2021 SMDP Biotech Mentors

Khary Adams, MBA, Senior Director, Laboratory Animal Resources, Incyte Corporation Khary Adams has over 15 years of experience working in the pharmaceutical and life sciences industry and is currently Senior Director for Laboratory Animal Resources at Incyte Research Institute in Wilmington DE. In this role, Khary is responsible for management and oversight of the animal facility and laboratory animal care program. Khary is an active member of 3R’s IQ Consortium Leadership Group and is board member of the PA Society for Biomedical Research and Americans for Medical Progress.

Khary received his Bachelor of Science in Biology/Animal Science from Virginia State University, Master of Science in Laboratory Animal Science from Drexel University College of Medicine and Master in Business Administration Pharmaceutical Management from Drexel University’s LeBow College of Business. Khary enjoys a very active lifestyle of running and exercise daily. Khary lives in the Old City neighborhood of downtown Philadelphia and has a hairless cat (sphynx), named Foxy.

Lourdes Alonso, MD, Medical Science Liaison, Neurology & Immunology, Millipore Sigma Lourdes Alonso is a Medical Science Liaison in the United States for the Neurology & Immunology (N&I) Division of EMD Serono, the biopharma division of Merck KGaA, Darmstadt, Germany. In this field-based role within Medical Affairs, Lourdes is responsible for supporting the N&I pipeline through scientific communication and medical insights, with the primary responsibility of engaging key thought leaders and healthcare providers within the medical community in her respective territory (South Florida, Puerto Rico) and therapeutic area. Lourdes also delivers comprehensive scientific education on disease states, data on the therapeutic assets and research advances of strategic importance.

Lourdes joined EMD Serono from Tardis Medical Consultancy, North America Inc. (Division of Publicis Healthcare) providing medical support to Novartis Pharmaceutical Medical Corporation - USMDMA. She was a part of Field Medical Affairs in the Immunology Division to support furthering scientific advances in psoriasis, psoriatic-arthritis, and ankylosing spondylitis.

Prior to joining industry, Lourdes is a radiologist by training, specializing in breast imaging. She graduated from the University of Central East, Dominican Republic and trained at Mount Sinai Medical Center, Miami Beach, Florida in the Radiology Program.

In her free time, she is involved in RestoreNations New Life Project in Mozambique, Africa helping local villages in Dondo and Beira with food, clothing, digging water wells and building homes for the needy.

Alejandro Amador Arjona PhD, Director, Cellular Assays and Technologies, Incyte Corporation Alejandro Amador is an experienced cell biology leader. Born in Barcelona, Spain, he did his PhD Thesis at the Center for Genomic Regulation (CRG) working in molecular and cognitive aspects underlying neurodegenerative and neuropsychiatric diseases. He then moved to San Diego, California, to do a postdoctoral work to elucidate molecular and cellular mechanisms of adult neurogenesis and glioblastoma.

His first job in the industry was with Takeda Pharmaceuticals in San Diego, where he led some of the pre-clinical CNS programs from target identification and validation, through candidate nomination. Later on, he joined GlaxoSmithKline in Collegeville, Pennsylvania, where he led the High Throughput Biology group to accelerate the identification of new oncology combination therapies.

Now, at Incyte, Alejandro leads the Cellular Assays and Technologies group, where the focus is to identify high-value oncology hits and the progression of small molecule and antibody programs.

Brandon Atkins, MD PhD, Senior Principal Scientist, Clinical Research, Merck Brandon Atkins, MD PhD is currently a Senior Principal Scientist and Clinical Director in Global Clinical Development at Merck Research Laboratories in Rahway, New Jersey. Over his six years at Merck he has worked in both Early Stage and Late Stage Clinical Development supporting multiple programs within Merck’s pharmaceutical pipeline. He has significant experience leading cross functional teams to collaborate on the strategy and execution of clinical development plans for novel drugs within several therapeutic areas including Cardiovascular Disease, Infectious Disease, and Oncology.

Brandon received his B.A. degree in Biochemistry from the University of Virginia and his MD and PhD in Molecular Biology from the University of Pennsylvania. He completed his Internal Medicine Residency at Brigham and Women’s Hospital and his Cardiology Fellowship at Massachusetts General Hospital, two Harvard Medical School affiliated hospitals in his hometown of Boston. Prior to Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 1 Website: www.icpdprograms.org joining Merck, he was an Assistant Professor in the Department of Medicine and Cardiovascular Division at University Hospitals Case Medical Center in Cleveland and a Principal Investigator in the Case Cardiovascular Research Institute within the Case Western Reserve University School of Medicine.

Randal Beans, Marketing Operations Manager, Millipore Sigma, EMD Serono Randal Beans is a Marketing Operations Manager who supports Commercial, Supply Chain and Operations teams by managing supply communications that are critical in helping customers to facilitate their projects. Randal has worked with the organization for over 20 years, leveraging his expertise in customer service, sales, and marketing to help drive strategy and influence results. He believes that the key to success is understanding stakeholders’ needs and knowing how to create a story to engage the people who can help you.

In addition to his core responsibilities, Randal co-founded the organization’s Black Leadership Network employee resource group and is an active member of additional ERG’s. His participation in the space of diversity, inclusion and equity helps to inform his ability to engage with people and understand diverse perspectives. Randal holds a BA in Communication from the University of Missouri - St. Louis, and an associate degree in Business Administration from St. Louis Community College - Forest Park.

Lisa Bollinger MD, Vice President, Regulatory Affairs, Merck Lisa Bollinger, MD, joined Global Regulatory Affairs and Clinical Safety as the Therapeutic Area Head of General Medicine and the U.S. Subsidiary. This role encompasses Cardiovascular, Diabetes and Endocrine, Neuroscience, and Respiratory and Immunology. The U.S Subsidiary is an industry leading regulatory specialty team for the U.S. primarily supporting drug shortages, regulatory materials compliance (import/export), financial disclosure, user fees, and emerging technologies.

Lisa is joining is from Amgen where she held several roles across regulatory and pharmacovigilance. Prior to Amgen, Lisa spent 13 years at the FDA in the Office of New Drugs with her last role being the head of the Pediatric and Maternal Health Staff in the immediate office. Lisa obtained her Doctor of Medicine at the Uniformed Services University of the Health Sciences F. Edward Hebert School of Medicine and completed a pediatric residency in Pediatrics at the University of California, Davis. Lisa also had a distinguished career of service in the United States Public Health Service progressing from the rank of Ensign to Captain.

Attilio Bondanza, MD PhD, Head of Cell Therapy Clinical, AstraZeneca Attilio Bondanza, MD PhD, is Head of Cell Therapy Clinical at Astrazeneca Oncology Research & Development in Cambridge United Kingdom. Prior to that, he was Senior Global Program Leader at Novartis Basel CH, where he contributed to the clinical development of tisagenlecleucel (Kymriah), the first CAR-T cell therapy approved in the US and initiated several other new CAR-T cell programs. Before joining the industry, Attilio was Associate Professor at the San Raffaele University of Milano Italy. He is board-certified in Internal Medicine and holds a PhD in Transplantation Immunology. He has an H-index of 36 and is the inventor of several granted patents in the field of CAR-T cell therapy.

Sheryl Bowley, PhD, Senior Principal Scientist, Pfizer Sheryl Bowley, PhD has been with Pfizer since 2016 and is currently the Biology Lead of a small molecule discovery program to identify transformative medicines for patients with Sickle Cell Disease. Sheryl earned a BS in Chemistry from the University of the Philippines and after graduation, spent three years as a lecturer and laboratory instructor for undergraduate Analytical, Organic and Biochemistry courses at the University of the Philippines. She then went on to obtain a PhD in Biological Chemistry from the University of North Carolina- Chapel Hill, where she studied the molecular basis of fibrin clot formation. It is during her graduate school training that Sheryl developed a strong interest in hematology, particularly for rare bleeding disorders like hemophilia. She went on to continue her postdoctoral training at Harvard Medical School, collaborating with colleagues to perform seminal work in discovery of a novel redox control of blood coagulation. She also earned a fellowship from the American Heart Association for her basic research on cardiovascular biology.

After completing the postdoctoral fellowship, Sheryl joined Pfizer-Rare Disease Research Unit to work across different modalities to discover medicines for hematological diseases. She enjoys working with highly innovative and creative cross-functional teams where new hypotheses and approaches are explored. She also continues to learn from her involvement in long-term industry-academic collaborations, as well as mentoring junior scientists and undergraduate students in the Biomedical Sciences.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 2 Website: www.icpdprograms.org Mike Boyle, DVM, PhD, Director Research, Amgen Michal Boyle, DVM, PhD is a Pathology Director at Amgen. He received his DVM from Michigan State University’s College of Veterinary Medicine, and his PhD working on chromatin biology in cardiac development and toxicity in the laboratory of Trevor Archer at the NIEHS/NIH in Research Triangle Park, North Carolina. He completed a postdoctoral fellowship in Toxicologic Pathology at the National Toxicology Program (NTP) where he was an NTP Pathology Working Group (PWG) member and contributed to NTP Technical Reports. He is a Diplomate of both the American College of Veterinary Pathologists and American Board of Toxicology and is a Fellow of the International Academy of Toxicologic Pathologists.

At Amgen Mike has served as the nonclinical Project Team Representative (toxicologist) for several programs and has contributed to 15 INDs across a variety of platforms and therapeutic areas, and currently is Nonclinical Lead and/or Project Pathologist for late- stage assets and is Amgen’s CRO Liaison for all outsourced toxicology studies. He has numerous peer-reviewed publications and book chapters, has served on the NTP’s Pathology Working Groups, and has been on the faculty for the American College of Toxicology’s (ACT) ‘Pathology for Non-pathologists’ course series. Mike has presented at many Society of Toxicologic Pathology (STP) Symposia and Continuing Education seminars and was awarded the 2016 Distinguished Early Career Award by the STP. He is a co-author of the International Nomenclature and Harmonization of Diagnostic Criteria (INHAND), Cardiovascular and Skeletal Systems, the guidances used by SEND for regulatory submissions. Mike has served on the Editorial Board of Toxicologic Pathology and has been a reviewer for Toxicological Sciences, Veterinary Pathology, and the Journal of the American Veterinary Medical Association.

Michael Bradley, PharmD, MPH, Senior Medical Science Liaison, Janssen Pharmaceuticals Michael Bradley is a Senior Medical Science Liaison (MSL) in the Cardiovascular & Metabolism division at Janssen Scientific Affairs, LLC. As a field-based medical affairs professional, he works to address the scientific and medical information needs of Key Opinion Leaders, Clinical Research Investigators, and Population Health Decision Makers. Additionally, he supports Janssen’s research and educational initiatives within the cardiovascular and metabolism therapeutic area. Michael earned his Doctor of Pharmacy degree (Pharm D) from Xavier University of Louisiana in 2003, and his Master of Public Health (MPH) from The University of North Texas Health Science Center in 2020. He completed post-doctoral residency training at the University of Alabama Hospital where he was awarded the Pharmacy Resident Research Award for his work in pharmacy-based health outcomes research.

Prior to entering the pharmaceutical industry as an MSL, he maintained a successful career as an ambulatory care clinical pharmacy specialist with the U.S. Department of Veteran Affairs in Dallas, Texas, and Grady Health System in Atlanta, Georgia. He also served as an Assistant Professor of Pharmacy Practice at the University of Arkansas for Medical Sciences College of Pharmacy in Little Rock, AR. His hobbies include traveling, reading, cooking and health/wellness coaching.

Charles Bridges, MD, Chief Technology Officer and Head of Cross Enterprise Innovation, Cardiovascular, Metabolism and Pulmonary Hypertension Therapeutic Area, Janssen Pharmaceuticals Charles R. Bridges, MD, ScD, is the Chief Technology Officer and Head of Cross Enterprise Innovation for the Cardiovascular/Metabolism/Retina and Pulmonary Hypertension Therapeutic Areas at Janssen Pharmaceuticals, where he leads the development of novel therapeutic and diagnostic devices and the application of advanced analytics to solve problems in research and development. The goal within this area is to accelerate the development of novel commercially available technologies for the early diagnosis of rare diseases including pulmonary arterial hypertension.

From January 2018 to June 2020 he was Global Chief Technology Officer for the Pulmonary Hypertension Therapeutic Area. From 2015 through January 2018, Charles was Global Vice President and the Cardiovascular Therapeutic Area Expert for Johnson & Johnson Medical Devices. He served as the scientific lead for high-profile investments and acquisitions in the cardiovascular and neurovascular spaces culminating in the formation of CERENOVUS, Johnson & Johnson’s fast growing neurovascular business in July 2017.

Charles was previously the first African American Full Professor of Surgery at the University of Pennsylvania and a member of the Bioengineering Graduate Group; Chief of Cardiac Surgery at Pennsylvania Hospital, and Professor and Chairman of Cardiovascular, Thoracic and Vascular Surgery at Carolina’s HealthCare System with the University of North Carolina. Charles has received more than $10 million in continuous National Institutes of Health (NIH) RO1 funding, has over 170 peer-reviewed publications and 15 patents (issued and pending). He served as a regular member of the Bioengineering, Technology and Surgical Sciences Study Section of NIH from 2010-2014, and was past Chairman of the Cardiovascular Committee of the American Society for Gene and Cell Therapy.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 3 Website: www.icpdprograms.org Kyle Brogden, Director Global Allergy Franchise R&D, Johnson & Johnson Consumer Healthcare Kyle Brogden is the Global Allergy Franchise R&D Director responsible for Upstream product innovation as well as Consumer Science Research for Self-Care. Kyle has been with the Self-Care Consumer R&D organization at Johnson and Johnson for 4 ½ years. As a R&D leader passionate about improving consumers and patient lives. He Leads a Global Research and Development team responsible for developing new innovative products based on sound science and technology. This includes developing and implementing R&D strategies to advance the identification of unique science while working cross functionally to deliver consumer-centric product solutions to the marketplace. He is also responsible for the R&D Consumer Science Team which incorporates the learnings of the targeted consumer into every stage of the product development cycle in an iterative way. With consumer and descriptive testing we can close the gap between research & development and desired consumer attributes that’ll help ensure our product will be a consumer- preferred success.

Through out his 25+ year career he has work for a number of OTC Medicine companies and has helped to develop and launch over 35 new consumer and OTC products in over 25 countries. He holds a: BS degree in Chemistry from Morgan State University in Baltimore , MD; MS degree in Organic Synthesis and is a PhD candidate at Seton Hall University in South Orange, NJ.

Fernanda Bruzadin, Senior Director, Wound Care and SEI, Johnson & Johnson Consumer Healtcare Fernanda has a B.S in Chemical Engineering and joined Johnson & Johnson in 1999 as an intern in the Consumer Science team giving remarkable contributions to different franchises through her deep consumer knowledge. In 2003, she joined the FemCare R&D team, where she spent 13 years in multiple regional and global functions, eventually leading the Global FemCare R&D Need State, with teams across the 4 regions. In 2016, Fernanda took leadership of Global Sun R&D and LATAM Beauty Franchise. In this role, she was responsible for re-setting the global Sun Need State strategy, leading a global team to develop best-in-class ex-US sun chassis, delivering winning US innovation such as Hydroboost Sun, creating new mineral and facial forms, and the soon to be launched oxybenzone-free portfolio reformulation. In 2018, Fernanda re-located from Brazil to US to lead the Global Wound Care Need State and PEI teams.

Fernanda is married with 2 children and loves to travel, get to know new places and watch movies.

Roberto Burgarini, Executive Director - Head of Oncology Early Dev. Biostatistics, Phfizer Roberto Bugarini has been working in the field of medical research for more than 20 years. He graduated with a degree in Biostatistics (La Sapienza - University of Rome) in 1998 and his dissertation was about the development of spatial-statistic models to estimate the incidence of HIV. He continued to refine and apply this work at the Italian Institute of Infectious Diseases until 2001. After that, Roberto joined the private industry and he supported the clinical development of innovative vaccines and biomarkers discovery both in Europe and the US, where he moved to permanently in 2006. He joined Pfizer in San Diego, CA in 2012 where he has held various positions of increasing responsibility to support the development of new oncology medicines. He is currently Executive Director and Group Head of Oncology Biostatistics in Early Clinical Development, leading a high-performing team of statisticians who are focused on statistical innovative methods to evaluate and transition new effective molecules from research to later phases of clinical development. Roberto firmly believes that diversity and inclusion are key to innovation and success.

Alicia Alexander Cadogan, PharmD, Director, Medical Information, Pfizer Alicia Cadogan, PharmD, is the Director, North America Team Lead, and Regional Therapy Area Lead for Oncology Medical Information at Pfizer Inc. Alicia received her Bachelor of Science degree in Pharmacy from St. John’s University in Queens, NY, and her Doctor of Pharmacy degree from Albany College of Pharmacy in Albany, NY. She then completed a 2-year Clinical Research Fellowship at the University of Pittsburgh School of Pharmacy (Pitt) with a focus in Nephrology, followed by 2 years at Pitt as an Assistant Professor of Nephrology Pharmacy and Therapeutics. Following her years in academia Alicia spent 5 years as the Medical Director of CoMed Communications - a medical communications and advertising agency in Philadelphia, PA, where her responsibilities included providing medical direction to the development of continuing education materials, product launches, and promotional materials for several pharmaceutical companies. In 2003 Alicia join the Medical Communications team at Wyeth Pharmaceuticals. She was promoted to Team Lead in 2006 and since then has managed Medical Information teams in various therapeutic areas at Wyeth and Pfizer. Building high-performing teams and helping each person find and focus on their strengths is what keeps her energized in the workplace.

Alicia has been an active member of the Drug Information Association (DIA) for more than 15 years. She has participated as a Core Curriculum faculty member for 4 years, including serving as Chairperson of this program for 2 years. In this Chairperson role she led the day-long program designed to provide a comprehensive foundation for those who were new to the field of Medical Information.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 4 Website: www.icpdprograms.org In 2010, she had the honor of serving as Chairperson of the DIA Medical Communications Workshop (now known as the Medical Affairs and Scientific Communications Forum). She has spent the next 11 years leading the Fellow and Resident Research Poster Presentation sessions and developing a Fellow and Resident Professional Development Workshop where she led sessions each year offering Fellows, Residents, and Preceptors a wide range of topics that were meaningful at this particular point in their career path.

Alicia's passion for mentoring and professional development extends to her personal life. As an active member of the National Charity League Inc, she has mentored groups of 20+ girls in grades 7 and 8 who are committed to a 6-year, mother-daughter journey centered around leadership, philanthropy, and cultural experiences. In addition, she serves as the Vice President of the Diversity, Equity, and Inclusion Task Force. She co-founded this non-profit organization in 2020 to help promote diversity in her local school district and community through the support and development of equity and inclusion practices. Most importantly, Alicia lives in Audubon, PA with Sean, her husband of 24 years, and is a dedicated mother to Audrey (20), Steven (18), and Arlene (13).

Gossett Campbell, PhD, Team Leader, GSK Gossett received his PhD from Drexel University, Philadelphia PA, in Chemical and Biological Engineering focusing on the detection of Proteins, Cells and DNA’s using Biosensors. Also, his PhD work included the synthesis of proteins and recombinant DNA and cell banking. He also received a bachelor’s of science in Chemical Engineering from Drexel University and Chemical Technology from the University of Technology Jamaica. Gossett has a combined 17 years of experience in the Pharmaceutical and Biopharmaceutical industry with numerous scientific journal publications and patents. Since joining GlaxoSmithKline R&D facility in Collegeville PA fourteen years ago, Gossett has taken on roles of increasing responsibilities and is currently a Team Leader in the Sterile Pharmaceutical Development Department. His team develops sterile drug products of different modalities including solution, nano/micro suspension, liposomes, emulsions, lipid nanoparticles (LNP), microsphere and implants. Outside of work, Gossett enjoys biking, tennis, soccer and spending time with his family.

Danaise Carrion Colon, PhD, Director Manufacturing, Amgen Manufacturing Limited Danaise Carrión-Colón PhD is currently a Director within the Drug Substance (DS) Manufacturing unit in Amgen, Puerto Rico (AML). She joined the DS manufacturing unit in June 2020. Her organization is responsible for the Investigations/Deviations, Inspection Readiness, Risk Management and Training Strategy of the two DS plants in AML. Danaise has over 16 years of experience in the Biotechnology industry.

Born and raised in Carolina, Puerto Rico, Danaise grew up with a special interest for science. She started her science career in her middle school and high school years doing Science Fair projects; competing both locally in PR and internationally. Later, she went on to complete her B.S. from the University of Puerto Rico and received her MS and PhD from the Albert Einstein College of Medicine in Bronx, NY. She also conducted post-doctoral work at Harvard Medical School in Boston, MA. Danaise worked on research using mouse models to understand cancer progression and chromosomal aneuploidy.

Danaise first joined Amgen in 2004 as a scientist working in technology transfer, process characterization and commercial support of cell culture processes. She worked in developing Process Analytical Technologies (PAT) applications using Raman for cell culture continuous monitoring. In 2011, Danaise joined the Quality organization as a Lead investigator for Critical Deviations in AML, and later in 2015, she became the senior manager of the team. During her tenure as leader of Critical Investigations, the team successfully investigated events across the whole site while achieving a 17% reduction in investigation cycle time. Danaise was appointed as Director of Quality Control in November 2016 responsible for Technical Resources. Her organization led the Method Implementations, Investigations/Deviations, Document Retention, and Reference Standards and Critical Reagents Programs for QC. Also, in 2019, she oversaw the Operations of the QC Biochemistry Laboratories. While in the QC Laboratory, she was instrumental in leading efforts that significantly reduced Human Performance events. Under her leadership, AML QC implemented several programs including Inspection Readiness, the Technical Academia, and the Overview program for college students. In 2019, as part of the FUEL Operations Leadership Program, Danaise worked as part of a Global team on a business case project for Amgen’s Operations strategy for the China market.

Danaise has a passion for mentorship and collaboration. In her time in Amgen, she has hosted many internship and Coop students in her organizations. Also, she is currently a mentor in several programs within Amgen.

Hamza Celik, PhD, Principal Investigator, Pharmacology, Incyte Corporation Hamza Celik, PhD received his undergraduate degree from the University of Westminster in London in 2009 and his PhD from French Center for Scientific Research in 2013 as a Marie Curie fellow. After completing his thesis work, he joined Washington University (WashU) in St. Louis, where he made important contributions to understanding normal and malignant hematopoiesis, mainly in the context of myelofibrosis and acute myeloid leukaemia. During his time as a faculty member at WashU, Hamza received various competitive awards and fellowships such as ASH Scholar Award, WES Foundation, American Cancer Society, EvansMDS young investigator Award and Hollis Brownstein Research Award. He joined Incyte Research Institue as a principal investigator in December 2020, where his team seeks to develop novel therapies for intractable cancers.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 5 Website: www.icpdprograms.org Outside work, Hamza enjoys fishing, running, and playing chess with friends. His favourite leisure activity is hiking with his wife, Emma Vidal and two little puppies, a Chihuahua and an Italian greyhound.

Alison Chalker, PhD, Vice President, Portfolio Strategy and Data Sciences Integration - Neuroscience, Janssen Pharmaceuticals As Vice President, Portfolio Strategy and Data Sciences Integration for the Neuroscience Therapeutic Area, Alison Chalker, PhD leads a team responsible for leading strategic planning, portfolio management and decision making; delivering operational excellence across the TA; and driving the integration of Data Sciences across the spectrum of Neuroscience Discovery, Development and Commercialization. Most recently, Alison served as PMO Therapeutic Area Leader for Neuroscience and Established Products, where she partnered with TA leadership to drive and operationalize portfolio strategy, provided accurate and transparent reporting on portfolio progress, and delivered data driven insights that optimized future value generation. In this role, she led a group of Project Management Leaders across the US and Belgium, who provided end-to-end cross-functional program management leadership to R&D teams, from Discovery through Development to Lifecycle Management and product maturity.

Prior to joining Janssen in 2013, Alison was Executive Project Leader in the Neuroscience franchise at Merck. Prior to Merck, she was Senior Project Director for several oncology monoclonal antibodies at ImClone Systems and was subsequently appointed Vice President and Department Head, Global Regulatory Affairs, Oncology. Previous to ImClone, Alison held various positions in Shire Pharmaceuticals’ Global Strategic Planning and Program Management function. She began her career in the pharmaceutical industry as a post-doctoral scientist in anti-infectives research at GlaxoSmithKline, then transitioned to Drug Development Project Management.

Alison has a doctorate in Molecular Microbiology from the University of Edinburgh, UK, and conducted postdoctoral research funded by the UK Medical Research Council Human Genome Mapping Project.

Ilaria Conti, MD, PhD, Executive Director, Early Clinical Development, AstraZeneca Ilaria Conti, MD, PhD was born in Lucca, Italy and grew up in Tuscany. She obtained her Medical and specialty degree in Pulmonary Medicine at the University of Pisa Medical School in Italy and went on for a postdoctoral fellowship at the Dana-Farber Cancer Institute in Boston, MA, where she conducted research work on the role of chemokines in cancer. She was awarded a PhD from the University of Pisa for her work on the role of MCP-1 in cancer.

During her 15 years in the pharmaceutical industry, she has focused her work on oncology and immuno-oncology, leading the clinical development of novel assets in early and late phase. She has worked extensively in sarcoma and biliary tumors with a particular interest in the tumor-host interactions and tumor microenvironment and has authored and co-authored numerous peer- reviewed publications on clinical drug development.

Jill Crouse-Zeineddini, PhD, Scientific Director Process Development, Amgen Jill Crouse-Zeineddini, PhD is a Scientific Director at Amgen Inc. She has over 22 years of experience in potency assay development and is currently the leader of the Process Development Potency and Characterization Assay Group, with responsibilities for the development and transfer of potency assays in support of Amgen’s products. She is a CASSS Associate Director and has been a United States Pharmacopeia volunteer since 2010, serving on Expert Committees and Expert Panels. She is also a member of the European Pharmacopeia Monoclonal Antibody Working Party.

Jill received her B.S in Biology and M.S. in Experimental Pathology from Vanderbilt University, and her PhD in Biochemistry and Molecular Biology from the University of Southern California.

Allitia DiBernardo, MD, Head of GMAF, Neurology, Clinical, Janssen Pharmaceuticals Allitia DiBernardo, MD, leads Medical Affairs for Janssen Neurology within GCSO. She joined Janssen in 2015 in Global Medical Affairs, previously working at GSK and Novartis in Medical Affairs, having started in industry in R&D at Janssen in 2008. Prior to joining industry, Allitia was an attending Neurologist at Massachusetts General Hospital, core investigator at their Neurology Clinical Trials Unit, core teaching faculty for Harvard Medical School, and the recipient of the Massachusetts General Hospital Young Investigator Award for her clinical research. She trained in Neurology at Massachusetts General Hospital, Harvard Medical School, where she also did a Neuromuscular Fellowship before completing her research post-doc at the Harvard Institutes of Medicine on the neurodegenerative aspects of MS. A passionate communicator, she has authored more than 50 manuscripts, abstracts, and invited chapters and given dozens of presentations across the globe.

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In her spare time, Allitia is a volunteer tutor for Philadelphia school children, takes her rescue pit bull on walks, and is an avid urban gardener who recently tried to introduce butterflies she raised to her alley garden (but they all flew away).

Lisa Drew, PhD, Executive Director, Astra Zeneca Lisa Drew, PhD, is Executive Director, Head of Oncology Bioscience at AstraZeneca R&D Boston in Waltham, USA. In this role, she is responsible for leading cutting-edge bioscience capability development and delivery of all pharmacology and bioscience data for an expansive, diverse and innovative portfolio of oncology projects from idea to market. She led establishment of science clusters in the group to support excellence in delivery against the key strategic focus areas including tumor drivers and resistance, cell death, immune-oncology, hematological malignancies and more recently epigenetics. Lisa is also a member of the Oncology Discovery Leadership Team, Oncology Discovery Management Team, Hematology R&D Leadership Team and Acerta Research and Early Development Leadership Team.

Lisa joined AstraZeneca in 2001 as one of the early hires in Oncology and has led multiple preclinical small molecule cancer drug discovery programs from target selection through to candidate drug nomination as lead biologist. Most recently, Lisa was the champion and lead biologist for the CDK9 program resulting in delivery of AZD4573 which is currently in Ph2 clinical trials. She also worked closely on the current AstraZeneca cell death portfolio as the Oncology Cell Death Strategy lead. Lisa has also overseen biology delivery for multiple programs as a team leader and supported cross project cell science capability build. More recently she was part of a team that developed the strategies leading to extensive builds in Epigenetics and Hematology Discovery. She was previously an active member of the global AstraZeneca IMED postdoc program committee as the Oncology representative and has been a scientific lead on the AstraZeneca Science Symposia Committee responsible for successful delivery of multiple local and global Science Retreats. Before joining AstraZeneca, Lisa received her BSc in Biology and PhD in cancer cell biology from University of York, England and did postdoctoral training at University of California, Irvine and Columbia University, New York.

Ngozi Erondu, PhD, Senior Director, PDPL - Immunology TA - IMM, Janssen Pharmaceuticals Research & Development Ngozi Erondu, PhD is a Senior Director and Product Development Portfolio Leader in the Immunology Therapeutic Area at Janssen Pharmaceutical Companies of Johnson and Johnson. He graduated from the College of Medicine, University of Lagos, Lagos, Nigeria, after which he proceeded to the California Institute of Technology where he obtained a PhD in Neurobiology. From 1987 to 1991, he conducted post-doctoral research in the department of Biochemistry, University of Iowa, Iowa City working on the molecular biology of Onchocerca volvulus (causative agent for river blindness) and Trypanosoma brucei (causative agent for sleeping sickness). Subsequently, Ngozi completed residency in internal medicine and fellowship in endocrinology followed by an academic appointment in 1996 as an assistant professor in the division of endocrinology at the University of Iowa, doing mostly molecular biology research on insulin-like growth factor binding proteins.

In October 2000, Ngozi was hired by Merck & Co where he rose to become the head of the clinical obesity group. In 2009, he joined the Global Alliance for TB Drug Development where he worked on the development of new drug regimens for the treatment of drug sensitive and multi-drug resistant TB. In 2011, he joined the inflammation TA at Amgen where he worked on the development of antibody-based treatments for inflammatory diseases. In January 2015, Ngozi accepted an offer at Janssen to run 2 ongoing cardiovascular outcomes studies with canagliflozin, and to supervise an obesity program. He was also appointed an adjunct clinical assistant professor in the division of endocrinology at the Rutgers Robert Wood Johnson University Hospital, New Brunswick.

From January 2018 to April 2020, Ngozi was on assignment at Janssen Japan to head the clinical science division, responsible for clinical drug development in all therapeutic areas (Oncology [solid and hematology], Immunology, Neuroscience, Cardiovascular/Metabolism, Infectious Disease/Vaccines and Pulmonary Hypertension).

Jeff Faris, PharmD, Global Head Med AFF STRAT and Exec, Janssen Pharmaceuticals Global Medical Affairs Jeff Faris, PharmD is the Global Head, Medical Affairs Strategy & Execution for Oncology at the Janssen Pharmaceutical Companies of Johnson & Johnson.

Jeff supports the strategic execution of Janssen Oncology Global Medical Affairs activities where he leverages best practice approaches to support the development and execution of publication plans, scientific exchange, thought leader and stakeholder engagement, and key medical and scientific congress plans. Jeff’s team supports the execution of global pre-approval access programs and manages the overall oncology global medical affairs budget and business planning process. Jeff and his team are accountable in supporting the overall execution and planning of medical affairs strategies and tactics including oversight of the global integrated evidence and generation plans (IEGPs), scientific communication platforms (SCPs), global publication plans, internal knowledge exchange and data dissemination, R&D congress booth content development, and support of early pipeline assets.

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Jeff has more than 15 years of experience in a variety of medical affairs roles within the pharmaceutical industry. Prior to joining industry, Jeff worked as a clinical and research pharmacist in HIV at the University of Washington in Seattle, WA, where he supported the conduct of NIH-DAIDS sponsored HIV vaccine and treatment clinical trials. In 2004, Jeff joined Roche and later Idenix Pharmaceuticals as a medical science liaison (MSL) supporting investigational agents for hepatitis B and C.

Jeff has been with J&J for 14 years, joining Janssen Therapeutics in 2007 as an MSL supporting the launch of two HIV medicines, darunavir and etravirine. He quickly transitioned into a leadership role supporting operational effectiveness and training of the HIV MSL team. In 2010, Jeff joined the Janssen Global Medical Affairs team, supporting several therapeutic area teams, including the launch of simeprevir for HCV, siltuximab for MCD, and the Established Brands portfolio of products.

Jeff joined the Janssen Oncology therapeutic area in 2015, supporting the strategic execution of medical affairs activities for ibrutinib. In 2016, Jeff became the Head, Global Medical Affairs for Oncology Operations and led the development and expansion of the oncology operations team. Jeff has also led cross Pharma systems and SOPs for the last 10 years, such as the ReCAPv3 system for research concept review and approval, and the launch of the JanssenIIS.com global investigator-initiated study submission portal.

Jeff obtained his MBA at the University of Washington-Bothell in Seattle, WA and his Doctor of Pharmacy degree from Idaho State University in Pocatello, ID. He currently resides in Washington Crossing, PA with his partner and son.

Andrea Feldman, PharmD, National Field Director, Janssen Pharmaceuticals Andrea Feldman PharmD, BCPP is the National Field Director for Neuroscience Medical Affairs. Andrea brings over 20 years of diverse leadership and Neuroscience therapeutic experience to her role. The Neuroscience Field Based Medical Team is comprised of J&J and contracted healthcare professionals disseminating evidence and educating multidisciplinary health care practitioners who treat patients with serious mental illnesses such as Schizophrenia and within the Mood therapeutic areas. Additionally, there is a focus on Neurodegenerative disease states with an emphasis on novel treatment opportunities for multiple sclerosis patients.

Andrea trained as a pharmacist with a BS in Pharmacy from the Philadelphia College of Pharmacy & Science and received her PharmD from Nova-Southeastern University in Florida. Upon completion, Andrea completed a psychiatric pharmacy practice residency at the Albany College of Pharmacy in upstate, NY and is a board-certified psychiatric pharmacist. After several years in academia at Florida A&M University, with a psychiatry clinical pharmacy practice at the Veterans Affairs Medical Center in Miami, FL, Andrea joined J&J in early 2000 holding roles of increasing responsibility leading Field Based Medical Teams, partnering cross functionally within a matrix environment, and successfully leading teams through multiple product launches over the course of her tenure.

Andrea has a passion for people development and enjoys shaping teams towards growth opportunities and has mentored many colleagues over the years both internal and external to J&J. Andrea enjoys traveling and while originally from Philadelphia has resided in Miami, Florida for many years where currently she and her husband are adjusting to life as their two sons are away at college.

Matt Fesinmeyer, PhD, Director Process Development, Amgen Matt Fesinmeyer, PhD is a scientist and group leader with fifteen years of experience in the biopharmaceutical industry. He joined Amgen in 2006, working on large-molecule parenteral formulation development and has taken on roles of increasing responsibility over time. He is currently a Director in the late-stage drug product development function, leading a group of twenty scientists and engineers responsible for drug product formulation and process development, validation, and commercial filing. His group is responsible for seven active projects, ranging from novel molecules, to biosimilars, to products undergoing life-cycle management activities. Matthew started his work in biotechnology in high school, working summers at a small contract manufacturing company, where his responsibilities ranged from protein liquid chromatography to running ethernet wiring. His college education focused on organic chemistry, with degrees in the subject from the University of California, Davis (BS) and the University of Washington (MS, PhD). In graduate school he found a pathway back to biotechnology through structured synthetic peptides and the biophysical analysis of proteins.

Outside of work, Matthew can be found troubleshooting the vegetable garden with his wife, building Legos with his children, and fighting with his 3D printer and other electronic gadgets.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 8 Website: www.icpdprograms.org Tara Flagg, Director Human Resources, Incyte Corporation Tara Flagg brings over twenty years of diverse experience in providing ongoing HR support to employees in areas including recruitment, benefits, performance management, organizational design and employee development. Tara joined Incyte Corporation in December 2020 as the Director, Human Resources supporting the Executive Vice President & Chief Scientific Officer and the Biology Discovery team.

Prior to joining Incyte, Tara was at Suez WTS where she was a Senior Human Resources Manager responsible for partnering with client groups to develop and execute short and long term HR strategies to support business needs. She was responsible for selection, retention and development of talent including succession planning, career path development and performance management.

Tara has over ten years of experience within the pharmaceutical industry having held positions at Teva Pharmaceuticals and Shire Pharmaceuticals where she designed and implemented the Employee Relations COE for both organizations.

Tara is a suburban Philadelphia native and a Temple University alumni. She is the proud mother of Kylie and a pet parent to Bob Marley, a shih-tzu.

Julie Flemming, MBA, Partner, Trinity Lifesciences Julie Fleming is a Partner in Trinity Life Sciences’ Strategic Advisory practice in New York City. She has more than 10 years of experience leading strategic primary market research engagements to support pharmaceutical products and medical devices in various stages of commercial development. Her experience spans a broad set of therapeutic areas, including CNS disorders, Cardiometabolic disorders, Oncology, Ophthalmology, Immunology and Women’s Health.

Prior to joining Trinity, Julie was a Partner with BluePrint Research Group (acquired by Trinity in 2020) and worked as a sales and marketing consultant for ZS Associates, supporting a range of engagements, including sales force sizing, design and deployment. Before making a career change to join the life sciences industry, Julie spent time in the consumer marketing analytics industry, supporting marketing optimization efforts for companies in the luxury retail, banking, restaurant and packaged goods sectors (including consumer health brands).

Julie has a BS in Systems Engineering and Economics from the University of Virginia and an MBA in marketing and strategy from the Kellogg School of Management at Northwestern University. She lives in Connecticut with her husband, two children and energetic English Bulldog.

Phil Floyd, PhD, Head, Drug Substance and Product Analysis, US, GSK Phil Floyd received his PhD in Analytical Chemistry under Jonathan Sweedler at University of Illinois. While at Illinois he performed the research for his dissertation at the Beckman Institute of Technology working collaboratively with varying disciplines, such as Molecular and Cellular Biology, Computational Chemistry, Engineering and Physical Chemistry, in performing research on neuronal signaling pathways.

Prior to joining GSK, Phil spent 2 years at Johnson & Johnson in Analytical Development as bench scientist responsible for the development, validation and technical transfer of analytical methods in support of their RX and OTC portfolio. He joined GSK in PA in 2001 and served as Analytical Lead for Altabax, Promacta/Revolade, and Horizant/Solzira from Candidate Selection through successful NDA/MAA File and Launch. In 2007 he moved to GSK site in RTP, NC to serve as Team Leader within Product Development, leading a diverse group of formulators and analytical scientists in the development of multiple Phase III assets. In addition, he represented GSK on a number of Due Diligences which directly led to acquisition of assets by GSK. Phil also served for a number of years on the Japan CMC Steering Team representing the Late Stage Portfolio intended for entry into the Japan Market.

In 2013, he returned to PA to become US Head of Analytical Development and continues to serve in this capacity with a department of over 150 analysts within Analytical Sciences and Development with a current portfolio of 30 assets, including 4 late stage assets including both large and small molecules. Phil has over 30 scientific presentations, including invited panel speaker in collaboration with Pfizer and FDA at the most recent DIA Conference, and has over 20 publications in peer reviewed journals.

Sergio Fonseca, MD, Senior Director, CDTL, Established Products, Johnson & Johnson Office of Chief Medical Officer Sergio A. Fonseca MD has been with J&J for more than 6 years serving as Senior Director, Portfolio Leader (Compound Development Team Leader) within the Established Products group in Janssen. As a portfolio leader, Sergio is responsible for development and execution of portfolio and compound global cross-functional strategies for multiple marketed legacy products in the Women’s Health, Urology and Anti-Infectives portfolios. He also leads the Talent Development Strategy & Programs in Janssen’s Established Products Group.

Sergio began his pharmaceutical career in Novartis Pharmaceuticals in 2006 in Clinical Operations, then moving to Field Medical Affairs at EMD Serono and at BMS. Sergio was then promoted to the BMS’ Global Diabetes team as Associate Medical Director and

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 9 Website: www.icpdprograms.org Global Thought Leader and Scientific Relations Lead. Sergio joined JNJ from Merck Serono where he was Director of Strategic Operations, Fertility Global Medical Affairs from 2013-2015.

Sergio started his clinical research career as a regulatory coordinator, investigator, and ultimately as the Chief Operating Officer at the Metabolic Research Institute, Inc, a major clinical trial site in South Florida (USA). Prior to moving to the US in 2001, