OMB No. 0925-0001 and 0925-0002 (Rev. 09/17 Approved Through 03/31/2020)
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: Ira Shoulson eRA COMMONS USER NAME (credential, e.g., agency login): ishoulson
POSITION TITLE: Principal Mentor; Professor of Neurology, Center for Health and Technology (CHeT), University of Rochester; Adjunct Professor of Neurology, Georgetown University 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 Pennsylvania, Philadelphia PA BA 08/63-06/67 Psychology University of Rochester, Rochester, NY MD 08/67-06/71 Medicine Cambridge University, Cambridge, England 05/70-09/70 Summer Fellow Strong Memorial Hospital, Rochester, NY 07/71-06/73 Resident in Medicine NIMH and NINCDS, NIH Bethesda, MD 07/73-06/75 Experimental Therapeutics Strong Memorial Hospital, Rochester, NY 07/75-06/77 Resident in Neurology Strong Memorial Hospital, Rochester, NY 07/77-06/78 Chief Resident in Neurology and Medicine
A. Personal Statement
I have continuously trained and mentored 28 postgraduate fellows in clinical and translational research over the past 30 years in my capacity as a co-director of the ongoing University of Rochester T32 NIH training program in the Experimental Therapeutics of Neurological Disorders (NS-07338) and as PI of the FDA- Georgetown Center of Excellence in Regulatory Science (CERSI: FD004319), including the support of foundation and industry sponsors. Nearly all my trained fellows remain actively engaged in biomedical research in academic, government, industry, and non-profit settings. My professional pursuits have thrived from the intellectual vigor and learning I have gained from training high-quality individuals to carve out meaningful and productive careers in experimental therapeutics. For the past three years, I have mentored Monica Javidnia PhD, at both Georgetown University and the University of Rochester through the support of the FDA-Georgetown CERSI and the Michael J Fox Foundation (MJFF) for Parkinson’s Disease Research. Dr. Javidnia’s research aims to create a more complete understanding of Parkinson’s disease motor and non-motor symptoms, as they manifest over the course of the disease, how the symptoms are treated (pharmacologically and otherwise), and how these treatments relate to patient outcomes, including how they affect daily functioning. These objectives relate directly to important scientific and regulatory approaches bearing on the development of new, safe and effective medical products. Dr. Javidnia’s diverse mentoring and advisory team consists of some of the top researchers in their respective fields, working in the University of Rochester Center for Health & Technology (CHeT), which features a strong track record in clinical research and therapeutic development. She has a diverse and deliberate training plan that will support her career and fellowship plans. She has full access to all resources necessary to carry out her research and training objectives. I and the University of Rochester stand ready to ensure successful KL2 learning, so Dr. Javidnia will achieve her research and career goals.
B. Positions and Honors
Positions and Employment
1975-77 Instructor in Neurology, Pharmacology and Toxicology, University of Rochester School of Medicine 1977-80 Assistant Professor of Neurology, Medicine, Pharmacology and Toxicology, University of Rochester, and Associate Neurologist and Physician, Strong Memorial Hospital, Rochester, NY 1980-85 Associate Professor of Neurology (1980), Medicine (1980) and Pharmacology (1984), University of Rochester; and Senior Associate Neurologist and Physician, Strong Memorial Hospital, Rochester, NY 1985-90 Professor of Neurology (1985), Pharmacology (1985), and Medicine (1987), University of Rochester; and Neurologist and Physician, Strong Memorial Hospital, Rochester, NY 1990-91 Public Policy Fellow, The Joseph P. Kennedy Jr. Foundation (sponsor), U.S. Senate Subcommittee on Disability Policy (Senator Tom Harkin, Chair), Washington, D.C. 1990-2011 Louis C. Lasagna Professor of Experimental Therapeutics and Professor of Neurology, Pharmacology & Physiology, and Medicine, University of Rochester School of Medicine; and Neurologist and Physician, Strong Memorial Hospital, Rochester, NY 2011-18 Professor of Neurology, Pharmacology and Human Science and Director, Program for Regulatory Science and Medicine (PRSM), Georgetown University, Washington, DC 2018- Professor of Neurology, University of Rochester, Center for Health & Technology (CHeT), and Adjunct Professor of Neurology, Georgetown University
Other Professional Experience
1986-2006 Co-Founder and Chair, Parkinson Study Group 1990- Co-Director, Training Program: Experimental Therapeutics of Neurological Disorders (NS-07338) 1992-96 Member, FDA Peripheral and Central Nervous System Advisory Committee 1996-2017 Assistant/Associate Editor, JAMA Neurology (formerly Archives of Neurology) 1996-2014 Co-Founder, Chair, and President, Huntington Study Group 2001-03 President, American Society Experimental Neurotherapeutics (ASENT), Co-Founder (1998) 2002-12 PI, Prospective Huntington At Risk Observational Study, NIH (HG02449) 2002-05 Member, National Institute of Neurological Disorders and Stroke (NINDS) Advisory Council 2009- Member, Institute of Medicine Standing Committee to Advise the Social Security Administration on Disability 2011-12 Chair, Institute of Medicine Committee on Cognitive Rehabilitation Therapy for Traumatic Brain Injury 2011-18 PI, Collaborating Center of Excellence in Regulatory Science and Innovation (CERSI) 2014- NINDS, Co-chair, NeuroNEXT Advisory Committee 2015-16 Member, IOM Committee: Multiple Sclerosis and Other Neurologic Diseases: among Veterans 2015- Member, NIH NINDS StrokeNet Advisory Committee 2017- Founder and Principal, Grey Matter Technologies LLC, www.greymattertech,org
