J, Poskus D, Ong E; A comparison of unguided versus guided case-based instruction on the surgery clerkship; Journal of Surgical Education; 2012; http://dx.doi.org/10.1016/j.jsurg.2012.06.014.

5. Medical student pre-clinical curricula throughout the United States is key to assisting our medical students with performing well on the USMLE Step 1 examination. This high-stakes examination is often viewed as one of the key factors in medical students getting residency interviews and subsequent residency positions in the specialty of their choosing. It is often difficult to determine what any medical school pre-clinical curriculum is teaching as it pertains to the USMLE Step 1. Our Office of Medical Student Education in an effort to better map our content to what is on USMLE Step 1 developed a comprehensive mapping process to link and show that our curriculum is adequately preparing and exposing our medical students to the needed content. I was one of the three key people involved in the development and implementation of this process which continues to be utilized at our institution.

a. Dexter J, Koshland G, Waer A, Anderson D; Mapping a curriculum content database to the USMLE Step 1 content outline; Medical Teacher; 2012;34;666-675. .

List of Published Work in MyBibliography: https://www.ncbi.nlm.nih.gov/pubmed/?term=amy+waer

II. DIVISION OF GENERAL SURGERY JAMES WARNEKE

BIOGRAPHICAL SKETCH

NAME: James Warneke, MD eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Associate Professor of Surgery EDUCATION/TRAINING

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of California – Riverside BS 1979 Biomedical Sciences

University of California – Los Angeles MD 1982 Doctor of Medicine

University of Arizona, Department of Surgery - Tucson Residency 1982-1987 General Surgery

Roswell park Cancer Institute – Buffalo, New York Fellowship 1987-1989 Surgical Oncology

A. Personal Statement

Dr. James A. Warneke is an Associate Professor in the Department of Surgery. He joined the faculty at the University of Arizona's College of Medicine in the Department of Surgery, Section of Surgical Oncology in 1991. From 1992-2002, Dr. Warneke was the Medical Student Clerkship Director and then Residency Director from 2001-2009. Currently, Dr. Warneke serves as Vice Chair of Education.

Dr. Warneke is involved in various research endeavors that will allow him to continue to provide his patients with the most up to date treatment options available. His research interests include treatment of skin malignancies, especially melanoma and sarcoma, as well as chemoprevention of skin cancer.

B. Positions and Honors

Positions

2001- 2009 Residency Director, Department of Surgery University of Arizona College of Medicine, Tucson, Arizona

1997-Present Associate Professor, Department of Surgery University of Arizona College of Medicine, Tucson, Arizona

JAMES WARNEKE

1992-2002 Clerkship Director, Department of Surgery University of Arizona College of Medicine, Tucson, Arizona

1991-1997 Assistant Professor, Department of Surgery University of Arizona College of Medicine, Tucson, Arizona

1991-2000 Surgeon, Department of Veterans Affairs Medical Center, Tucson, Arizona

1989-1991 Assistant Professor, State University of New York Roswell Park Cancer Institute, Buffalo, New York Honors

2008 Teaching Award, University of Arizona, College of Medicine 1996 Included in The Best Doctors in the West 1994 Virginia Furrow Award: Feedback of Clinical Competence Using an OSCE during the Third Year Family Medicine and Surgical Clerkships 1993-94 Dean’s Teaching Scholar University of Arizona, College of Medicine

C. Contributions to Science

1. Hess LM, Saboda K, Malone DC, Salasche S, Warneke J, Alberts DS: Adherence assessment using medication weight in a phase IIb clinical trial of difluoromethylornithine for the chemoprevention of skin cancer. Cancer Epidemiol Biomarkers Prev 14(11 Pt 1):2579-2583, 2005. 2. Bernstein H, Prasad A, Holubec H, Bernstein C, Payne CM, Ramsey L, Dvorakova K, Wilson M, Warneke JA, Garewal H: Reduced Pms2 expression in non-neoplastic flat mucosa from patients with colon cancer correlates with reduced apoptosis competence. Appl Immunohistochem Mol Morphol. 2006 Jun; 14(2): 166-72. 3. Shi J, Kahle A, Hershey JW, Honchak BM, Warneke JA, Leong SP, Nelson MA: Decreased expression of eukaryotic initiation factor 3f deregulates translation and apoptosis in tumor cells. Oncogene. 2006 Aug 10;25 (35):4923-36. Epub 2006 Mar 13. 4. Einspahr JG, Xu MJ, Warneke J, Saboda K, Ranger-Moore J, Bozzo P, Duckett L, Goldman R, Lin P, Buckmeier J, Alberts DS: Reproducibility and expression of skin biomarkers in sun-damaged skin and actinic keratoses. Cancer Epidemiol Biomarkers Prev 15(10):1841-1848, 2006. 5. Einspahr JG, Thomas TL, Saboda K, Nickoloff BJ, Warneke J, Curiel-Lewandrowski C, Ranger-Moore J, Duckett L, Bangert J, Fruehauf JP, Alberts DS: Expression of vascular endothelial growth factor in early cutaneous melanocytic lesion progression. Cancer 110(11):2519-2527, 2007. 6. Korde V, Bonnema G, Xu W, Krishnamurthy C, Ranger-Moore J, Saboda K, Slayton L, Salasche S, Warneke J, Alberts D, Barton JK: Using optical coherence tomography to evaluate skin sun damage and precancer. Lasers in Surgery and Medicine 39(9):687-695, 2007.

JAMES WARNEKE

7. Stratton SP, Saboda K, Myrdal PB, Gupta A, McKenzie NE, Brooks C, Salasche SJ, Warneke JA, Ranger- Moore J, Bozzo PD, Blanchard J, Einspahr JE, Dorr RT, Levine N, Alberts DS: Phase 1 study of topical perillyl alcohol cream for chemoprevention of skin cancer. Nutr Cancer 60(3):325-330, 2008 8. Einspahr JG, Bowden GT, Alberts DS, McKenzie N, Saboda K, Warneke J, Salasche S, Ranger-Moore J, Curiel-Lewandrowski C, Nagle RB, Nickoloff BJ, Brooks C, Dong Z, Stratton SP: Cross-validation of murine UV signal transduction pathways in human skin. Photochem Photobiol 84(2):463-476, 2008. 9. Bedogni B, Warneke JA, Nickoloff BJ, Giaccia AJ, Powell MB: Notch 1 is an effector of Akt and hypoxia in melanoma development. J Clin Invest. 2008 Nov; 118 (11): 3660-70. Epub 2008 Oct 16. 10. Foote JA, Ranger-Moore JR, Einspahr JG, Saboda K, Kenyon J, Warneke J, Miller RC, Goldman R, Xu MJ, Roe DJ, Alberts DS: Chemoprevention of Human Actinic Keratoses by Topical DL-{alpha}-Tocopherol. Cancer Prev Res. 2009 Mar 31. Epub ahead of print.

D. Additional Information: Research Support and/or Scholastic Performance

Federal Current

Apoptosis in Colon Cancer Chemoprevention. NIH/NCI (Gerner) #P01-CA72008. 5 year award $6,029,652. Co-Investigator. (2%)

Woman’s Intervention Nutrition Study. NIH/AHF (Thomson/Alberts) #R01-CA45504 $420,000. Clinical Site Director. (1%)

Colon Cancer Prevention Program Project. NIH/NCI (Alberts), # CA-41108 2000-2005 $3,541,037 per year. Co- Investigator. (3%)

Southwest Oncology Group (Miller). #CA-13612-31 2004-2009 $1,910,646 total. Surgery Module Leader. (5%)

Federal Past

Chemoprevention of Skin Cancer Program Project. NIH/NCI (Alberts), #PO1-27502-19 1998-2003 $1,814,951 per year. Co-Principal Investigator. (10%)

The Characterization of T-cell Receptor Usage by T-cells That Infiltrate Melanoma. Basic Science Research Grant (BSRG) 1993-94 $5000 College of Medicine with matching funds from the Department of Surgery. Principal Investigator. (10%)

Characterization of Tumor Infiltrating T-cells From Tissue Samples of Melanoma That Represent Different Stages of Progression and from Neoplastic Melanotic Lesions. Institutional Research Grant (IRG) 1993-94 $12000 American Cancer Society. Principal Investigator. (10%)

JAMES WARNEKE

Chemoprevention of Skin Cancer Using Vitamins A and E. NIH/NCI (Alberts) #P01-CA27502, $1,914,455/year. Co-Principal Investigator. (7%)

Industry Past Phase I Trial of Interleukin-2 Plasmid DNA DMRIE-DOPE Lipid Complex as an Immunotherapeutic Agent in Solid Malignant Tumors or Lymphomas by Direct Gene Transfer. Vical, Inc. #VCL1102-101 $125,000 per year. Co-Principal Investigator. (5%)

HLAB-7 Phase II Study of Immunotherapy of Metastatic Cancer by Direct Gene Therapy. Vical, Inc. #VCL1005-210 $97,000 per year. Co-Principal Investigator (5%)

Phase I/II Trial of Interleukin-2 DNA/DMRIE/DOPE Lipid Complexes as an Immunotherapeutic Agent in Cancer by Direct Gene Transfer. Vical, Inc. #VCL1102-102 $251,000 per year. Co-Principal Investigator. (5%)

Phase II Study of Immunotherapy of Metastatic Melanoma by Direct Gene Transfer. Vical, Inc. #VCL1005- 203 $235,000 per year. Co-Principal Investigator. (5%)

Private Foundations Women’s Healthy Eating and Living Study. Walton Foundation (Thomson/Alberts) $130,023. Co-clinical Site Director (10%).

III. DIVISION OF NEUROSURGERY GERALD LEMOLE

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Lemole Jr, Gerald Michael eRA COMMONS USER NAME (credential, e.g., agency login): MLEMOLE POSITION TITLE: Professor of Surgery, Chief of Neurosurgery EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Harvard University (Cum Laude) AB/AM 06/1991 Biology University of Pennsylvania, School of Medicine MD 05/1995 Medicine Barrow Neurological Institute Residency 06/2002 Neurosurgery Barrow Neurological Institute Fellowship 06/2000 Complex Spinal Surgery (infolded) Barrow Neurological Institute Fellowship 12/2000 Cerebrovascular/Skull Base (infolded)

A. Personal Statement

As Chief of the Division of Neurosurgery at the University of Arizona, I wear many hats. I am a firm believer that ultimate effectiveness in neurosurgical education and research is based in a robust clinical practice. As such, I have developed and maintain expertise in all aspects of Complex Cranial Neurosurgery with an emphasis on Skull Base Surgery including minimally-invasive endoscopic techniques, classic approaches, and radiosurgical treatments. I focus on creating multidisciplinary teams of surgeons and specialists who collaborate to offer the full range of cutting-edge surgical, radiosurgical, and medical treatments for these patients. The outgrowth of this clinical effort is a strong desire to improve skull base neurosurgery tools, techniques, and training. Much of my contribution to the science of neurosurgery is based upon the development of effective neurosurgical simulators to address the steep learning curve in our specialty. This is particularly true in skull base neurosurgery. I have been involved in a number of funded research projects (ranging from federal to intramural) that address neurosurgical anatomy and procedural teaching, from the creation of effective cadaveric laboratories to the design and testing of part-task simulators. I also actively seek better tools to perform the delicate tasks required of the skull base neurosurgeon. These efforts have led to multidisciplinary collaborations, intellectual property, and

GERALD LEMOLE the development of novel surgical technologies. Even before I was a physician I was investigating the science behind laser-induced formal welding of biological tissues. I have also been involved with efforts to improve operative visualization of blood vessels and tumors. I am also excited about my most recent project to measure and quantify cranial nerve responses to surgical manipulation using reflex pupillometry. Two of my latest funded research projects address novel technology creation. I also maintain academic output through the publication of case reports and series. It is important to understand the longitudinal impact of a surgical practice. This is especially true with a low-volume subspecialty such as cranial base surgery. It is through these reports of professional experience that better insights for case management and optimal practice are achieved.

B. Positions and Honors

Employment and Academic Appointments (selected):

2003 – 2009 Department of Neurosurgery, University of Illinois at Chicago (Assistant/Associate Professor) 2004 – 2008 Chief, Section of Skull Base Neurosurgery, University of Illinois at Chicago 2006 – 2009 Codirector, Chicago CyberKnife Radiosurgery Ctr, Advocate Christ Medical Ctr, Oak Lawn, IL 2008 – 2009 Codirector, Skull Base Surgery Program, University of Illinois at Chicago 2008 – 2009 Codirector, Neuro Intensive Care Unit, University of Illinois at Chicago 2009 – Chief, Division of Neurosurgery, University of Arizona 2009 – 2012 Associate Professor, Division of Neurosurgery, University of Arizona (Tenured) 2010 – Codirector, University of Arizona Center for Sinonasal & Skull Base Tumors 2012 – Professor – Division of Neurosurgery, University of Arizona (Tenured) 2015 – Joint Appointment, Professor, Department of Otolaryngology, University of Arizona

Administrative Appointments (selected):

2009 – Trauma Peer Review Committee, University Medical Center 2009 – 2014 Perioperative Services Committee, University Medical Center 2010 – 2013 Operating Room Executive Committee, University Medical Center 2011 – 2013 Credentials Committee, University Medical Center 2011 – 2013 Promotion and Tenure Committee, Department of Surgery, University of Arizona 2012 – 2013 Chair, Quality Review Committee, University of Arizona Medical Center, Main Campus 2012 – 2013 Chair, Peer Review Committee, University of Arizona Medical Center, Main Campus 2012 – 2015 Quality and Safety Board, University of Arizona Medical Center, Main Campus 2012 Five Year Administrative Review Committee, Department of Surgery, University of Arizona 2013 – 2015 Chief-of-Staff (elected), University of Arizona Medical Center - Main Campus 2013 – 2014 UA Strategic Planning and Budget Advisory Committee (elected)

GERALD LEMOLE 2014 – 2015 Vice Chair, Hospitals/Practice Plan Board of Directors, UA Medical Center Corporation 2015 Chief-of-Staff, Banner University Medical Center 2015 – Banner Neuroscience Clinical Consensus Group, Banner Medical Division 2015 Vice Chair for Safety and Quality, Department of Surgery, University of Arizona 2015 Annual Review Peer Review Committee, Department of Surgery, University of Arizona

2015 Ad hoc, Otolaryngology, Head & Neck Surgery Department Promotion & Tenure Committee 2016 Five Year Administrative Review, Department of Medical Imaging, University of Arizona

2016 – Provider Led Entity (PLE) Oversight Committee on Diagnostic Imaging

Honors and Awards (selected):

1991 Magna Cum Laude graduate thesis (Harvard University) 1991 Cum Laude AB/AM degree in biology (Harvard University) 2002 Cushing Clinical Fellowship Award, Congress of Neurological Surgeons 2005 ΛΩΛ Chapter, Outstanding Clinical Instructor, University of Illinois at Chicago Medical School 2012 First Place Research Abstract, 12th International Meeting on Simulation in Healthcare 2009, 2014 America’s Top Surgeons, Consumers’ Research Council of America 2011 2011 Physician of the Year Award, Pima County Medical Society, Tucson, AZ 2011 Congressional Citation (Services to Congresswoman Gabrielle Giffords) Friends of the National Library of Medicine, 2011 Annual Awards Gala, Washington, DC 2011 Medscape News Physicians of the Year, Best of 2011 http://www.medscape.com/features/slideshow/physicians-of-the-year/2011?src=mp&spon=14 2012 – 2016 Top Doctors - US News and World Report, Castle Connolly Medical Ltd. 2013 Doximity Fellow: https://www.doximity.com Critiquing & curating the most relevant medical literature & liaison providing product advice and strategic guidance 2013 – 2016 Best Doctors in America, Best Doctors, Inc. 2015 Endless Possibilities Leader Award, Banner – University Medical Group 2011 Keynote Speaker, Association of Health Care Journalists, Annual Conference, Philadelphia, PA 2013 Opening Reception Speaker, American Association of Neurological Surgeons, 81st Annual Mtg 2014 Invited Lecturer, UA Science Lecture Series, “The Evolving Brain”, University of Arizona 2011 – 2014 Honorary Commander, 355th Medical Group, Davis Monthan Air Force Base, Tucson, AZ 2012 – 2013 Program Chair, Western Neurosurgical Society 2013 (Spring) Guest Examiner, American Board of Neurological Surgery 2016 – 2018 Chair, Constitution & Bylaws Committee, North American Skull Base Society

GERALD LEMOLE C. Contributions to Science

a. Neurosurgery is a complex discipline with a very steep learning curve. A significant portion of my academic effort has focused on neurosurgical simulation and education. This has included the development of tools for better anatomical depiction as well as surgical part-task simulation. The goal is to provide the student with an immersive experience so that they become intimately familiar with the complex neurosurgical anatomy before performing procedures on living patients. This work has been particularly rewarding in my close work with neurosurgical residents at two institutions over the course of my career. This effort is reflected by a selection of publications listed below as well as several funded projects. 1. Henn JS, Lemole GM Jr, Ferreira MA, Gonzales FL, Schornak M, Preul MC, Spetzler RF: Interactive Stereoscopic Virtual Reality: A New Tool for Neurosurgical Education. J Neurosurg 96(1):144-149, 2002 2. Luciano, C, Banerjee PP, Lemole GM Jr, Charbel FT: Second Generation Haptic Ventriculostomy Simulator Using the ImmersiveTouch™ System. Medicine Meets Virtual Reality 14: Accelerating Change in Healthcare: Next Medical Toolkit, Stud Health Technol Inform. 119:343-348, 2006 3. Lemole GM Jr, Banerjee PP, Luciano C, Neckrysh S, Charbel FT: Virtual Reality in Neurosurgical Education: Part-task Ventriculostomy Simulation with Dynamic Visual and Haptic Feedback. Neurosurgery 61(1):142-149, 2007 4. Banerjee PP, Luciano C, Lemole GM Jr, Charbel FT, Oh MY: Accuracy of Ventriculostomy Catheter Placement Using a Head- and Hand-Tracked High-Resolution Virtual Reality Simulator with Haptic Feedback. J Neurosurg 107(3):515-521, 2007 5. Lemole M, Banerjee PP, Luciano C, Charbel F, Oh M: Virtual Ventriculostomy with “Shifted Ventricle”: Neurosurgery Resident Surgical Skill Assessment Using a High-Fidelity Haptic/Graphics Virtual Reality Simulator. Neurol Res 31(4):430-431, 2009 6. Alaraj A, Lemole GM Jr, Finkle JH, Yudkowsky R, Wallace A, Luciano C, Banerjee PP, Rizzi SH, Charbel FT: Virtual Reality Training in Neurosurgery: Review of Current Status and Future Applications. Surg Neurol Int 2:52, 2011 7. Luciano CJ, Banerjee PP, Bellotte NJB, Lemole GM Jr, Oh M, Charbel FT, Roitberg BZ: Learning Retention of Thoracic Pedicle Screw Placement Using a High-resolution Augmented Reality Simulator with Haptic Feedback. Neurosurgery 69 (1 Suppl Operative):ons14-19, 2011 8. Yudkowsky R, Luciano C, Banerjee P, Schwartz A, Alaraj A, Lemole GM Jr, Charbel F, Smith K, Rizzi S, Byrne R, Bendok B, Frim D: Practice on an Augmented Reality/Haptic Simulator and Library of Virtual Brains Improves Residents’ Ability to Perform a Ventriculostomy. Simulation in Healthcare 8(1):25-31, 2013

b. An important part of any clinical practice is the periodic reassessment of clinical results. Especially in lower volume specialties, it is important to present and publish important findings from case reports and clinical series so that a better understanding can be gained

GERALD LEMOLE for these less common disease processes. Likewise, academic description and dissemination of complex surgical techniques is vital to the advancement of understanding the specialty. I endeavor to regularly publish my skull base neurosurgery approaches and outcomes. 1. Lemole GM Jr, Henn JS, Zabramski JM, Spetzler RF: Modifications to the Orbitozygomatic Approach. J Neurosurg 99(5):924-930, 2003 2. Miller C, Khan R, Lemole GM Jr, Jacob A: Osteoblastoma of the Lateral Skull Base: Workup, Surgical Management, and a Review of the Literature. J Neurol Surg Rep 74(1):37-42, 2013 3. Skoch J, Ansay TL, Lemole GM: Injury to the Temporal Lobe via Medial Transorbital Entry of a Toothbrush. J Neurol Surg Rep 74(1):23-28, 2013 4. Palejwala SK, Skoch J, Lemole GM Jr: Removal of symptomatic craniofacial titanium hardware following craniotomy: Case series and review. Interdisciplinary Neurosurgery: Advanced Techniques and Case Management 2(2):15-119, 2015, doi:10.1016/j.inat.2015.04.002. 5. Palejwala SK, Barry J, Rodriguez CN, Parikh CA, Goldstein SA, Lemole GM Jr: Combined Approaches to the Skull Base for Intracranial Extension of Tumors via Perineural Spread Can Improve Patient Outcomes. Clin Neurol Neurosurg 150:46-53, 2016, doi:10.1016/j.clineuro.2016.08.029 6. Palejwala SK, Zangeneh TT, Goldstein SA, Lemole GM Jr: An Aggressive Multidisciplinary Approach Reduces Mortality in Rhinocerebral Mucormycosis. Surg Neurol Int 7:61, 2016, doi: 10.4103/2152-7806.182964 (eCollection 2016) c. Modern neurosurgery could not be performed without the significant advances in technology over the past several decades. We routinely rely on such devices as complex microscopes, intraoperative navigation, and electrophysiologic monitoring to make sure that the operative experience is safe and effective. I have devoted a significant amount of my academic effort toward neurosurgical innovation and technology development. This work is demonstrated by the selected publications below and several funded projects. 1. Lemole GM Jr, Anderson RR, DeCoste S: Preliminary Evaluation of Collagen as a Component in the Thermally-Induced ‘Weld’. Proc. SPIE. 1422, Lasers in Dermatology and Tissue Welding, 151. (June 01, 1991); doi: 10.1117/12.43954 2. Ashton RC, Oz MC, Lontz JF, Matsumae M, Taylor R, Lemole GM Jr, Shapira N, Lemole GM: Laser-assisted fibrinogen bonding of vascular tissue. J Surg Res 51(4):324-328, 1991 3. Lemole GM Jr, Ashton RC, Oz MC, Arikan I, Arikan D, Lemole GM: Effects of Additives on Laser-Assisted Fibrinogen Bonding. Proc. SPIE. 1643, Laser Surgery: Advanced Characterization, Therapeutics, and Systems III, 271. (June 01, 1992); doi: 10.1117/12.137352 4. Lemole GM Jr, Henn JS, Riina HA, Spetzler RF: Cranial Application of Frameless Stereotaxy. BNI Quarterly 17(1):16-24, 2001 5. Watson JR, Martirosyan N, Skoch J, Lemole GM Jr, Anton R, Romanowski M: Augmented microscopy with near-infrared fluorescence detection. Proc. SPIE. 9311, Molecular-Guided Surgery: Molecules, Devices, and Applications, 93110I. (March 04, 2015); doi: 10.1117/12.2077008

GERALD LEMOLE 6. Watson JR, Gainer CF, Martirosyan NL, Skoch J, Lemole GM Jr, Anton R, Romanowski M: Augmented microscopy: Real-time overlay of bright-field and near-infrared fluorescence images. J Biomed Opt 20(10), October, 2015, doi:10.1117/1.JBO.20.10.106002 7. Martirosyan NL, Skoch J, Watson JR, Lemole GM Jr, Romanowski M, Anton R: Integration of indocyanine green videoangiography with operative microscope: augmented reality for interactive assessment of vascular structures and blood flow. Neurosurg 11 Suppl 2:252-257, 2015, doi: 10.1227/NEU.0000000000000681 8. Watson JR, Martirosyan NL, Garland S, Lemole GM Jr, Romanowski M: Intraoperative imaging using intravascular contrast agents. Proc SPIE9696, Molecular-Guided Surgery: Molecules, Devices, and Applications II, Proc SPIE 142296960L (March 4, 2016); doi:10.1117/12.2213867

Complete List of Published Work as Listed in PubMed: https://www.ncbi.nlm.nih.gov/sites/myncbi/1xgfyx9nk0Y53/bibliography/51935063/public/?sort=date&direction=descending

D. Additional Information: Research Support and/or Scholastic Performance

Federal:

1. Cerebrospinal Fluid Drainage and Induced Hypertension to Improve Spinal Cord Perfusion in Acute Spinal Cord Injury. Phase 2B Randomized Controlled Trial Source: Department of the Army - USAMRAA Role: Co-Investigator (PI Local Site) Amount: $1,653,933.77 (all sites) Year(s) of Grant: 2015 - 2019 Principle Investigator: Nicholas Theodore, M.D. (Barrow Neurological Institute) 2. Spinal Surgical Simulation Translational Research Using Collocated Virtual Reality and Haptics Source: NIH - National Institute of Biomedical Imaging and Bioengineering (NIBIB) R21 Role: Co-Investigator Amount: $275,000 Year(s) of grant: 2008 – 2010 Principle Investigator: P. Pat Banerjee, PhD (UIC College Engineering) 3. Practice makes perfect: Does practice on a virtual reality/haptics simulator improve residents’ ability to perform a ventriculostomy Source: Agency for Healthcare Research and Quality (AHRQ) R03 Role: Co-Investigator Amount: $99,989 Year(s) of Grant: 2007 – 2008 Principle Investigator: Rachel Yudkowsky, M.D. (UIC College of Medicine)

GERALD LEMOLE Internal/Institutional Funding:

1. Realtime Reflex Pupillometry Device for Neuro-physiologic Monitoring Source: Tech Launch Arizona (ID UA15141) Role: Co-Principal Investigator Amount: $37,588 Year(s) of Grant: 2016 – 2017 2. Augmented Surgical Microscope for Image Guided Interventions in Brain Tumors Source: Barrett Cancer Imaging Grant, University of Arizona Role: Co-Investigator Amount: $25,000 Year(s) of Grant: 2014 – 2015 Principle Investigator: Marek Romanowski, Ph.D. (UA College of Engineering) 3. Development of a Neurosurgical Anatomy and Micro-Dissection Laboratory at UIC Source: Council for Excellence in Teaching and Learning, UIC Role: Principle Investigator Amount: $8,130 Year(s) of Grant: 2004 4. Pilot Project Virtual Neurosurgery - An Interactive, Computer-Based Atlas of Neurosurgical Approaches Source: Barrow Neurologic Institute Women’s Board Role: Co-Investigator Amount: $20,000 Year(s) of Grant: 2000 – 2001 Principle Investigator: Jeffrey S. Henn, M.D. (Barrow Neurological Institute)

Private Foundation:

1. Pilot Study: A promising new marker to guide brain cancer treatment”: Serum Nagalase Levels and Brain Tumor Burden Source: Community Foundation for Southern Arizona Role: Primary Investigator Amount: $50,000 Year(s) of Grant: 2011

III. DIVISION OF NEUROSURGERY TRAVIS DUMONT

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Dumont, Travis eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Assistant Professor of Surgery, Assistant Professor of Medical Imaging EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

Mathematics and Claremont McKenna College, Claremont CA B.A. 05/2001 Biology-Chemistry Tufts University School of Medicine, Boston MA M.D 05/2005 Medicine University of Vermont, Burlington VT Residency 06/2011 Neurological Surgery State University of New York Buffalo, Buffalo Neuroendovascular Fellowship 06/2013 NY Surgery

A. Personal Statement

As an Associate Professor of Surgery at the University of Arizona, College of Medicine, board certified in neurological surgery, I will conduct overall project oversight, project design, project implementation, staff education, data collection, and data analysis. As an academic surgeon, I am actively involved in direct patient care and training of medical students, residents, and fellows. Within four years of my post-graduate surgical career, I have overly invested myself in clinical and scientific research. Due to the unique blend of my scientific training, clinical environment, choice of collaborators and mentors, and experience as a PI on multiple projects and site PI on large federally funded trials I was able to contribute more than eighty peer-reviewed publications and multiple oral presentations covering a variety of issues within the specialty of neurological surgery. Most significant part of my clinical research has been dedicated to study of treatment of ischemic and hemorrhagic stroke. With I have taken interest in socioeconomic discrepancies of clinical care and irregularities of graduate medical education, and published extensively on these matters. With interest in clinical modeling, I have developed experience in prediction modeling and published several clinical prediction models for cerebrovascular disease and trauma. My experience with multicenter clinical research is as a site PI including enrollment of patients for stroke registry and spinal cord injury trials.

TRAVIS DUMONT

B. Positions and Honors

Employment and Academic Appointments:

2005-2011 Clinical Instructor, Surgery University of Vermont, Burlington VT 2012-2013 Clinical Assistant Professor of Neurosurgery, SUNY Buffalo, Buffalo NY 2013- Assistant Professor of Surgery, University of Arizona, Tucson, AZ 2013- Assistant Professor of Medical Imaging, University of Arizona, Tucson AZ 2013- Director, Cerebrovascular Surgery Program, University of Arizona, Tucson AZ 2016- Faculty, Vascular Neurology Fellowship University of Arizona, Tucson AZ

Administrative Appointments:

2013- Committee Member, Clinical Competency Committee University of Arizona Neurological Surgery Residency Program 2013- Board Member, Tucson Stroke Leadership Group, Tucson AZ 2014-Board Member, Banner-University Medical Center Credentialing Committee, Tucson AZ 2016- Chairman, Clinical Competency Committee University of Arizona Neurological Surgery Residency Program 2016- Associate Residency Program Director, Residency in Neurological Surgery University of Arizona Program, Tucson AZ

Honors and Awards:

2001 Best Poster Project, American Mathematical Association National Convention, January 10, 2001 2001 Honors in major, Mathematics Claremont McKenna College, May 19, 2001 2001 Honors in major, Biology/Chemistry Claremont McKenna College, May 19, 2001 2001 Presidential Scholar (highest academic award) Claremont McKenna College, May 19, 2001 2006 Resident Teaching Award, Department of Surgery University of Vermont 2005/2006 academic year, June 17, 2006 2006 Resident Presentation Award, New England Neurosurgical Society, October 2006 2008 Scoville Award (Best Clinical Research Resident Project) New England Neurosurgical Society, June 2008 2009 Scoville Award (Best Clinical Research Resident Project) New England Neurosurgical Society, June 2009 2014 Rookie of the Year – 2014 (In appreciation of outstanding first year performance), The University of Arizona Health Network, March 2014 2014 Depuy Synthes Award (AANS resident abstract awarded to Vernard Fennell – Travis Dumont as senior author), American Association of Neurological Surgeons annual meeting, April 2014 2014 Charles W. Needham Award for Neurosurgery Educator of the Year University of Arizona Medical Center, May 2014

TRAVIS DUMONT

2015 Charles W. Needham Award for Neurosurgery Educator of the Year University of Arizona Medical Center, May 2015 2015 Galbraith Award (CNS Oral Presentations Award Abstract awarded to Ashish Sonig – Travis Dumont as First Author) Congress of Neurological Surgeons, August 2015

C. Contribution to Science

a) I have extensive experience with mathematical modeling within neurological surgery systems, including development of models for prediction of vasospasm after aneurysm rupture which has become a useful part of my practice. The following is a selected personal bibliography on this topic: 1. Dumont TM. Prospective assessment of a symptomatic cerebral vasospasm predictive neural network model. World Neurosurg. 2016 Jul 5. pii: S1878-8750(16)30498-3. doi: 10.1016/j.wneu.2016.06.110. [Epub ahead of print] No abstract available. PMID: 27392898 2. Fanous AA, Natarajan SK, Jowdy PK, Dumont TM, Mokin M, Yu J, Goldstein A, Wach MM, Budny JL, Hopkins LN, Snyder KV, Siddiqui AH, Levy EI. High-Risk Factors in Symptomatic Patients Undergoing Carotid Artery Stenting With Distal Protection: Buffalo Risk Assessment Scale (BRASS). Neurosurgery. 2015 Oct;77(4):531-42; discussion 542-3. doi: 10.1227/NEU.0000000000000871. PMID: 26308641 3. Dumont TM, Kan P, Snyder KV, Hopkins LN, Siddiqui AH, Levy EI. A proposed grading system for endovascular treatment of cerebral arteriovenous malformations: Buffalo score.Surg Neurol Int. 2015 Jan 7;6:3. doi: 10.4103/2152-7806.148847. eCollection 2015. PMID: 25657856 4. Dumont TM, Mokin M, Wach MM, Drummond PS, Siddiqui AH, Levy EI, Hopkins LN. Understanding risk factors for perioperative ischemic events with carotid stenting: is patient age over 80 years or is unfavorable arch anatomy to blame? J Neurointerv Surg. 2013 May 17. [Epub ahead of print] PMID: 23685755 5. Dumont TM, Rughani AI, Tranmer BI. Prediction of symptomatic cerebral vasospasm after aneurysmal subarachnoid hemorrhage with an artificial neural network: feasibility and comparison with logistic regression models. World Neurosurg. 2011 Jan;75(1):57-63; discussion 25-8. PMID: 2149266 6. Rughani AI, Dumont TM, Lu Z, Bongard J, Horgan MA, Penar PL, Tranmer BI. Use of an artificial neural network to predict head injury outcome. J Neurosurg. 2010 Sep;113(3):585-90. PMID: 20020844 b) I have contributed extensively to the literature with respect to socioeconomics issues within neurological surgery and graduate medical education of neurological surgery residents. The following is a selected personal bibliography on this topic: 1. Palejwala SK, Rughani AI, Dumont TM. Increased Utilization of Cervical Disk Arthroplasty in University Hospitals with Regional Variation and Socioeconomic Discrepancies. World Neurosurg. 2016 Dec 16. pii: S1878-8750(16)31328-6. doi: 10.1016/j.wneu.2016.12.016. [Epub ahead of print] PMID: 27993738

TRAVIS DUMONT 2. Bina RW, Lemole GM, Dumont TM. Measuring quality of neurosurgical care: Readmission is affected by patient factors. World Neurosurg. 2016 Jan 12. pii: S1878-8750(16)00009-7. doi: 10.1016/j.wneu.2015.12.091. [Epub ahead of print] PMID: 26806064 3. Bina RW, Lemole GM Jr, Dumont TM. On resident duty hour restrictions and neurosurgical training: review of the literature. J Neurosurg. 2016 Mar;124(3):842-8. doi: 10.3171/2015.3.JNS142796. Epub 2015 Oct 16. Review. PMID: 26473789 4. Fennell VS, Martirosyan NL, Palejwala SK, Lemole GM Jr, Dumont TM. Morbidity and mortality of patients with endovascularly treated intracerebral aneurysms: does physician specialty matter? J Neurosurg. 2016 Jan;124(1):13-7. doi: 10.3171/2014.11.JNS141030. Epub 2015 Aug 14. PMID: 26274987 5. James WS, Rughani AI, Dumont TM. A socioeconomic analysis of intraoperative neurophysiological monitoring during spine surgery: national use, regional variation, and patient outcomes. Neurosurg Focus. 2014 Nov;37(5):E10. doi: 10.3171/2014.8.FOCUS14449. PMID: 25363427 6. Dumont TM, Tranmer BI, Horgan MA, Rughani AI. Trends in Neurosurgical Complication Rates at Teaching vs. Non-teaching Hospitals Following Duty Hour Restrictions. Neurosurgery. 2012 Aug 14. [Epub ahead of print] PMID:22895406 7. Dumont TM, Rughani AI, Goeckes T, Tranmer BI. Chronic Subdural Hematoma: A Sentinel Health Event. World Neurosurg. 2012 Jun 19. [Epub ahead of print] PMID: 22722034 8. Dumont TM, Rughani AI. National trends in carotid artery revascularization surgery. J Neurosurg. 2012 Jun;116(6):1251-7. Epub 2012 Apr 6. PMID: 22482791 9. Dumont TM, Rughani AI, Penar PL, Horgan MA, Tranmer BI, Jewell RP. Increased rate of complications on a neurological surgery service after implementation of the Accreditation Council for Graduate Medical Education work-hour restriction. J Neurosurg. 2012 Mar;116(3):483-6. Epub 2011 Dec 2. PMID: 22136642 c) I am most proud of my contributions to understanding treatment of symptomatic intracranial atherosclerosis, which includes prospective study. 1. Dumont TM, Sonig A, Mokin M, Eller JL, Sorkin GC, Snyder KV, Nelson Hopkins L, Levy EI, Siddiqui AH. Submaximal angioplasty for symptomatic intracranial atherosclerosis: a prospective Phase I study. J Neurosurg. 2016 Jan 8:1-8. [Epub ahead of print] PMID: 26745485 2. Dumont TM, Kan P, Snyder KV, Hopkins LN, Siddiqui AH, Levy EI. Revisiting Angioplasty without Stenting for Symptomatic Intracranial Atherosclerotic Stenosis after the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) Study. Neurosurgery. 2012 Dec;71(6):1103-10. PMID: 22986593

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TRAVIS DUMONT d) I have extensive experience with use of flow diversion stents for treatment of cerebral aneurysm. The following is a selected personal bibliography on this topic: 1. Lin N, Lanzino G, Lopes DK, Arthur AS, Ogilvy CS, Ecker RD, Dumont TM, Turner RD 4th, Gooch MR, Boulos AS, Kan P, Snyder KV, Levy EI, Siddiqui AH. Treatment of Distal Anterior Circulation Aneurysms With the Pipeline Embolization Device: A US Multicenter Experience. Neurosurgery. 2016 Jul;79(1):14-22. doi: 10.1227/NEU.0000000000001117. PMID: 26579967 2. Yoon JW, Siddiqui AH, Dumont TM, Levy EI, Hopkins LN, Lanzino G, Lopes DK, Moftakhar R, Billingsley JT, Welch BG, Boulos AS, Yamamoto J, Tawk RG, Ringer AJ, Hanel RA; for the Endovascular Neurosurgery Research Group (ENRG). Feasibility and Safety of Pipeline Embolization Device in Patients with Ruptured Carotid Blister Aneurysms. Neurosurgery. 2014 Jul 3. [Epub ahead of print] PMID: 24991709 3. Ma D, Xiang J, Choi H, Dumont TM, Natarajan SK, Siddiqui AH, Meng H.Enhanced aneurysmal flow diversion using a dynamic push-pull technique: an experimental and modeling study. AJNR Am J Neuroradiol. 2014 Sep;35(9):1779-85. doi: 10.3174/ajnr.A3933. Epub 2014 Apr 24. PMID: 24763414 4. Eller JL, Dumont TM, Sorkin GC, Mokin M, Levy EI, Snyder KV, Hopkins LN, Siddiqui AH. The Pipeline embolization device for treatment of intracranial aneurysms. Expert Rev Med Devices. 2014 Mar;11(2):137-50. doi: 10.1586/17434440.2014.877188. PMID: 24506298 5. Dumont TM, Eller JL, Mokin M, Sorkin GC, Levy EI. Advances in endovascular approaches to cerebral aneurysms. Neurosurgery. 2014 Feb 6. Dumont TM, Eller JL, Sorkin GC, Mokin M, Lo TP Jr, Snyder KV, Hopkins LN, Siddiqui AH, Levy EI. Aneurysm treatment with flow diversion: two live cases from the gates vascular institute. Neurosurgery. 2013 Aug;60 Suppl 1:48-56. doi: 10.1227/01.neu.0000430317.01821.8b. No abstract available. PMID:23839352 7. Ma D, Dumont TM, Kosukegawa H, Ohta M, Yang X, Siddiqui AH, Meng H. High Fidelity Virtual Stenting (HiFiVS) for Intracranial Aneurysm Flow Diversion: In Vitro and In Silico.Ann Biomed Eng. 2013 Apr 20. [Epub ahead of print] PMID:23604850 8. Kan P, Siddiqui AH, Veznedaroglu E, Liebman KM, Binning MJ, Dumont TM, Ogilvy CS, Gaughen JR, Mocco J, Velat GJ, Ringer AJ, Welch BG, Horowitz MB, Snyder KV, Hopkins LN, Levy EI. Early Postmarket Results After Treatment of Intracranial Aneurysms with the Pipeline Embolization Device: A U.S. Multicenter Experience. Neurosurgery. 2012 Aug 31. [Epub ahead of print] PMID: 22948199 9. Siddiqui AH, Abla AA, Kan P, Dumont TM, Jahshan S, Britz GW, Hopkins LN, Levy EI. Panacea or problem: flow diverters in the treatment of symptomatic large or giant fusiform vertebrobasilar aneurysms. J Neurosurg. 2012 Jun;116(6):1258-66. Epub 2012 Mar 9. PMID: 22404673 e) I have contributed to understanding of treatment of emergent large vessel ischemic stroke with stent devices. The following is a selected personal bibliography on this topic:

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TRAVIS DUMONT 1. Mokin M, Fargen KM, Primiani CT, Ren Z, Dumont TM, Brasiliense LB, Dabus G, Linfante I, Kan P, Srinivasan VM, Binning MJ, Gupta R, Turk AS, Elijovich L, Arthur A, Shallwani H, Levy EI, Siddiqui AH. Vessel perforation during stent retriever thrombectomy for acute ischemic stroke: technical details and clinical outcomes. J Neurointerv Surg. 2016 Sep 29. pii: neurintsurg- 2016-012707. doi: 10.1136/neurintsurg-2016-012707. [Epub ahead of print] PMID: 27688267 2. Natarajan SK, Sonig A, Mocco J, Dumont TM, Thind H, Hartney ML, Snyder KV, Hopkins LN, Siddiqui AH, Levy EI. Primary Stenting for Acute Ischemic Stroke Using the Enterprise Intracranial Stent: 2-Year Results of a Phase-I Trial. J Vasc Interv Neurol. 2015 Jul;8(3):62-7. PMID: 26301034 3. Dumont TM, Mokin M, Sorkin GC, Levy EI, Siddiqui AH. Aspiration thrombectomy in concert with stent thrombectomy. J Neurointerv Surg. 2013 Jul 18. [Epub ahead of print] PMID: 23868216 4. Dumont TM, Natarajan SK, Eller JL, Mocco J, Kelly WH Jr, Snyder KV, Hopkins LN, Siddiqui AH, Levy EI. Primary stenting for acute ischemic stroke using the Enterprise vascular reconstruction device: early results. J Neurointerv Surg. 2013 Jul 2. [Epub ahead of print] PMID: 23821672 5. Mokin M, Dumont TM, Veznedaroglu E, Binning MJ, Liebman KM, Fessler RD 2nd, To CY, Turner RD 4th, Turk AS, Chaudry MI, Arthur AS, Fox BD, Hanel RA, Tawk RG, Kan P, Gaughen JR Jr, Lanzino G, Lopes DK, Chen M, Moftakhar R, Billingsley JT, Ringer AJ, Snyder KV, Hopkins LN, Siddiqui AH, Levy EI. Solitaire Flow Restoration Thrombectomy for Acute Ischemic Stroke: Retrospective Multicenter Analysis of Early Postmarket Experience After FDA Approval. Neurosurgery. 2013 Jul;73(1):19-26. PMID: 23719060

Complete List of Published Work as listed in PubMed: https://www.ncbi.nlm.nih.gov/pubmed/?term=travis+dumont

D. Research Support

Ongoing Research Support Systematic Evaluation of Patients Treated with Neurothrombectomy Devices for Acute Ischemic Stroke (STRATIS) Registry Role: Site Principal Investigator Sponsor: Medtronic Pilot Study of Clinical Safety and Feasibility of the PLGA Poly-L-Lysine Scaffold for the Treatment of Complete Traumatic Acute Spinal cord Injury Role: Site Principal Investigator Sponsor: InVivo Therapeutics Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury Role: Site Principal Investigator; Sponsor: Vertex Pharmaceuticals

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III. DIVISION OF NEUROSURGERY ROBERT HURLBERT

NIH BIOGRAPHICAL SKETCH

Name: Dr. R. John Hurlbert, MD, PhD, FRCSC, FACS Title: Professor of Neurosurgery, Department of Surgery, College of Medicine eRA Commons User Name: NA

The University of Arizona Neurosurgery Room 4303 1501 N. Campbell Ave. PO Box 245070 Tucson, AZ, 85724 Telephone: (520) 626-2164 E-mail: [email protected]

Education & Training

Completion Field of Study Institution and Location Degree Date

University of Regina, Saskatchewan, Canada BS 04/1980 Pre-med, Biochemistry

University of Saskatchewan, Canada MD 04/1985 Doctorate of Medicine

University of Toronto, Ontario, Canada PhD 06/1993 Doctorate of Medical Science

University of Toronto, Ontario, Canada 09/1994 Neurosurgical Resident

The Royal College of Physicians and Surgeons of FRCSC 09/1994 Board Examination Canada, Ottawa, Canada

The Toronto Hospital, Ontario, Canada 06/1995 Neurosurgical Spine Fellow

Barrow Neurological Institute, Phoenix, AZ, USA 06/1996 Neurosurgical Spine Fellow

American Board of Neurological Surgery, USA 05/1999 Diplomate

American Board of Neurological Surgery, USA 05/2009 Recertification

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A. Personal Statement

As Professor of Neurosurgery and Co-Chair of The Spine Program at The University of Arizona, Department of Surgery, College of Medicine, I look forward to contributing my clinical perspective, expertise, and extensive research background investigating and treating spinal cord injury to help develop innovative new therapies to ultimately improve patient care and outcomes. I joined The University of Arizona in August 2016. I was previously Professor and Residency Program Director of Neurosurgery at The University of Calgary where I served as Chairman of the Spine Program. Please refer to Section B to review my other professional experience and honors. I will collaborate with Dr. Rick G. Schnellman, PhD, Professor and Dean of the College of Pharmacy at The University of Arizona to help further develop his novel therapeutic research regarding B2 adrenergic receptor agonists, in the setting of spinal cord injury.

B. Positions and Honors

Positions and Employment 1993-1998 Examiner, Medical Council of Canada 1996-2000 Assistant Professor, Department of Clinical Neurosciences, The University of Calgary 1997-2000 Member, American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS), Neurotrauma Guidelines Committee 1997 Affiliate, Neurosurgery, The University of Calgary 1997-2003 Chairman, University of Calgary Spine Program 1999-2009 Member, Executive & Scientific Committee AANS/CNS 2000-2016 Associate Professor, Medicine, The University of Calgary 2000-2010 Medical Director of the Nurse Practitioner Program, Neurosurgery, The University of Calgary 2000-2002 President, Canadian Spine Society 2000-2003 Vice-Chairman, Division of Neurosurgery, The University of Calgary 2002-2005 Member, Executive Committee, Canadian Spine Society 2004-2009 Examiner, Neurosurgery, The Royal College of Physicians and Surgeons of Canada 2005-2016 Residency Program Director, Division of Neurosurgery, The University of Calgary 2009-2012 Treasurer, Joint Section on Disorders of the Spine and Peripheral Nerves AANS/CNS, The University of Calgary 2010-2015 Chief Examiner, Neurosurgery, The Royal College of Physicians and Surgeons of Canada 2013-2014 Chair-Elect, Joint Section on Disorders of the Spine and Peripheral Nerves AANS/CNS 2014-2015 Chair, Joint Section on Disorders of the Spine and Peripheral Nerves AANS/CNS

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ROBERT HURLBERT Other Experience and Professional Memberships 1986-1996 Ontario Medical Association 1987-1997 Congress of Neurological Surgeons Resident Member 1989-1995 Society for Neuroscience 1989-1995 Neurotrauma Society 1990-1994 Clinical Research Society of Toronto 1994-present Joint Section on Disorders of the Spine and Peripheral Nerves (PN) 1995-present Royal College of Physicians and Surgeons of Canada 1995-present Canadian Neurosurgical Society 1996-present Alberta Medical Association 1997-2008 North American Spine Society 1997-present Congress of Neurological Surgeons 1999-present Canadian Spine Society 2000-present American College of Surgeons 2000-present Executive Committee – AANS/CNS Joint Section on Disorders of the Spine and PN 2002-2009 Spine Trauma Study Group 2006-2007 Spine Arthroplasty Society 2006-present Editorial Board – Neurosurgery

2008-present Editorial Board – Canadian Journal of Neurological Sciences 2010-present Society of Neurological Surgeons 2015-present Section Editor (Spine) – World Neurosurgery 2016-present Evaluation / Education Research Unit – Royal College of Physicians and Surgeons of Canada

Honors 1990 General Motors Neurotrauma Award - Best Resident's Research Paper, AANS / CNS Joint Section on Neurotrauma 1990 Mayfield Award - Best Resident's Research Paper, AANS / CNS Joint Section on Disorders of the Spine and Peripheral Nerves 1990 Morely Award - Best Resident's Research Paper, Division of Neurosurgery, University of Toronto 1992 Award of Excellence Postgraduate Research, Institute of Medical Science, University of Toronto 1992 Gallie-Bateman Resident Research Award - 3rd place, Dept. of Surgery, University of Toronto 1992 Physicians Services Institute Award for best Resident's research paper, Dept. of Postgraduate Medical Education, University of Toronto 1992 Second Place (miscellaneous category) Poster Award, Congress of Neurological Surgeons Meeting, Washington, D.C. 1993 First Annual Horsey Award for best Resident's clinical research paper, Division of Neurosurgery, University of Toronto 1993 Young Neurosurgeon Award, presented by the World Federation of Neurosurgical Societies, Acapulco, Mexico 1993 Hospital for Sick Children Humanitarian Award 1994 Finalist, Gallie Bateman Resident Research Awards, Department of Surgery, University of Toronto 1995 Spine Fellowship Award, Joint Section on Disorders of the Spine and Peripheral Nerves, American Association of Neurological Surgeons and Congress of Neurological Surgeons 1995 Travelling Fellowship Award, North American Spine Society 1998 Outstanding Paper Award, 13th Annual Meeting North American Spine Society 2002 Sonntag Award, AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves 2010-2016 Chair, Joint Section for Spine and Peripheral Nerves, AANS/CNS

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C. Contributions to Science Selected journal articles, past three years:

1. Goldstein CL, Hurlbert RJ. (2014/12). Symptomatic Spinal epidural Hematoma after posterior cervical Surgery: Incidence and risk factors. Spine.

2. Hurlbert RJ, Alexander D, Bailey S, Mahood, Abraham E, Fisher C. (2013/12). rhBMP-2 for Posterolateral instrumented lumbar fusion:A multicenter prospective randomized Controlled Trial. Spine: 2139-48. 3. Ghogawala, Shaffrey, Heary, Logvinenko, Malhotra, Hurlbert RJ. (2013/11). The Efficacy of Lumbar Discectomy and single-level fusion for spondylolisthesis: Results from the NeuroPoint-SD registry. Neurosurgery Spine: 555-63. 4. Walters, Hadley, Aarabi, Hurlbert RJ. (2013/8). Guidelines for the management of acute cervical spine and spinal cord injuries. Neurosurgery: 82-91. 5. Theodore N, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, Rozzelle CJ, Ryken TC, Walters BC, Hadley MN. (2013/3). Transportation of patients with acute traumatic cervical spine injuries. Neurosurgery: 35-39. 6. Gelb DE, Aarabi B, Dhall SS,Hurlbert RJ, Rozzelle CJ, Ryken TC, Theodore N, Walters BC, Hadley MN. (2013/3). Treatment of subaxial cervical spinal injuries. Neurosurgery: 187-94. 7. Ryken TC, Hadley MN, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, Rozzelle CJ, Theodore N, Walters BC. (2013/3). Management of isolated fractures of the axis in adults. Neurosurgery: 132-150. 8. Gelb DE, Hadley MN, Aarabi B, Dhall SS, Hurlbert RJ, Rozzelle CJ, Ryken TC, Theodore N, Walters BC. (2013/3). Initial closed reduction of cervical spinal fracture-dislocation injuries. Neurosurgery: 73-83. 9. Ryken TC, Hadley MN,Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, Rozzelle CJ, Theodore N, Walters BC. (2013/3). Management of acute combination fractures of the atlas and axis in adults. Neurosurgery: 151-158. 10. Harrigan MR, Hadley MN, Dhall SS, Walters BC, Aarabi B, Hurlbert RJ. (2013/3). Management of Vertebral artery injuries following non-penetrating cervical trauma. Neurosurgery: 234-43.

Complete List of Published Work: CV available upon request

D. Research Support (selected, past three years)

Research Support 4/2013 – 4/2016 Sponsor: Alberta Paraplegic Foundation Recipient: The University of Calgary Department of Neurosciences PI: Steve Casha Co-investigator : Hurlbert

9/2008 – 10/2015 Sponsor: Rick Hansen Foundation Recipient: The University of Calgary Department of Neurosciences PI: Hurlbert

9/2014 – 9/2015 Sponsor: STEMCELLS Inc. Recipient: The University of Calgary Department of Neurosciences PI: Hurlbert Co-investigator : Casha

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III. DIVISION OF NEUROSURGERY WILLARD KASOFF

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Kasoff, Willard Stein eRA COMMONS USER NAME (credential, e.g., agency login): wkasoff POSITION TITLE: Assistant Professor of Surgery, Assistant Professor of Neurology, Director of the Neuromodulation Program EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

Harvard University, Cambridge MA B.A. 06/1999 Biology Albert Einstein College of Medicine, Bronx NY M.D. 06/2005 Medicine Yale School of Medicine, New Haven CT Residency 06/2012 Neurological Surgery

Yale Epilepsy Surgery Program, New Haven CT Fellowship 06/2009 Epilepsy Surgery Health Policy & Yale School of Public Health, New Haven, CT M.P.H. 06/2010 Administration Functional & Emory University School of Medicine, Atlanta, GA Fellowship 07/2013 Stereotactic Neurosurgery

A. Personal Statement

I am a broadly-trained functional neurosurgeon with clinical expertise and fellowship training in: epilepsy surgery; surgery for movement disorders; craniofacial, spinal and peripheral pain surgery; and surgery for psychiatric diseases. My clinical interests are in stereotactic procedures for epilepsy, deep brain stimulation (DBS), craniofacial neuromodulation and surgery for adult hydrocephalus. My research interests, in collaboration with colleagues in neuroradiology, are primarily in using innovative MRI techniques to investigate the mechanism of action of DBS and to guide rational DBS therapy. I am also interested in objective measurements of gait and balance in Parkinson’s disease and normal-pressure hydrocephalus as biomarkers for disease status and treatment. Future areas of translational interest include closed-loop DBS systems and electrical biomarkers for PD symptoms and response to treatment.

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B. Positions and Honors

Professional Experience:

2016 – present Assistant Professor, Department of Neurology, University of Arizona College of Medicine, Tucson, AZ

2014 – present Assistant Professor, Division of Neurosurgery, Department of Surgery, University of Arizona College of Medicine, Tucson, AZ

2014 – present Director, Neuromodulation Program, University of Arizona College of Medicine, Tucson, AZ

Other Experience and Professional Memberships

2015 – present Member, North American Neuromodulation Society

2014 – present Arizona Medical Board, License #48925

2013 – 2014 Illinois Department of Financial and Professional Regulation, License #036133775

2012 – present Member, American Society for Stereotactic and Functional Neurosurgery

2012 – present DEA #FK3267730

2012 – 2013 Georgia Composite Medical Board, License #68042

2011 – present Member, American Epilepsy Society

2010 – present Member, American College of Surgeons

2008 – present NPI #122-521-4166

2006 – present Member, Yale Surgical Society

2005 – present Member, American Association of Neurological Surgeons

2005 – present Member, Congress of Neurological Surgeons

Honors and Awards

2011 Chief Resident, Department of Neurological Surgery, Yale School of Medicine, New Haven, CT

2011 Young Investigator Award, American Epilepsy Society

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2002 – 2003 Einstein Research Fellowship, Albert Einstein College of Medicine, Bronx, NY

1996 – 1999 Harvard College Scholarship, Harvard University, Cambridge, MA

Administrative Appointments:

2016 – present Bioethics Committee, Banner-University Medical Center, Tucson, AZ

2014 – present Institutional Review Board, Human Subjects Protection Program, University of Arizona

2014 – present Clinical Competency Committee, Division of Neurosurgery, University of Arizona

2009 – 2012 Clinical Ethics Committee, Yale-New Haven Hospital, New Haven, CT

2009 – 2010 Provider Advisory Committee, SustiNet Health Partnership, Hartford, CT

2009 – 2010 Committee on Academic and Professional Integrity, Yale School of Public Health, New Haven, CT

2006 – 2009 Graduate Medical Education Committee, Yale University School of Medicine, New Haven, CT

2001 – 2005 Committee on Student Promotions and Professional Standards, Albert Einstein College of Medicine, Bronx, NY

2001 – 2005 Bioethics Committee, Montefiore Medical Center, Bronx, NY

2001 – 2003 Preclerkship Curriculum Committee, Albert Einstein College of Medicine, Bronx, NY

C. Contribution to Science

a) I have extensive experience with deep brain stimulation and its use in movement disorders and psychiatric disease. Forthcoming investigations will address advanced MRI techniques for direct targeting of thalamic nuclei at clinical field strengths and for direct visualization of DBS electrode fields in vitro and in vivo.

List of Published Work as listed in PubMed: https://www.ncbi.nlm.nih.gov/pubmed/?term=willard+kasoff

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D. Research Support

Ongoing Research Support

1/2017 – 12/2017 Co-Principal Investigator, Department of Surgery Faculty Seed Grant: Direct Measurement of Current Flow from Deep Brain Stimulation Electrodes Using Magnetic Resonance Electrical Impedance Tomography (MREIT).

2/5/2016 – present Principal Investigator, IRB 1200000616, “Assessing Gait And Balance Using Body Worn Sensors: Does a Successful Clinical Intervention Also Improve Gait and Balance?”

10/2015 – present Sub-Investigator, Boston Scientific RELIEF Registry Protocol. PI: Mohab Ibrahim.

6/23/2015 – present Principal Investigator, IRB 1506936307, “Deep Brain Stimulation for Dystonia.”

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III. DIVISION OF NEUROSURGERY MARTIN WEINAND

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Weinand, Martin E. eRA COMMONS USER NAME (credential, e.g., agency login): MWEINAND POSITION TITLE: Professor of Surgery (Neurosurgery) EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

DEGREE Completion INSTITUTION AND LOCATION (if Date FIELD OF STUDY applicable) MM/YYYY

Emory University, Atlanta, GA B.S. 1980 Chemistry

St. Louis University School of Medicine, St. Louis, M.D. 1984 Medicine MO

A. Personal Statement I am a broadly trained practicing academic neurosurgeon with an equal interest in basic and translational research specifically in the blood brain barrier, neuroprotection and drug delivery, epilepsy and temporal lobectomy, neurosurgical genomics, narcotics addiction, spinal cord stimulation and Alzheimer’s disease. I have mentored medical students, high school and undergraduate student trainees and residents in these research projects. I also coordinate the educational activities of the Division of Neurosurgery. I have one ongoing project with IRB approval in epilepsy patients and I am particularly excited about the prospects of neurosurgical genomics technology. There is a great need for better selection criteria for epilepsy surgery candidates which pre-operative whole blood RNA expression may offer. An increasing number of student researchers here are being attracted to these areas and to academic careers at the frontiers of neurosurgery.

B. Positions and Honors

Professional Experience: 2002- Professor, Department of Surgery, University of Arizona, Tucson, AZ 2003- Program Director, Neurosurgery Residency, University of Arizona, Tucson, AZ 2004-2009 Chief, Division of Neurosurgery, University of Arizona, Tucson, AZ

Other Experience and Professional Memberships 1994- Certified, American Board of Neurological Surgery (Lifetime) 1995- American Association of Neurological Surgeons (AANS) 1996- Fellow, American College of Surgeons

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2003- Promotion & Tenure Committee, Department of Surgery 2005 Guest Examiner, American Board of Neurological Surgery 2006- Society of Neurological Surgeons (SNS) 2011-2017 Committee on Trauma, American College of Surgeons 2013 James Taren Visiting Professor, Department of Neurosurgery, University of Michigan 2014 Visiting Professor, Department of Neurosurgery, University of New Mexico 2014-2015 Scientific Program Chairman, Western Neurosurgical Society 2015- Secretary-Treasurer, Medical Staff, Banner University Medical Center 2015- Neuroscience Clinical Consensus Group, Banner Health 2015-2016 Reviewer, Neurosurgery 2015-2025 Certified, NeuroCriticalCare, Committee on Advanced Surgical Techniques, SNS 2016-2019 Editorial Board, Neurosurgery Portal, Neurotrauma and Critical Care, AANS/SNS 2017-2018 President-Elect, Western Neurosurgical Society

Honors and Awards 1988 Annual Resident Award, Congress of Neurological Surgeons 1993 Junior Investigator Award, American Epilepsy Society 1998-1999 Dean’s Teaching Scholar Award, College of Medicine, University of Arizona, Tucson, AZ

C. Contributions to Science

Temporal lobe epilepsy pathophysiology. The pathophysiology of temporal lobe epilepsy (TLE) involves cerebral vascular abnormalities which may be more fundamental in causation and which precede electrocorticographic manifestations of ictal seizure activity (a,b). Long-term cortical cerebral blood flow recording has demonstrated that temporal lobe epileptogenicity is inversely correlated with cerebral perfusion and that up to 20 minutes prior to a seizure, epileptogenic temporal lobe perfusion significantly increases from a hypoperfused baseline to approximate non-epileptogenic cortical blood flow at the time of the ictus (a,b). Epilepsy is a disorder of neuroinflammation, including the development of neuronal apoptosis (c). The upstream signals of neuronal apoptosis in temporal lobe epilepsy have been shown to be the cytoplasmic cell- cycle regulatory transcription factor E2F1 and nuclear effects of the chemokine RANTES (c). Approximately two-thirds of patients with intractable temporal lobe epilepsy can be cured with resective surgery (d). Subdural electrocorticographic prognostic factors for the selection of temporal lobe epilepsy candidates and correlates of temporal lobe epileptogenicity contributing to operative candidate selection and improved understanding of the pathophysiology of TLE, respectively, have been elucidated (d).

Weinand, M.E., Carter, L.P., el-Saadany, W.F., Sioutos, P.J., Labiner, D.M., & Oommen, K.J. (1997). Cerebral blood flow andtemporal lobe epileptogenicity. J Neurosurg. Feb;86(2):226-32. PMID: 9010424 a) Weinand, M.E., Carter, L.P., Patton, D.D., Oommen, K.J., Labiner, D.M., & Talwar, D. (1994). Long- term surface cortical cerebral blood flow monitoring in temporal lobe epilepsy. Neurosurgery. Oct;35(4):657-64. PMID: 7808608

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b) Fiala, M., Avagyan, H., Merino, J.J., Bernas, M., Valdivia, J., Espinosa-Jeffrey, A., Witte, M., Weinand, M. (2013). Chemotactic and mitogenic stimuli of neuronal apoptosis in patients with medically intractable temporal lobe epilepsy. Pathophysiology. Feb;20(1):59-69. PMID: 22444245; PMCID: PMC4038119 Weinand, M.E., Deogaonkar, M., Kester, M., Ahern, G.L., & Labiner, D.M. (2000). Electrocorticographic factors associated with temporal lobe epileptogenicity. Pathophysiology. 7(1):33-39. PMID: 10825683

Blood-brain barrier pathophysiology. A novel technique for establishing primary cultures of human brain microvascular endothelial cells has been developed, providing an in vitro cellular model for blood-brain barrier research (a). With this cellular model, pathophysiological mechanisms of neurological diseases have been delineated. In Alzheimer disease, macrophages have been shown to shuttle amyloid-beta from neurons to vessels, contributing to amyloid angiopathy (b). The blood-brain barrier technology developed in our laboratory has improved understanding of the interaction between cocaine abuse and HIV neuroinvasion. For example, cocaine at blood concentrations in drug abusers disrupts endothelial cell junctions in parallel with signaling by phosphorylation of extracellular signal-regulated kinase, myristoylated alanine-rich C kinase and myosin light chain (c). Furthermore, cocaine has been shown to increase human immunodeficiency virus type 1 neuroinvasion through remodeling brain microvascular endothelial cells (d).

Bernas, M.J., Cardoso, F.L., Daley, S.K., Weinand, M.E., Campos, A.R., Ferreira, A.J., Hoying, J.B., Witte, M.H., Brites, D., Persidsky, Y., Ramirez, S.H., & Brito, M.A. (2010). Establishment of primary cultures of human brain microvscularendothelial cells to provide an in vitro cellular model of the blood-brain barrier. Nat Protoc. Jul;5(7):1265-72. PMID: 20595955; PMCID: PMC3109429 Zaghi, J., Goldenson, B., Inayathullah, M., Lossinsky, A.S., Masoumi, A. Avagyan, H., Mahanian, M., Bernas, M., Weinand, M., Rosenthal, M.J., Espinosa-Jeffrey, A., de Vellis, J. Teplow, D.B., & Fiala, M. (2009). Alzheimer disease macrophages shuttle amyloid-beta from neurons to vessels, contributing to amyloid angiopathy. Acta Neuropathol. Feb;117(2):111-24. PMID: 19139910 Fiala, M., Singer, E.J., Commins, D., Mirzapoiazova, T., Verin, A., Espinosa, A., Ugen, K., Bernas, M., Witte, M., Weinand, M., & Lossinsky, A.S. (2008). HIV-1 Antigens in Neurons of Cocaine-Abusing Patients. Open Virol J. 2:24-31. PMID: 19440461; PMCID: PMC2678818 Fiala, M., Eshleman, A.J., Cashman, J., Lin, J., Lossinsky, A.S., Suarez, V., Yang, W., Zhang, J., Popik, W., Singer, E., Chiappelli, F., Carro, E., Weinand, M., Witte, M., & Arthos, J. (2005). Cocaine increases human immunodeficiency virus type 1 neuroinvasion through remodeling brain microvascular endothelial cells. J Neurovirol. 2005 Jul;11(3):281-91. PMID: 16036808

Neurosurgical Treatment of Chronic Pain. The neurosurgical treatment of chronic facial, lower extremity and low back pain has been improved through expansion of indications for neurosurgical operative techniques, spinal cord stimulation (SCS) trial methods and enhanced applications of neuromodulation technology. Data from a clinical trial of acute versus prolonged screening for spinal cord stimulation in chronic low back pain have provided a rationale for eliminating prolonged and retaining acute (intraoperative) SCS screening for selection of permanent SCS implantation candidates (a). The feasibility of relieving chronic pain with an expanded indication for spinal cord stimulation was supported

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by the application of this neuromodulation technique to isolated or predominate low back pain (b). The significant level of effectiveness and satisfactory safety profiles of nonrechargeable spinal cord stimulation devices for treatment of chronic, intractable pain was supported by a meta-analysis of clinical SCS studies (c). For peripheral nerve intractable pain syndromes, peripheral field stimulation therapy has been shown to be safe & effective in neuromodulation relief of intractable trigeminal neuropathic pain (d).

Weinand, M.E., Madhusudan, H., Davis, B., & Melgar, M. (2003). Acute vs. Prolonged Screening for Spinal Cord Stimulation in Chronic Pain. Neuromodulation. Jan;6(1):15-9. PMID: 22150909 a) Stidd, D.A., Rivero, S., & Weinand, M.E. (2014). Spinal cord stimulation with implanted epidural paddle lead relieves chronic axial low back pain. J Pain Res. Aug 12;7:465-70. PMID: 25143753; PMCID: PMC4136982 b) Slavin, K.V., Vaisman, J., Pollack, K.L., Simopoulos, T.T., Kowlowitz, E., Weinand, M.E., Norregaard, T.V. (2013). Genesis Study Investigators.Treatment of chronic, intractable pain with a conventional implantable pulse generator: a meta-analysis of 4 clinical studies. Clin J Pain. Jan;29(1):78-85. PMID: 22751030 c) Stidd, D.A., Wuollet, A.L., Bowden, K., Price, T., Patwardhan, A., Barker, S., Weinand, M.E., & Annabi, J., Annabi, E. (2012). Peripheral nerve stimulation for trigeminal neuropathic pain. Pain Physician. Jan- Feb;15(1):27-33. PMID 22270735; PMCID: PMC4664452

4. Neurosurgical Genomics in Temporal lobe Epilepsy. Whole genome analyses have been performed to test the hypothesis that temporal cortical gene expression differs between patients with epilepsy with increased baseline seizure frequency relative to those with lower baseline seizure frequency (a). Forty genes have been identified whose expression levels were significantly associated with one of two baseline seizure frequency groups. Of the five most significant, four genes have been linked to other neurologic diseases in varying ways. Gene expression associated with the high seizure frequency group included comparatively low expression levels of Homeobox A10 (HOXA10, chromosome 7p15.2), Forkhead box A2 (FOXA2, chromosome 20p11), Lymphoblastic leukemia derived sequence 1 (LYL1, chromosome 19p13.13), HGF activator (HGFAC, chromosome 4p16.3), and Kelch repeat and BTB (POZ) domain containing 11 (KBTBD11, chromosome 8p23.3), and three RNA probes (1). Future investigation of these genes could establish new biomarkers for predicting brain epileptogenicity, and could have significant implications for diagnosis and management of temporal lobe epilepsy, as well as epilepsy pathogenesis (a). Whole genome analyses have also been performed to test the hypothesis that temporal cortical gene expression differs between epilepsy patients rendered seizure-free versus non-seizure-free following anterior temporal lobectomy with amygdalohippocampectomy (ATL/AH) (b,c). Four genes and seven RNA probes have been found with prognostic value for post-operative seizure-free outcome. Gene expression associated with seizure-free outcome included relative down-regulation of: zinc finger protein 852 (ZNF852, chromosome 3p21.31); CUB domain containing protein 2 (CDCP2, chromosome 1p32.3); proline-rich transmembrane protein 1 (PRRT1, chromosome 6p21.32); hypothetical LOC440200 (FLJ41170, chromosome 14q32.31); RNA probe 8047763; RNA probe 8126238; RNA probe 8113489; RNA probe 8092883; RNA probe 7935228; RNA probe 806293 and RNA probe 8104131 (b,c). Future prospective investigation of these genes and probes in human brain tissue and blood could establish new biomarkers predictive of seizure outcome following ATL/AH (b,c,d).

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a) McCallum, A., Gallek, M., Manziello, A., Witte, M., Bernas, M., Ramey, W., & Weinand, M. (2015). Cortical Gene Expression Correlates of Temporal Lobe Epileptogenicity. Arizona Neurosurgical Society Fall 2015 Annual Meeting, Dove Mountain in Marana, AZ, November 21, 2015. b) Skoch, J., Gallek, M.J., Ansay, T.L., Behbahani, M., Stidd, D., Mount, D., Manziello, A., Witte, M., Bernas, M., Labiner, D.M., & Weinand, M.E. (2015). Cortical Gene Expression Associated with Seizure Outcome Following Temporal Lobectomy with Amygdalohippocampectomy. Resident Award: Clinical Science, Western Neurosurgical Society 61st Annual Meeting, Grand Hyatt, Kaua’I, HI, September 12, 2015. c) Skoch, J., Gallek, M., & Weinand, M. (2013). Whole Genome Analysis of Resected Temporal Cortex Identifies Predictors of Seizure-Free Outcome Following Temporal Lobectomy for Intractable Seizures. Abstract 470. Congress of Neurological Surgeons Annual Meeting, San Francisco, CA. October 21, 2013. d) Weinand, ME, Gallek, MJ, Stoch J. US Patent, Neurosurgical Genomics, Publication number US20160115543 A1, Application number US 14/894,963, PCT number PCT/US2014/040045, The Arizona Board of Regents On Behalf of The University of Arizona, Publication date Apr 28, 2016, Filing date May 29, 2014, Priority date May 29, 2013.

URL full list of Pub Med cited publications: http://www.ncbi.nlm.nih.gov/pubmed/?term=weinand+m

D. Research Support Ongoing Research Support 5 R01 MH065151 UA subcontract Persidsky (PI) 07/01/08 - 06/30/17 DHHS/NIH/NIMH BBB Tight Junctions During HIV-1 Dementia: Anti-Inflammatory Effects of GSK-3b Suppression” Primary human brain microvascular endothelial cells (BMVEC) will be isolated and cultured from the temporal cortex of brain tissue obtained during surgical removal of epileptogenic foci in adult patients to examine GSK- 3b suppression. Role: Subcontract Co-PI

NIH-R24 Witte (PI) 09/27/15 – 09/27/18 NIMH High resolution electrical brain mapping by real-time and portable 4D Acoustoelectric Imaging Role: Co-I

Clinical Research Pilot Program Award Weinand (PI) 2016-2017 University of Arizona Health Sciences Whole blood RNA Expression Prognostic Factors for Selecting Selective Laser Ablation Amygdalohippocampotomy Candidates Role: PI

Seed Grant Weinand (PI) 2016-2017 Department of Surgery, University of Arizona Whole blood RNA Expression Prognostic Factors for Selecting Selective Laser Ablation Amygdalohippocampotomy Candidates Role: PI

Completed Research Support (for the last three years) Visualase Corporation Weinand (PI) 2011-2014 A pilot study to evaluate MR-guided laser ablation of epileptic Role: Neurological PI 115

IV. DIVISION OF TRUAMA, CRITICAL CARE, BURN AND EMERGENCY SURGERY TERENCE O’KEEFFE

eRA COMMONS USER NAME (credential, e.g., agency login):

POSITION TITLE: Associate Professor In Surgery

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of Edinburgh, Edinburgh, Scotland, UK BSc 07/92 Molecular Biology University of Edinburgh, Edinburgh, Scotland, UK MB ChB 07/94 Medicine University of Miami, Miami, Florida MSPH 06/03 Public Health

A. Personal Statement

I am an academic trauma surgeon with research interests in injury epidemiology and injury prevention, as well as transfusion practices. Until 2016, I was the medical director of the Surgical ICU at our medical center, and therefore have strong professional and research interests in critical care medicine. I now serve as the Interim Division Chief of Trauma I and am in charge of our group of research specialists who provide 24/7 coverage for our clinical trials. We have a strong history of trauma-related clinical trials, and have the necessary experience as shown below in the successful completion of the PROPPR trial and PROHS trial.

B. Positions and Honors 2003 - 2005. Trauma/Critical Care Fellow, Ryder Trauma Center, Miami, FL 2006 - 2008. Assistant Professor, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX 2008 - 2012. Assistant Professor, Department of Surgery, University of Arizona, Tucson, AZ 2012 - present. Associate Professor with Tenure, Department of Surgery, University of Arizona, Tucson, AZ Current Licensure

Arizona 40631

Professional Certifications

American Board of Surgery. 2003. Recertified 2014 Certificate of added qualifications in Critical Care. 2004. Recertified 2015

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Honors

1992 First Class Honors in Intercalated Bachelor of Science Degree, Edinburgh 2001 Joint winner State Prize ACS Committee on Trauma Resident Research Paper 2002 Elected Housestaff Member of Alpha Omega Alpha 2015 Fellow of the American College of Critical Care Medicine 2015 Honorary Member of the Brazilian Trauma Society (SBAIT) 2015 SCCM presidential Citation

C. Contributions to Science

Injury Prevention

During my trauma fellowship, I also completed a master’s in public health, and became more interested in injury prevention. I have performed projects here at the University of Arizona, and mentored medical students and residents with their projects in addition.

O’Keeffe T, Dearwater S, Gentilello L, Cohen T, Wilkinson J and McKenney M. “Increased Fatalities Following Motorcycle Helmet Law Repeal: Is It All Due To Lack Of Helmets?”. Journal of Trauma 2007;63(5);1006-1009

Blecker N, Rhee P, Judkins DG, Wynne JL, Friese RS, Kulvatunyou N, Latifi R, O’Keeffe T. “Pediatric ATV Trauma: The Epidemic Continues Unabated” Pediatr Emerg Care. 2012 Apr 23.

Joseph B, Khalil M, Zangbar B, Kulvatunyou N, Orouji T, Pandit V, O'Keeffe T, Tang A, Gries L, Friese RS, Rhee P, Davis JW. “Prevalence of Domestic Violence Among Trauma Patients”. JAMA Surg. 2015 Sep 9:1-7.

Joseph B, Pandit V, Zangbar B, Amman M, Khalil M, O'Keeffe T, Orouji T, Asif A, Katta A, Judkins D, Friese RS, Rhee P. “Rethinking Bicycle Helmets as a Preventive Tool: a 4-year Review of Bicycle Injuries. Eur J Trauma Emerg Surg. 2014 Dec;40(6):729-32.Sep;79(3):463-7.

Alcohol

In my first faculty position, I was lucky enough to be monitored in alcohol research by Dr. Gentilello, who developed the brief intervention for alcohol in trauma patients. This has continued to remain a research focus of mine, and I have worked with residents and fellows on some of these projects.

1. O’Keeffe T, Shafi S, Sperry J and Gentilello L. “The Implications of Alcohol Intoxication and the Uniform Policy Provision Law on Trauma Centers”. Journal of Trauma. 2009;66(2):495-8

2. Hadjizacharia P, O’Keeffe T, Plurad DS, Green DJ, Brown CVR, Chan LS, Demetriades, D, Rhee, P. “Alcohol Exposure and Outcomes in Trauma Patients”. Eur Journal of Trauma and Emergency Surgery. 2011 April:37(2):169-175

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3. O’Keeffe T, Rhee P, Shafi S, Friese RS, Gentilello LM. “Alcohol Use Increases Diagnostic Testing, Procedures, Charges, and the Risk of Hospital Admission: A Population-Based Study of Injured Patients in the Emergency Department.” The American Journal of Surgery. 2013 Jul;206(1):16-22.

4. Aziz H, Siordia JA, Rhee P, Pandit V, O'Keeffe T, Kulvatunyou N, Joseph B. “Analyzing the Effects of Alcohol on Adolescent Trauma Using the National Trauma Data Bank.” J Trauma Acute Care Surg. 2015

Traumatic Brain Injury

This has been a long term interest of mine, particularly in terms of therapeutics such a beta-blockers as well as the use of medications for seizure prophylaxis. We have developed some novel protocols here at the University of Arizona in managing TBI, and continue to publish many research articles on this topic.

Warner MA, O’Keeffe T, Bhavsar P, Shringer R, Moore C, Harper C, Madden CJ, Sarode R, Gentilello LM, Diaz-Arrastia R. “Transfusions and Long-term Functional Outcomes in Traumatic Brain Injury”. Journal of Neurosurgery. 2010 Jan 29.

Joseph B, Haider AA, Pandit V, Tang A, Kulvatunyou N, OʼKeeffe T, Rhee P. “Changing Paradigms in the Management of 2184 Patients with Traumatic Brain Injury.” Ann Surg. 2015 Sep;262(3):440-8.

Zangbar B, Khalil M, Rhee P, Joseph B, Kulvatunyou N, Tang A, Friese RS, O'Keeffe T. “Metoprolol improves survival in severe traumatic brain injury independent of heart rate control.” J Surg Res. 2015 Aug 21.

Zangbar, B, Rhee P, Wynne JL, Friese RS, Kulvatunyou N, Joseph B, Tang AL, O'Keeffe T. “Levetiracetam Prophylaxis For Post-Traumatic Brain Injury Seizures Is Ineffective; A Propensity Score Analysis”. World J Surg. 2016 Jun 15.

Massive Transfusion

I have been interested in transfusion medicine and massive transfusion protocols since I was a faculty at UT Southwestern in 2006, and was the first author on one of the seminal articles looking at effectiveness. I was also the site-PI for the PROPPR trial, which is now my most cited article. I continue to remain involved with this as a research interest, and clinically, as it pertains to blood management

O’Keeffe T, Refaai M, Tchorz K, Forestner JE and Sarode R. “A Massive Transfusion Protocol to Decrease Blood Component Usage and Costs.” Archives of Surgery. 2008;143(7): 686-691

Baraniuk S, Tilley BC, Del Junco DJ, Fox EE, van Belle G, Wade CE, Podbielski JM, Beeler AM, Hess JR, Bulger EM, Schreiber MA, Inaba K, Fabian TC, Kerby JD, Cohen MJ, Miller CN, Rizoli S, Scalea TM, O'Keeffe T, Brasel KJ, Cotton BA, Muskat P, Holcomb JB; PROPPR Study Group. “Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: Design, Rationale and Implementation.” Injury. 2014 Sep;45(9):1287-95.

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Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. “Transfusion of Plasma, Platelets, and Red Blood Cells in a 1:1:1 vs a 1:1:2 Ratio and Mortality in Patients with Severe Trauma: the PROPPR Randomized Clinical Trial.” JAMA. 2015 Feb 3;313(5):471-82.

D. Additional Information: Research Support and/or Scholastic Performance

Current Research Support

Title: Study of Tranexamic Acid during Air Medical Prehospital transport trial (STAAMP) PI: Dr Jason Sperry (University of Pittsburgh) Role: Site Co-I 5% Effort. 2016-2018

Title: Prehospital Resuscitation On Helicopter Study (PROHS) NIH Grant (Project 5 U01 HL077863-11) PI: John Holcomb Role: Co-Investigator/Site PI. 10% effort years 1 & 2. 5% year 3. Jan 1st 2015 - December 2016 Site funds $782,462

Completed Research Support

Title: RE-VERSE-AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigitran) Trial Industryfunded: Boehringer-ingelheim PI: Charles V. Pollack, Jr Role: Site PI. Study funds: Study closed early by sponsor before site could be initiated.

Title: Prospective, Randomized Optimal Platelet and Plasma Ratios NIH Grant (Project U01 HL077863-07S2) PI: John Holcomb Role: Co-Investigator/Site PI. 15% effort. July 1st 2011 - September 2015 Site funds $1.6 million.

Title: Pathophysiological & Biochemical Changes of Thermal Injury NIH Grant (Project Number 2P50GM021681-40A1) PI: Jureta W Horton Date of research:02/01/1996-8/31/2010 Role: Co-Investigator. September 2007 – August 2008. 5% effort

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IV. DIVISION OF TRUAMA, CRITICAL CARE, BURN AND EMERGENCY SURGERY RANDALL FRIESE

Please see the following faculty profile link: http://surgery.arizona.edu/profile/randall-s-friese- md-facs-fccm

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IV. DIVISION OF TRUAMA, CRITICAL CARE, BURN AND EMERGENCY SURGERY LYNN GRIES

Please see the following faculty profile link: http://surgery.arizona.edu/profile/lynn-m-gries-md

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IV. DIVISION OF TRUAMA, CRITICAL CARE, BURN AND EMERGENCY SURGERY ARPANA JAIN

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Arpana Jain, MD eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Assistant Professor of Surgery EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Maulana Azad Medical College, New Delhi, MD 06/2007 Medical School

India

Michael E. DeBakey Dept of Surgery, Baylor Internship 06/2009 Surgery

College of Medicine, Houston, TX Residency 06/2013 Surgery Michael E. DeBakey Dept of Surgery, Baylor College of Medicine, Houston, TX

Fellowship 06/2014 Surgical Critical Care Surgical Critical Care, University of Arizona, Tucson, AZ Fellowship 06/2015 Acute Care Surgery

Acute Care Surgery and Trauma, University of Arizona, Tucson, AZ, Fellowship 06/2016 Burn Surgery

University of California Davis and Shriner’s Children Hospital, Sacramento, CA

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A. Personal Statement

I am committed to being an academic trauma surgeon. Since medical school I have found this specialty to be fast paced, diverse, inspiring, and challenging. Trauma surgeons are frequently called upon to use a wide range of surgical skills and knowledge, often with little time and incomplete information. We commonly start with critically ill and injured patients and we must be proficient in all aspects of their care. For me, there is no greater honor than helping these patients and their families navigate recovery. I have been highly dedicated to academics from a very young age. My life experiences have allowed me to develop many of the qualities that I will rely on to excel in a program and as a trauma surgeon: enthusiasm, dedication, sacrifice, teamwork, a drive for perfection, focused motivation, compassion and endurance. I plan to continue this journey and make strides in Burn Surgery and patient care.

B. Positions and Honors

Positions: Assistant Professor Banner University Medical Center – 08/2016

Honors: Charles H. Nicholson Travelling Fellowship in General Surgery, 2012

Gold Medal for the Best Performing Student in Otolaryngology, 2005

Honor for Excellence in Anatomy and Biochemistry, 2002

C. Contributions to Science

Publications Jain A, Vargas HD. Advances and Challenges in the Management of Acute Colonic Pseudo-Obstruction (Ogilvie Syndrome). Clinics in Colon and Rectal Surgery 2012; 25(01): 037-045

Sharabi SE, Hatef DA, Koshy JC, Jain A, Cole PD, Hollier LH Jr. Is primary thinning of the anterolateral thigh flap recommended? Annals of Plastic Surgery 2010 Dec; 65(6):555-9.

Abstracts 1. LeverageS,JainA,HalemaneG,GedalyR,PawaR.AllLiverCysts Are Not Created Equally. The American Journal of Gastroenterology 2010; 105 (S): 285-6

D. Additional Information: Research Support and/or Scholastic Performance Book Chapters Jain A, Watt J, O’Keeffe T. “Thoracic Ultrasonography in the Critically Ill” In: Ultrasonography in the ICU, Edited by: Paula Ferrada, MD.

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Grand Rounds/Presentations:

1. ‘HemostaticResuscitation’atCriticalcareMultidisciplinary Conference, University of Arizona, 2015

2. ‘AbdominalVascularTrauma,SpinalTrauma,AcuteBurn Management, Mangled Extremity’ at Resident Didactics, University of Arizona, 2014-15

3. ‘NursingcareforBurnPatient’atPediatricNursingBurnPrep Course, University of Arizona, 2015

4. ‘CombinedOrthopedicandVascularTraumatoLowerExtremity’at Ortho-Trauma Conference, University of Arizona, 2014

5. ‘RecurrentGallstonepancreatitis’atVisitingProfessorGrand Rounds, University of Kentucky, 2012

6. ‘Graves’Disease–acasepresentation’atSchwartzTeaching Conference, University of Kentucky, 2012

7. ‘PersonalizedMedicine’atSurgeryGrandRounds,Universityof Kentucky, 2011

8. ‘Para-esophagealHernia–CasePresentation’atSchwartz Teaching Conference, University of Kentucky, 2011

9. ‘VascularSurgery–MedicalStudentTeachingWorkshop’at University of Kentucky, 2011

10.‘Persistent Mullerian Duct Syndrome’ at UTSW Spence Grand Rounds, Dept of Urology UT Southwestern Medical Center, Dallas, Texas, 2007

11.‘Staging and Treatment Options of Carcinoma of Larynx’ at Grand Rounds, Dept of Otorhinolaryngology, Maulana Azad Medical College, New Delhi, 2004

12.‘Three Dimensional Anatomy of Eye and Orbit’ at Head and Neck Presentation Series, Dept of Anatomy, Maulana Azad Medical College, New Delhi, 2002

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IV. DIVISION OF TRUAMA, CRITICAL CARE, BURN AND EMERGENCY SURGERY BELLAL JOSEPH

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Joseph, Bellal eRA COMMONS USER NAME (credential, e.g., agency login): BJOSEPH POSITION TITLE: Associate Professor of Surgery EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

Michigan State University, East Lansing, Biochemistry and B.S 06/1999 Michigan Biotechnology Saba University School of Medicine, Saba, M.D 06/2003 Medicine Dutch Caribbean Henry Ford Hospital, Detroit, Michigan Residency 06/2008 General Surgery Trauma/Surgical University of Maryland, Baltimore, Maryland Fellowship 06/2009 Critical Care

A. Personal Statement

As an Associate Professor of Surgery at the University of Arizona, College of Medicine, board certified in general surgery and critical care, I will conduct overall project oversight, project design, project implementation, staff education, data collection, and data analysis. As an academic surgeon, I am actively involved in direct patient care and training of medical students, residents, and research fellows. Within seven years of my postgraduate surgical career, I have overly invested myself in clinical and scientific research. Due to the unique blend of my scientific training, clinical environment, choice of collaborators and mentors, and experience as a PI on multiple projects and co-Investigator on large federally funded trials I was able to contribute more than one hundred and twenty peer-reviewed publications and multiple oral presentations covering a variety of issues within the specialty of trauma, emergency general surgery and critical care. Most significant part of my clinical research has been dedicated to change the clinical practice in critically injured patients. The focus has been directed at injured patient outcomes with emphasis in geriatric and traumatic brain injury. My efforts have led to introduction of frailty measurement tools to both trauma and emergency surgery I have also extensively published on traumatic brain injury and I have been the pioneer in establishing new guidelines defining the safety limits for managing traumatic brain injury (TBI) patients by trauma surgeons with limited use of repeat head CT and neurosurgical consultation.

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Moreover, I have made significant contribution in world of telemedicine by publishing literature and pushing the need of implementation of telemedicine in trauma. I have been involved in many national and international collaborative projects and multi-institutional studies, which have provided the highest level of clinical evidence for redefining the management in trauma and acute care surgery. I was also involved in investigating the effects of Remote Ischemic Conditioning in TBI patients. I conducted the study on human subjects and discovered positive effects of RIC on serum markers in TBI patients. This project helped me in securing DARPA grant for investigating the molecular basis of effects of RIC in TBI in an animal model, which is one of my ongoing projects right now. My clinical environment is excellent as University of Arizona Medical Center Tucson. It is a high-volume Level-I trauma center, which actively enrolls over 4000 trauma and emergency surgery patients annually. Additionally, our trauma center has a high-quality research infrastructure with a long history of success in federally funded endeavors. Finally, my success and enthusiasm as a researcher and clinical investigator is reflected by quality and volume of literature I have published in such a short period of time. My efforts in this field were well acknowledged by my mentors at university of Arizona and recently I have been appointed as a Vice Chair of Research and Knowledge Expansion at University of Arizona. This has provided me with more power and liberty to utilize available resources for expansion of my research projects and activities that can help revolutionize medical knowledge and refine patient care.

Following are few multicenter studies in which I was involved:

1. Hodgman, Erica MD; Joseph, Bellal MD; Mohler, Jane MSN, MPH, PhD; Wolf, Steven E. MD; Paulk, M. Elizabeth MD; Rhodes, Ramona L. MD, MSCS; Nakonezny, Paul A. PhD; Phelan, Herb A. MD, MSCS, Creation of a decision aid for goal-setting after geriatric burns: A study from the prognostic assessment of life and limitations after trauma in the elderly [PALLIATE] consortium. Journal of Trauma and Acute Care Surgery: February 16, 2016 2. Cook, Allyson C. MD; Joseph, Bellal MD; Inaba, Kenji MD; Nakonezny, Paul A. PhD; Bruns, Brandon R. MD; Kerby, Jeff D. MD, PhD; Brasel, Karen J. MD, MPH; Wolf, Steve E. MD; Cuschieri, Joe MD; Paulk, M. Elizabeth MD; Rhodes, Ramona L. MD, MSCS; Brakenridge, Scott C. MD, MSCS; Phelan, Herb A. MD, MSCS. Multicenter external validation of the Geriatric Trauma Outcome Score: A study by the Prognostic Assessment of Life and Limitations After Trauma in the Elderly (PALLIATE) consortium. Journal of Trauma and Acute Care Surgery: February 2016 - Volume 80 3. Fortuna, Gerald MD; DuBose, Joseph J. MD; Mendelsberg, Ranan MD; Inaba, Kenji MD; Haider, Ansab MD; Joseph, Bellal MD; Skarupa, David MD; Selleck, Matthew J. DO; O’Callaghan, Thomas A. MD; Charlton-Ouw, Kristofer MD; and the Lower Extremity Vascular Repairs Outcome Group. Contemporary outcomes of lower extremity vascular repairs extending below the knee: A multicenter retrospective study. Journal of Trauma and Acute Care Surgery: February 16, 2016

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B. Positions and Honors

Employment and Academic Appointments: 2009- Assistant Professor of Surgery, University of Arizona, Tucson, AZ. 2009- Program Director, International Research Fellowship, Division of Trauma, University of Arizona, Tucson, AZ. 2011- Director of Trauma Research, University of Arizona, Tucson, AZ. 2011- Associate Director, Tele-Surgery, Arizona Tele-medicine Program, University of Arizona, Tucson, AZ. 2013- Associate Director, Surgical-Critical Fellowship, Division of Trauma, University of Arizona, Tucson, AZ. 2014- Associate Professor of Surgery, University of Arizona, Tucson, AZ.

Administrative Appointments: 2009- Course Director, Advanced Trauma Life Support, Division of Trauma, University of Arizona, Tucson, AZ. 2009- Trauma CBI and Trauma Labs for Surgery Clerkship, College of Medicine, University of Arizona, Tucson, AZ. 2009- Clinical Director of Multispecialty Surgery Clinic, Division of Trauma, University of Arizona, Tucson, AZ. 2009- Trauma Medical Student Rotation Coordinator, College of Medicine, University of Arizona, Tucson, AZ. 2011- Board Member, Emerge! Center against Domestic Abuse, Arizona, Tucson, AZ. 2013- Faculty Senate Representative, University of Arizona, Tucson, AZ. 2014- Director of Trauma Research, University of Arizona, Tucson, AZ. 2015- Vice Chair of Knowledge Expansion, University of Arizona, Tucson, Arizona.

Honors and Awards: 2004- Andrew S. Rowan Surgical Intern of the Year, Henry Ford Hospital 2007- Wayne State University School of Medicine Chapter of the Good Humanism Honor Society 2008- Henry Ford Hospital Resident Surgical Research Award 2011- Dean’s List for Excellence in Teaching Award- Year III and IV, University of Arizona College of Medicine 2012- Indian Health Services (IHS) Trauma Care and Injury Prevention Program Award 2013- Reynolds Scholar in Aging, Arizona Center on Aging 2014- American College of Surgeons Excellence in Research Award in Geriatric Surgery 2014- Co char, Geriatric Trauma Delphi, Arizona Center on Aging and Division of Trauma 2014- American Association for Surgery of Trauma Geriatric Trauma/ American College of Surgeons Committee 2015- The Anthony C. Guzaukas Award for Excellence in Clinical Teaching, University of Arizona College of Medicine, Tucson, AZ.

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C. Contribution to Science: a) My early publications addressed the lack of management guidelines in traumatic brain injury by trauma surgeons. Overall there is an increase in the incidence of traumatic brain injury, while there is a declining trend in the number of neurosurgeons available. Moreover, patients with traumatic brain injury receive multiple repeat head CT scans routinely. While trauma surgeons can safely manage mild traumatic brain injury, there was no guideline to define the safety limits for neurosurgical consultation and repeat head CT scans. These publications fund the basis of management of patients with traumatic brain injuries by trauma surgeons without neurosurgical consultation and the optimal patients to receive routine repeat head CT scans. Also, these publications documented the evidence to tailor the Brain Injury Guidelines. This body of work has changed the standards of care for patients with traumatic brain injury in multiple trauma centers and will continue to provide assistance in relevant trauma settings well into the future. I served as the primary investigator in all of these studies.

1. Joseph B, Aziz H, Pandit V, Kulvatunyou N, Sadoun M, Tang A, O'Keeffe T, Gries L, Green DJ, Friese RS, Lemole MG Jr, Rhee P. Prospective validation of the brain injury guidelines: managing traumatic brain injury without neurosurgical consultation. The journal of trauma and acute care surgery. 2014; 77(6):984-8. 2. Joseph B, Aziz H, Pandit V, Kulvatunyou N, Hashmi A, Tang A, Sadoun M, O'Keeffe T, Vercruysse G, Green DJ, Friese RS, Rhee P. A three-year prospective study of repeat head computed tomography in patients with traumatic brain injury. Journal of the American College of Surgeons. 2014; 219(1):45-51. 3. Joseph B, Friese RS, Sadoun M, Aziz H, Kulvatunyou N, Pandit V, Wynne J, Tang A, O'Keeffe T, Rhee P. The BIG (brain injury guidelines) project: defining the management of traumatic brain injury by acute care surgeons. The journal of trauma and acute care surgery. 2014; 76(4):965-9. 4. Joseph B, Aziz H, Sadoun M, Kulvatunyou N, Tang A, O'Keeffe T, Wynne J, Gries L, Green DJ, Friese RS, Rhee P. The acute care surgery model: managing traumatic brain injury without an inpatient neurosurgical consultation. The journal of trauma and acute care surgery. 2013; 75(1):102- 5; discussion 105. b) My publications regarding geriatrics and elderly population directly addressed the knowledge gap in management of geriatric trauma patients. Geriatric population is the fastest growing segment in US population accounting for 20% of all hospital admissions and with their active lifestyle there is an increasing burden on the trauma centers across the US. These publications found the difference in the elderly patient’s outcomes after trauma can be attributable to the frailty syndrome. These publications documented these differences and assessed the frailty using a measurable scale. I also defined the trauma specific frailty index and validated this index for the first time, which will help trauma surgeons to quickly and efficiently assess injured geriatric patients. This work has won the American College of Surgeons Excellence in Research Award. By providing evidence and a simple clinical questionnaire, this body of work has changed the standards of care for frail older adults and will continue to provide assistance in relevant medical settings well into the future. I served as the primary investigator or co- investigator in all of these studies.

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1. Joseph B, Pandit V, Zangbar B, Kulvatunyou N, Tang A, O'Keeffe T, Green DJ, Vercruysse G, Fain MJ, Friese RS, et al. Validating trauma-specific frailty index for geriatric trauma patients: a prospective analysis. J Am Coll Surg. 2014;219(1):10-17. PMID: 24952434 2. Joseph B, Pandit V, Zangbar B, Kulvatunyou N, Hashmi A, Green DJ, O'Keeffe T, Tang A, Vercruysse G, Fain MJ, et al. Superiority of Frailty Over Age in Predicting Outcomes Among Geriatric Trauma Patients: A Prospective Analysis. JAMA Surg. 2014. Aug; 149(8). 766-72. PMID: 24920308 3. Joseph B, Pandit V, Sadoun M, Zangbar B, Fain MJ, Friese RS, Rhee P. Frailty in surgery. J Trauma Acute Care Surg. 2014;76(4):1151-6. PMID: 24662884 4. Joseph B, Pandit V, Rhee P, Aziz H, Sadoun M, Wynne J, Tang A, Kulvatunyou N, O'Keeffe T, Fain MJ, et al. Predicting hospital discharge disposition in geriatric trauma patients: is frailty the answer? J Trauma Acute Care Surg. 2014;76(1):196-200. PMID: 24368379

e) Patient outcomes and trauma systems is another area of focus of my research. I have published papers on Affordable Care Act, gun laws, safety profile of bicycle and motorcycle helmets, and domestic abuse. These articles left a significant impact by creating hype in news and media leading to substantial changes in policies contributing to better trauma systems and safer environment.

1. Safavi A, Rhee P, Pandit V, Kulvatunyou N, Tang A, Aziz H, Green D, O’Keeffe T, Vercruysse G, Friese R, Joseph B. Children are safer in states with strict firearm laws: A National Inpatient Sample study. Journal of Trauma and Acute Care Surgery: January 2014 2. Joseph B, Pandit V, Zangbar B, Amman M, Khalil M, O’Keeffe T, Orouji T, Asif A, Katta A, Judkins D, Friese RS, Rhee P. Rethinking Bicycle Helmets As A Preventive Tool: A 4 Year Review Of Bicycle Injuries. European Journal of Trauma and Emergency Surgery. December 2014. 3. Joseph B, MD; Mazhar Khalil, MD; Bardiya Zangbar, MD; Narong Kulvatunyou, MD; Tahereh Orouji, MD; Viraj Pandit, MD; Terence O’Keeffe, MD; Andrew Tang, MD; Lynn Gries, MD; Randall S. Friese, MD; Peter Rhee, MD, MPH; James W. Davis, MD. Prevalence of Domestic Violence Among Trauma Patients. JAMA Surg. 2015;150(12):1177-1183.

Complete List of Published Work in MyBibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/1fY4DxSKI81Ay/bibliography/47793245/public/?sort=date&directio n=ascending

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D. Research Support

Ongoing Research Support

DARPA-BAA-12-120, DoD Joseph (PI) 5/1/2015-6/30/2016 Reducing secondary traumatic brain injury by early remote ischemic pre-conditioning The purpose of this grant is to perform an animal study testing RIPC’s effect for protecting brain tissue against secondary traumatic brain injury. Role: PI Proposal Number 67191-LS-DRP

Donald W. Reynolds Foundation Fain/Mohler (PI) 7/1/2013-6/30/2017 Arizona Reynolds Program in Applied Geriatrics: Next Steps The purpose of this grant is to strengthen specialist physician training in geriatrics, with an emphasis on improving care delivered by hospitalists, surgical and medical specialists with the overarching aim of improving care for the frail elderly, and building geriatric models of care Role: Aging Scholar

National Institute of Aging Gwin/ Joseph MD/ Najafi (PI) 06/15/2015 – 03/31/2017 The purpose of this grant is to develop an upper extremity frailty device to identify elderly trauma patients at high risk for adverse outcomes. This is done in collaboration with the University of Arizona Center on Aging and i-CAMP and the division of Trauma. Role: PI Award Number R44AG050338

Completed Research Support

LifeCell Corporation 5/1/2012-5/1/2013 Patient Outcomes and Evaluation or Strattice and Spy Elite in Trauma and Emergency General Surgery. The purpose of this grant was to evaluate long term outcomes and utility of biological mesh in critically injured trauma patients. Role: PI

Faculty Seed Grant FY2105, University of Arizona 7/1/2014-6/30/2015 Reducing Secondary Brain Injury with Remote Ischemic Conditioning The purpose of this seed grant is to perform a pilot project testing RIC’s effect for protecting organs/ tissues against acute ischemia perfusion injury. Role: PI

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IV. DIVISION OF TRUAMA, CRITICAL CARE, BURN AND EMERGENCY SURGERY NARONG KULVATUNYOU

BIOGRAPHICAL SKETCH b) Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAME Kulvatunyou, Narong eRA COMMONS USER NAME eRA EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) DEGREE INSTITUTION AND LOCATION YEAR(s) FIELD OF STUDY (if applicable) Berry College, Mt. Berry Georgia BS 1985-1989 Biology and Pre-med University of Alabama at Birmingham, MS 1989-1990 Birmingham, Alabama (incomplete) University of Alabama at Birmingham, d) 1990- c) MD e) Medicine Birmingham, Alabama 1994 General Surgery, NY Methodist-Cornell f) Residenc g) 1994- h) General Surgery University Hospital y 1999 University of Massachusetts Fellowship 1999-2000 Surgical Critical Care University of Minnesota Fellowship 2000-2001 Research Fellowship

A. Personal Statement

I am a practicing general surgeon specializing in trauma, emergency surgery, and critical care. As a member of the faculty at the University of Arizona since 2009, I have made it my life’s calling to provide excellent patient care, pursue innovative and creative research, and teach and serve as a good role model for my medical students and surgical residents Fulfilling my other life’s goal is to help Thailand, the developing country, to develop a trauma system. I spent 3 years in Thailand and helped them open a trauma and surgical intensive care unit at one of its university hospitals. It was a gratifying experience and something I want to continue to pursue. I have several research Interests including the bio-mechanism of blunt traumatic injury, the changing role of pigtail catheter in chest wall trauma, the pathophysiology and outcome of acute appendicitis and diagnosis and outcome of small bowel obstruction. Finally, I am very passion about teaching as well as understanding how students and residents learn.

B. Positions and Honors. Employment and Academic Appointments

07/2000-06/2001 Instructor, Department of Surgery/Critical Care, University of Minnesota 07/2000-06/2001 Attending Trauma Surgical Staff, North Memorial Medical Center, Level I Trauma center, Robinsdale, Minnesota 07/2001-06/2002 Attending Surgical Staff, Surgical Affiliates Group, Mercy San Juan Hospital, Level II Trauma Center, Sacramento, California

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07/2002-12/2002 Accepting and then withdrawing, an Assistant Professor, Department of Surgery, University of Oklahoma, Oklahoma City, OK to return to Bangkok, Thailand for personal reasons 01/2003-05/2005 Instructor, Department of Surgery, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand 06/2005-08/2005 Transition back to the United States 09/2005-02/2009 Assistant Professor, Department of Surgery, University of Oklahoma, Oklahoma City, OK 03/2009-04/2009 Transition to Arizona 05/2009-08/2014 Assistant Professor, Department of Surgery, University of Arizona and University Physicians Healthcare, Tucson, AZ 09/2014 – Associate Professor, Department of Surgery, University of Arizona and University Physicians Healthcare, Tucson, AZ

Awards and Honors 1985-1986 Academic Scholarship, Berry College, Mt Berry, Ga, 1988 Summer Research Scholarship, U of S. Carolina, Charleston, SC 1993 International Student Scholarship, U of Ala at Birmingham, AL 1999 Best Chief Resident, NY Methodist-Cornell U Hospital Banner-University Medical Center Medical Staff Grant award, $2,500, 3/2015

Administrative Appointments 2009 Medical Director, Surgical/Trauma Intermediate Care, University of Arizona 2010 Director of ATLS course, The American College of Surgery 2014 Coordinator of weekly trauma M & M process 2010-2015 Associated Trauma Medical Director 2015- Director, Acute Care Surgery Fellowship Program Director, Surgical Critical Care Fellowship Program Banner University Medical Center Tucson, Arizona

Committees 2001-2004 The American College of Surgeons, Associate Fellows 2002- Society of Critical Care 2005-2009 Oklahoma Society of Surgery 2006- EAST, society of trauma 2006- Fellow of the American College of Surgeons (FACS) 2008- Academic Associate Surgeon 2012- Southwest Surgical Society 2012- American Association Society of trauma 2014- Arizona Trauma Association Board members Member, Western Trauma Association (WTA) 2015- American Medical Writer Association

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C. Contributions to Science: Provide evidence that will lead to the change in clinical practice by replacing a large bore- chest tube with a percutaneous pigtail catheter in trauma patients with hemothorax

D. Complete List of Published Work in MyBibliography

https://www.ncbi.nlm.nih.gov/pubmed?term=narong+kulvatunyou&cmd=DetailsSearch

E. Research Support

Completed Research Support

2005-2007 Sub-investigator: Novo Nordisk Inc: A Randomized, open-label, efficacy and safety study of Factor VII, University of Oklahoma. 2006-2009 Co-investigator: Octapharma: “A Randomized, open-label, efficacy and safety study of Octaplex and Fresh Frozen Plasma (FFP) in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures”, University of Oklahoma. 2009 Principle Investigator: Management of Post-Traumatic Retained Hemothorax: A Prospective, Observational, Multicenter AAST study, University of Arizona. 2009 Principle Investigator: Artisan123 Treatment of Sepsis-related Overted DIC Trial; Multi-institutional Study.

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IV. DIVISION OF TRUAMA, CRITICAL CARE, BURN AND EMERGENCY SURGERY ANDREW TANG

POSITION TITLE: Associate Professor of Trauma, Surgical Critical Care and General Surgery

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of Arizona BS 06/1999 Biochemistry University of Arizona College of Medicine MD 06/2003 Medicine University of Southern California Postgrad 07/2009 Surgical Residency University of Southern California Postgrad 07/2006 Research fellowship in Thoracic-Foregut University of Southern California Postgrad 07/2010 Fellowship in Surgical Critical Care

NOTE: The Biographical Sketch may not exceed five pages. Follow the formats and instructions below.

A. Personal Statement

I am an academic surgeon with a robust clinical practice that entails trauma, surgical critical care and emergency general surgery. I also serve as the Trauma Medical Director for our Level I Trauma Center. In this capacity, I have intimate involvement and influence over the daily operations of the trauma service. This study will examine the effects of methocarbamol on rib fracture pain in the trauma population, as compared to placebo. I will have a direct oversight of the patients enrolled in the study. I have also established a robust research profile that entails prospective randomized and observation studies. My background in clinical studies and insight to patient care as a physician will contribute to the quality of the study. This topic is also of personal interest as musculoskeletal pain management is a prevalent challenge to all trauma surgeons taking care of the injured.

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B. Positions and Honors

Positions and Employment 2006 – 2007 Clinical Instructor, Division of Thoracic Foregut, Department of Surgery, University of Southern California, Los Angeles, CA

2009 – 2010 Clinical Instructor, Division of Trauma and Critical Care, Department of Surgery, University of Southern California, Los Angeles, CA

2010 - 2005 Assistant Professor, Department of Surgery, University of Arizona, Tucson, AZ

2015 - Associate Professor, Department of Surgery, University of Arizona, Tucson, AZ

2016 - Trauma Medical Director, Department of Surgery, University of Arizona, Tucson, AZ

Other Experience and Professional Memberships 1999 - Member, American Medical Association 2009 - Member, University of Southern California Society of Graduate Surgeons 2009 - Member, Society of Critical Care Medicine 2011 - Member, Eastern Association for the Surgery of Trauma 2011 - Member, Association of Academic Surgeons 2011 - Member, Tucson Surgical Society 2012 - Fellow, American College of Surgeons 2012 - Member, Association for Surgical Education 2014 - Member, State of Arizona Trauma Verification Site Surveyor 2016 - Member, State Trauma Advisory Board, Arizona Department of Health Services

Honors 1995 - 1999 Higher Education Multicultural Scholar, University of Arizona, Tucson, AZ 1995 - 1999 Dean’s List, University of Arizona, Tucson, AZ 1999 Magna Cum Laude, University of Arizona, Tucson, AZ 2007-2008 Best Senior Surgery Resident Teaching Award, University of Southern California, Los Angeles, CA 2008 Los Angeles County Sheriff’s Department Certificate of Appreciation, Los Angeles, CA 2009 Best Teacher-Chief Resident Award, University of Southern California, Los Angeles, CA 2010 Keck School of Medicine Best Housestaff Teaching Award, University of Southern California, Los Angeles, CA 2010 Los Angeles County Department of Health Certificate of Appreciation, Los Angeles, CA 2010 The St. Calamus Good Samaritan Award, Los Angeles, CA

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2012 UACOM Dean’s List for Excellence in Teaching Award – Years III and IV, University of Arizona College of Medicine, Tucson, AZ 2013 UACOM Dept. of Surgery Outstanding Teacher Surgery Clerkship, University of Arizona College of Medicine, Tucson, AZ 2014 Asian American Faculty, Staff and Alumni Association Outstanding Faculty Award, University of Arizona, Tucson, AZ 2015 College of Medicine Class 2015 and 2016 Professionalism Award, University of Arizona College of Medicine, Tucson, AZ

C. Contribution to Science 1. Tension pneumothorax is a deadly injury that affects up to 1.7% of civilian trauma victims and is responsible for up to 4% of battlefield deaths. It results from lung injury that causes escape of air into the chest cavity without a means of evacuation because the escaped air is no longer in communication with the airway itself. Consequently, the chest cavity becomes pneumatically compressed and results in physical shift of the heart, great vessels and airway. The patient suffers from decreased blood return to the heart due to the shifted anatomy, which in turn leads to death. The current standard of care is to decompress the pneumothorax from the chest cavity with a needle. However, it is well established that the current device for chest decompression is ineffective in 75% of cases. I had created a chest decompression device using tools purchased from a hardware store. It addresses all of the problematic areas of the traditional device. The modified veress needle was validated in an animal model and found to be overwhelmingly more effective compared to the currently available device. The device has since been patented and I am working with the University of Arizona on refining the product and possibly marketing it. 5. Lubin D, Tang A.L, Friese R.S., Martin M., Green D. J., Jones T., Means R.R., Ginwalla R., O'Keeffe T.S, Joseph B.A., Wynne J.L., Kulvatunyou N., Vercruysse G., Gries L., Rhee P, Modified Veress needle decompression of tension pneumothorax: A randomized crossover animal study, Journal of Trauma and Acute Care Surgery, 2013 Dec;75(6):1071-5.

2. Gun violence is becoming more prevalent in American society. There is question on the impact of liberal gun laws, such as that passed in Arizona in 2010, which legalized concealed carry without the previously mandated training. I was the senior investigator on the study evaluating the number of gun related violence in Arizona before and after the passage of SB-1108. The study did not identify a change in the prevalence of gun related violence in the 6-months periods before and passage of SB-1108. a. Ginwalla R, Rhee P, Friese R, Green D, Gries L, Joseph B, Kulvatunyou N, Lubin D, O’Keeffe T, Vercruysse G, Wynne J, Tang A. Repeal of the concealed weapons law and its impact on gun-related injuries and deaths. J Trauma Acute Care Surg. 2014. 76(3): 569-575.

3. Repairing vascular injuries require technical expertise, specialized equipment, all the while under time constraints due to tissue ischemia. Even in the best of hands, an extremity vascular injury will take anywhere between 30 to 45 minutes to repair. I had developed a novel surgical technique to repair extremity vascular injuries by combining aspects of open and endovascular approaches. This new technique was tested in a sheep model for feasibility and vascular patency. The time to complete revascularization took anywhere between 5 to 15 minutes with a good short term patency rate. This technique, once

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validated in larger animal studies, will have tremendous implication on the future of civilian and military vascular trauma management. a. Tang A, Divens C, Kulvatunyou N, Joseph B, Green DJ, O’Keeffe T, Friese R, Rhee P. The Elimination of Anastomosis in Open Trauma Vascular Reconstruction: A Novel Technique Using an Animal Model. J Trauma and Acute Care Surg. 2015 Dec;79(6):937-42.

4. In trauma triage, there has to be a delicate balance between appropriate and over-triage in order to optimize resource allocation, yet minimizing preventable morbidity and mortality. Non-trauma centers often transfer trauma patients due to the lack of expertise and resources. However, there is also the observation that there is an exceptionally high overtriage rate from these referring hospitals. In other words, many patients are minimally injured and do not benefit from transfer to a regional Level I trauma center. I senior authored this study to examine our regional referring hospital practices and identified a 25% overtriage rate. This opens a tremendous opportunity for outreach to referring hospitals on trauma education and utilization of resources. Successful outreach efforts will result in tremendous unnecessary health expenditure reduction. a. Tang A, Hashmi A, Pandit V, Joseph B, Kulvatunyou N, Vercruysse G, Zangbar B, Gries L, O’Keeffe T, Green DJ, Friese R, Rhee P. A critical analysis of secondary overtriage to a Level I trauma center. J Trauma Acute Care Surg. 2014 Dec;77(6):969-73.

5. Advanced Trauma Life Support is the fundamental trauma management curriculum developed by the American College of Surgeons. Given its importance, it is also the most widely implemented of all ACS educational programs. As a senior author, I sought to identify the predictors of student failure of ATLS. English as a second language, non-trauma/non- Emergency Medicine specialties, age greater than 55, and pretest scores less than 75 all portended a worse passage rate. This information may allow ATLS course directors to identify earlier the at-risk participants and tailor the educational materials as needed. a. Mobily M, Branco B, Friese R, Joseph B, Hernandez N, Catalano R, Frantz N, Judkins D, Green DJ, Kulvatunyou N, O’Keeffe T, Rhee P, Tang A. Predictors of failure of Advanced Trauma Life Support (ATLS) course participants, American Journal of Surgery. Accepted March 3, 2015.

D. Research Support Ongoing Research Support INvestigating TREatments for the Prevention of secondary Injury and Disability following Traumatic Brain Injuries (INTREPID) Tang (co-PI) 9/2014-present The goal of this phase III clinical trial was to test the clinical efficacy of an investigational drug for the treatment of traumatic brain injury. Role: PI

Prospective Evaluation of Wound Management Using the Vacuum Assisted Instillation Therapy in Emergent Contaminated Wounds Tang (PI) 9/2014-present The goal of this clinical study was to investigate the impact of using a vacuum assisted wound device along with infusion of 0.125% Dakin’s solution, on contaminated surgical wounds Role: PI

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A phase IV, multicenter, prospective, randomized, controlled clinical study to compare the IrrisSept system versus Standard of Care on the prevalence of surgical site infection in patients with abdominal trauma or acute surgical abdomen Tang (PI) 9/2016-present The purpose of this study is to investigate the impact of a novel surgical wound dressing on the prevalence of surgical site infections in contaminated surgical wounds. Role: PI

An animal model comparison of chest tube insertion: The Reactor versus standard insertion Tang (PI) 5/2015-7/2017 The goal of the study is to compare the safety and technical ease of a new chest tube insertion device (Reactor) to the traditional chest tube. Role: PI

Effects of Non-selective Pelvic Angioembolization on Pelvic Venous Flow Tang (PI) 5/2015-7/2017 The goal of this study is to measure the effect of unilateral and bilateral internal iliac artery embolization on pelvic venous flow, in a porcine model. The result will help address the clinical question of the effect of pelvic arterial embolization on pelvic hemorrhage following pelvic fractures. Role: PI

Completed Research Support The Elimination of Anastomosis in Open Trauma Vascular Reconstruction: A Novel Technique Using an Animal Model Tang (PI) 1/2013-1/2015 The purpose of this study was to evaluate the feasibility of a novel surgical technique in reconstructing traumatic vascular wounds using commercially available vascular stents in a sheep model. Role: PI

Modified Veress needle decompression of tension pneumothorax: a randomized crossover animal study Tang (PI) 1/2012-1/2014 The goal of this animal study was to test the efficacy of a home-made medical device in decompressing tension pneumothoraces in a porcine model. The study resulted in patent No. PCT/US14/20027 Role: PI

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IV. DIVISION OF TRUAMA, CRITICAL CARE, BURN AND EMERGENCY SURGERY GARY VERCRUYSSE

Please the following faculty profile link: http://surgery.arizona.edu/profile/gary- vercruysse-md-facs

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IV. DIVISION OF TRUAMA, CRITICAL CARE, BURN AND EMERGENCY SURGERY EL RASHEID ZAKARIA

Please the following faculty profile link: http://surgery.arizona.edu/profile/el- rasheid-zakaria-md-phd

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V. DIVISION OF UROLOGY BENJAMIN LEE

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES.

c) NAME: Lee, Benjamin R d) POSITION TITLE: Professor and Chief of Urology e) eRA COMMONS USER NAME (credential, e.g., agency login): BRLEE1 f) EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Cornell University, Ithaca, New York BA 05/1990 Biochemistry The Johns Hopkins School of Medicine, Baltimore, MD 05/1994 Doctor of Medicine Maryland The Johns Hopkins School of Medicine, Baltimore, 06/1996 General Surgery Residency Maryland The Johns Hopkins School of Medicine, Baltimore, 06/2000 Urology Residency Maryland, Brady Urological Institute

A. Personal Statement I hold the appointment of Professor and Chief of Urology at the University of Arizona College of Medicine as well as Director of the Disease Oriented Strategic Planning team at the University of Arizona Cancer Center. I will serve as a co-investigator and mentor for the proposed grant application. The focus of the proposed work is to develop genetic markers of aggressive prostate cancer and to understand their role in cancer biology. I have significant experience with clinical trial development and execution, including participation in Clinical protocol FSI-003, A multicenter clinical study of the Sonablate 500 (SB-500) for the treatment of locally recurrent prostate cancer with high intensity focused ultrasound, as well as CLINICAL TRIAL PROTOCOL: AGS-003-007. International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT), My research and clinical efforts are focused on renal cell carcinoma, prostate cancer and kidney stones. I am an enthusiastic adopter of new biomedical technologies, and I have a particular interest in image- guided surgery. Specific publications (of 140 refereed articles and reviews) that cover my research and clinical activities are included:

B. Positions and Honors

Positions and Employment 1994-95 General Surgery Internship, The Johns Hopkins Hospital 1995-96 General Surgery Resident, The Johns Hopkins Hospital 1996-00 Urology Resident, James Buchanan Brady Urological Institute, The Johns Hopkins Hospital 2000-01 Assistant Chief of Service (ACS), The Johns Hopkins Hospital Clinical Instructor

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2001-04 Assistant Professor, North Shore - Long Island Jewish Medical Center, Albert Einstein College of Medicine 2004-08 Associate Professor, North Shore - Long Island Jewish Medical Center, Albert Einstein College of Medicine 2004-08 Director, Laparoscopy Section, Long Island Jewish Medical Center 2008-2016 Professor (with tenure), Department of Urology, Tulane University School of Medicine 2010-2016 Clinical Professor of Medicine, Section of Hematology-Oncology 2016-present Professor of Surgery (with tenure) Chief, Division of Urology, University of Arizona, College of Medicine 2016-Present Director GU Cancer & Disease Oriented Strategic Planning Team University of Arizona Cancer Center

Honors and Awards Magna Cum Laude, Cornell University Westinghouse National Science Talent Search, Honorable Mention, 1986 Dean’s List, College of Arts and Sciences, Cornell University, 1986-87, 1987-88 Outstanding College Students of America, 1990 1st place overall, Case of the Week Competition, Dept of Radiology, Johns Hopkins Hospital, 1992-93 1st place, Best video, International TelesurgicalTelementoring, 16th World Congress of Endourology & SWL, New York City, New York, 1998. 1st place, Essay Contest, 16th World Congress on Endourology & SWL, New York City, New York, 1998. Information Technology Innovators and 21st Century Pioneer Awards Laureate. ComputerWorld Smithsonian Innovation Collection to the Smithsonian Institute, Permanent Research Collection, National Museum of American History, Smithsonian Institute, 1999. Selected to represent the United States for the 2004 Academic Fellowship Program, European Exchange between the American Urological Association and European Association of Urology. Vienna, Austria. March 17-April 6, 2004. Podium Presentation selected for Highlights in Endourology & Laparoscopic Surgery, “Changing Practice Patterns in the surgical treatment of kidney disease: Analysis of the ACGME data.” American Urological Association, San Francisco, CA, May 2004. Best Video Award, “Laparoscopic Pyeloplasty”, 15th Video Urology World Congress, Busan, Korea, June 17-19, 2004. Smith Award, presented to the Endourologist who has made the most significant contributions to Minimally Invasive Urology, Robotics, Laparoscopy, Endourology within 10 years of finishing residency. World Congress of Endourology, Shanghai, China, December 2008. American Urological Association Leadership Program, 2010-2011, Southeastern Section. Second Place, Montague Boyd Essay Contest, 2011. Southeastern Section, AUA. “Retrograde Hypothermia via continuous retrograde irrigation: Results in porcine model and initial experience in a series of patients undergoing robotic partial nephrectomy in a solitary kidney.” Philip Dorsey, Brian Richardson, Sarah Conley and Benjamin Lee. 1st Place, Endourological Society Essay Contest, Basic Science Section, Kyoto, Japan, December 3, 2011.“Measuring the Protective Effect of Allopurinol using Isoprostane after Renal Ischemia in an Animal Model. Zijun Wang, Jan Colli, Christopher Keel, and Benjamin R. Lee

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1st Place, Montague Boyd Essay Contest, 2012. Southeastern Section, AUA. “PROTECTIVE EFFECTS OF REDUCING RENAL ISCHEMIA-REPERFUSION INJURY DURING RENAL HILAR CLAMPING: USE OF ALLOPURINOL AS A NEPHROPROTECTIVE AGENT. Christopher Keel, Zijun Wang, Jan Colliand Benjamin R. Lee. Dean of the School of Medicine Award for Excellence in Research and Presentation.Stage Migration of Prostate Cancer Following a National Disaster – Analysis of the Surveillance Epidemiology End Results Database. Sree Harsha Mandava, Ted D. Klein, Jan Colli, Leah E. Grossman, Greg Mitchel, Larry S. Webber, Oliver Sartor, and Benjamin R. Lee, 2012 Best Video: Retrograde cooling for Induction of cold ischemia in a Solitary kidney during Robotic Partial Nephrectomy” Hong Kong, November 10, 2012.

C. Contribution to Science

1. Novel Treatment of Kidney Cancer: Kidney cancer is now the 6th highest incidence of cancer in the United States, and has been steadily rising with 65,150 new cases diagnosed in 2013 with over 13,680 patients dying from this disease. The five-fold increase in incidence is largely due to the advent of better imaging studies. There has been a host of new FDA approved chemotherapeutic agents now approved for treatment of metastatic renal cell carcinoma including tyrosine kinase inhibitors, mTor inhibitors, and monoclonal antibodies. The focus of my work has been to develop Nanotechnology to assess drug delivery combined with gold rod laser ablation to determine if we can improve treatment of renal cell carcinoma. a. James Liu, Benjawan Boonkaew, Jaspreet Arora, Sree Harsha Mandava, Michael Maddox, Srinivas Chava, Cameron Callaghan, Jibao He, Srikanta Dash, Vijay John, and Benjamin R Lee. Comparison of Sorafenib-loaded Poly (Lactic/Glycolic) Acid and DPPC liposome nanoparticles in the in vitro treatment of renal cell carcinoma. J Pharm Sci. 2015 Mar;104(3):1187-96. b. Ujwal S. Patil, Shiva Adireddy, AshvinJaiswal, Sree Mandava, Benjamin R. Lee, and Douglas B. Chrisey. In Vitro/In Vivo Toxicity Evaluation and Quantification of Iron Oxide Nanoparticles. Int J Mol Sci. 2015 Oct 15;16(10):24417-24450. c. Cameron Callaghan, Donna Peralta, James Liu, Sree Mandava, Michael Maddox, Srikanta Dash, Matthew Tarr and Benjamin R. Lee. Combined Treatment of Tyrosine Kinase Inhibitor labelled Gold Nanorod Encapsulated Albumin with Laser Thermal Ablation in a Renal Cell Carcinoma Model, J Pharm Sci, 105:284-292, 2016 d. Jonathan L. Silberstein, Michael Maddox, Phillip Dorsey, Allison Feibus, Raju Thomas, and Benjamin R Lee. Physical models of renal malignancies using standard cross-sectional imaging and three-dimensional printers: A pilot study. Urology. 2014 Aug;84(2):268-73. e. Andonian S, Coulthard T, Smith AD, Singhal PS, Lee, BR. Real-time Quantitation of Renal Ischemia using Targeted Microbubbles: In vivo Measurement of P-selectin expression. J Endourol, 2009 Mar; 23(3): 373-8.

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2. Prostate Cancer: Over the past couple of decades I have been involved in several roles in the development of an understanding and treatment of prostate cancer. My early publications were with Alan Partin and Patrick Walsh and significantly showed that there is a genetic component of benign prostatic disease. My later studies have focused on the treatment with robotic surgery and we have developed several approaches that enhance surgical treatment.

a. Cao B, Liu X, Li J, Xiong Z, Liu S, Wiese T, Fu X, Gu J, Cheng H, Rennie PS, Sartor O, Lee BR, Zhao L, Zhang H, Dong Y.“Downregulation of Androgen Receptor as an Important Mechanism Underlying the Anticancer Action of 20(S)-Protopanaxadiol- aglycone in Prostate Cancer, Int J Cancer. 2013 Mar 15;132(6):1277-87. b. Mei Wang,Hillary Z. Kimbrell, Andrew B. Sholl, David B. Tulman, Katherine N. Elfer, Tyler C. Schlichenmeyer, Benjamin R. Lee, Michelle Lacey, and J. Quincy Brown. High-resolution rapid diagnostic imaging of whole prostate biopsies using video-rate fluorescence structured illumination microscopy. Cancer Res. 2015 Oct 1;75(19):4032-41. c. Boylu U, Oommen M, Raynor M, Lee BR, Thomas R, “Robot assisted Laparoscopic Radical Prostatectomy in patients with previous abdominal surgery: A Novel laparoscopic adhesiolysis technique,” Journal of Endourology, Vol 24(2): p229-32, 2010. PMID: 20039827 d. Pelvic lymph node dissection during laparoscopic/robotic prostatectomy. Han M, Tewari AK, Lee, BR. J Urol. 2011 May;185(5):1667. e. Partin, A.W., Page, W.F., Lee, B.R., Sanda, M.G., Miller, R.N. and Walsh, P.C.: Concordance rates for benign prostatic disease among twins suggest hereditary influence, Urology, 44(5):646-650, 1994. f. Cadeddu, J.A., Pearson, J.D., Lee, B.R., Partin, A.W., Epstein, J.I. and Carter, H.B.: Relationship between changes in prostate-specific antigen and the percent of prostatic epithelium in men with benign prostatic hyperplasia. Urology, 45(5):795- 800, 1995.

3. Innovations Surgical Techniques and Training: My academic research has centered on the development of novel laparoscopic techniques, the physiology of laparoscopy and other minimally invasive techniques.

a. Ost MC, Patel KP, Rastinehad AR, Chu PY, Anderson AE, Smith AD, Lee BR, Pneumoperitoneum with carbon dioxide inhibits macrophage TNF-alpha secretion: An etiology for Transitional Cell carcinoma port site metastasis and Prophylactic Irrigation strategies to decrease Laparoscopic Oncologic Risks,” Journal of Endourology,22(1):105-12, 2008. PMID: 18315481 b. Mandava SH, Liu J, Maddox MM, Woodson B, Thomas R and Lee BR. Stratification of Expert vs Novice Laparoscopists using the Basic Laparoscopic Urologic Sugery (BLUS) Curriculum at a single institution. J Surg Educ. 2015 Sep-Oct;72(5):964-8. c. Andonian S, Coulthard T, Smith AD, Singhal PS, Lee, BR. Real-time Quantitation of Renal Ischemia using Targeted Microbubbles: In vivo Measurement of P-selectin expression. J Endourol, 2009 Mar; 23(3): 373-8. d. Michael Maddox, SreeHarsha Mandava, James Liu, Aaron Boonjindasup, Benjamin R. Lee. Robotic Partial Nephrectomy for Clinical Stage T1b Tumors: Intermediate Oncologic and Functional Outcomes. Clin Genitourin Cancer. 2015 Feb;13(1):94-9.

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e. Vanderbrink BA, Ost MC, Rastinehad AR, Levine MA, Anderson A, Badlani GH, Smith AD, Lee BR, “Laparoscopic versus Open Radical Nephrectomy for the Treatment of Xanthogranulomatous Pyelonephritis: Contemporary Outcome Analysis,”Journal of Endourology. 21(1): 65-70, 2007. PMID: 17263611.

Complete List of Published Articles from Pubmed:

D. Research Support

Ongoing Research Support NIH- R33, R33 CA196457-01 (PI Brown) 8/15/2015-7/31/2018 , Co- investigator.NIH/NCI $945,617 (total costs). Improving biospecimen quality by verifying adequacy at the point-of-acquisition with ex vivo structured illumination microscopy.

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V. DIVISION OF UROLOGY KEN BATAI

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Batai, Ken eRA COMMONS USER NAME (credential, e.g., agency login): KBATAI POSITION TITLE: Research Scientist EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Southern Illinois University, Carbondale BA 05/00 Anthropology University of Illinois at Chicago MA 05/03 Anthropology University of Illinois at Chicago PhD 05/12 Anthropology University of Illinois at Chicago Postdoctoral 08/14 Genetic Epidemiology Health Disparities University of Illinois at Chicago Certificate 08/14 Research

A. Personal Statement As an anthropologist specializing in medical anthropology and anthropological genetics, I am broadly trained to investigate the complex relationship between genomic/biological and social/biological factors. The overarching goal of my research is to understand the interactions of genetic, biological, and social/behavioral factors causing cancer health disparities and identify genomic and behavioral factors that predict cancer progression.

While in graduate program and Cancer Education and Career Development program in University of Illinois at Chicago (UIC) as a postdoctoral research fellow (NCI: 5R25 CA057699), I received a basic training in molecular genetics, including DNA extraction and PCR for DNA amplification, sequencing, and genotyping. However, my work focuses on bioinformatics and statistical genetics. I have experience in sequence alignment and genotyping calling of genome wide association study (GWAS) data. During my training, I also obtained knowledge on genetic and molecular epidemiology, cancer epidemiology, and genetic ancestry. To investigate genomic variation, I utilized various types of population genetics, evolutionary genetics, and statistical genetics software, including program that use computationally intensive maximum likelihood method. In one of past projects, we investigated if IL16 polymorphisms were associated with prostate cancer (PCa). I performed imputation of a genomic region in and around the IL16 gene using African American (AA) PCa GWAS data. We were first to demonstrate the associations between IL16 polymorphisms and PCa in AAs.

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Currently, I have several projects exploring the relationship between behavioral/biological characteristics, tumor molecular profiles, and tumor characteristics. In one project, we are investigating if serum vitamin D influences expression of immune-related genes in normal prostate and prostate tumor tissues from AA and European American (EA) PCa patients. There were only a few studies specifically addressing how the relationship between immune genes and vitamin D affects PCa pathogenesis and progression. Renal cell carcinoma (RCC) also disproportionately affects racial/ethnic minority groups. Hispanic Americans (HAs) and Native Americans (NAs) in Arizona have higher kidney cancer incidence rate than EA, possibly due to lifestyle factors. Despite high burden of RCC in these racial/ethnic minority groups, they are underrepresented in RCC clinical and molecular research. I developed a collaborative research team of urologic oncologist, pathologist, geneticists, and biostatistician to compare clinical and molecular characteristics of RCC between HAs, NAs, and EAs.

a. Batai K, Shah E, Murphy AB, Newsome J, Ruden M, Ahaghotu C, Kittles RA. 2012. Fine-mapping of IL16 gene and prostate cancer risk in African Americans. Cancer Epidemiol Biomarkers Prev 21(11): 2059-2068. PMCID: PMC3493680 b. Batai K, Murphy AB, Nonn L, Kittles RA. 2016. Vitamin D and immune response: implications for prostate cancer in African Americans. Front Immunol 7:53. PMCID: PMC4761841 c. Batai K, Kittles RA. 2016. Can Vitamin D supplementation reduce prostate cancer disparities? Pharmacogenomics 17(10):1117-1120.

B. Positions and Honors Position and Employment 2000 Center for Archaeological Investigation, Southern Illinois University, Carbondale, IL 2002-2011 Teaching Assistant, Department of Anthropology, University of Illinois at Chicago, IL 2006 Adjunct Instructor, Department of Science, Triton College, River Grove, IL. 2009-2011 Research Assistant, Department of Anthropology, University of Illinois at Chicago, IL 2011 Graduate Researcher, Section of Hematology/Oncology, Department of Medicine, University of Illinois at Chicago, IL 2012 Postdoctoral Research Fellow, Section of Hematology/Oncology, Department of Medicine, University of Illinois at Chicago, IL 2012-2014 Postdoctoral Research Fellow, Cancer Education and Career Training Program, Institute for Health Research and Policy, University of Illinois at Chicago, IL 2014- Research Scientist, Division of Urology, Department of Surgery, University of Arizona

Other Experience and Professional Memberships 2007-2012 American Association of Physical Anthropologists 2011- American Society of Human Genetics 2011- American Association of Cancer Research 2013- American Society for Preventive Oncology 2014- Endocrine Society

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KEN BATAI

Honors 1999 Excellence in Anthropology Award, Southern Illinois University, Carbondale 1999 Scholastic Honor Award on Honors Day, Southern Illinois University, Carbondale 1999 Dean’s List, Summer and Fall, Southern Illinois University, Carbondale 2000 Scholastic Honors Award on Honors Day, Southern Illinois University, Carbondale 2004 Provost’s Award, University of Illinois at Chicago 2007 Sigma Xi Grant-in-Aid of Research 2008 University of Illinois at Chicago Department of Anthropology Charles Reed Fund 2011 University of Illinois at Chicago, Graduate Student Council Travel Award 2014 Outstanding Abstract Award, 2014 International Congress of Endocrinology/The Endocrine Society meeting 2014 Scholar-in-Training Award, the 7th American Association for Cancer Research: The Science of Cancer Health Disparities in Ethnic Minorities and Medically Underserved, 2014 (Sponsored by NCI Center to Reduce Cancer Health Disparities) C. Contribution to Science 1. Vitamin D and Prostate Cancer During graduate and postdoc training at UIC, I started working on a project investigating roles of vitamin D in PCa and established collaborations with my former mentor (Dr. Kittles). Currently, I am investigating the role of serum vitamin D and vitamin D pathway genes in PCa risk and PCa aggressiveness in AAs and if biological and behavioral factors modify the associations. I designed genotyping assay and am performing statistical analyses. In our preliminary analysis, we demonstrated that different vitamin D pathway gene polymorphisms predict serum vitamin D levels in AAs and EAs. In our Chicago study participants, low serum vitamin D levels were also associated with increased odds of adverse pathology after undergoing radical prostatectomy as well as prostate volume. We also demonstrated that high vitamin D intake reduced the odds of high risk PCa in AAs and behavioral characteristics that affected serum vitamin D levels, such vitamin D intake, modified the associations between vitamin D receptor polymorphisms and PCa diagnosis.

a. Batai K, Murphy AB, Shah E, Ruden M, Newsome J, Agate S, Dixon MA, Chen HY, Deane LA, Hollowell CMP, Ahaghotu C, Kittles RA. 2014. Common vitamin D pathway gene variants reveal contrasting effects on serum vitamin D levels in African Americans and European Americans. Hum Genet 133(11): 1395-1405. PMCID: PMC4185105 b. Nyame YA, Murphy AB, Bowen DK, Jordan G, Batai K, Dixon M, Hollowell CMP, Kielb S, Meeks JJ, Gann PH, Kajdacsy-Balla A, Catalona WJ, Kittles R. 2016. Associations between serum vitamin D and adverse pathology in men undergoing radical prostatectomy. J Clin Oncol 2016. 34 (12):1345-1349. PMCID: PMC4872348 c. Murphy AB, Nyame YA, Bowen DK, Jordan G, Batai K, Dixon M, Hollowell CMP, Kielb S, Meeks JJ, Gann PH, Kajdacsy-Balla A, Catalona WJ, Kittles R. 2016. Does prostate volume correlate with vitamin D deficiency among men undergoing prostate biopsy? Prostate Cancer Prostatic Dis [Epub ahead of print]. d. Batai K, Murphy AB, Ruden M, Newsome J, Shah E, Dixon MA, Hollowell CMP, Jacobs ET, Ahaghotu C, Kittles RA. 2017. Race and BMI modify associations of calcium and vitamin D intake with prostate cancer. BMC Cancer 17:64.

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2. Genetic Ancestry and Health Disparities Genetic ancestry is a useful tool to assess if the ancestry related genetic and biologic factors play roles in health disparities. However, both gene/biology and environment are risk factors for many complex diseases, and the casual use of “race” to define groups in biomedical research limited understanding of complex disease pathogenesis and risk factors increasing health disparities. Through graduate training in anthropology, I gained understanding of population genetics methods to estimate genetic ancestry, history of admixture in AAs and Hispanic Americans, and interactions of socio-cultural factors and genetics/biology. Using my expertise in genetic ancestry, genetic epidemiology, and population genetics, I was involved in a project investigating relationship between genetic ancestry and breast cancer aggressiveness. Among AA breast cancer patients from Chicago, West African Ancestry was associated with high grade breast cancer in unadjusted model, but not after adjusting for relevant behavioral and social factors.

a. Batai K, Kittles RA. 2013. Race, Genetic ancestry, and health. Race and Social Problems 5(2): 81-87. b. Al-Alem U, Rauscher G, Shah E, Batai K, Mostafa A, Silva A, Peterson C, Kittles RA. 2014. The relevance of genetic ancestry in aggressive breast cancer. PLoS One 9(11): e112916. PMCID: PMC 4244099

3. Human Genomic and Cultural Diversity How cultural practices, such as language and food production technology, population growth, and migration/admixture affected regional genetic variation is still underappreciated. For my dissertation, I utilized various population genetics analytical methods and investigated how these social and cultural factors influenced mitochondrial DNA (mtDNA) sequence variation of African and New World populations. I showed that in East Africa, there was an extensive admixture with local populations after a large scale prehistoric migration by Bantu speakers to the area. On the other hand, intensive food production supported large population size in the Andean region of South America. For my dissertation project, I designed research and performed laboratory experiment (DNA extraction, PCR reaction, and sequencing) and bioinformatic and statistical analysis.

a. Batai K, Babrowski KB, Arroyo JP, Kusimba CM, Williams SR. 2013 Mitochondrial DNA diversity in two ethnic groups in southeastern Kenya: Perspectives from the northeastern periphery of the Bantu expansion. Am J Phys Anthropol 150(3): 482-491. PMCID: PMC3581736 b. Batai K, Williams SR. 2014 Genetic evidence of the Aymara expansion and mitochondrial variation in the central Andes. Am J Hum Biol 26(3): 321-330. PMCID: PMC4289594

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Full List of Published Works: http://www.ncbi.nlm.nih.gov/sites/myncbi/ken.batai.1/bibliography/43275856/public/?sort=date& direction=ascending

D. Research Support Current Support University of Arizona Cancer Center American Cancer Society Institutional Research Grant01/01/2017- Title: Clinical and molecular profiling of renal cell carcinoma toward therapeutic precision in Hispanic and European American patients Role: PI Summary: This project aims to characterize renal cell carcinoma using molecular genomics technology in order to understand racial/ethnic differences and to help predict aggressiveness and treatment outcomes.

Support Pending Arizona Area Health Education Centers Research Grants Title: Identifying barriers and facilitators to cancer screening among Hispanic Americans living in the Sunnyside neighborhood, Tucson, Arizona Amount: $10,000 Role: Principal Investigator

Arizona Area Health Education Centers Research Grants Title: Identification of predictive genetic and histologic markers in the progression of benign prostatic hyperplasia Amount: $10,000 Role: Co-Investigator

Completed Support University of Arizona Cancer Center Precision Health Grant (PI: Kittles) 08/014/2015-08/12/2016 Title: Vitamin D and differential expression of immune-related genes in prostate cancer Role: Co-Investigator Summary: In this pilot project, we investigate if vitamin D alters the relationship between immune gene expression and prostate cancer. I am responsible for development of experimental design, data analysis, and preparing the manuscript.

R25CA057699 (PI: Fitzgibbon) 10/16/2012-08/04/2015 Title: NCI Cancer Education and Career Development Program Role: Postdoctoral Trainee Summary: This is a National Cancer Institute (NIC) funded program that provides trainings in cancer epidemiology, molecular/genetic epidemiology, behavioral and health disparities research, and community based research.

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V. DIVISION OF UROLOGY JOEL FUNK

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Funk, Joel eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Assistant Professor of Clinical Surgery; Chief of Surgery - BUMCS

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Aquinas College, Grand Rapids, Michigan BS 05/1997 Biology Northwestern University Feinberg School of Medicine, MD 06/2001 Doctor of Medicine Chicago, Illinois University of Arizona, Department of General Surgery 06/2003 General Surgery Resident University of Arizona, Division of Urology 06/2007 Urology Resident Cambridge University – Addensbrooke Hospital, Clinical Preceptorship in Holmium Laser Prostate Surgery 04/2009

A. Personal Statement I hold the appointment of Assistant Professor of Urology at the University of Arizona College of Medicine as well as Director of Urologic Surgery and Chief of Surgery at Banner University Medical Center-South Campus. I will serve as primary investigator and mentor for the proposed grant application. My clinical and research efforts are focused on developing novel biomarkers and genetic markers that play a role in the development of benign prostatic hyperplasia and resultant obstructive urinary dysfunction. Moreover, I have clinical research interests and active investigational efforts looking into autologous tissue utilization and surgical techniques to address pelvic organ prolapse in female urology. I am an enthusiastic adopter of new and innovative diagnostic and surgical techniques in the management of both areas. As demonstrated by my published and accepted manuscripts in these areas, it is both a intellectual interest and clinical passion of mine.

B. Positions and Honors

Positions and Employment

2007-2009 Prescott Urology, Ltd, Prescott, Arizona – Private Practice 2009-Present Assistant Professor of Clinical Surgery-Banner University Medical Group 2009-Present Director of Urological Surgery BUMC South 2015-Pesent Chief of Surgery – Banner University Medical Center South

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Honors and Awards Dean’s List, 1993-1997 Sophomore Medical Student Research Scholar, 1999 Alpha Omega Alpha Honor Society, 2001 “Best Tip or Trick” Western Section AUA Annual Meeting, Maui, HI, 2005 Best Poster Award for “Factors Influencing Fluid Intake Among Kidney Stone Patients”, 58th Annual Kimbrough Seminar, Seattle, WA, 2011 Faculty Teaching Award, University of Arizona, Division of Urology, 2011 Faculty Teaching Award, University of Arizona, Division of Urology, 2016

C. Contributions to Science

Scholarly Book Chapters 1. Funk J, Comiter C.; Dynamic MRI in the Evaluation of Pelvic Organ Prolapse; In: Raz and Rodriquez, Ed. Female Urology; 3rd Edition; Elsevier Press 2005

2. Funk J, Ullrich N, Ramakumar S.; Urinary Biomarkers for Urologic Malignancy; In: D. Lamm Ed; Genitourinary Oncology; Marcel Drekker; 2005

3. Funk, J.; Twiss, C. O.; Michalak, J.; Kim, S.; Adult and Pediatric Neuromodulation; Springer International, 2017.

Journal Articles

1. Ramakumar S, Phull H, Funk J, Purves T, Copeland D, Ulreich JB, Lai LW, Lien YH. Novel Delivery of Oligonucleotides using a Topical Hydrogel Tissue Sealant in a Murine Partial Nephrectomy Model. Journal of Urology; 174 (3):1133-6. 2005

2. Phull H, Salkini M, Purves T, Funk J, Copeland D, and Comiter CV. Angiotensin II plays a role in acute murine experimental autoimmune cystitis. BJU International; Sep; 100 (3):664-7. 2007

3. Stern K, Satyanarayan A, Funk, JT.; Recent Advances and Emerging Technology in the Surgical Management of BPH-Related Voiding Dysfunction; Current Bladder Dysfunction Reports.; June; Vol 9, Issue 2: 129-133. 2014

4. Michalak J, Tzou D, Funk JT. HoLEP: The Gold Standard For The Surgical Management of BPH in the 21st Century. Am. Journal Clinical and Experimental Urology: Am J Clin Exp Urol. 2015; 3(1): 36-42.

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Scholarly Presentations Abstract Poster Presentations: 1. John Michalak, Christian Twiss, Matt Gretzer, Jonathan Walker, Joel Funk, “The Impact of Surgical Masks on the Rate of Postoperative Urinary Tract Infection After Cystoscopic Urologic Surgery” World Congress of Endourology Annual Meeting Cape Town, South Africa, November 2016

2. John Michalak, Christian Twiss, Matt Gretzer, Jonathan Walker, Joel Funk, “Mask Use in Endoscopy and Cystoscopy, Do They Affect Infection Rates? Western Section American Urological Society Annual Meeting, Kauai, HI, October 2016

1. Hina Arif Mumtaz, Bobby Kalb, Joel Funk, Diego Martin, Christian Twiss, “Comparison of Defocography Phase to Non-Defocography Valsalva Maneuver in Dynamic Pelvic Floor MRI.” Canadian Annual Radiology Meeting, April 14-17, 2016.

2. Elizabeth Tourville E, Joel Funk, Christian Twiss, “Validation of the SEAPI-S Questionnaire” Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction Winter Meeting, Scottsdale, AZ, February 2015.

3. AJ Dyer, Arthi Satyanarayan, Joel Funk, Christian Twiss, “Comparison of Success and Complication Rates of the Distal Urethral Polypropylene Sling (DUPS) and the MiniArc Sling for Female Stress Incontinence.” Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction Meeting, Miami, FL, February 2014.

4. Hina Arif Mumtaz, Bobby Kalb, Joel Funk, Diego Martin, Christian Twiss, “Addition of a Defecography Phase to Dynamic Pelvic MRI Enhances Detection and Visualization of Pelvic Organ Prolapse.” Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction Meeting, Miami, FL, February 2014.

5. Hina Arif Mumtaz, Bobby Kalb, Joel Funk, Diego Martin, Christian Twiss, “Addition of a Defecography Phase to Dynamic Pelvic MRI Enhances Detection and Visualization of Pelvic Organ Prolapse.” American Urological Association Meeting, Orlando, FL, May 2014.

Peer Reviewed Abstract Presentations

10/2012 “Use of Holmium Laser for Urolume Stent Removal”, DVD session, Western Section American Urological Association Annual Meeting, Waikoloa, Hawaii. 10/2012 “Transurethral Laser Excision of Mid-urethral Sling Erosion and Associated Massive Bladder Calculus”, Western Section American Urological Association Annual Meeting, Waikoloa, Hawaii

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V. DIVISION OF UROLOGY MATTHEW GRETZER

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Gretzer, Matthew B eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Associate Professor of Surgery EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of Colorado, Boulder, Colorado BS 12/1992 Biological Sciences University of Texas Health Science Center, San Antonio, MD 05/1998 Doctor of Medicine Texas Johns Hopkins Hospital, Baltimore, Maryland 06/1999 General Surgery Internship Johns Hopkins Hospital, Baltimore, Maryland 06/2000 General Surgery Resident James Buchanan Brady Urological Institute, Johns Hopkins 06/2004 Urology Resident Hospital, Baltimore, Maryland Johns Hopkins Brady Urological Institute, Baltimore, Maryla 06/2005 Instructor of Urology Advanced Specialty Training, GU Reconstruction/Pelvic Laparoscopy/Robotic Surgery

A. Personal Statement I hold the appointment of Associate Professor of Clinical Urology at the University of Arizona College of Medicine. My area of expertise is Genitourinary Trauma and Reconstruction. To date, my primary academic mission has been directed at education of medical students and residents. I was a co-investigator in the Phase 3 clinical trial investigating the efficacy and safety of the Adjustable continence device for men with post-prostatectomy incontinence. I have also participated in multicenter review of outcomes in men undergoing artificial urinary sphincter following radiation therapy for prostate cancer.

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B. Positions and Honors

Positions and Employment

1/1992 - 6/1994 University of Texas, MD Anderson Cancer Center, Department of Diagnostic Imaging, Houston, Texas Department of Diagnostic Imaging, Houston, Texas 6/2001 - 12/2002 Urology Research, Alan W. Partin, M.D., Ph.D./Robert Veltri, Ph.D., Tumor Markers/PSA, Clinical Trials for Microwave Therapy, Prostate Cancer Outcomes 7/2004 - 6/2005 Johns Hopkins Brady Urological Institute, Baltimore, Maryland, Instructor of Urology 6/2005 - Current University of Arizona College of Medicine, Tucson, Arizona, Associate Professor of Surgery 10/2007 - 6/2009 UPH Hospital at Kino Campus, Tucson, Arizona, Urology Residency Site Director 10/2006 - 6/2009 UPH Hospital at Kino Campus, Tucson, Arizona, Medical Director of Urology

Honors and Awards • Undergraduate Research Opportunity Award, 1990 • University of Colorado at Boulder, Boulder, Colorado; Awarded grant to develop method for measurement of dissolved organic nitrogen in aquatic ecosystems. 1990 • Golden Key National Honor Society, University of Colorado at Boulder, Boulder, Colorado. 1991 • Dean’s List, University of Colorado at Boulder, Boulder, Colorado. 1989 – 1992 • Microscopic Anatomy Honors Award, University of Texas Health Science Center, San Antonio, Texas. 1995 • Alpha Omega Alpha Honor Medical Society; Elected as Junior Medical Student; University of Texas, San Antonio, Texas 1997 • Gerald P. Murphy Scholar in Prostate Cancer; 2002 Annual Meeting of the AUA. • AUA/ACMI Essay Contest, Laboratory Research 3rd Prize; 2003 Annual Meeting of the AUA. • General P. Murphy Scholar in Prostate Cancer; 2004 Annual Meeting of the American Urological Association. • American Board of Urology: Diplomat; 2007 • American College of Surgeons: Fellow; 2008 • University of Arizona Division of Urology Resident Teaching Award; 2010 • University of Arizona Division of Urology Resident Teaching Award; 2014 • Castle Connely Top Doctor 2013,1015,2016

C. Contributions to Science Scholarly Book Chapters

1. Gretzer, M.B. and Partin A.W.: Kavoussi, L.R., Novick, A.C., Partin, A.W., Peters, C.A. (eds), Prostate Cancer Tumor Markers. Campbell’s-Walsh Urology. 9th ed. Chapter 93. 2896-2911. 2007. 2. Gretzer, M.B.: Benign Prostatic Hyperplasia. In Parson, K. and Wright, E.G. (eds), Brady Urology Manual 1st Edition, pp. 71-84, 2006 3. Gretzer, M.B., Partin, A.W., and Chan, D.Y.: Lower Urinary Tract Symptoms and BPH. In Moore, R.G., Bishoff, J.T., Loening, S. and Docimo, S.G. (eds), Minimally Invasive Urologic Surgery, Taylor & Francis, London and New York, pp. 351-373, 2004.

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4. Gretzer, M.B. and Wright, E.J.: Use of Cadaveric Fascia Lata Allograft for Pubovaginal Slings. In Vasavada, S.P., Appell, R.A., Sand, P.K., Raz, S.R. (eds), Female Urology, Urogynecology, and Voiding Dysfunction, Marcel Dekker, New York, pp. 353-361, 2004.

Journal Articles

1. Dyer, A., Sadow, P., Bracamonte, E., Gretzer, M. Immunoglobulin G4-related Retroperiotoneal Fibrosis of the Pelvis. Reivews in Urology. 15(2): 92-94, 2014. 2. Nguyen MM, Ahmann FR, Nagle RB, Hsu CH, Tangrea JA, Parnes HL, Sokoloff MH, Gretzer MB, Chow HH. Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: evaluation of potential chemopreventive activities. Cancer Prevention Research (Philadelphia, Pennsylvania). Feb;5(2):290-8. 2012. 3. Sroka I, Anderson T, McDaniel K, Nagle R, Gretzer MB, and Cress A. The Q1 Laminin Binding Integrin alpha-6-beta1 in Prostate Cancer Perineural Invasion. Journal of Cellular Physiology, 2010. 4. Malik G, Rojahn E, Ward MD, Gretzer MB, Partin AW, Semmes OJ, Veltri RW. SELDI protein profiling of dunning R-3327 derived cell lines: identification of molecular markers of prostate cancer progression. The Prostate. 2007;67(14):1565–75.

Abstracts/Research Presentation

1. Haney, N.; Chiang, J.; DeLay, K.; Stewart, C.; Yafi, F.; Angermeier, K.; Lacey, J.; Wood, H.; Boone, T.; Kavanagh, A. G.; Gretzer, M.; Boyd, S.; Doyle, J.-L.; Hellstrom, W.; Comparison of Adjuvant Radiation Therapy Before or After Artificial Urinary Sphincter Placement: A Multi-Institutional Analysis. Southeastern Section AUA 2017, 2017. 2. Funk, J. T.; Walker, J. R.; Matthew, G.; Twiss, C. O.; Michalak, J.; The Impact of Surgical Masks on the Rate of Postoperative Urinary Tract Infection after Cystoscopic Urologic Surgery. 34th World Congress of Endourology, 2016. 3. Reyblat PX, Nash S, Gilling P, Gretzer M, Rose M, Pommerville P, Slutsky J, Siegel S, Samowitz H, Tu LM. Three-Year Follow-Up on 81 Patients with a New Post-Operatively Adjustable Long-term Implant for Post Prostatectomy Stress Incontinence: ProACT. Submitted for ACA 2017

Work in Progress

Outcomes assessment in men following urethroplasty. Fluid dynamics and morphological assessment of voiding before and after management of urethral stricture.

D. Additional Information: Research Support and/or Scholastic Performance

Initial development and maintenance of weekly didactic session for urology residents. Participation in medical school clerkship lectures

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V. DIVISION OF UROLOGY CHRISTIAN TWISS

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Twiss, Christian O eRA COMMONS USER NAME (credential, e.g., agency login): ctwiss POSITION TITLE: Associate Professor of Surgery EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Brown University, Providence, RI AB 05/1995 Biology New York University School of Medicine, New York, NY MD 05/2000 Doctor of Medicine

New York University Medical Center, New York, NY 07/2002 General Surgery Residency New York University Medical Center, New York, NY 06/2006 Urology Residency

University of California, Los Angeles, Los Angeles, CA 07/2008 Fellow

A. Personal Statement I am currently an Associate Professor of Surgery and Director of Female Pelvic Medicine and Reconstructive Surgery at the University of Arizona College of Medicine. My work is currently focused on outcomes associated with vaginal mesh removal and on the nature of vaginal mesh complications. I have developed and I am collecting outcomes data on several novel non-mesh surgical techniques utilizing autologous fascia lata to treat pelvic organ prolapse in mesh-injured patients and in patients who do not desire vaginal mesh implants. I am also involved in several ongoing collaborative projects with my colleagues in radiology on the use of dynamic pelvic MRI in the evaluating patients with pelvic organ prolapse.

B. Positions and Honors Positions and Employment

6/2000-7/2002 General Surgery Resident, New York University Medical Center, New York, NY 7/2002-6/2006 Urology Resident, New York University Medical Center, New York, NY 6/2006-7/2008 Fellow in Female Urology and Female Pelvic Medicine and Reconstructive Surgery, University of California, Los Angeles, Los Angeles, CA

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7/2008-6/2013 Assistant Professor of Surgery, Director of Female Urology, Pelvic Medicine, and Pelvic Reconstructive Surgery University of Arizona College of Medicine, Tucson, AZ 7/2013-Current Associate Professor of Surgery, Director of Female Urology, Pelvic Medicine, and Pelvic Reconstructive Surgery, University of Arizona College of Medicine, Tucson, AZ Honors and Awards

• Magna Cum Laude with Honors, Brown University,1995 • Valentine Mott Medal, 1997 • NYU Urology Award, 2000 • Alpha Omega Alpha National Medical Honor Society, 2000 • Pfizer Scholar in Urology, 2004 • Praecis/AUA Gerald P. Murphy Scholars Program, 2005 • American Urogynecologic Society Foundation Research Grant Awardee, Project Title: LAMC-1 as a Predictor of Pelvic Organ Prolapse, 2006 • AUA Annual Meeting Best of Posters Award, 2007 • International Continence Society Award for Best Science Presentation, 2007 • Faculty Teaching Award, University of Arizona Division of Urology, 2012

C. Contributions to Science 1. New Surgical Techniques. Autologous fascia has historically been used as a urethral sling to treat female stress incontinence with good long term success. Given the problems associated with vaginal mesh, we have developed a new technique to harvest autologous fascia lata and utilize it as a graft for the treatment of pelvic organ prolapse. This technique can be used to treat cystocele, apical prolapse and rectocele.

Twiss C., Craig M., Lin F., Funk J. Total Autologous Fascia Lata Anterior Repair and Apical Suspension: A New Technique. SUFU Meeting, Scottsdale, AZ and AUA Meeting, Boston, MA, 2017.

2. Evaluation of Pelvic Organ Prolapse. We have demonstrated that addition of a defecography phase to dynamic pelvic MRI significantly improves the detection of pelvic organ prolapse. Additionally, our work has shown that dynamic pelvic MRI provides the most useful information in the evaluation for enteroceles which may not be apparent on physical examination and could potentially affect preoperative decision-making and counseling.

Lin F., Arif Tiwari H., Kalb B., Funk J., Twiss C. Dynamic Pelvic MRI in the Evaluation of Pelvic Organ Prolapse and Correlation with Physical Exam Findings. SUFU Meeting, Scottsdale, AZ and AUA Meeting, Boston, MA, 2017

Arif Mumtaz H, Kalb B, Funk J, Martin D, Twiss C. “Addition of a Defecography Phase to Dynamic Pelvic MRI Enhances Detection and Visualization of Pelvic Organ Prolapse.” SUFU Meeting, Miami, FL, 2014.

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3. The Nature of Bladder and Pelvic Pain. The findings of heightened startle reflex in patients suffering from painful bladder syndrome supports the hypothesis that there is a connection between the limbic pain centers and chronic visceral pain. This provides a conceptual framework for the use of anti-depressants and other agents modulating the limbic pain centers in the treatment of chronic visceral pain. This work won Best Science Presentation at the 2007 International Continence Society Meeting and a Best of Posters Award at the 2007 American Urological Association Meeting.

Twiss C., Kilpatrick L., Craske M., Buffington T., Ornitz E., Rodriguez L., Mayer E. A., Naliboff B. D. Increased Startle Responses in Interstitial Cystitis: Evidence for Central Hyperresponsiveness to Visceral-Related Threat. J Urol, 181: 2127-33, 2009.

Journal Publications Michalak J., Lin F, and Twiss C. Preoperative Evaluation and Optimization of the 2016 Geriatric Urologic Patient. Urol Practice, 2016, In Press Brown C., Onyishi S., and Twiss C. Detrusor Underactivity and Detrusor Hyperactivity 2014 with Impaired Contractility. Curr Bladder Dysfunct Rep, 9: 341-9, 2014. Onyishi S. and Twiss C. Pressure Flow Studies in Men and Women. Urol Clin North 2014 Am, 41: 453-67, 2014. Dyer A.J. and Twiss C. Painful Bladder Syndrome: An Update and Review of Current 2014 Management Strategies. Curr Urol Rep, 15: 384-94, 2014. Dyer J, Funk J, Twiss C. Endoscopic Removal of Urolume Urethral Stent with High 2013 Power Holmium Laser. Videourol, 27(6), 2013. Twiss C., Triaca V., Anger J., Patel M., Smith A., Kim JH., Raz S., Rodriguez L.V. 2009 Validating the Incontinence Symptom Severity Index: A Self-Assessment Instrument for Voiding Symptom Severity in Women. J Urol, 182: 2384-91, 2009 Twiss C., Kilpatrick L., Craske M., Buffington T., Ornitz E., Rodriguez L., Mayer E. A., 2009 Naliboff B. D. Increased Startle Responses in Interstitial Cystitis: Evidence for Central Hyperresponsiveness to Visceral-Related Threat. J Urol, 181: 2127-33, 2009. Wang L., Zou X., Berger A. D., Twiss C., Peng Y., Li Y., Chiu J., Guo H, Satagopan J., 2009 Wilton A., Gerald W., Basch R., Osman I., Lee P. Increased expression of histone deacetylaces (HDACs) and inhibition of prostate cancer growth and invasion by HDAC inhibitor SAHA. Am J Translat Res, 1: 62, 2009. Twiss C. and Raz S. Complications of Synthetic Mid-Urethral Slings. Issues in Incont, 2008 Spring Issue, 2008. Twiss C. and Rodriguez, LV. Female Stress Urinary Incontinence—Where are We? J 2008 Urol, 179: 1664-5, 2008 Twiss C., Triaca V., Bergman J., Rodriguez LV. The Epidemiology, Social Burden, 2008 and Genetics of Pelvic Organ Prolapse. Curr Bladder Dysfunc Rep. Curr Bladder Dys Rep, 3: 90-94, 2008. Twiss C., Triaca V., Rodriguez LV. Familial Transmission of Urogenital Prolapse and 2007 Incontinence. Curr Opin Ob Gyn, 19: 464, 2007. Triaca V., Twiss C., and Raz S. The Posterior Compartment: Evaluation and 2007 Functional Outcomes after Surgical Repair. Curr Bladder Dysfunct Rep, 2:205-13. Twiss C., Fischer M., Nitti V. Comparison between reduction in 24-hour pad weight, 2007 International Consultation on Incontinence-Short Form (ICIQ-SF) score, International Prostate Symptom Score (IPSS), and Post-Operative Patient Global Impression of Improvement (PGI-I) score in patient evaluation after male perineal sling. Neurourol Urodyn, 26: 8, 2007.

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Triaca V., Twiss C., Raz S. Urethral Compression for the Treatment of 2007 Postprostatectomy Urinary Incontinence: Is History Repeating Itself? Eur Urol, 51: 304, 2007. Twiss C., Fleischmann N., Nitti V. Correlation of Abdominal Leak Point Pressure with 2005 Objective Incontinence Severity in Men with Post-Prostatectomy Stress Incontinence. Neurourol and Urodyn, 24: 207, 2005. Huackabay C., Twiss C., Berger A., Nitti V.W. A Urodynamics Protocol to Optimally 2005 Assess Men with Post-Prostatectomy Incontinence. Neurourol and Urodyn, 24: 622, 2005. Twiss C., Slova D., Lepor H. Outcomes for Men Under 50 Years of Age Undergoing 2005 Radical Prostatectomy: A Rationale for Earlier PSA Screening. Urol, 66: 141, 2005. Twiss C., Martin S., Shore R., and Lepor H. A Continence Index Predicts the Return 2000 of Urinary Continence Following Radical Retropubic Prostatectomy. J Urol, 164: 1241, 2000. Twiss C., and Grasso M. Abdominal Pain Associated with an Intra-Abdominal Gonad 2000 in an Adult. Rev Urol, 2: 178, 2000.

Book Chapters

Michalak J, Kim S, Funk J, Twiss C. Sacral Neuromodulation for Overactive Bladder. 2017 Adult and Pediatric Neuromodulation. Eds. Alpert S. and Gilleran J. Springer International, 2017 Raz S., Twiss C., and Triaca V. Bulbocavernosus Muscle and Fat Pad Supplement. 2012 Hinman’s Atlas of Urologic Surgery, 3rd Ed. Eds. Joseph Smith, Stuart Howards, and Glenn Preminger. Elsevier Saunders, 2012. Twiss C., Triaca V., Konijeti R., Raz S. “Surgery for Pelvic Floor Relaxation.” Textbook 2008 of Reconstructive Urologic Surgery. Eds. Drogo Montague, Inderbir Gill, Jonathan Ross, and Kenneth W. Angermeier, Informa Press, 2008. Twiss C. and Rosenblum N. “Perineal Hernia and Perineocele.” Female Urology, 3rd 2008 Edition. Eds. Shlomo Raz and Larissa Rodriguez, Saunders Press, 2008.

Proceedings and Invited Lectures

Panelist, Point-Counterpoint Debate, AUA Plenary Session, Boston, MA 2017 • Crossfire: Controversies in Urology: Vaginal Mesh Should be Removed by Radical Meshectomy Moderator, Fellows Forum, SUFU Meeting, Scottsdale, AZ 2017 Faculty, Course Director, Western Section AUA, Indian Wells, CA 2015 • Prep-C Course “Female Pelvic Medicine” Panelist, Point-Counterpoint Debate, SUFU General Session, Scottsdale, AZ 2015 • “Radiological Evaluation of SUI and Pelvic Prolapse—Is it Necessary?” Faculty, SUFU Basic Urodynamics Course, Miami, FL • “Voiding Phase Dysfunction and Neurogenic Bladder” 2014 Faculty, SUFU Fellows Forum, Miami, FL 2014 • “Starting an Academic Practice” Faculty, 23rd Annual Southwestern Conference on Medicine, Tucson, AZ 2014 • “Incontinence and Overactive Bladder for Primary Care Physicians” Moderator, Male Incontinence/NGB/BPH Session, SUFU Meeting, Las Vegas, NV 2013

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Panelist, Point-Counterpoint Debate, Western Section AUA, Monterey, CA 2013 • “Urodynamics for Stress Incontinence: Do They Matter?” Panelist, State-of-the-Art Lecturer, Western Section AUA, Hawaii, HI 2012 • “Synthetic Mesh vs. Biologic Slings for Treatment of Stress Incontinence” Moderator, Pelvic Floor Medicine Session, Western Section AUA, Vancouver, BC 2011 Faculty, Course Director, Western Section AUA Meeting, Hawaii, HI 2010 • Prep-C Course, “Female Urology” Moderator, IC/Pelvic Pain/BPH Session, SUFU Meeting, Phoenix, AZ 2009 Guest Faculty, North Central Section AUA Meeting 2009 • “Neuromodulation in Patients with Neurologic Disease”

Recently Accepted Abstracts

Twiss C., Craig M., Lin F., Funk J. Total Autologous Fascia Lata Anterior Repair and 2017 Apical Suspension: A New Technique. SUFU Meeting, Scottsdale, AZ and AUA Meeting, Boston, MA Lin F., Arif Tiwari H., Kalb B., Funk J., Twiss C. Dynamic Pelvic MRI in the Evaluation 2017 of Pelvic Organ Prolapse and Correlation with Physical Exam Findings. SUFU Meeting, Scottsdale, AZ and AUA Meeting, Boston, MA Michalak J, MD, Bruno EH, Walker JR, Twiss C, Gretzer MB, Funk, J. “Impact of 2016 Surgical Masks on the Rate of Postoperative Urinary Tract Infection after Cystoscopic Urologic Surgery.” Western Section AUA Meeting, Kuai, HI. Arif Mumtaz H, Kalb B, Funk J, Martin D, Twiss C. “Comparison of Defocography 2016 Phase to Non-Defocography Valsalva Maneuver in Dynamic Pelvic Floor MRI.” Canadian Annual Radiology Meeting, Montreal, Canada. Poster. Tourville E, Funk J, Twiss C. “Validation of the SEAPI-S Questionnaire.” SUFU 2015 Meeting, Scottsdale, AZ. Non-moderated Poster. Dyer AJ, Satyanarayan A, Funk J, Twiss C. “Comparison of Success and Complication 2014 Rates of the Distal Urethral Polypropylene Sling (DUPS) and the MiniArc Sling for Female Stress Incontinence.” SUFU Meeting, Miami, FL. Non-moderated Poster. Arif Mumtaz H, Kalb B, Funk J, Martin D, Twiss C. “Addition of a Defecography Phase 2014 to Dynamic Pelvic MRI Enhances Detection and Visualization of Pelvic Organ Prolapse.” SUFU Meeting, Miami, FL. Non-Moderated Poster, AUA Meeting, Orlando, FL, Podium Presentation.

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VI. DIVISION OF VASCULAR & ENDOVASCULAR SURGERY WEI ZHOU

BIOGRAPHICAL SKETCH

NAME POSITION TITLE Wei Zhou, MD Professor of Surgery EDUCATION/TRAINING INSTITUTION AND LOCATION DEGREE YEAR(s) FIELD OF STUDY University of California – San Diego, CA B.S. 1994 Biochemistry/Cell Bio. New York Medical College, NY M.D. 1994-1998 Medicine University of California-San Diego, CA M.D. 1998-2003 Surgery Residency Baylor College of Medicine, Houston, TX M.D. 2003-2005 Vascular Surgery

A. Personal Statement Over the last decade, I have established a strong translational research program for mechanistic investigation of atherosclerosis and a robust clinical research paradigm to improve clinical outcomes of vascular interventions. As the chief of vascular service, I have a broad experience in clinical practice with a focus on carotid artery disease management and carotid interventions. My research team focuses on systemic and imaging biomarkers predicting long-term neurocognitive function following carotid interventions using advanced imaging techniques and analytical tools through collaboration with multiple specialties and institutions. Our research efforts have led to several funded proposals and >100 publications, through which we have advanced our knowledge in atherosclerosis and atherosclerotic complications. The current application aligns perfectly with my prior work with a realistic research plan, timeline, and budget. a. Hitchner E, Baughman BD, Soman S, Long B, Rosen A, Zhou W. Microembolization is associated with transient cognitive decline in patients undergoing carotid interventions. Journal of Vascular Surgery, 2016.06.104. [Epub ahead of print]. PMID: 27633169 b. Soman S, Prasad G, Hitchner E, Massaband P, Moseley M, Zhou W, Rosen A. Brain Structural Connectivity Distinguishes Patients at Risk for Cognitive Decline after Carotid Interventions. Human Brain Mapping, 2016;37(6):2185-94. PMID: 27028955 c. Zuniga MC, Tran TB, Baughman BD, Raghuraman G, Hitchner E, Rosen A, Zhou W. A Prospective Evaluation of Systemic Biomarkers and Cognitive Function Associated with Carotid Revascularization. Ann Surg. 2016, 264(4): 659-65. PMID: 27433899 d. Zhou W, Baughman BD, Soman S, Wintermark M, Lazzeroni LC, Hitchner E, Bhat J, Rosen A. Volume of Subclinical Embolic Infarct Correlates to Long-term Cognitive Changes following Carotid Revascularization. Journal of Vascular Surgery (In Press) e. Zhou W. Hitchner E, Gillis K, Sun L, Floyd R, Lane B, Rosen A. Prospective Neurocognitive Evaluation of Patients Undergoing Carotid Interventions, Journal of Vascular Surgery, 2012, 56(6):1571-8. PMCID: PMC3508143

B. Positions and Honors

Positions and Employment 8/05 - 7/07 Assistant Professor of Surgery, Baylor College of Medicine, Houston, TX 8/05 - 7/07 Staff Surgeon, Michael E. DeBakey VA Medical Center, Houston, TX

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10/05 - 5/07 Associate Program Director, Vascular Surgery, Baylor College of Medicine 1/06 - 7/07 Director, Vascular Laboratory, Michael E. DeBakey VA Medical Center 7/07 - 6/12 Associate Professor of Surgery, Stanford University, Stanford, CA 7/07 -12/16 Chief, Vascular Surgery, VA Palo Alto Health Care System, Palo Alto, CA 7/12 -12/16 Professor of Surgery, Stanford University, Stanford, CA 1/17-present Professor and Chief of Vascular Surgery, University of Arizona, Tucson

Honors/Awards 2004 Molecular Surgeon Young Investigator Research Award, BCM 2006 Molecular Surgeon Faculty Research Achievement Award, BCM 2010 Stanford Faculty Fellowship Program 2010 Stanford Leadership Development Program 2013 American College of Surgeons Australia/New Zealand Traveling Fellowship 2013 Association for Academic Surgery/Taiwan Surgical Society Visiting Professorship 2013 VA National Surgery Advisory Board 2014 Ad Hoc Grant Reviewer, NIH special Emphasis Panel (ZHL1 CSR) 2015 Ad Hoc Grant Reviewer and Chair, AHA BSI study section

Other Experience and Professional memberships 2003 American College of Surgeons, Scholarship Committee (2016-present) 2005- Vascular and Endovascular Surgical Society, Industry Relationship Committee, Chair (2007-2009); Woman and Diversity Committee, Chair (2012-2014) 2005 Association for Academic Surgeons, Education Committee, Chair (2012- 2014) 2006- Society of Vascular Surgeons: Clinical research and Comparative Effective Committee (2010- present), Chair (2013-2016); VA surgeon’s Committee, Vice Chair (2015-present) 2006 Society for University Surgeons, Education Committee (2012-2014) 2007 American Heart Association, member 2013 American Surgical Association, member 2014- AHA – Grant Reviewer, Surgery-Bsc Committee (Chair)

C. Contributions to Science

1. Cardiovascular interventions are frequently required to prevent atherosclerosis- associated morbidities and mortalities. However, the long-term benefits of these procedures are markedly compromised by intimal hyperplasia, a delayed complication leading to recurrent stenosis (restenosis) in up to 70% of patients despite initial technical successes. Strategies of preventing restenotic complications are imperative in improving the long-term outcome of cardiovascular interventions. My research lab focuses on understanding the risk factors and molecular mechanisms of intimal hyperplasia. We have identified PKCε modification as a potential therapy in reducing risk factor-induced vascular cell dysfunction and subsequently re-stenosis. Our modified wire-injury model mimics real life vascular intervention. This body of work improves our understanding of intimal hyperplasia and reveals potential strategies to improve the clinical outcome of vascular interventions. I am the principle investigator who conceived the ideas, supervised the designs and progresses of these studies.

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a. Chai H, Dong Y, Wang X, Zhou W. Ginsenoside Rb1 attenuates homocysteine- augmented guidewire injury-induced intimal hyperplasia in mice. Journal of Surgical Research 2009, 157(2):193-8. PMID: 19041102 b. Chai H, Schultz, G, Aghaie K, Zhou W. In vivo assessment of the effects of ginsenoside Rb1 on intimal hyperplasia in ApoE knockout mice. Journal of Surgical Research 2010, 162(1): 26-32. PMCID: PMC2885510 c. Ding Q, Chai H, Mahmood N, Tsao J, Mochly-Rosen D, Zhou W. Matrix Metalloproteinases Modulated by PKCε Mediate Resistin-Induced Migration of Human Coronary Artery Smooth Muscle Cells, Journal of Vascular Surgery 2011; 53(4):1044-51. PMCID: PMC3538810 d. Ding Q, Tsao J, Chai H, Mochly-Rosen D, Zhou W. Therapeutic Potential for Protein Kinase C Inhibitor in Vascular Restenosis. Journal of Cardiovascular Pharmacology and Therapeutics 2011 Jun; 16(2):160-7. PMID: 21183728 e. Raghuraman G, Zuniga MC, Yuan H, Zhou W. PKCε mediates resistin-induced NADPH oxidase activation and inflammation leading to smooth muscle cell dysfunction and intimal hyperplasia. Atherosclerosis 2016; 253: 29-37. PMID: 27573736 2. Bench top research often has limited clinical relevance due to lack of clinical translation. As a clinician scientist, I have adapted a more patient-driven approach to study atherosclerosis and atherosclerotic complications. The publications reflect my effort to understanding disease process in a more clinically relevant setting. Recognizing the roles of inflammatory mediators within plaques from different anatomical locations helps us to understand the pathogenesis of various atherosclerotic lesions and enables us to provide lesion-directed target therapy. Understanding various vascular smooth muscle cells-macrophages co-culture systems helps researchers to examine individual cellular function in a more clinically relevant environment, which promotes translational potential of bench top research. I am the PI for all the studies. a. Zhou W, Chai H, Ding R, Lam HY. Distribution of Inflammatory Mediators in Carotid and Femoral Plaques. Journal of the American College of Surgeons 2010, 211(1): 92- 8: PMID: 20610254 b. Chai H, Aghaie K, Zhou W. Soluble CD40 Ligand Induces Human Coronary Artery Smooth Muscle Cells Proliferation and Migration. Surgery 2009, 146(1): 5-11. PMID: 19541004 c. Zuniga M, White S, Zhou W. Design and utilization of macrophage and vascular smooth muscle cell co-culture systems in atherosclerotic cardiovascular disease investigation. Vascular Medicine, 2015, 19 (5), 394-406. PMID 25204605 d. Raghuraman G, Hsiung J, Zuniga MC, Baughman BD, Hitchner E, Guzman RJ, Zhou W. Eotaxin Augments Calcification in Vascular Smooth Muscle Cells. J Cell Biochem. 2016 Sep 28. doi: 10.1002/jcb.25752. [Epub ahead of print]. PMID: 27681294 3. Although carotid intervention is proven to be safe and effective in stroke prevention, procedure- related subclinical microembolization is common in up to 70% of patients despite absence of clinical symptoms. The clinical significance of microemboli has not been systematically assessed and their long-term effects on cognitive function are largely unknown. To elucidate these important issues, I assembled a multi-disciplinary team including vascular specialists, neurologists, neuroradiologists, neuropsychologists, psychiatrists, and cardiologists at four academic institutions with complementary expertise in carotid disease management, neuroimaging, neurocognitive function, and biostatistics. Our multidisciplinary team over the last five years has significantly contributed to our understanding of carotid disease and outcomes of carotid interventions. I am the PI for all the relevant projects.

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a. Zhou W, Dinishak D, Lane B, Hernandez-Boussard T, Bech F, Rosen A Long-term radiographic outcomes of microemboli following carotid interventions. J Vasc Surg. 2009 Dec;50(6):1314-9. PMID: 19837533 b. Hitchner E, Zayed MA, Lee G, Morrison D, Lane B, Zhou W. Intravascular Ultrasound as a Clinical Adjunct for Carotid Plaque Characterization. Journal of Vascular Surgery 2014, 59(3):774-80. PMCID: PMC3937765 c. Casey K, Hitchner E, Lane B, Zhou W. Series on Contralateral Microemboli Following CAS in Patients with Occluded ICA. Journal of Vascular Surgery, 2013; 58(3): 794-797 d. Zhou W, Zareie R, Tedesco N, Gholibeikian S, Lane B, Hernandez-Boussard T, Rosen A. Risk Factors Predictive of CAS-associated Subclinical Microemboli. Internal Journal of Angiology 2011; 20(1):025-32 e. Tedesco MM, Dalman RL, Zhou W, Coogan SM, Lane B, Lee JT. Reduction of postprocedure microemboli following retrospective quality assessment and practice improvement measures for carotid angioplasty and stenting. J Vasc Surg. 2009, 49(3): 607-12 4. As a clinician, I am intimately involved in patient care. With a large population of elderly diabetic patients with cardiovascular diseases in my VA practice, I am committed to improve diabetic management and minimize intervention-related complications. These publications reflect my efforts and commitments to decrease complications and improve long-term outcomes of vascular interventions. This body of work has led to significant changes in clinical managements of vascular diseases. a. Zhou W, Reardon M, Peden EK, Lin PH, Lumsden AB. Hybrid Approach to Complex Thoracic Aortic Aneurysms in High Risk Patients: Surgical Challenges and Clinical Outcomes. Journal of Vascular Surgery, 2006, 44(4): 688-93 b. Zhou W, Felkai DD, Evans M, McCoy SA, Lin PH, Kougias P, El-Sayed HF, and Lumsden AB. Ultrasound Criteria for Severe In-Stent Restenosis Following Carotid Artery Stenting. Journal of Vascular Surgery 2008; 47(1):74-80 c. Zhou W, Blay E, Varu V, Ali S, Jin M, Sun L, Joh J. Outcome and Clinical Significance of Delayed Endoleaks Following Endovascular Aneurysm Repair. Journal of Vascular Surgery, 2014; 59(4):915-20 d. Lal BK, Zhou W, Li Z, Kyriakides T, Matsumura J, Lederle FA, Freischlag J; OVER Veterans Affairs Cooperative Study Group. Predictors and outcomes of endoleaks in the Veterans Affairs Open Versus Endovascular Repair (OVER) Trial of Abdominal Aortic Aneurysms. J Vasc Surg. 2015 Dec; 62(6):1394-404

Complete List of Published Work in MyBibliography http://www.ncbi.nlm.nih.gov/myncbi/collections/bibliography/43437704/

D. Research Support Ongoing

R01 NS070308 (Zhou) 4/1/11 – 3/31/16 NIH / NINDS (no cost extension) Long-term Cognitive Effects of Microembolization Associated with Carotid Stenting A multi-institutional study to determine long-term neurocognitive sequelae of subclinical microemboli associated with carotid stenting procedures Role: PI

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R01 HL127113 (Huang) 2/1/16-1/31/21 NIH/NHLBI Aligned Nanofibrillar Scaffolds Enhance Angiogenesis and Viability in Ischemia To test the hypothesis that parallel-aligned pattern of nanofibrillar scaffolds enhance iPSC-EC survival and angiogenesis under ischemic conditions in vitro. We will then assess the temporal kinetics of arteriogenesis, blood perfusion recovery, and cell survival upon implantation of the iPSC-EC seeded scaffold in animal models of PAD Role: Collaborator

BEST Trial (Mernard/Farber) 1/14/15 – 2020 NIH / NHLBI Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia To compare modern endovascular versus best surgical therapy for patient with critical limb ischemia Role: Site- PI

CREST-2 (Brott, PI) 2015 - 2020 NIH Carotid Revascularization and Medical Therapy for Asymptomatic Carotid Stenosis Trial Role: Site-PI

VOYEGER PAD 2015 - Present Bayer An international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures Role: Site-PI

CCT-PDA-002-DFU-002 (Zhou) 2/23/2015 – Present Celgene Corporation A Phase 2 Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Efficacy Of Intramuscular Injection of Human Placenta-derived Cells (PDA-002) in Subjects with Peripheral Arterial Disease and Diabetic Foot Ulcer The primary objective of the study is to assess the efficacy of PDA-002 in treating diabetic foot ulcer. Role: Site-PI

Completed

R21 NS081416 (Zhou, Rosen) 9/30/12 – 8/31/15 NIH / NINDS Neuroimaging Correlates of Memory Decline Following Carotid Interventions To evaluate whether cutting edge MRI measures can help to predict patients at risk for procedure- associated memory decline, and therefore individualized patient care can be applied. Role: PI

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I01 BX001398 (Zhou) 7/1/12 – 6/30/16 VA Merit Review (no cost extension) PKC Epsilon in Vascular Dysfunction To evaluate the protective role of PKC epsilon modulation in vascular cell and tissue dysfunction Role: PI AHA CRP2610312 (Zhou) 1/1/2010-12/31/2011 American Heart Association Neurocognitive Effects of Subclinical Microembolization Associated with Carotid Interventions A pilot study to evaluate cognitive function of patients undergoing carotid interventions and to correlate microembolization with cognitive changes following carotid interventions Role: PI R21AT005136-01A1 (Zhou) 9/1/2009-8/31/2011 NIH/NCCAM Ginsenoside Rb1 decreases injury-induced vascular restenosis To study the effects and mechanisms of ginsenoside Rb1 in homocysteine-induced intimal hyperplasia and restenosis Role: PI

ZHW0039 (Zhou) 2/27/15 – 3/2016 Cook, Inc Zilver PTX V Post Market Study To evaluate efficacy and long-term outcome of Zilver PTX for lower extremity claudication. Role: Site-PI

AVG1201.004-M (Zhou) 10/10/14 – 2016 CryoLife Prospective Multicenter Primary Below the Knee Bypass Evaluation with CryoVein® Cryopreserved Saphenous Vein Allograft in Patients with Critical Limb Ischemia The objective of this post market study is to collect additional information about how well CryoVein works for restoring blood flow to the lower leg and healing wounds and preventing or delaying an amputation. Role: Site-PI

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VI. DIVISION OF VASCULAR & ENDOVASCULAR SURGERY ERIC ESPENSEN

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Eric H. Espensen DPM, DABMSP eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Assistant Professor of Surgery, Clinical Scholar Track (SALSA) EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

Brigham Young University BS 1995 Psychology

The Ohio College of Podiatric Medicine DPM 2000 Podiatry Residency, Foot and Ankle Surgery 2002 Podiatry Fellowship, Specialty in Diabetic Foot 2002 Podiatry A. Personal Statement

• I am an Assistant Professor of Surgery at the University of Arizona. Previously I was an Assistant Professor of Podiatric Medicine and Surgery at Western University of Health Sciences. I hold a Bachelor’s of Science from Brigham Young University. • I opened and served as Director of The Diabetic Foot Center in Burbank, California, the first dedicated diabetic foot treatment center in the world. This center, opened with the guidance of David G. Armstrong, DPM, PHD, MD was the first of its kind and served as template for modern amputation prevention centers/limb salvage centers. The SALSA (Southern Arizona Limbs Salvage Alliance) within the University of Arizona/Banner is based upon our pilot program and research. • I served as the Chief of Foot and Ankle Surgery at Providence Saint Joseph Medical Center, being the youngest chief ever named to that position. I served in that position for 10 years in a row. • I served as Medical Director of The Amputation Prevention Center in Los Angeles, California which was the first of the current chain of such centers for Restorix Health, now spanning the United States. • I helped to Co-Found and host the International Diabetic Foot Conference(DF-Con), the largest annual international symposium on the diabetic foot in the world. • I have spent the last 15 years maintaining a successful private practice in Southern California while lecturing frequently both nationally and internationally, giving more than 85 lectures. • I have received numerous service awards from hospitals and the communities I have served over the course of my career.

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• I have been active in surgical instruction hosting and participating at more than 20 surgical labs and workshops over the last 10 years. • I have published more than 10 peer-reviewed research papers in scholarly medical journals. I have served as guest editor for more than 75 articles in Podiatry Today, the leading resource for the podiatric profession. • I serve as consultant for 14 different companies with the goal of advancing Podiatry and care of the Diabetic Foot.

B. Positions and Honors Positions 1996 - 1998 Microbiology Teaching Assistant / Tutor, The Ohio College of Podiatric Medicine, Cleveland, Ohio 1996 - 1999 Senior Histology Teaching Assistant / Head Tutor, The Ohio College of Podiatric Medicine, Cleveland, Ohio 1996 - 2000 Tissue Recovery Technician/ Call Coordinator / Team Leader, LifeBanc and MTF (Musculoskeletal Transplant Foundation), The Cleveland Clinic Foundation and University Hospitals, Ohio 2002 - 2005 Director of Research, The Diabetic Foot Center at Providence St. Joseph Medical Center, Burbank, California 2002 - 2005 Clinical Director, The Diabetic Foot Center at Providence St. Joseph Medical Center, Burbank, California 2003 - 2014 Institutional Review Board Committee Member, Providence St. Joseph Medical Center, Burbank, California 2004 - 2014 Chief of Foot and Ankle Surgery/Section Chairman, Providence St. Joseph Medical Center, Burbank, California 2005 - 2014 Pain & Palliative Care Committee Member, Providence St. Joseph Medical Center, Burbank, California 2014 - 2016 Medical Director, Amputation Prevention Center – Valley Presbyterian Hospital, Van Nuys, California 2014 - 2016 Assistant Clinical Professor of Podiatric Medicine and Surgery, Western University of Health Sciences, Pomona, California 2014 - 2016 Clinical Education Director, Valley Presbyterian Hospital, Van Nuys, California 2016- present Assistant Professor, Department of Surgery, The University of Arizona 2016- present Director of Medical Student, Surgical Resident and Fellowship Education, Department of Surgery, The University of Arizona

Honors 2016 Valley Presbyterian Physician Achievement Recognition Award 2015 San Fernando Valley Physician of the Year 2014 City of Burbank Physician of the Year 2005 Society of Advanced Wound Care Trustee 2003 Respect Core Value Award Winner, Providence St. Joseph Medical Center 2003 Recipient of Proclamation from the City of Los Angeles on Efforts and Treatments of the Diabetic Foot

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C. Contributions to Science

1. I researched the use of vacuum or negative pressure on wounds to help remove fluid, provide mechanical stretch of the wound bed to help reduce volume and encourage increased vascularity, which became the foundation for negative pressure wound care. a. Armstrong DG, Lavery LA, Abu-Rumman PL, Espensen EH, Vazquez JR., Nixon, BP, Boulton AJM: Outcomes of Subatmospheric Pressure Dressing Therapy on Wounds of the Diabetic Foot. Ostomy/Wound Management, 48(4): 64–68 2002. b. Espensen EH, Nixon BP, Lavery LA, Armstrong DG: Use of Subatmospheric (VAC) Therapy to Improve Survival of Bioengineered Tissue Grafting in Diabetic Foot Wounds. Journal of the American Podiatric Medical Association, 92(7): 395- 397, 2002. 2. I researched the use of GPS tracking built into off-loading devices for the lower extremity of patients which showed the frequency of use of the offloading devices combined with the overall compliance of the patients. a. Armstrong DG, Abu-Rumman PL, Espensen EH, Nixon BP, Boulton AJM: Outside-Inside Activity Ratio: The Relationship of In-Home Activity and Obesity in Persons at High Risk for Diabetic Foot Ulceration, Ulceration 2003. 3. I researched the use of Subatmospheric Therapy to improve the survival of tissue grafting in Diabetic Foot Wounds. This paper helped establish Standard of Care with both autografts and allografts on the diabetic foot by incorporating the use of subatmospheric pressure dressings to improve graft incorporation. a. Espensen EH, Nixon BP, Lavery LA, Armstrong DG: Use of Subatmospheric (VAC) Therapy to Improve Survival of Bioengineered Tissue Grafting in Diabetic Foot Wounds. Journal of the American Podiatric Medical Association, 92(7): 395- 397, 2002. 4. I researched the viability and options for the use of Total Contact Casting versus alternatives such as utilization of an “Instant Total-Contact Cast” and this paper helped to establish Standard of Care treatment of neuropathic diabetic foot ulcers and the evolution of total-contact casting techniques and materials. a. Armstrong DG, Short B. Espensen EH, Abu-Rumman P, Nixon BP, Boulton AJM: Technique for Fabrication of an “Instant Total-Contact Cast” for Treatment of Neuropathic Diabetic Foot Ulcers. Journal of the American Podiatric Medical Association, 92(7): 405-408, 2002. D. Research Support Protocols Project Investigator Subatmospheric Pressure Dressing therapy, Diabetic Foot; KCI

Subatmospheric Pressure Dressing therapy, venous stasis ulcers; KCI

My first research accomplishment was working with KCI on the Diabetic Foot Indication Trial and Venous Leg Ulcer Indication Trails in 2003. Their pioneering product, the use of vacuum or negative pressure on wounds to help remove fluid, provide mechanical stretch of the wound bed to help reduce volume and encourage increased vascularity was a true advancement in medicine and wound care. The data collected from these trials resulted in KCI being able to establish the first FDA indication for negative pressure dressings in these areas. This was the foundation for negative pressure wound care to grow into a pillar in the industry.

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Bacterial Burden Diabetic Foot Ulcer Protocol – JoAn

My second research protocol was designed to study the Bacterial Burden of the Diabetic Foot and to assess Biofilm formation and possible inhibition of Biofilm with both ionic silver preparations in combination with surgical debridement. The end goal was to reduce the amount of empiric antibiotics used in conjunction with treatment of a Diabetic foot ulcer. The data collected was very impressive and this pilot study laid the foundation for a randomized control trial in the use of ionic silver combined with calcium alginate.

Aquacel AG Research Protocol; Convatec

My third research area was the use of ionic silver with calcium alginate for topical wounds of the lower extremities. Due to the high use of antibiotics, bacterial resistance continues to be a strong concern and alternatives are constantly being sought. The use of ionic silver in topical application has been used since the time of Roman soldiers placing silver coins on their wounds to fight infection. We were able to determine through clinical research the proper level of ionic silver to provide antibacterial coverage as well and prevent tissue injury from excessive application of a potent product. Aquacel AG is now an industry standard and used worldwide to help heal wounds and reduce the use of antibiotics for diabetic patients.

Fixation Development Investigator, Osteomed

This was a unique experience to work closely with small group of surgeons and the company engineers to re-invent the existing product line of bone fixation plates and instruments. This occurred over 16 months with the result being a new product line of fixation hardware and instruments in use today by extremity surgeons around the world. Several patents were filed as a result of this project.

Diabetic Foot Infection Study, Linazolide vs. Zosyn/Augmentin; Bayer

I was involved as a project investigator in this antibiotic study trial to show the superiority of Linazolide versus Zosyn. I ran the primary site with 5 satellite sites assisting with data collection during the trial. The information gleaned from this study has led to use protocols of Linazolide in Diabetic Foot infections and Complicated Skin/Soft tissue infections (CSSi’s) world-wide.

HCG Study for Venous Stasis Ulcer Treatment

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Activity Monitoring in the High-Risk Patient with Diabetes; Sportbrain

This study yielded a published paper noted in Section C: Armstrong DG, Abu-Rumman PL, Espensen EH, Nixon BP, Boulton AJM: Outside-Inside Activity Ratio: The Relationship of In-Home Activity and Obesity in Persons at High Risk for Diabetic Foot Ulceration, Ulceration 2003.

Dermal Thermography and the Diabetic Foot

Engineered Dermal Replacement Research Protocols, II & III

Bioengineered Alternative Tissues – Advisory panel – CMS/FDA/RAC

Most recently, I was involved in data collection for a Medicare Program in a recently approved “Pass through” on a medical product seeking FDA approval. Aurix was able to receive provisional approval of Platelet-Rich Plasma for the treatment of diabetic foot ulcers. Dr. Carol Fyling, the strongest proponent of PRP has worked tirelessly with this product for more than 2 decades and was the research coordinator for several of these studies and I could work together with her over a year collecting data for Medicare.

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VI. DIVISION OF VASCULAR & ENDOVASCULAR SURGERY KAORU GOSHIMA

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Kaoru Ruth Goshima, MD eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Associate Professor of Surgery EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

University of California @ Los Angeles B.S 06/1994 St. Louis University School of Medicine M.D. 05/1999 Medical Degree University of Arizona Health Sciences Center General Surgery 06/2004 General Surgery Residency Residency Program University of Arizona Health Sciences Center Vascular 06/2006 Vascular Surgery Surgery Fellowship Fellowship Program A) Personal Statement

I am an Associate Professor of Surgery at the University of Arizona. I am certified by the American Board of Surgery in General Surgery and Vascular Surgery, and certified as a Registered Physician in Vascular Interpretation by the American Registry for Diagnostic Medical Sonography and the Medical Director of the Noninvasive Vascular Lab at Banner, University Medical Center.

As Program Director of the Vascular Surgery Residency and Fellowship Programs, I work with and oversee several research and quality improvement projects that our residents are working on. Recent projects include: 1. Weinkauf C, Berman S, Goshima KR, Leon L, Marinelli E, Millus R, Unger E: Vascular cell adhesion molecule 1 is a promising target to identify high-risk carotid plaques using contrast-enhanced duplex ultrasound. J VASC SURG. 64(2):549, 2016.

2. IRB approved research project # 1411576077. “Peripheral Vascular Complications In Patients Undergoing Different Percutaneous Ventricular Assist Devices; A Single Center Retrospective Review”. Banner University Medical Center. Department of Vascular & Endovascular Surgery and Department of Cardiology. FJ Yanquez, J Hughes, K Goshima, K Lotun, R Shetty. 11/2014-pres

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3. I have been a co-investigator on numerous clinical trials, currently I am a co- investigator of the Prospective Aneurysm Trial: High Angle Aorfix Bifurcated Stent Graft (PYTHAGORAS). In addition, I am also a co-investigator in the Noninvasive Treatment of Abdominal Aortic Aneurysm Clinical Trial; N-TA3CT.

B) Positions and Honors

Positions and Employment Associate Professor, Surgery (Clinical Scholar Track) Division of Vascular Surgery Department of Surgery University of Arizona Tucson, Arizona - July 2013 - Present

Assistant Professor, Surgery (Clinical Scholar Track) Division of Vascular Surgery Department of Surgery University of Arizona Tucson, Arizona - August 2006 – June 2013

Southern Arizona VA Hospital. Tucson, Arizona Vascular Surgeon – Staff Surgeon August 2006 - Present

Assistant Program Director (December 2009 – June 2015) Vascular Surgery Fellowship Program 0-5 Integrated Vascular Surgery Residency Program

Program Director (June 2015 – Present) Vascular Surgery Fellowship Program 0-5 Integrated Vascular Surgery Residency Program

Medical Director, Noninvasive Vascular Lab June 2015 – Present

Other Experience and Professional Memberships National/International Outreach: Society for Vascular Ultrasound 2007 – Present

American College of Surgeons, Fellow 2008 – Present

AZ Chapter, American College of Surgeons, Fellow 2008 - Present

Society of Vascular Surgery 2008 – Present

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National Association of Veterans Affairs Physicians And Dentists, 2013 – Present

Association of Program Directors, Vascular Surgery June 2015 – Present

Rocky Mountain Vascular Quality Initiative Committee, May 2015 – Present

Examination Consultant, Vascular Surgery Board, American Board of Surgery. September 2016 – Present

Honors & Awards

Dean’s Honors List, UCLA (1994)

Department Honors in Biochemistry, UCLA (1994)

Phi Beta Kappa, UCLA (1994)

Magna Cum Laude, UCLA (1994)

Preclinical Year Honors in Biochemistry, Human Genetics, Microbiology St. Louis University (1997)

Clinical Year Honors in Neurology and Psychiatry. Near Honors in Internal Medicine and OB/GYN, St. Louis University (1998)

Teaching Award, General Surgery Residency, University of Arizona, Department of Surgery - Tucson, Arizona (2004)

C) Contribution to Science -

I will be focusing on mentoring the vascular surgery residents and fellows on their scholarly activities and quality improvement projects.

4. Bui TD, Mills JL, Ihnat DM, Gruessner AC, Goshima KR, Hughes JD: The natural history of duplex-detected stenosis after femoropopliteal endovascular therapy suggests questionable clinical utility of routine duplex surveillance. J. Vasc Surg. 55(2):346-352, 2012.

5. Aziz H, Branco BC, Braun J, Hughes JD, Goshima KR, Trinidad-Hernandez M, Hunter GC, Mills JL: The influence of do-not-resuscitate on the outcomes of patients undergoing emergency vascular operations. J VASC SURG. 61(6):1538-1542, 2015.

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6. Weinkauf C, Berman S, Goshima KR, Leon L, Marinelli E, Millus R, Unger E: Vascular cell adhesion molecule 1 is a promising target to identify high-risk carotid plaques using contrast-enhanced duplex ultrasound. J VASC SURG. 64(2):549, 2016.

7. IRB approved research project # 1411576077. “Peripheral Vascular Complications In Patients Undergoing Different Percutaneous Ventricular Assist Devices; A Single Center Retrospective Review”. Banner University Medical Center. Department of Vascular & Endovascular Surgery and Department of Cardiology. FJ Yanquez, J Hughes, K Goshima, K Lotun, R Shetty. 11/2014-pres

I also contribute book chapters to UpToDate.

1. Goshima KR. Primary (spontaneous) upper extremity deep vein thrombosis. In: UpToDate. Basow DS (Ed). UpToDate. Current – last updated 12/31/2012.

2. White ML, Goshima KR. Overview of the thoracic outlet syndrome. In: UpToDate, Basow, DS (ED), UpToDate, Waltham, MA. Current. Annually Updated, Updated 2013.

3. Goshima KR. Overview of the thoracic outlet syndrome. In: UpToDate, Basow, DS (ED), UpToDate, Waltham, MA. Annually Updated, July 15, 2014. Review is current December 2014.

4. Goshima KR. Primary (spontaneous) upper extremity deep vein thrombosis. In: UpToDate. Basow DS (Ed). UpToDate. Annually updated November 4, 2014. Review is current January 2016.

D) Additional Information: Research Support and/or Scholastic Performance Federal:

Instant Total Contact Cast To Heal Diabetic Foot Ulcers: An Investigation Blinded Randomized, Controlled Clinical Trial With Three Parallel Treatment Groups. NIH Grant Sub-Investigator - 5% Funding - $319 per patient August 1, 2008 – April 30, 2012

Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) NIH Grant Sub-Investigator - 10% Funding - $5600 per patient November 2004 - Present.

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Industry: A Pilot Study To Investigate The Feasibility, Tolerability & Effectiveness Of Altrazeal Collagen Transforming Powder Dressing In Chronic Venous Leg Ulcers (VLU’s). ULURU, Ind. Sub-Investigator - 3% Funding - $68,275 for entire study 09/01/10 – 08/31/11

A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding, Study Investigating The Efficacy of HP-802-247 in Venous Leg Ulcers. Health Point, Ltd. Sub-Investigator - 3% Funding - $425 per patient 02/19/10 – 2012

Lower Extremity Venous & Diabetic Ulcer Negative Pressure Wound Therapy Trial. Spiracur Sub-Investigator - 3% Funding - $400 per patient 04/24/09 – 2012

A Phase Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent - Graft in Patients with Thoracic Aortic Pathologies. Bolton Medical, Inc. Sub-Investigator - 2% Funding - $125,000 budget for entire study January 2009 - 2014 Industry:

Prospective Aneurysm Trial: High Angle Aorfix Bifurcated Stent Graft (PYTHAGORAS) Lombard Medical Sub-Investigator - 10% Funding - $3500 per patient June 2007 – Present

Noninvasive Treatment of Abdominal Aortic Aneurysm Clinical Trial. N-TA3CT Sub-Investigator – 8% May 2015 - Present

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VI. DIVISION OF VASCULAR & ENDOVASCULAR SURGERY JENNIFER PAPPALARDO

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Pappalardo, Jennifer Lynne eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Assistant Professor of Surgery, Clinical Scholar Track (SALSA) EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY

University of Illinois: Urbana-Champaign, IL B.S. 2005 Microbiology Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science: D.P.M. 2009 Podiatric Medicine/Surgery North Chicago, IL University of Arizona Southern Arizona Limb Salvage Fellowship 2013 Amputation Prevention Alliance (SALSA) Limb Salvage Fellowship Program

A. Personal Statement Dr. Pappalardo joined the University of Arizona Department of Surgery in 2013. She is also a member of the UA Southern Arizona Limb Salvage Alliance (SALSA) team. A diabetes foot care specialist, Dr. Pappalardo focuses on education and conservative treatment options, with elective surgeries if needed.

She received her doctoral degree in podiatric medicine from William M. Scholl College of Podiatric Medicine at Rosalind Franklin University. She completed her residency studies at Mount Sinai Medical Center.

She completed her first residency at St. Vincent Hospital, University of Massachusetts. The second residency was at Mount Sinai Hospital, focusing on management of diabetic Charcot neuroarthopathy. She completed a one year fellowship at the University of Arizona, rotating at the Pasqua Yaqui clinic and the Southern Arizona Veterans Affairs Hospital, focusing on split- thickness skin grafting the high-risk diabetic foot.

B. Positions and Honors Positions 2015-present Assistant Professor/Director of Education SALSA, Banner University of Arizona Department of Surgery Tucson, AZ 2014-2016 Chief of Surgery, Pascqua Yaqui Health Department: Tucson, AZ 2014-present Research Clinician, Saguaro Research: Tucson, AZ

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2013-2014 Associate Podiatrist, Premier Foot and Ankle Surgeons: Tucson, AZ 2013-2016 Clinical Assistant Professor, University of Arizona Department of Surgery: Tucson, AZ 2004-2005 Teaching Assistant, Molecular and Cellular Biology, Urbana- Champaign, IL 2003-2005 Researcher, Animal Sciences Research Laboratory, Urbana- Champaign, IL 2002-2005 Researcher, Molecular and Cellular Biology Laboratory, Urbana- Champaign, IL

Certifications 2014-present American Board of Foot and Ankle Surgeons Forefoot and Rearfoot Qualified 2012-present Arizona Podiatry Licensure 2011-present Basic and Advanced Cardiac Life Support 2005-present American College of Foot and Ankle Surgeons 2011-present National Board of Podiatric Medical Examiners, Part III 2009–present National Board of Podiatric Medical Examiners, Part II 2007-present National Board of Podiatric Medical Examiners, Part I 2006-2006 William M. Scholl Summer Research Fellow

C. Contributions to Science

1. With a team of collaborators, I contribute in evaluating techniques for better managing diabetic foot ulcers and wound healing. a. “Utilization of Advanced Modalities in the Management of Diabetic Charcot Neuroarthropathy,”Pappalardo J, Fitzgerald R. Journal of Diabetes Science and Technology 4(5): 1114-20, 2010. PMID 20920430 b. “What percentage of incident diabetic foot wounds become infected and receive amputation?” Armstrong DG, Bharara M, Elenzi T, Lavery LA, Pappalardo J. The International Journal of Lower Extremity Wounds. In Press

2. I contribute in performing and evaluating split skin thickness grafts in reconstructive foot surgery in the high risk diabetic foot.

a. “Plantar Fat Grafting and Tendon Balancing for the Diabetic Foot Ulcer in Remission.” Luu CA, Larson E, Rankin TM, Pappalardo JL, Slepian MJ, Armstrong DG. Plastic Reconstructive Surgery Global Open b. Plast Reconstr Surg Glob Open. 4(7):e810, 2016. PMID: 27536489 c. “Split Thickness Skin Grafting the High Risk Diabetic Foot.” Rose J, Giovinco N, Mills J, Najafi B, Pappalardo J, Armstrong D. Journal of Vascular Surgery 59(6): 1657-63, 2014. PMID 24518607 d. “A 10 Step Guide to Applying Split Thickness Skin Grafts.” Pappalardo J, Perry D, Armstrong D. Podiatry Today 26 (3): 2013.

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3. I manage complex lower extremity infections.

a. “Wound Healing Simplification: A Vertical and Horizonal Strategy Illustrated.” Pappalardo J, Plemmons B, Armstrong DG. Journal of Wound Technology. 19: 38-40, 2013. b. “Principles of Debridement in Infected Foot” in Sharad Pendsey New Dehli, Jaypee Brothers. “Contemporary Management of the Diabetic Foot.” Jennifer Pappalardo, David G Armstrong, 102-110, 2013. c. Scientific Literature Reviews: September 2009 ACFAS Online Edition d. “The Effect of Thrombin Activation of Platelet-Rich Plasma on Demineralized Bone Matrix Osteoinductivity.” Han B, Woodell-May J, Ponticiello M, Yang Z, Nimni M. The Journal of Bone and Joint Surgery. 91:1459-1470 (2009)

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VI. DIVISION OF VASCULAR & ENDOVASCULAR SURGERY WOEI TAN

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Tan, Tze-Woei eRA COMMONS USER NAME (credential, e.g., agency login): ttan POSITION TITLE: Assistant Professor EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

Completion DEGREE Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

University of Melbourne, Australia MBBS 12/2002 Medicine Brown University, Providence, RI 06/2010 General Surgery Boston University, Boston, MA 06/2012 Vascular Surgery

A. Personal Statement

I am an Assistant Professor at Division of Vascular Surgery. My main interest is in clinical research with specific focus on peripheral vascular disease and hemodialysis access. I bring interest and energy in clinical outcome and education research. I also have exposure to clinical trials. I am a co-investigator for of The VAscular Physician Offer and Report (VAPOR) Trial, a pilot cluster-randomized trial of a smoking cessation protocol and of Best Endovascular versus Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) Trial, an NHLBI sponsored, international, multispecialty, multicenter trial evaluating outcomes of patient with CLI. As the principle investigator (PI) for industry-sponsored education grant, I organize and oversee projects to create workshop for nurses and technicians in management of hemodialysis access.

B. Positions and Honors

Positions and Employment 2012-16 Assistant Professor of Surgery, Louisiana State University Health Sciences Center, LA 2013-16 Medical Director, Non-invasive Vascular Laboratory, LSUHSC, Shreveport, LA 2014-16 Assistant Program Director, LSUHSC, Shreveport, LA 2016 Director of Endovascular Services, LSUHSC, Shreveport, LA

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2016- Assistant Professor of Surgery, University of Arizona, Tucson, AZ

Other Experience and Professional Memberships 2013 Member, Association of Academic Surgery 2014 Fellow, American College of Surgeons 2015 Member, Society of Vascular Surgery 2016 Member, Vascular Endovascular Surgery 2016 Council, LA Chapter of ACS/ Surgical Association of Louisiana 2016 Member, Vascular Quality Initiative PSO regional Executive Committee 2016 Member, American College of Surgeons Resident Prep Curriculum Sub- Committee

Honors 2010 Best Resident Physician, Brown University, Providence, RI 2011 Best Clinical Paper, Massachusetts Chapter of the American College of Surgeons 2011 Clinical Science Winner, New England Annual Resident and Fellow Research Presentation

C. Contributions to Science

My primary research focus will be in the field of vascular disease and hemodialysis access. I have authored and co-authored nearly 40 articles in peer-reviewed journal and have lectured both regionally and nationally.

Selected publication: 1. Vascular disease • Tan TW, Garcia-Toca M, Marcaccio EJ Jr, Carney WI Jr, Machan JT, Slaiby JM. Predictors of shunt during carotid endarterectomy with routine electroencephalography monitoring. J Vasc Surg. 2009 Jun;49(6):1374-8. • Tan TW, Kalish JA, Hamburg NM, Rybin D, Doros G, Eberhardt RT, Farber A. Shorter duration of femoral-popliteal bypass is associated with decreased surgical site infection and shorter hospital length of stay. J Am Coll Surg. 2012 Oct;215(4):512-8 • Farber A, Tan TW, Rybin D, Kalish JA, Hamburg NM, Doros G, Goodney P, Cronenwett JL. Intraoperative use of dextran is associated with cardiac complications after carotid endarterectomy. J Vasc Surg. 2013 March;57(3):635-41 • Tan TW, Farber A, Hamburg NM, Rybin D, Doros G, Eberhardt RT, Goodney P, Cronenwett J, Kalish JA. Blood Transfusion Is Associated With Increased Perioperative Surgical Site Infection and Graft Failure In Lower Extremity Bypass. J Am Coll Surg. 2013 Mar 24 • Tan TW, Eslami MH, Kalish JA, Doros G, Goodney P, Cronenwett JL, Farber A; Vascular Study Group of New England. The need for treatment of hypotension or hypertension after CEA is associated with increased perioperative mortality and morbidity. J Vasc Surg. 2014 Jan;59(1):16-24.e1-2.

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• Tan TW, Rybin D, Kalish JA, Doros G, Eberhardt RT, Schanzer A, Cronenwett JL, Farber A. Vascular Study Group of New England. Routine Use of Completion Imaging after Infrainguinal Bypass is not Associated with Higher Bypass Graft Patency. J Vasc Surg. 2014 Sep;60(3):678-685.

2. Dialysis access • Tze-Woei Tan, Alik Farber. Brachiobasilic Arteriovenous Fistula. Seminar of Vasc Surg. June 2011;24(2):63-71. • Farber A, Tan TW, Bo H, Dember LM, Beck GJ, Dixon B, Kusek JW, Feldman HI. The Effect of Location and Configuration 1 on Forearm and Upper Arm Hemodialysis Arteriovenous Grafts. J Vasc Surg. 2015Nov;62(5):1258-65. Epub 2015 Aug 6. • Chong CC, Tan TW, Abreo K, Pahilan ME, Zhang WW, Farber A. Laparoscopic peritoneal dialysis catheter placement is associated with decreased peritonitis and reoperation. Clin Nephrol. 2015 Mar;83(3):161-166. • Sequeira A, Tan TW. Complications of a high flow access and its management. Semin Dial. 2015 Mar 23.

3. Education • Kim RH, Tan TW. Interventions that affect resident performance on the American Board of Surgery In-Training Examination: A systemic review. J Surg Educ. 2014 Oct 31. • Schoolfield CJ, Kim RH, Samra N, Shi RH, Zhang WW, Tan TW. Evaluating the effectiveness for the general surgery intern boot camp. Am Surg.2016 Mar;82(3):243-50.

D. Additional Information: Research Support and/or Scholastic Performance

Ongoing Research Support 1. Education grant, WL Gore and Associate 04/01/2013-04/01/2018 The goal of this project is to create and study the effectiveness of senior medical student entering surgical residency preparatory course

2. Education grant, WL Gore and Associate 06/01/2015-07/01/2017 The goal of this project is to create and study the effectiveness of dialysis access workshop for dialysis nurse and technician

3. Agency: New England Research Institutes, Inc Title: Multi-center, prospective, randomized, clinical trial to evaluate the safety and effectiveness of best endovascular (EVT) versus best open surgery (OPEN) therapy in subjects with critical limb ischemia (CLI). Role: Site Principle Investigator

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Completed Research Support 1. Agency: Shire Regenerative Medicine Title: A Phase 2, Single-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of SRM003 (Vascugel®) in the Treatment of Subjects With Vascular Injury Resulting From Arteriovenous Graft Surgery for Hemodialysis Access Role: Sub-Investigator

2. Agency: Shire Regenerative Medicine Title: A Phase 2, Single-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of SRM003 (Vascugel®) in the Treatment of Subjects With Vascular Injury Resulting From Arteriovenous Fistula Surgery for Hemodialysis Access Role: Sub-Investigator

3. Agency: Proteon Therapeutics, Inc. Title: Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately after Radiocephalic Arteriovenous Fistula Creation in Patients with Chronic Kidney Disease. Role: Sub-Investigator

4. Agency: Dartmouth-Hitchcock Medical Center Title: Vascular Physician Offer and Report (VAPOR) Trial Role: Sub-Investigator

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VI. DIVISION OF VASCULAR & ENDOVASCULAR SURGERY CRAIG WEINKAUF

Please see the following faculty profile link: http://surgery.arizona.edu/profile/craig-c-weinkauf

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VI. DIVISION OF VASCULAR & ENDOVASCULAR SURGERY MARLYS WITTE

OMB No. 0925-0001 and 0925-0002 (Rev. 10/15 Approved Through 10/31/2018)

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: MARLYS HEARST WITTE eRA COMMONS USER NAME (credential, e.g., agency login): mwitte POSITION TITLE: Professor of Surgery & Director, Student Research Programs

DEGREE Completion Date INSTITUTION AND LOCATION FIELD OF STUDY (if applicable) MM/YYYY Barnard College, New York, NY BA (summa 1955 Zoology cum laude) NY University College of Medicine, New York, NY MD (AOA) 1960 (1959) Medicine (Honors Prog)

A. PERSONAL STATEMENT As Professor of Surgery and Director of Student Research, University of Arizona College of Medicine, and Secretary-General of the 42-nation International Society of Lymphology, I am engaged in extensive activities in clinical and basic lymphology – the study of lymphatics, lymph, lymphocytes, and lymph nodes in health and disease. My translational interests and contributions have spanned blood/lymphatic vascular endothelial cell biology and pathobiology in vitro and in vivo, hepatosplanchnic lymphatic/microcirculatory physiology, small animal models, in vivo lymphatic imaging, thoracic duct lymph drainage, lymphogenous cancer spread, and genomics/proteomics of lymphedema-angiodysplasia syndromes in man and experimental models, including defects, deficiency, and overexpression of human and murine lymphangiogenesis genes and their syndromic/phenotypic manifestations. Collaborative research has touched upon HIV encephalo-pathy, blood-brain barrier, CNS fluid dynamics, and ocular development/ disorders. I continue to work on a variety of infectious diseases and immune disorders (e.g., inflammatory bowel disease, AIDS, Kaposi sarcoma, tuberculosis, filariasis, congenital/hereditary lymphatic system syndromes, opportunistic infections/neoplasms) and direct an internationally recognized Lymphedema-Angiodysplasia clinic. Author of more than 400 peer-reviewed publications, recipient of numerous international honors and the UA College of Medicine's Gold-Headed Cane, Founders Day, and Virginia Furrow Education and Innovation Awards, I have received continuous funding from NIH (as well as other government, AMA, and non-profit agency grants) since I was a medical resident. I have also served as Program Director of UA’s only NIH General Clinical Research Center (GCRC) and am a member of the UA Arizona Comprehensive Cancer Center, Sarver Heart Center, and Viper Institute and have mentored hundreds of students supported by a continuous sequence of NIH multi-institute training grants I have acquired since 1982. These NIH research pipeline/ training grants, an earlier federally funded nationwide “Women in Medical Academia” project organized in the mid-

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1970's, and my service reflect a long-standing commitment to multilevel leadership training, equity, diversity, and disadvantaged populations including but not limited to underrepresented ethnic minorities, women, and the disabled. My educational activities have an overlying theme of “medical ignorance” – “what we know we don’t know, don’t know we don’t know, and think we know but don’t,” which aims to nurture “curiosity” (an “addiction” to ignorance/ unanswered questions-unquestioned answers).

B. POSITIONS AND HONORS

Professional Experience 1960-61, Intern, UNC Memorial Hospital-Chapel Hill; Resident; Teaching 1962-65 Assistant/Tutor/Instructor, NYU Bellevue Hospital, Department of Medicine 1967-68 Head, ER & Admitting Department, St. Louis City Hospital 1966-70 Instructor/Res. Asst Prof, Depts of Medicine/Cardiology/Surgery, Washington Univ. St. Louis 1969- Asst Prof (1969-72); Assoc Prof (1972-77); Full Prof (1977-present), UA Dept. present of Surgery, Attending physician UA Health Network; 2015 University Banner Medical Center-Tucson/UA Main Campus 1972-81 Director, NIH General Clinical Research Center (CRC) in Surgery, AZ Hlth Sci Center 1981- Director, Medical Student Research Program (MSRP), U AZ present 1987- Director, NIH Minority/Disadvantaged High School Student /K-12 Science present Teacher Program, Medical Ignorance Collaboratory 2000-06, Virtual CRC/Medical Ignorance Exploratorium; 2006-2012 NIH NCRR SEPA/ARRA; Translating Translation and Scientific Questioning/curiosityforall. org; 2012- 2018, NIH OD SEPA, NIAID, NINDS, NICHD 1987- Secretary-General, International Society of Lymphology; Editor, Lymphology, present 2003- Selected Other Recent Experience, Honors and Professional Memberships 1963-67; 1972- USPHS Post-doc. & Special Fellow, NHLBI; Research Career 77 Development Award, NHLBI 1967-72 American Heart Association Established Investigator 1973-present Vice-President, International Society of Lymphology (1973-75); President (1985-87); Secretary-General (1987-2019); Executive Editor, Lymphology (1983-2003); Editor (2004-Present); 1987-95 Member, Independent Review Panel, IMREG Inc, Phase III trial of IMREG-1 in ARC/AIDS 1988 Earl of Litchfield Lecturer, Oxford Univ., John Radcliffe Hospital, England 1989 Commencement Speaker, St. Louis University School of Medicine, MO 1989 UA Mortar Board Hall of Fame Award; YMCA Woman on the Move Award

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1994-present Honorary Pres., Pan Amer. Soc. Lymphology 1989-92, 94- Chair, NIH Biological Science Review Group (BIOL-3) (S/T Medical/Health 97,99- Professional Student Research Program) T-35 02,04,07,11 1991-97 Member, Medical Int’l Advisory Board, National Lymphedema Network, San Francisco, CA 1992 AOA Lecturer, University of South Carolina 1995 Keynote Lecturer, American Academy of Family Physicians, Anaheim, CA; Society of Vascular Medicine and Biology, New Orleans, LA 1996 National Academy of Medicine Brazil, induction & gold medal 1998 MD (honoris causa), University of Valença, Brazil 1999-present Fellow, American Association for the Advancement of Science (AAAS) (Medical Sciences) 2001,05,09,11,13 Keynote lecturer, 10th Intl. Conf. Thinking, Auckland NZ ; 12th Melbourne, Australia (2005); 13th Stockholm, Sweden (Karolinska Institute) & Norrkőping (2009); 14th Kuala Lumpur (2010); 15th Belfast, Northern Ireland (2011); 16th Wellington, New Zealand (2013) 2003,07,09,11,13 Ceremonial/keynote lecturer, 19th (Freiburg), 21st (Shanghai), 22nd (Sydney), 23rd (Malmõ), 24th (Rome), International Congress of Lymphology 2004 1st Charles L. Witte Lifetime Achievement Award, National Lymphedema Network 2005-present Honorary Member, Sociedad Brasileira de Linfologia, Salvador, Brazil 2006-2013 Member, National Gynecologic Oncology Group 2006-09 Study Section Member NIH-NHLBI T32 (NITM), 2000-present President & Founder, Ignorance Foundation, Inc. 2010 Keynote lecturer, Int’l Congress of CV Surgery: Bicentennial of Argentine Republic 2011;12;14 Invited lecturer, Int’l Congress of CV Surgery Phlebology, & Lymphology, Buenos Aires 2011 Invited Keynote Lecturer: 10th Shanghai International Plastic Surgery Conference (SIPSC2011) 50th anniversary of Dept. Plastic/Recon Surgery, 20th of Operation Smile, Shanghai, China 2013 Invited TEDx Bloomington Talk; follow-up 2015 TEDx Women 2015 Keynote lecturer/Ignorance Mapping, British Lymphology Society Meeting, Birmingham, UK 2015 Co-President, 25th World Congress of Lymphology, San Francisco, CA 2015-2016 Arizona Board of Regents’ Professorship Nominee 2016 Keynote John Casley-Smith Lecturer: Asia Pacific Congress of Lymphology, Darwin, Australia

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C. Contributions to Science: 15 of >400 publications in basic and clinical journals including Am. J. Pathology, JAMA, NEJM, Circulation, Gastroenterology, Science, & Developmental Biology.

1. Lymphodynamics, lymph composition, and the Blood-Lymph Loop: My early publications provided original observations on central thoracic duct (TD) and regional hepatosplanchnic lymph dynamics and composition in a wide variety of human disorders and experimental models of these conditions. These studies established “lymphodynamics” (flows and pressures in the lymph circulation) as a sensitive barometer of hemodynamic alterations and microcirculatory events and lymph composition as a valuable clue to the presence and/or pathophysiology of a wide variety of clinical disorders. Using the technique of thoracic duct cannulation (TDC) and drainage in patients with hepatic cirrhosis and experimental models simulating this condition, we documented a marked increase in hepatosplanchnic lymph formation (and beneficial effects of TD drainage) related to disturbances in portal hypertension, hepatosplanchnic (blood) microcirculation, and Starling forces. From these initial studies, we developed the “lymph imbalance theory” of ascites formation and response to treatment. In patients with far-advanced right-sided congestive heart failure, TDC documented a marked increase in lymph formation but also severe resistance to central lymph return from elevated central venous pressure (CVP); TD external drainage produced dramatic clinical improvement with reduction in edema/effusion and CVP. In experimental pure R heart failure, TD lymph diversion to the L heart lowered CVP and eliminated ascites. These findings have recently been rediscovered to explain and manage life-threatening lymphatic complications (chylous effusions/protein-losing enteropathy) in children after successful surgical correction of previously inoperable congenital heart defects. Lymph flow and composition (particularly proteins, abnormal cells, microbes) also provided insight into various clinical disorders (e.g., TB, intestinal lipodystrophy, snake envenomation, obstructive jaundice, inflammatory bowel disease, cancer spread). Current collaborations are exploring the potential of interventional radiologic techniques to provide relatively non-invasive access to the TD and regional lymphatics for investigative and theranostic purposes. a) Witte MH, AE Dumont, WR Cole, CL Witte, K Kintner: Lymph circulation in hepatic cirrhosis: Effect of portacaval shunt. Ann. Intern. Med. 70:303-310, 1969. b) Witte MH, AE Dumont, RH Clauss, B Rader, N Levine, ES Breed: Lymph circulation in congestive heart failure: Effect of external thoracic duct drainage. Circulation 39:723-733, 1969. c) Witte MH, CL Witte, AE Dumont: Progress in liver disease: Physiologic factors involved in the causation of cirrhotic ascites. Gastroenterology 61:742-750, 1971. d) Witte MH, CL Witte, AE Dumont: Estimated net transcapillary water and protein flux in the liver and intestine of patients with portal hypertension from hepatic cirrhosis. Gastroenterology 80:265- 272, 1981. (Cited in Shepherds's text on Physiology of the Intestinal Circulation as a landmark article.)

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2. Lymphangiogenesis (LA), lymphatic vascular biology (LVB), and lymphovascular genetics (LVG): In the early 1980's – when the field of “angiogenesis” and programs in “vascular/endothelial cell biology” were just beginning to gain momentum, we reported the first isolation of lymphatic endothelial cells in tissue culture (from a human lymphangioma) along with “lymphangiogenesis in vitro” and proposed a terminology adjustment to distinguish hemangiogenesis/hemvasculogenesis and new terms “lymphangiogenesis/lymphvasculogenesis” from the general phenomenon of “angiogenesis.” In the years that followed, we organized the first international conference sessions on LA, LVB,LVG and prepared the first chapter (1997) ever written providing a conceptual framework, history, knowns and unknowns about LA and LVB, and the varied sequelae of lymph stasis (edema, fibrosis, adipogenesis, malnutrition, immunodysregulation, angiogenesis, oncogenesis). At the same time, VEGF-C the lymphatic growth factor was discovered by Finnish molecular biologist Kari Alitalo opening a new “chapter in the field.” In 2000, I was the NIH-R13 PI and scientific organizer for the first NIH Think Tank Conference at NIH’s Natcher Center: “Conquering Lymphatic Disease: Setting the Research Agenda,” the Proceedings of which has been a springboard for NIH initiatives in lymphatic research. a) Witte MH, D Way, CL Witte, M Bernas: Lymphangiogenesis: Mechanisms, significance, and clinical implications. In: Control of Angiogenesis. Goldberg ID, EM Rosen (Eds.), Birkhauser Verlag, Basel, Switzerland 1997, pp. 65-112 (earliest historical/literature review/conceptual framework on current “hot topic” of lymphangiogenesis). b) Witte MH, M Bernas, C Martin, CL Witte: Lymphangiogenesis and lymphangiodysplasias: from molecular to clinical lymphology. In: The Biology of Lymphangiogenesis. Wilting J (guest Ed.). Microscopy Research and Techniques 55:122-145, 2001. c) Witte M (Ed): “Conquering Lymphatic Disease: Setting the Research Agenda”. Proc NIH Think Tank Conf, Natcher Conf Center, Bethesda, MD, 5/11-13/00. ©U AZ, 2001, ISBN 0-9711731-0-9, 287 pp. d) Witte MH, K Jones, J Wilting, M Dictor, M Selg, N McHale, JE Gershenwald, D Jackson: Structure-function relationships in the lymphatic system: Implications for cancer biology. Cancer Metastasis Rev. 25:159-184, 2006. PMID: 16770531

3. Our team most recently through 2016 (2 new publications in 2016) has been actively involved in the discovery and mechanistic elucidation of important human and mouse genes – specifically VEGFR3, Angiopoietin 2, Prox1, FOXC2, and the gap junction connexin 37,43,47 proteins – involved in lymphangiogenesis and lymphatic valvulogenesis and genotype-phenotype correlations in human Milroy and Lymphedema-Distichiasis syndromes, and inflammatory bowel disease. Our Lymphedema-Angiodysplasia (LE-AD) Clinic receives referrals for evaluation and management of patients from around the world. a) Gale, N, G Thurston, SF Hackett, R Renard, Q Wang, J McClain, C Martin, C Witte, M Witte, C Suri, P Campochiaro, S Wiegand, G Yancopoulos: Angiopoietin-2 is required for postnatal angiogenesis and lymphatic patterning, and only the latter is rescued by angiopoietin-1. Developmental Cell 3:411-423, 2002. (cover photo and accompanying editorial). PMID:12361603 b) Dellinger, M, R Hunter, M Bernas, N Gale, G Yancopoulos, R Erickson, M Witte: Defective remodeling and maturation of the lymphatic vasculature in Angiopoietin-2 deficient mice. Developmental Biology 319:309-320, 2008. PMCID: PMC2536689

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c) Kanady, JD, MT Dellinger, SJ Munger, MH Witte, AM Simon: Connexin37 and Connexin43 deficiencies in mice disrupt lymphatic valve development and result in lymphatic disorders including lymphedema and chylothorax. Developmental Biology 354: 253-266, 2011. PMID:21515254 d) Witte, M, MT Dellinger, CM Papendieck, F Boccardo: Overlapping biomarkers, pathways, processes and syndromes in lymphatic development, growth and neoplasia. Clin Exp Metastasis 29(7):707-727, 2012. COI 10.1077/s10585-012-9493-1 published online prior to print publication.

4. Lymphatic imaging: We have published extensively on multimodal lymphatic imaging as a key to go beyond clinical descriptions to elucidate alterations in lymphatic structure and function in human and experimental (including genetically induced) LE-AD syndromes. Protocols have been developed for international use and characteristic findings described for the “gold standard” technique for screening – “whole body lymphangioscintigraphy (LAS)” in patients. We have reported LAS patterns and dynamics in primary and secondary lymphedema and specifically in AIDS-Kaposi sarcoma and lymphatic filariasis and, combined with SPECT-CT, in a variety of chylous reflux syndromes. In addition, we performed some of the earliest experimental studies on MR lymphography and CT lymphography as well as refining optical/fluorescence-based imaging techniques. Our recent active involvement in organizing international conferences (Sentinel Node Oncology Foundation, Joint Int’l Oncology Conference series, Int’l Congresses of Lymphology) has contributed to the major focus on advances in multimodal lymphatic imaging, which we have received a new $200,000 intramural grant to develop next generation techniques applicable to precision lymphology. a) McNeill GC, MH Witte, CL Witte, WH Williams, J Hall, DD Patton, GD Pond, J Woolfenden: Whole-body lymphangioscintigraphy: The preferred method for the initial assessment of the peripheral lymphatic system. Radiology 172:495-502, 1989. b) Witte CL, MH Witte, EC Unger, WH Williams, MJ Bernas, GC McNeill, A Stazzone: Advances in imaging of lymph flow disorders. RadioGraphics 20:1697-1719, 2000. c) Tanoura T, M Bernas, A Darkazanli, E Elam, E Unger, M Witte, A Green: MR imaging in experimental lymphatic filariasis using iron-oxide compound AMI-227. Am. J. Roentenology 159:875-881, 1992. d) Dellinger, MT, RJ Hunter, MJ Bernas, MH Witte, RP Erickson: Chy-3 mice are Vegfc haploinsufficient and exhibit defective dermal superficial to deep lymphatic transition and dermal lymphatic hypoplasia. Develop. Dynamics 236:2346-2355, 2007. PMID: 17584866

5. “Ignoramics” (how to recognize and deal with ignorance) – the theme for Research Training Programs: In an 8/24/15 Op-Ed piece in the New York Times, we were cited for shifting paradigms to “teaching ignorance” by developing a Curriculum on Medical Ignorance in the mid-1980's. Many presentations, interviews, assorted publications, and syllabi further evolved this theme – TEDx Bloomington 2013 presentation proposed the “Ignorance University – dedicated to all we have yet to learn and discover.” The focus on unanswered questions and unquestioned answers and exploring the Unknown has been the theme for our teaching innovations, conference design (“ignorance mapping”), research planning, Nobel Laureate interactions, evaluation approach, and leadership training, which have at the same time embraced equity and diversity. We have acquired a succession of NIH multi- institute training and curriculum grants to support and expand this effort and have developed a companion Curriculum Syllabus for Translating Translation and Scientific Questioning.

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Websites: http://msrp.medicine.arizona.edu; http://ignorance.medicine.arizona.edu; http:// medicalignorance.org; http://youtube.com/medicalignorance; http://curiosityforall.org (see Other Support) a) Witte, M, P Crown, M Bernas, F Garcia: “Ignoramics” in medical and pre-medical education. J. Inv. Med. 56: 897-901, 2008. b) Witte MH, P Crown, M Bernas, CL Witte: Lessons learned from ignorance: The curriculum on medical (and other) ignorance. In: The Virtues of Ignorance: Complexity, Sustainability, and the Limits of Knowledge. Vitek, W, Jackson W (Eds.), The University Press of Kentucky, Lexington, KY, pp 251-272, 2008. c) Curriculum Syllabus for Translating Translation and Scientific Questioning: Engaging Students in Translational Biomedical Science and Research, University of Arizona College of Medicine, 2014.

List of Published Manuscripts in MyBibliography: http://www.ncbi.nlm.nih.gov/myncbi/browse/collection/49570122/?sort=date&direction=ascendin g

D. RESEARCH SUPPORT Ongoing 5 R01 MH065151 UA subcontract (Persidsky, PI, 7/1/08-06/30/17 Temple Univ) DHHS/NIH/NIMH Title of study: BBB Tight Junctions During HIV-1 Dementia: Anti-Inflammatory Effects of GSK- 3b Suppression Role: Subcontract PI Major goals: Primary human brain microvascular endothelial cells will be isolated/cultured from the temporal cortex of tissue obtained during surgical removal of epileptogenic foci to examine GSK-3b suppression.

T35HL07479 12/1/14-11/30/19 NIH NHLBI Title of study: Short-Term Training in Professional Schools Role: PI Major goals: Funds for 26-35 medical students to conduct (summer) research for S/T 2-3 month vacation periods per year.

1R25 HL108837 6/1/11-5/31/17 NIH NHLBI Title of study: Short-Term Training to Increase the Diversity Pipeline in Heart/Lung/Blood Research Role: PI Major goals: To introduce, train, and nurture inquiring medical and undergraduate students (including under-represented minorities) in cardiovascular/lung/blood basic/clinical biomedical research and encourage intensive/ extensive research experiences to retain and strengthen the divrse student research pipeline.

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1R25NS076437 (Porreca/Witte, Multiple PI) 8/1/11-7/31/21 NIH NINDS Title of study: High School Student NeuroResearch Program (HSNRP) Role: PI Major goals: To develop/implement model program to recruit, train and mentor growing cadre of diverse/disadvantaged (including under-represented minority) high school students in biomedical research targeting neuro disorders & stroke.

R25 OD010487 (Witte/Garcia, Multiple PI) 8/1/12-7/31/17 NIH OD Administrative Supplement 8/19/13-7/31/15 Title of study: Translating Translation and Scientific Questioning in the Global K-12 Community Role: PI Major goals: To develop the Virtual Clinical Research Center/Questionarium (VCRC/Q) in web-based platform, for a real-life kindergarten to grade twelve experience linking scientists with students, teachers, CTSAs, and the public. R25AI097448 (Witte/Garcia, Multiple PI) 3/1/13-2/28/18 NIH NIAID Title of study: Infection and Immunity K-12 Science Program: Exploring Knowns/Unknowns via VCRC/Q Role: PI Major goals: To improve health/science literacy by developing inquiry-based comprehensive web-based/face-to-face curriculum focused globally on infection and immunity and designing and organizing teacher workshops and inservice training to assist in implementation and dissemination. R25HD080811 (Ghishan/Garcia/Witte, Multiple PI) 5/1/13-4/30/18 NIH NICHD Title of study: Summers in Children’s Research for Diverse High School Students Role: PI Major goals: This grant offers annually 8 diverse junior/senior high school students and 4 continuing undergraduates from Arizona an exciting educational 8-12 week summer experience in "hands on, brain on" basic and clinical research broadly targeting childhood and developmental disorders and maternal health and health disparities.

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R21HL122443 (Simon, PI/Burt, PI) 4/1/14-3/31/17 NIH NHLBI Title of study: Role of Connexin47 Mutations in Primary Lymphedema Role: Co-I Major goals: This grant explores in vivo and in vitro the molecular role of connexins in murine lymphatic system development and specifically the mechanisms of lymphatic valve development.

Translational Imaging Program Project Stimulus (TIPPS) Award 2016 8/14/16-8/15/17 TIPPS Program Project (M Witte/Kuo/Gmitro/R Witte) Title of study: Next Generation Multimodality Lymphatic Imaging: Translation to Precision Theranostics and Population Management of Lymphatic Disorders Role: Multiple PI Major goals: Translation of next generation gamma ray, MR, and photoacoustic imaging into clinical precision theranostics.

Translational Imaging Program Projects Stimulus (TIPPS) Award 2016 8/14/16-8/15/17 TIPPS Project 1 (M Witte/Kuo/Furenlid) Title of study: Faster/Adaptive Lymphscintigraphic (LAS) SPECT-CT Role: Multiple PI Major goals: Translation of next generation gamma ray imaging into clinical precision theranostics.

Completed PR100451 (Alexander, PI, Louisiana State University) 7/1/11-5/13/14 Department of Defense Idea Grant Title: Lymphatic Vascular-based Therapy for IBD Role: Subcontract PI

PR100654 9/30/11-10/29/13 Department of Defense Title: Progression of Inflammatory Bowel Disease to Cancer: Is the Patient “Better Off” without Lymphatic Vessels or Nodes (or Angiopoietin 2)? Role: PI

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VII. RESEARCH & EDUCATION ALLAN HAMILTON

BIOGRAPHICAL SKETCH g) Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAME Hamilton, Allan J. eRA COMMONS USER NAME (credential, e.g., agency login) EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing include postdoctoral training and residency training if applicable ) DEGREE INSTITUTION AND LOCATION (if MM/YY FIELD OF STUDY applicable) Ithaca College BA English Literature & Education Harvard Medical School MD 1982 Medicine

A. Personal Statement Dr. Hamilton holds a fully tenured Professorship in Surgery at the University of Arizona, as well as three additional professorships in Radiation Oncology, Psychology, and Electrical and Computer Engineering. He graduated from Harvard Medical School and completed his neurosurgical residency training at the Massachusetts General Hospital in Boston, Massachusetts. He completed an NIH fellowship under the supervision of Peter Black, MD, Ph.D. He has carried extensive research into biological and radiation-related treatments in tumors, computer-guidance systems for neurosurgery, and was the first person to develop a system capable of delivering radiosurgery to extracranial targets, a clinical challenge that had been unresolved since 1954. Dr. Hamilton remains the only American to ever receive the Lars Leksell Prize from the European Society of Neurosurgery for pioneering innovation in the field of neurosurgery. He has been selected by his surgical colleagues as “One of America’s Best Doctors in America” for the last fourteen consecutive years. Dr. Hamilton has authored two award-winning nonfiction books about the brain, more than twenty medical textbook chapters, fifty research articles, and has served on the editorial board of several medical journals. He has been a vocal advocate for reform of medical education and the peer-review process to reduce morbidity and mortality from medical mistakes and surgical mishaps. He has been the Executive Director of the Arizona Simulation Technology and Education Center (ASTEC) since 2004. ASTEC serves as the simulation center for the Arizona Health Sciences Center and serves more than thirty-five different user groups. It has become a think-tank and research and development center to create new approaches and methodologies to reduce the impact of medical adverse events on patient outcomes by incorporating realistic simulation into medical and surgical training as well as developing new technologies to prevent these mishaps.

B. Positions and Honors Positions and Employment 1989 – 1990 Clinical Assistant, Dept. of Neurosurgery, Massachusetts General Hospital, Boston, MA

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ALLAN HAMILTON 1990 – 1996 Assistant Professor, Surgery, Section of Neurosurgery, Dept. of Surgery, University of Arizona, Tucson, AZ 1995 – 2004 Chief, Division of Neurosurgery, Dept. of Surgery, University of Arizona, Tucson, AZ 1996 – 2000 Associate Professor (with tenure), Dept. of Surgery, Division of Neurosurgery, University of Arizona, Tucson, AZ 1997 - Faculty, Biomedical Engineering Program, Graduate College, University of Arizona, Tucson, AZ 1999 – 2004 Chairman, Dept. of Surgery, University of Arizona, Tucson, AZ 2000 - Professor (with tenure), Department of Surgery, Division of Neurosurgery, University of Arizona, Tucson, AZ 2000 - Clinical Professor, Dept. of Radiation Oncology, University of Arizona, Tucson, AZ 2001 - Professor, Dept. of Psychology, University of Arizona, Tucson, AZ 2007 - Professor, Dept. of Electrical and Computer Engineering, College of Engineering, University of Arizona, Tucson, AZ 2004 - Exec. Director, Arizona Simulation Technology & Education Center (ASTEC), Arizona Health Sciences Center, University of Arizona, Tucson, AZ Honors and Awards 1981 Albert Schweitzer Fellow, International Albert Schweitzer Foundation 1982 Cabot Prize, Best Senior Thesis in History of Medicine, Harvard Medical School 1983 National Institutes of Health Neurology & Neurosurgery Research Fellowship 1988 Finalist, National United States Army Science Conference, U.S. Military Academy at West Point 1990 - Honorary Associate, International Albert Schweitzer Foundation, United Nations, NY 1991 Biography in Military Surgical Heritage, Uniformed Services University of the Health Sciences, Bethesda, MD 1993 Dean's Teaching Scholar, University of Arizona College of Medicine, 1993 1994 – 1996 Robert G. Ojemann Award for Excellence in Neurosurgical Teaching (Upjohn Co.) 1995 International Lars Leksell Award for Pioneering Contribution to the field of Neurosurgery by a Young Neurosurgeon, 10th European Congress of Neurosurgery. Presented in Berlin, Germany 1995 Bernard J. Cosman Award for Innovation, American Society for Stereotactic and Functional Neurosurgery, presented Marina del Rey, CA 1996 - Fellow, American College of Surgeons 1998 – 2002 Elected to Board of Directors, AANS and CNS Joint Section on Stereotactic & Functional Neurosurgery 2001 Outstanding Research Faculty Mentor of the Year 2001 Included 10th Ed. International Directory of Distinguished Leadership 2001 Elected to Glioma Outcomes Project National Advisory Board 2001 - 2013 Selected as "One of America's Best Doctors" (14 consecutive years) 2002 - Included in The Contemporary Who’s Who 2003 - Included in Strathmore’s Who’s Who 2008 - Included in Who’s Who in American Science and Technology 2009 Silver Nautilus Award for non-fiction works “that change the world one book at a time.”

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ALLAN HAMILTON 2011 Congressional Award for Excellence & Innovation in Training for Fire-fighters and EMS – Award from the Congressional Fire Safety Institute

2011 Named Senior Research Fellow, Medical Institute for Innovation, Washington, DC 2012 Recipient, 2012 Vernon & Virginia Furrow Award for Academy of Medical Education Scholars Grant 2012 University of Arizona simulation facility chosen as the Finalist by Amer. Assoc. of Medical Colleges for most innovative new design in a multi-disciplinary medical simulation facility, AAMC Annual Meeting of Deans of American Medical Colleges, San Francisco, Nov. 8, 2012 2012 Selected as “One of America’s Top Surgeons,” 2012, Consumers Research Council of America 2012 Gold Nautilus Award for non-fiction

Other Experience and Professional Memberships 1984 – 2000 High Altitude Medicine Consultant, Medical Research and Development Cmd., Fort Meade, MD 1987 – 1988 Medical Officer and Advisor, U. S. Marine Corps Mountain Warfare Training Ctr., Bridgeport, CA 1987 – 1988 Medical and Scientific Consultant, 1988 Uniformed Services University of Health Sciences Research Expedition to Mt. Aconcagua (Argentina) 1987 – 1989 Medical Curriculum Advisor, Aerospace and Aviation Medicine, Fort Rucker, AL, 1987-1989 1987 – 1999 Scientific Consultant, U.S. Army Medical Research and Development Cmd., Fort Detrick, MD 1988 – 1988 Medical and Scientific Consultant, 1988 Northwest American Everest Expedition to Mt. Everest 1988 – 1989 Medical Consultant, 1989 Wyoming Centennial Expedition to Mt. Everest 1990 - Member, American Association of Neurological Surgeons 1990 - Member, Congress of Neurological Surgeons 1990 - Member, Surgical Advisory Committee, Uniformed Services University of the Health Sciences 1992 - Physician Member, Mexico Outreach Planning Committee 1993 - Member, Rocky Mountain Neurosurgical Society 1995 - Member, Fellow, American College of Surgeons 1995 - Member, The Western Neurosurgical Society 1995 - Member, The Society of Neurological Surgeons 1999 - Clinical Consultant, Sunstone Healing Center (Arizona Cancer Center), Tucson, AZ 1999 – 2003 Advisor, National Executive Committee, Case Management Society of America (CMSA) 1999 – 2004 Member, Advisory Board, Gliomas Outcomes Project 1999 – 2004 Member, Executive Committee for the International Society for Radiosurgery 2000 - American Association for Advancement of Science, 2000-present 2001 - Member, Scientific Board of Advisors, Re-Wired for Life 2005 - Member, Society for Simulation in Healthcare 2011 Member, Advisory Board, Collaborating Across Boarders, 3rd Biennial Interprofessional Educational Conference

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ALLAN HAMILTON 2012 - Member, Taskforce for National Initiative to Reduce Maternal and Neonatal Mortality in Childbirth, Republic of Gabon in conjunction with Albert Schweitzer International Fellowship and Harvard School of Public Health 2013 Consortium on Healthcare & Hygiene Education in the Third World: “The role of simulation training among illiterate village-based childbirth attendants in Africa,” TEDGlobal Meeting, Edinburgh, Scotland, July 8, 2013

C. Selected Peer-reviewed Publications 1. Haniffa, H., Rozenblit, J.W., Peng, J., Hamilton, A.J., Salkini, M. (2007). Motion Planning System for Minimally Invasive Surgery. Proceedings of the IEEE: International Conference and Workshops on the Engineering of Computer-Based Systems, 7, 1-2. 2. Feng, C., Rozenblit, J.W., Hamilton, A.J. (2007). A Hybrid View in a Laparoscopic Surgery Training System. Proceedings of the IEEE. International Conference and Workshops on the Engineering of Computer-Based Systems.7, 3-7 3. Chiocca EA, Smith KM, McKinney B, Palmer CA, Rosenfeld S, Lillehei K, Hamilton A [REMOVE BOLD FONT HERE], DeMasters BK, Judy K, Kirn D (2008). A Phase I Trial of Ad.hIFN-Beta Gene Therapy for Glioma. Mol, Ther.,16 (3), 618-26 4. Krupinski, E.A., Patel, B., Berger, W., Hamilton, A.J., Knapp, A.E., Becker, G.J., Gatenby, R.A. (2009). Assessing Radiology Resident Preparedness to manage IV Contrast Media Reactions Using Simulation Technology. Proceed. of 17th Annual Medicine Meets Virtual Reality,17, 139-141 5. Feng, C., Rozenblit, J.W., Hamilton, A.J. (2010). A Computerized Assessment to Compare the Impact of Standard, Stereoscopic, and High-Definition Laparoscopic Monitor Displays on Surgical Technique. Surg. Endosc., 24, 2743-2748. 6. Rojas, M., Feng, C., Hamilton, A.J., Rozenblitt, J.W. (2010). Knowledge Elicitation for Performance Assessment in a Computerized Training System, Applied Soft Computing, (10), 1-12. 7. Prescher H., Biffar, D., Galvani, C., Rozenblit, J., Hamilton, A. (2013). Evaluation of a Navigation Grid to increase the Efficacy of Instrument Movement during Laparoscopic Surgery. In Press to Surgical Innovation. 8. Hamilton AJ, Prescher H, Biffar D, Poston RS. (2015). Simulation trainer for practicing emergent open thoracotomy procedures. J Surg Res,197(1):78-84 9. Prescher H, Grover E, Mosier J, Stolz U, Biffar D, Hamilton AJ, Sakles J. (2015) Telepresent intubation supervision is as effective as in-person supervision of procedurally naïve operators. Telemed J E Health, 21(3).

D. Research Support Federal 1. Co-Investigator (10% effort): Hyperthermia and Radiation in the Treatment of Brain Tumors. American Cancer Society Grant PDT-310 (N. Guthkelch, M.D., PI), 1989-1991, $300,000 2. Principal Investigator (30% effort): Development of a Prototype Device for Spinal Radiosurgery. American Cancer Society, Institutional Research Grant (IRG#91-080), 1991- 1992, $10,000 3. Principal Investigator (20% effort): Young Clinical Investigator Career Development Award, American Cancer Society (93-021); July 1, 1993-June 30, 1996, $100,000 4. Co-Investigator (15% effort): Center for Frontier Medicine in Biofield Science. NIH-NCCAM, 09/15/02-04/30/05, $599,664

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ALLAN HAMILTON State 1. Principal Investigator (5% effort): Mitogenic Capacity of Aspirates and Washings from Intracranial Malignant Gliomas. Basic Research Support Grant, University of Arizona, 1993- 1994, $5,000 2. Co-Investigator (5% effort): Retinal Pigment Cell Transplantation for Macular Degeneration and Parkinson’s Disease. University Physicians/University Medical Center Experimental Research for Clinical Care Program, 2003-2006, $125,000/yr x 3 3. Principle Investigator (2% effort), The Effect of In Situ Simulation in Medical Education: Assessment of Training Methods for Future Developments, Practice Plan Risk Management Process Improvement for Patient Safety Fund Program, UA Healthcare, $25,000 (2012 – 2014) 4. Co-Investigator, Mannequin Development for Cardiothoracic Surgery Robotics: Interprofessional Simulation Training, Practice Plan Risk Management Process Improvement for Patient Safety Fund Program, UA Healthcare, $25,000 (2010 - 2012) 5. Principle Investigator, Using artificial tissue to design high-fidelity teaching modalities – preparing medical students for clinical training; Vernon & Virginia Furrow Award, Academy of Medical Education Scholars (AMES) Grant for Medical Education Research, University of Arizona, College of Medicine; $5,000 (2012) 6. Co-Investigator, Assessing the effectiveness of self assessment versus group assessment using tablet computers for debriefing neonatal resuscitation program (NRP) simulations for pediatric residents; Vernon & Virginia Furrow Award, Academy of Medical Education Scholars (AMES) Grant for Medical Education Research, University of Arizona, College of Medicine, $5,000 (2012) Industry 1. Co-Investigator (2% effort): Efficacy Study of Tirilazad Mesylate in Moderate and Severe Head Injury (Multi-Center Trial). Upjohn Co. (#2700-0017), April 1994-Jan 1995, $2,500 2. Principal Investigator (10% effort): Prototype Development of Extracranial Stereotactic Radiosurgical Frame. Fischer-Leibinger, Inc., Nov 1, 1993-October 30, 1996, $317,000 3. Principal Investigator (10% effort): Phase III of Surgically Implanted BCNU-Impregnated Polymers for Recurrent Malignant Astrocytomas. Guilford Pharmaceuticals, June 1996- June 1997, $45,000 4. Principal Investigator (10% effort): Phase III Randomized Double-Blind Placebo Controlled Trial of Gliadel vs. Polymer Placebo for Treatment of Primary Malignant Astrocytomas. Rhone-Poulenc Rorer Pharmaceuticals, June 1997-June 1999, $175,000 5. Co-Principal Investigator (5% effort): NCP Study protocol E05: Assessment of Vagus Nerve Stimulation (VNS) for Adjunctive Treatment of Epilepsy Patients Who Have Refractory Partial Onset Seizures with Alterations of Consciousness. Multi-center trial; opened Jan 1, 1996-Dec 30, 1997, $15,000 6. Principal Investigator (5% effort): “Braincare.org”: Establishing an Internet-based Portal to Serve Brain Tumor Patients, Families, Physicians and Other Health Care Providers. Rhone- Poulenc-Rorer, Jan 1, 2000-Dec 31, 2002, $205,000 7. Principal Investigator (5% effort): Prototype Development for Spinal Stereotactic Radiosurgery. Howemedica Leibinger, July 1, 1996 to Jan 2000, $300,000 8. Principal Investigator (5% effort): Clinical Applications of Frameless Stereotaxy. Zeiss, Inc., September 1, 1996-Aug, 30, 2001, $326,000 9. Principal Investigator (2% effort): Educational Program on Glioma Therapy and the Intraoperative Use of Intracavitary Polymer Chemotherapy Delivery Systems for Treatment of Malignant Gliomas. Rhone-Polenc-Rorer, July 1999-June 2000, $7,000

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ALLAN HAMILTON 10. Executive Director (10% effort): Education Grant to Arizona Simulation Technology & Education Center, Karl Storz Endoscopy, Brechthold Corporation, Exhibit One/Marconi $750,000 (2005-2008) 11. Principal Investigator (2% effort): Video series, Direct Laryngoscopy in Emergent Airway Management, Karl Storz Endoscopy of America, Inc. $60,000 (2011-2013)

Ongoing Research Support 1. PI, W911NF-15-R-0001 Simulation and Training Engineering Services (STES) - Medical Simulation Research (MSR) - TA2, Simulations and Training Engineering Services (STES) Multiple Award Indefinite Delivery/Indefinite Quantity Contract (ID/IQC) Solicitation Number: W911NF-15-0001; Agency: Department of the Army; Office of Army Contracting Command ($775,000 per year through 2019) 2. Co-Principal Investigator (10% effort), NIH RO1 EB 18921-01 “Multi-Resolution Foveated Laparoscope for Safer Minimally Invasive Surgery (PI Hung Hua, PhD, Optics, UA) $3.4 million Dates 2014-2018. 3. Jerzy Rozenblit (PI), Allan Hamilton (Co-PI): Collaborative Research: Computer Guided Laparoscopy Training.National Science Foundation, $1,118,923 2016-2020 4. Co-Investigator (2% effort), Department of Defense Contract (PI Jennifer Barton PhD, Biomedical Engineering) “Optical Imaging Falloposcope for Minimally Invasive Ovarian Cancer Detection” $750,000 Dates 2014-2017

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VII. RESEARCH & EDUCATION RONALD HEIMARK

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES.

h) NAME: Heimark, Ronald i) POSITION TITLE: Professor, Dept. of Surgery j) eRA COMMONS USER NAME (credential, e.g., agency login): rheimark6331 k) EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion Date FIELD OF STUDY INSTITUTION AND LOCATION (if applicable) MM/YYYY

Western Washington University, Bellingham, WA BA 06/1970 Biology University of California, Davis, CA PhD 09/1976 Biochemistry University of Washington, Dept. of Biochemistry Postdoc 09/1981 Biochemistry University of Washington, Dept. of Pathology Postdoc 12/1986 Experimental Pathology

A. Personal Statement Dr. Heimark’s laboratory has a broad background in cancer research on the signal transduction and transcriptional deregulation of intercellular adhesion receptors in the epithelial-to-mesenchymal transition during prostate cancer progression.1 We have recently discovered and evaluated a biofunctional SNPs affecting competitive endogenous RNA interaction networks important in prostate cancer. We have recently discovered that the SNP rs13136837(G/T), which resides in the flanking region of the miR-302/367 pri- miRNA sequence, affects processing and expression of mature miR-367. We genotyped prostate cancer patients and found the miR-302/367 T-allele associated with aggressive prostate cancer risk and may be able to significantly distinguish between aggressive and non-aggressive disease. My long term goal is to develop a mechanistic understanding and predictive biomarkers of aggressive prostate cancer from non- aggressive disease. He has been a Full member of the University of Arizona Cancer Center since 1993 and has been actively involved in the Cancer Biology, Biomedical Engineering, and the Physiological Sciences interdepartmental graduate programs and in the Cell and Molecular Medicine. I have served on 68 predoctoral committees in MCB, Cell and Molecular Medicine, Nutrition Sciences, Immunobiology, Genetics, Physiological Sciences, Biomedical Engineering, Aerospace and Mechanical Engineering and Cancer Biology. Dr. Heimark has mentored 8 predoctoral students and 3 postdoctoral scholars. He was also the mentor for three general surgery residents (3rd year) who obtained their Masters degree in the Clinical Translational Sciences Graduate Program. The sponsor is currently mentoring two Cell and Molecular Medicine Masters students, who are Native American (Navajo and Chocktaw/Cherokee). In the past 5 years Dr. Heimark has mentored sixteen undergraduate students (three Native American students, and two Hispanic students). Four undergraduate students are in Medical School and in addition one who is attending graduate school at California Institute of Technology, and one at the University of Washington. 1. Tran NL, Cress AE, Nagle RB, and Heimark RL. N-cadherin Expression in Human Prostate Carcinoma Cell Lines: An Epithelial-Mesenchymal Transformation Mediating Adhesion with Stromal Cells. Am J Path. 1999;155(3):787-98.PMID: 10487836 [224 citations]

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B. Positions and Honors Positions and Employment 1986-1990 Research Assistant Professor, Dept of Pathology, University of Washington 1990-1993 Director Cell Biology, ICOS Corporation, Bothell, WA [one of the Founding Scientific Members (product Cialis; tadalafil)] 1990-1993 Affiliate Assistant Professor, Department of Pathology, University of Washington, Seattle, WA 1993-2005 Associate Professor, Departments of Surgery, and Cellular & Molecular Medicine, University of Arizona 1993-Pres. Faculty Member of Cancer Biology Interdepartmental Graduate Program, University of Arizona, 1995-Pres. Full Member of the University of Arizona Cancer Center (NCI Comprehensive Center) 1999-2005 Associate Professor, with Tenure, University of Arizona, School of Medicine, Dept. of Surgery 2000-2009 Chief Surgical Research Section, Department of Surgery, University of Arizona 2005-Pres. Professor, University of Arizona, School of Medicine, Department of Surgery 2006-Pres. Professor, University of Arizona, School of Medicine, Department of Ophthalmology

Other Experience and Professional Memberships 1993–1994 Member: Review Committee, National Institutes of Health -NHLBI, SCORE in Ischemic Heart Disease, Sudden Cardiac Death, and Heart Failure 1998-1999 Co-Chair, Vascular Biology Study Section 2B, American Heart Association 1999-2001 Chair, Vascular Biology Study Section 2B, American Heart Association 1995-2000 Member: Special Emphasis Panel on Research Training Awards, NIH -NHLBI 2006-2008 Adhoc Member: Cancer Biomarkers Study Section (CBSS), Oncology 2, NIH, NCI 2008-2010 Member: Cancer Biomarkers Study Section (CBSS), Oncology 2, National Institutes of Health 2010-2011 Adhoc Member: ZRG1 OCT-X (02) Translational Clinical Oncology, NIH, NCI 2011-Pres. Adhoc Member: ZRG1 FO9-P(20) Fellowship: Oncological Sciences, NIH, NCI

Honors 1984 Irvine H. Page Research Award for Young Investigators, (American Heart Association)

C. Contribution to Science I have published >70 peer-reviewed research publications and several reviews and book chapters. My current H-index is 36 (Google Scholar 8/18/16).

1. Metastasis and Regulation of Adhesion in Prostate Cancer: My lab was the first group to propose that a late step in prostate cancer progression is the loss of differentiation in EMT. At the time the current theory was that loss of the epithelial cell-cell adhesion molecule, E-cadherin, through transcriptional repression led to detachment of cells from the primary tumor. Our results showed a switch in cadherin types with the loss of E-cadherin which was accompanied by the gain of N-cadherin. This cadherin switch was beneficial for invasive cells and N-cadherin engagement initiated prosurvival signaling and adhesion to stroma. There was very little known regarding the induction of N-cadherin transcription in EMT. We identified the bHLH factor Twist1 as a positive effecter of Cdh2 gene expression by binding to a site in the first intron. We continue to examine the transcriptional drivers of Cdh2 including MZF1 and Twist1 and inactivation of the transcriptional repressors FoxP1, FoxP4 and

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RONALD HEIMARK NRSF. Analysis of the expression of the transcription factors and transcriptional repressors binding to the N-cadherin gene and their localization in high grade tumors suggests the interacting network of factor regulating the gene might be prognostic for tumors that will be clinically significant and progress to metastatic cancer. We have proposed that understanding the transcriptional regulators of N-cadherin will lead us to better understand the drivers of lethal cancer. With Dr. Futscher we explored the loss of epithelial differentiation through 5’UTR CpG hypermethylation and suppression of miR-200c expression, which functions in regulation by Zeb1. To analyze differential signaling in precursor lesions of prostate and pancreatic collaboration with Drs. Doetschman and Galbraith developed to create a nuclear tagged mouse models to use RNA sequencing of single nuclei from populations of epithelium. a. Tran NL, Adams DG, Vaillancourt RR, Heimark RL. Signal Transduction from N-cadherin Increases Bcl-2: Regulation of the Phosphatidylinositol 3-Kinase/Akt Pathway by Homophilic Adhesion and Actin Cytoskeletal Organization. J Biol Chem. 2002;277(36):32905-14.PMID: 12095980[151 citations] b. Alexander NR, Tran NL, Rekapally H, Summers, CE, Glackin C, Heimark RL. N-cadherin Gene Expression in Prostate Carcinoma is Modulated by Integrin-Dependent Nuclear Translocation of Twist1. Cancer Research. 2006;66(7):3365-9.PMID: 16585154[183 citations] c. Verba L, Jensen TJ, Garbe JC, Heimark RL, Cress AE, Dickinson S, Stampfer MR, Futscher BW. Role for DNA Methylation in the Regulation of miR-200c and miR-141 Expression in Normal and Cancer Cells. PloS ONE. 2010;5(1):e8697. PMCID: PMC2805718 [213 citations] d. Samadder P, Weng N, Doetschman, Heimark, RL, and Galbraith DW. 2016. Flow Cytometry and Single Nucleus Sorting for Cre-based Analysis of Changes in Transcriptional States. Cytometry 89(5):430-442. doi:10.1002/cyto.a.22847; PMID:27003621

2. Endothelial Integrity in Vascular Biology: My previous work in cardiovascular biology addressed molecular mechanisms that controlled the maintenance of integrity of vascular endothelium. Evidence suggested that endothelial dysfunction and loss of integrity due to soluble factors and mechanics of flow resulted in increased endothelial permeability and growth were early events in cardiovascular disease. Our studies on the cardiovascular role of the TGFβ1 showed a transient inhibition of endothelial growth and migration and studies with Dr.Krieg describe a role Hedgehog signaling is essential for endothelial tube formation during vasculogenesis. We further identified a calcium-dependent growth inhibitory activity in the plasma membrane of endothelium. At the time only E-, N- and P-cadherin were known and they were not localized in endothelial cells. We proposed and identified a new cadherin subtype in the junctions of endothelium that mediated contact dependent control of growth. With a team of collaborators we were able to show that the cytokines TNFα and γIFN increases permeability at sites of loss of VE-cadherin in mesenteric venular endothelium, rearrangement of VE– cadherin adherens junctions by TGFβ1,and that the lining cells of the Schlemm’s canal is endothelium with VE-cadherin junctions (Patent: US7803558 Modulation of aqueous humor outflow). In collaboration with Dr. Suzuki we extended studies on that identification and cellular localization of a new family of cadherin- like molecules, called protocadherins. Thus, our work on vessel integrity led to the identification of VE- cadherin and a family of cadherin-like molecules. a. Heimark RL, Twardzik D, Schwartz SM. Inhibition of endothelial regeneration by type-beta transforming growth factor from platelets. Science. 1986;233(4768):1078-80. PMID: 3461562[418 citations] b. Heimark RL, Degner M, Schwartz SM. Identification of a Ca2+ dependent cell adhesion molecule in endothelial cells. J Cell Biol. 1990;110(5):1745-56. PMID: 2335569 [97 citations]

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RONALD HEIMARK c. Coffin JD, Harrison J, Schwartz SM and Heimark RL: 1991. Angioblast differentiation and morphogenesis of the vascular endothelium in the mouse. Embryo. Developmental Biology 148:51-62.[166 citations] d. Sano K, Tanihara H, Heimark RL, Obata S, Davidson M, St. John T, Taketani S, Suzuki S. Protocadherins: a large family of cadherin-related molecules in central nervous system. EMBO J. 1993;12(6):2249-56. PMID: 8508762[306 citations]

3. Molecular Mechanisms of Contact activation: In addition, to the contributions already described my early publications described functional interactive sites of multiprotein complex in the initiation of translation and activation of the intrinsic pathway of blood coagulation. While the coagulation cascade had been well described one of the major questions was the formation and activation of the contact dependent pathway in hemostasis. Our data indicated the surface activation of single chain factor XII can initiate blood coagulation, fibrinolysis or kinin generation by converting prekallikrein to kallikrein. The enzyme cascade is then generated leading to the formation of fibrin, plasmin or bradykinin in three closely related physiological events. f. Heimark RL, Kurachi K, Fujikawa K, Davie WE: 1980. The surface activation of blood coagulation, fibrinolysis and kinin formation. Nature 286:456-460.[149 citations] g. Heimark RL and Schwartz SM: 1983. Binding of coagulation factor IX and factor X to the endothelial cell surface. BBRC 111:723-731.[88 citations]

4. Ribosome Structure in Initiation of Protein Synthesis My early studies examined biofunctional organization of ribosome proteins in the ribonucleoprotien complex the ribosome. Our approached used bifunctional crosslinking reagents and nearest neighbor analysis. a. Heimark RL, Kahan L, Johnston K, Hershey JWB and Traut RR: 1976. Cross-linking of initiation factor IF-3 to proteins of the Escherichia coli 3OS ribosomal subunit. Journal of Molecular Biology 105:219-230. [88 citations] Complete List of Published Articles from Pubmed: http://www.ncbi.nlm.nih.gov/sites/myncbi/1jon8_exZ7Yko/bibliograpahy/48076986/public/?sort=da te&direction=ascending

D. Research Support Ongoing Research Support NIH/NCI 09/19/14-8/30/17 Partnership for Native American Cancer Prevention 5U54CA143924-06 PI David S. Alberts Project 1: Ronald L. Heimark and Jason A Wilder co-PIs “Functional Genetic variants as modifiers of prostate cancer progression in Native Americans” Our proposal will identify biofunctional SNPs that affect competitive endogenous RNA (ceRNA) networks by and associate with progression of prostate cancer and lncRNAs. Our research plan will investigate the role of SNP variation in MREs as modulators of oncogenic miRNAs that may cancer progression. This approach will allow us to characterize genetic biomarkers and risk factors of particular importance to Native American populations. No Overlap

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RONALD HEIMARK Submitted Department of Defense 3/1/2017-2/28/2020 PC160237 Ronald L. Heimark and Jason A Wilder co-PIs “Functional Genetic Modifiers of Prostate Cancer Progression” The proposed studies will be on identifying in Hispanic men molecular networks that distinguish lethal disease from low risk disease. This will lead to improved biomarkers for aggressive PCa and help address the disparity in mortality between Hispanic and NHW men. Aim 1. To test whether individual-level Native American genomic ancestry is associated with prostate cancerrisk or risk of aggressive prostate cancer. Aim 2. To discover functional single nucleotide polymorphisms in non-coding regions affecting prostate cancer tumor suppressor/oncogene function. Aim 3. To validate these biofunctional variants in independent Hispanic prostate cancer cohorts. No Overlap

Completed Research Support within last 3 years ABRC ABC #13530 (Galbraith, PI; Doetschman, Co-PI and Heimark Co-PI) 10/23/14-10/22/16 Arizona Biomedical Research Commission “Identification of changes in gene expression at the earliest stages of prostate oncogenesis” In our mouse prostate cancer model, the nuclei of prostate cells initiating cancer are identified following induction of tamoxifen-regulated Cre under control of the probasin promoter, which generates H2b-GFP and, at the same time, inactivates expression of the tumor suppressor proteins (PTEN). Analysis of RNA expression in nuclei should identify biomarkers and whether the nucleus is derived from luminal or basal cells. i) Isolation of individual tumorigenic prostate cell nuclei. ii) RNAseq of individual nuclei to determine biomarkers for early stage prostate cancer. No Overlap

Partnership for Native American Cancer Prevention U54 CA143925-05 (Huenneke/Alberts) 9/1/2009 – 8/30/2014 Ronald L. Heimark co-Principal Investigator Pilot Project: “Prostate Cancer Risk: Role of Genetic Variation in the microRNA Stress Response to Arsenic Exposure” The hypothesis to be tested is that an important mechanism of arsenic toxicity is its ability to alter prostate carcinoma differentiation through altering the normal regulatory mechanisms of specific non- coding microRNAs.

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VII. RESEARCH & EDUCATION ROBERT JOHNSON

Please see the following faculty profile link: http://medicine.arizona.edu/news/2017/dr-robert-c-johnson-appointed-ua-institute- cellular-transplantation

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VII. RESEARCH & EDUCATION KLEARCHOS PAPAS BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Papas, Klearchos K. eRA COMMONS USER NAME (credential, e.g., agency login): papa006 POSITION TITLE: Professor of Surgery; Director, Institute for Cellular Transplantation EDUCATION/TRAINING Completion INSTITUTION AND LOCATION DEGREE FIELD OF STUDY Date Georgia Institute of Technology, Atlanta, GA B.ChE May 1990 Chemical Engineering Georgia Institute of Technology, Atlanta, GA M.S. May 1992 Chemical Engineering Georgia Institute of Technology, Atlanta, GA Ph.D. May 1996 Chemical Engineering Novartis Pharmaceuticals, Summit, NJ Postdoc Training 1996-1999 Analytics/BioNMR

A. Personal Statement I have devoted my research career to the application of engineering principles and the development of enabling technologies in the fields of cell therapy and tissue engineering with a focus on the treatment of diabetes. I have studied and utilized the properties of insulin-secreting tissue and their relationship to viability and function in the context cell therapies for diabetes with the objective of improving cost- effectiveness, availability, and clinical outcomes of this approach.

I have worked on the development and validation of assays and sensors (especially ones based on mitochondrial function such as oxygen consumption rate, OCR) for the real-time, objective assessment of islet quality prior to transplantation. The OCR assay has been validated based on its ability to predict diabetes reversal in mice and clinical human islet auto transplants in patients with chronic pancreatitis. I have used these assays along with engineering principles to optimize the islet transplantation process from pancreas procurement (pancreas preservation, islet isolation and purification, islet culture and shipment and islet infusion to the recipient. As an example, my group has developed tools for the real-time, noninvasive assessment of pancreases and other organs during preservation, and is actively involved in research for improvements in organ preservation technology (by enhancing oxygen delivery and oxygenation). I have had continuous NIH funding for the past 12 years in the area of pancreas preservation and have spearheaded the effort for the development of humidified oxygen gas perfusion (persufflation) of the pancreas using novel technology for portable in situ oxygen generation from water via electrochemistry. These technologies aim to extend the allowable time window from procurement to transplantation and the utilization of organs from expanded criteria donors without compromising clinical outcomes.

Another example and a major focus of the ongoing research in my group is improving beta-cell engraftment post-transplantation and eliminating the need for immunosuppression utilizing in situ oxygen delivery [via a miniaturized (size of a few pennies), ultimately implantable persufflator] to retrievable vascularization inducing macro-encapsulation devices that block cell to cell contact. Enhanced oxygenation in vivo can: 1) dramatically reduce the necessary size of such beta-cell containing devices (from that of a large flat-screen TV to that of a postage stamp); 2) enhance beta cell functionality (in terms of glucose-stimulated secretion within them); and 3) reduce the dose of cells required to reverse diabetes. If successfully translated to the clinic, our work in this area has the potential to have a profound impact on reducing overall costs, increasing availability, and improving short-and long-term outcomes in beta-cell therapies for the treatment of diabetes while eliminating the need for immunosuppression.

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KLEARCHOS PAPAS B. Positions and Honors Positions 1999 - 2010 MIT, Dept. of Chemical Engineering, Research Associate (2005-2010, Research Affiliate). 1999 - 2003 Yale University, Medical School, Boyer Center of Molecular Medicine and Cellular and Molecular Physiology, Visiting Scientist / Research Consultant. 2001 - 2003 Harvard Medical School, JDRF Center for Islet Transplantation, Investigator. 2003 - pres. University of Minnesota, Medical School, Surgery, Associate Professor (2003-2009, Assistant Professor, 2011- Present Adjunct Professor). 2003 - 2011 University of Minnesota, Medical School, Associate Director of Islet Transplantation Program, Diabetes Institute for Immunology and Transplantation. 2003 – 2011 University of Minnesota, Medical School, Director of Islet Processing Research and Development, Diabetes Institute for Immunology and Transplantation. 2005 - pres. University of Minnesota, Dept. of Biomedical Engineering, Graduate Faculty (Full membership). 2007 - pres. University of Minnesota, MD/PhD Program, Preceptor. 2007 – 2011 University of Minnesota, Medical School, Director of Islet Quality Control Core, Diabetes Institute for Immunology and Transplantation. 2010 - pres. University of Minnesota, Radiology (Biophysical Sciences and Medical Physics), Graduate Faculty 2010 - pres. University of Minnesota, Institute of Engineering in Medicine, Member. 2011 - pres. University of Minnesota, Dept. of Chemical Engineering and Materials Science, Graduate Faculty 2011 - pres. University of Arizona, Tucson, Medical School, Professor of Surgery. 2011 - pres. University of Arizona, Dept. of Surgery, Scientific Director, Institute for Cellular Transplantation. 2012 - pres. University of Minnesota, Radiology, Center for Magnetic Resonance Research (CMRR), Adjunct Professor 2013 - pres. University of Arizona, Dept. of Biomedical Engineering, Dept. of Physiology, Dept. of Medical Imaging, Member of Graduate Faculty.

Honors: 1986 - 1990 Fulbright Scholar 1990 Omega Chi Epsilon (Chemical Engineering Honors Society) National award for leadership and service as president of the Georgia Tech Chapter 1996 Outstanding Ph.D. Thesis, Georgia Institute of Technology (Georgia Tech) 1996 National Institute of Advanced Interdisciplinary Research (NAIR), Tsukuba, Ibaraki, Japan, Invited Fellow, Tissue Engineering/Bionic Design 1998 Business Excellence Award, Novartis Institute for Biomedical Research, Novartis Pharmaceuticals 1999 EASD Travel Award 2003 Iacocca Fellow 2005 Larry Hillblom Lecture - The Larry Hillblom Islet Research Center, UCLA 2008 Iacocca Foundation – mentor based fellowship. Mentor MD/PhD student in “islet tissue engineering” 2009 - pres. Editorial Board Member: Cell Transplantation, “The Regenerative Medicine Journal”, Islets and Other Endocrines 2010 - pres. Editorial Board Member: Cell Medicine 2011 - pres. Councilor; Cell Transplant and Regenerative Medicine Society (CTRMS) – formally known as Cell Transplant Society 2012 - pres. Editorial Board Member: Xenotransplantation 2013 JDRF Encapsulation Consortium: Co-chair, Islet Characterization Assays Working Group 2013 - 2014 UA College of Medicine Committee of Ten 2013 - 2015 Member; CTS Social Media and Web Committee 2013 - pres. Editorial Board Member: CellR4

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KLEARCHOS PAPAS 2013 - pres. Chair, CTS membership committee 2013 - pres. Editorial Board Member: Frontiers in Bioengineering and Biotechnology, Biomaterials

C. Contribution to Science 1. Development of tools for islet quality (viability and potency) assessment prior to transplantation: The field of islet transplantation was plagued by the unavailability of reliable real-time islet quality assessment methods that would help avoid transplantation of non-viable, non-functional islet preparations in patients, and enable critically needed improvements in protocols for pancreas procurement, preservation, islet isolation, culture, and shipment. While at the Massachusetts Institute of Technology (MIT), I identified this as an area of interest in which I could make a significant contribution and embarked on developing rapid, reliable, and quantitative islet quality assays based on measurements of oxygen consumption rate (OCR). Working collaboratively, we demonstrated that these assays are predictive of transplantation outcome in immunosuppressed mice. We were able to extend these findings and demonstrate that the OCR assay is predictive of transplant outcome in the clinical human islet auto transplants. These findings resulted in the funding by NIH of a proposal (awarded while at the U of A) for conducting OCR measurements on all islet products prior to transplantation at all centers participating in the NIH funded Clinical Islet Transplant Consortium (CIT) conducting islet transplant phase III registration trials aimed at establishing islet transplantation as standard of care which led to a close collaboration with Dr. James Shapiro which demonstrated the utility of this assay for predicting clinical allo-transplantation outcome. Several diabetes research labs as well as major islet transplant centers within the US, Canada, Europe, Korea, New Zealand and Australia have acquired equipment and have been trained on conducting the OCR assay. The concept of using OCR for islet quality assessment was recently extended by our group to the assessment of whole organs prior to transplantation. Further exploratory work is being conducted through seed funding in collaboration with industrial partners (Cell and Tissue Systems, Organ Recovery Systems). This is an area of increasing importance, due to the high and increasing organ donor demand that far exceeds the available supply. To address the demand issue, marginal quality organs procured from extended criteria donors (ECD) and donors after cardiac death (DCD) are increasingly being utilized. In order to maximize the odds of a successful clinical outcome, assessment of organ viability prior to transplantation is emerging as a critical issue. Current ex vivo quality assessment of donor kidneys is limited to measuring vascular resistance and histological analysis. New techniques for organ quality assessment prior to transplantation (such as the OCR) may facilitate the much needed use of expanded criteria donors without compromising clinical outcomes, and the utilization of organs from donors that are currently considered unfit but may be ultimately appropriate to use. a. Papas KK, Pisania A, Wu H, Weir GC, Colton CK. A stirred microchamber for oxygen consumption rate measurements with pancreatic islets. Biotechnology and Bioegineering, 2007, 98:1071-1082. PMID: 17497731, PMCID: PMC2859188 b. Papas KK, Colton CK, Qipo A, Wu HY, Nelson RA, Hering BJ, et al. Prediction of Marginal Mass Required for Successful Islet Transplantation. Journal of Investigative Surgery. 2010; 23(1):28-34. PMID: 20233002 PMCID: PMC3786417 c. BP Weegman, J Ferrer-Fabrega, WE Scott III … K.K. Papas, “Whole Pancreas Oxygen Consumption Measurement: A Technique for Real-Time Viability Assessment”, Transplant Proc 42(6):2020-2023, 2010. d. K.K. Papas, M. Bellin, et al. Viable Islet Dose Based on Oxygen Consumption Rate Predicts Clinical Islet Auto-transplant Outcome. PLoS One, 2015, 10(8):e0134428. doi:10.1371/journal.pone.0134428.

2. Pancreas preservation: Our lab applied theoretical engineering principles and combined them with laboratory measurements to demonstrate that, contrary to literature reports, the state-of-the-art two-layer method (TLM) for pancreas preservation did not provide adequate oxygenation of the human pancreas during preservation. In fact, more than 80% of the human pancreas may be oxygen limited, and thus damaged, during preservation with this method. Our findings were confirmed by other investigators in the field and led to a collaborative project with Giner, Inc., which was funded by an NIH Small Business Innovation Research (SBIR) Phase 2 grant (following successful completion of an exploratory Phase 1 SBIR grant), aimed at improving pancreas preservation by delivering humidified oxygen gas to the native

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KLEARCHOS PAPAS pancreas vasculature. The Phase 2 SBIR program, was successfully completed since my move to the UA with very promising findings demonstrating 24 hour preservation of human pancreata without compromising islet yield and quality. It was demonstrated that islet yield is 76% higher after 24 hours of persufflation relative to that obtained from pancreata preserved with the TLM for 8-12 hrs. If this is confirmed it can have significant implications in clinical practice. Following presentation of these results at National and International meetings, several renowned groups have approached our lab for collaborations to apply persufflation in their pre-clinical and clinical programs. Recently, McGill University Health Centre in Montreal, Canada conducted their first islet cell transplant, which included organ preservation by persufflation. a. Papas KK, Hering BJ, Gunther L, Rappel MJ, Colton CK, Avgoustiniatos ES. Pancreas oxygenation is limited during preservation with the two-layer method. Transplant Proc 37;2005: 3501-3504. PMID: 16298642 b. Scott III WE, O'Brien TD, Ferrer-Fabrega J… Papas KK. Persufflation improves pancreas preservation compared with the two-layer method. Transplant Proc 42; 2010: 2016-2019. PMID: 20692396; PMCID: PMC2956134 c. Scott III WE, Weegman BP, Ferrer-Fabrega J… Papas KK. Pancreas oxygen persufflation increases ATP levels as shown by NMR. Transplant Proc 42; 2010: 2011-2015. PMCID: PMC2947552 d. T.M. Suszynski, M.D. Rizzari, W.E. Scott III, L.A. Tempelman, M.J. Taylor, K.K. Papas, Persufflation (or Gaseous Oxygen Perfusion) as a Method of Organ Preservation: Review, Cryobiology, 64(3):125-43 2012. PMID: 22301419; PMCID: PMC3519283

3. Islet culture and shipment: Progress in finding a cure and understanding human diabetes has been limited by the unavailability of highly purified human islets for research purposes. The majority of previous work was conducted with rodent islets, which appear to differ significantly from human. NIH and JDRF have recognized this need, and have funded several highly qualified islet isolation centers through the Islet Cell Resource Consortium to isolate and distribute human islets to scientists within the US and around the world. In addition, large-scale clinical application of islet transplantation will require centralized certified islet isolation facilities at a handful of centers and culture and shipment of islets for clinical transplantation will be essential for performing these procedures without compromising islet quality. Recognizing the need for improved and more efficient methods for islet culture and shipment, I have teamed up with a small biotech company (Wilson-Wolf Inc.) to develop an integrated device for islet culture and shipping. This device improves oxygen transfer by replacing the solid bottoms of conventional flasks with gas permeable silicone rubber membranes and allows for culture and shipment of islets from an entire isolation in a single flask. This would otherwise require 30-60 flasks in order for the islets to be sufficiently apart so as to avoid hypoxia induced death. This flask facilitates preservation of sterility and islet handling and can be incorporated into a portable container that maintains pressure, temperature, and oxygen during culture and shipment. The utility of these flasks and shipping vessels has been recognized world-wide and our lab, upon request, is collaborating on validating the use of these vessels with several academic centers within the US and Canada as well as Australia and Europe (Switzerland, Greece and UK). a. Papas KK, Avgoustiniatos ES, Tempelman LA, Weir GC, Colton CK, et al. High-density culture of human islets on top of silicone rubber membranes. Transplant Proc 37; 2005:3412-3414. PMID: 16298611 b. Rozak PR, Weegman BP, Avgoustiniatos ES, … Papas KK. Devices and methods for maintenance of temperature and pressure during islet shipment. Transplant Proc 40; 2008:407-410. PMCID: PMC2799926 c. Avgoustiniatos ES, Hering BJ, Rozak PR, … Papas KK. Commercially available gas-permeable cell culture bags may not prevent anoxia in cultured or shipped islets. Transplant Proc 40; 2008:395-400. PMID: 18374080; PMCID: PMC2764539 d. Kitzmann JP, Pepper AR, Lopez BG,… Papas K.K.. Human islet viability and function is maintained during high density shipment on silicone rubber membrane vessels. Transplantation Proceedings, 2014 Jul-Aug;46(6):1989-91. PMID: 25131090; PMCID: PMC4169700

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KLEARCHOS PAPAS

Complete list of Published Work in My Biography: http://www.ncbi.nlm.nih.gov/sites/myncbi/1TManVmaa46QH/bibliography/49060141/public/?sort =date&direction=ascending

D. Research Support Current Research Support 1DP3DK106933-01 NIH/NIDDK DP3 (Diabetes Impact Award) K. K. Papas (PI) 01/01/16-12/31/19 High Cell-Density Bioartificial Pancreas Enabled By Miniaturized Wearable Oxygen Generator Role: PI

3-SRA-2016-254-S-B JDRF/University of Arizona K.K. Papas (PI) 08/01/16-07/31/19 Retrievable High-Capacity Scaffolds for β-Cell Replacement Therapy in Humans Role: PI

1-PNF-2016-320-S-B JDRF/University of Arizona K.K. Papas (PI) 09/01/16-08/31/17 Pairing of Human Stem Cell Derived Beta-like Cells with a High Capacity, Oxygen-Enabled Immunosiolation Device Role: PI N.C.E.

UA Pilot Interdisciplinary Grant Program K.K. Papas (PI) 07/01/16-06/31/17 Novel Methods for Real-Time Kidney Quality Assessment Prior to Transplantation Role: PI

3-SRA-2015-40-Q-R JDRF/University of Arizona K.K. Papas (PI) 06/01/15-05/31/18 Towards Clinical Translation of a High Density Encapsulation Device with Enhanced Oxygen Supply Role: PI

3-SRA-2015-40-Q-R JDRF/University of Arizona K.K. Papas (PI) 08/01/14-07/31/17 Oxygen Demand and Effects of Oxygenation on Neonatal, Juvenile, and Adult Porcine Islets in vitro and in vivo Role: PI

2-SRA-2014-290-Q-R JDRF/Harvard Medical School Poznansky (PI) 07/01/14-11/30/17 TransCelerate: A Pilot and Feasibility Study in Non-Human Primates of CXCL12-Eluting Alginate Microcapsules Containing Porcine Islets for Treatment of Type 1 Diabetes with Implementation of a Quality-Based Islet Microcapsule Production and Evaluation Process Role: Co-Principal Investigator; Site Principal Investigator

1R44DK100999-01 NIH-NIDDK SBIR Phase 2 / Giner, Inc. Tempelman (PI) 01/01/16-12/31/18 High-Density Bioartificial Pancreas Enabled by Implantable Oxygen Generator Role: Co-Principal Investigator; Site Principal Investigator

5R44DK070400-04 NIH-NIDDK SBIR Phase 2B / Giner, Inc. Tempelman (PI) 09/24/14-08/31/17 Portable Gas Perfusion System for Pancreas Preservation Role: Co-Principal Investigator; Site Principal Investigator

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Private Industry / Instituto Grifols, S.A. K.K. Papas (PI) 07/01/15-06/30/17 The Use of GFS in Islet Transplantation Role: PI

5R01DK084842-05 NIH-NIDDK / University of Arizona Limesand (PI) 04/01/15-03/31/20 Impact of Catecholamine to Insulin-Glucose Homeostasis in IUGR Fetuses Role: Co-Investigator

1R43DK113519-01 NIH-NIDDK SBIR Phase 1 / Profusa, Inc. Wisniewski (PI) 04/01/17-03/31/18 Wireless technology for long-term non-invasive O2 sensing within cell encapsulation devices in vivo Role: Co-Principal Investigator ** pending – notice of intent to award received

1R43DK113537-01 NIH-NIDDK SBIR Phase 1 / Sylvatica Bio., Inc. Taylor (PI) 04/01/17-09/30/17 Nature-inspired methods for long-term banking of endocrine cells within encapsulation devices Role: Co-Principal Investigator ** pending – notice of intent to award received

Recently Completed Research Support (within the last 3 years)

5R44DK072647-04 NIH-NIDDK SBIR Phase 2 / Techshot, Inc. Todd (PI) 09/01/13-12/31/16 Magnetic Flow Sorter for Pancreatic Islet Isolation Role: Site Principal Investigator

1-PNF-2016-167-A-N JDRF/Emory University Safely (PI) 03/01/16-09/31/16 Measurement of Dissolved Oxygen by 19F MRI of Microcapsules Implanted IP in NHPs Role: Co-Principal Investigator

1 R41 DK108620-01 NIH-NIDDK STTR Phase I / Giner, Inc. Tempelman (PI) 12/01/15-08/30/16 Persufflation as a Tool for Kidney Preservation prior to Transplantation Role: Co-Principal Investigator; Site Principal Investigator

Private Industry / Instituto Grifols, S.A. K.K. Papas (PI) 01/06/14-06/05/16 The Use of Human Serum Supplement in Islet Culture for Transplantation Role: PI

Private Industry / Betalogics (Giner, Inc.) K.K. Papas (PI) 09/01/15-12/31/15 Evaluation of stem cell derived human beta-cells in vitro and in vivo Role: PI

Private Industry / SEMMA (Giner, Inc.) K.K. Papas (PI) 12/01/15-01/31/16 Evaluation of stem cell derived human beta-cells in vitro and in vivo Role: PI

5R44DK070400-04, NIH-NIDDK SBIR Phase 2 / Giner, Inc. Tempelman (PI) 09/24/14-03/31/16 Portable Gas Perfusion System for Pancreas Preservation: develop an electrochemical oxygen generator to preserve pancreata prior to islet isolation to increase the window of allowed cold ischemia time and maintain/improve viability. Role: Co-Principal Investigator; Site Principal Investigator

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5-2013-141 JDRF/Innovative Grant K.K. Papas (PI) 04/01/13-04/01/15

Enhanced O2 Supply to Immunoisolated Islets Role: PI

1R43DK100999-01 NIH/NIDDK SBIR Phase 1 / Giner, Inc. Tempelman PI 01/01/14-12/31/14 High-Density Bioartificial Pancreas Enabled by Implantable Oxygen Generator [Phase 2 SBIR awarded 07/15/15]. Role: Co-Principal Investigator; Site Principal Investigator

R44DK069865 NIH/NIDDK SBIR Phase 2 / Wilson Wolf, Inc. K.K. Papas (site PI) 12/01/07–11/30/14 Islet Culture, Shipping, and Infusion Device. Role: PI

1R43DK075211-01A2 NIH-NIDDK STTR Phase 1 / Bioinventions, Inc.K.K. Papas PI 07/01/10–01/31/14 Islet Protection from Hypoxia Post Transplant Role: Site Principal Investigator

U01DK070431-09 NIH/NIDDK CIT ancillary study K.K. Papas (PI) 07/01/11–06/30/14 Establishment of Oxygen Consumption Rate Measurements for Pre-Transplant Assessment of Clinical Islet Products at all Centers Participating in the NIH sponsored Phase III CIT Consortium. Role: PI

Private Industry / SANOFI (Arizona) K.K. Papas (PI) 12/20/13-12/31/14 Testing Cell Proliferation in Intact Islets Role: PI

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VII. RESEARCH & EDUCATION WILLIAM ADAMAS-RAPPAPORT

Please see the following faculty profile link: http://surgery.arizona.edu/profile/william-rappaport-md-facs

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