Honors
1998 Guthrie Family Humanitarian Award, Huntington’s Disease Society of America 2000 American Academy of Neurology Movement Disorder Award 2000 Rochester Academy of Medicine Award of Merit 2005 H. Houston Merritt Lecturer, American Academy of Neurology 2006 Outstanding Leadership, Parkinson Study Group 20 Years of Service 2008 Elected Member, National Academy of Medicine (formerly Institute of Medicine) of the National Academies 2009 Honorary Member, Movement Disorder Society 2011 Nathan L. Cohen Lecturer, Johns Hopkins University, Department of Neurology 2015 American Academy of Neurology, Kenneth M. Viste, Jr., MD, Patient Advocate of the Year Award 2015 Huntington’s Disease Society of America, DC Metro Chapter, Honoree 2016 Michael J Fox Foundation for Parkinson’s Disease Research, Robert A. Pritzker Prize for Leadership, Innovation, Mentorship, and Patient Focus
C. Contributions to Science
I am currently professor of Neurology in the Center for Health & Technology (CHeT) at the University of Rochester, and adjunct professor of Neurology at Georgetown University. From 2011 to July 2018, I was professor of Neurology, Pharmacology and Human Science and Director of the Program for Regulatory Science and Medicine (PRSM) at Georgetown University where I was principal investigator of the FDA- Georgetown University Collaborating Center of Excellence in Regulatory Science and Innovation. In 2017, I founded Grey Matter Technologies LLC (www.greymattertech.org), a company focused on “Making Patients Heard” by capturing and interpreting verbatim patient reports using natural language processing and machine learning, and applying these technologies to clinical research and care. From 1990 to 2011, I was the Louis C. Lasagna Professor of Experimental Therapeutics and Professor of Neurology, Pharmacology and Medicine at the University of Rochester. I received my MD degree with Honors (1971) and postdoctoral training in medicine (1971-73) and neurology (1975-77) at the University of Rochester and in experimental therapeutics at the National Institutes of Health (1973-75). I have served as principal investigator of the National Institutes of Health-sponsored trials "Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism" (DATATOP), the “Prospective Huntington At Risk Observational Study” (PHAROS), and in the leadership of more than 40 other multi-center clinical research studies. I have played an instrumental role in the development of 10 new drugs for neurological disorders, including for Parkinson disease (selegiline, lazabemide, pramipexole, entacapone, clozapine, rasagiline, rotigitine), Huntington disease (tetrabenazine, dutetetrabenazine) and attention deficit disorder (Concerta). In the past 30 years, I have continuously trained and mentored 28 postgraduate fellows in clinical and translational research, including in my capacity as co-director of the ongoing University of Rochester T32 NIH training program in the Experimental Therapeutics of Neurological Disorders. I remain committed to clinical and translational research and training the next generation of scientists aimed at developing innovative, safe, and effective medical products.
D. Additional Information: Research Support and/or Scholastic Performance
Ongoing Research Support
Computational Science Grant (Shoulson, PI) 02/1/2018-1/30/2019 Michael J. Fox Foundation Grant funds the development of natural language processing and machine learning for Fox Insight Patient Reports of Problems (PROP) development, analyses and scientific sharing.
Fellowship in Regulatory Science (Shoulson, PI) 12/01/2017-11/30/2018 Provides funding for a fellow for training to optimize clinical trial design and support approval of novel therapies.
Completed Research Support
LABS-PD (Shoulson, PI) 07/01/11-12/31/15 Parkinson Disease Foundation “Longitudinal and Biomarker Study in PD” The Longitudinal and Biomarker Study in PD (LABS-PD) is an observational study of the natural history of Parkinson disease and associated biological and genetic markers.
1U01FD004319-01 (Shoulson, PI) 09/15/11-09/30/15 Collaborating Center of Excellence in Regulatory Science and Innovation (CERSI) Role: PI
R01 HG02449 (no cost extension) (Shoulson, PI) 09/30/02-06/30/12 “Prospective Huntington at Risk Observational Study (PHAROS)” An observational study to prospectively determine, in a double-blinded controlled fashion, the characteristics and rate of illness onset (phenoconversion) in individuals who are at immediate risk for inheriting the HD gene and who are unaware and wish to remain unaware of their HD gene status. Role: PI
1R01NS50324-01A1 (no cost extension) (Oakes/Beal PI) 09/01/05-08/31/12 “Effects of Coenzyme Q10 in Parkinson’s Disease – Phase 3 (QE3)” A multicenter, double blind, randomized, parallel-group, placebo-controlled study of the effects of two doses of coenzyme Q10 in slowing disease progression in early Parkinson’s disease subjects. Role: Co-PI
COHORT (Shoulson, PI) 01/01/04-06/30/12 CHDI Management Inc. “Cooperative Huntington’s Observational Research Trial (COHORT)” An observational study to collect prospective data from individuals who are part of an HD family in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of HD. Role: PI
COHORT (Shoulson, PI) 02/01/12-06/30/13 Johns Hopkins University Natural History of Huntington disease and chorea, the clinical management of chorea, and the safety of tetrabenazine in clinical practice. Role: PI at Georgetown University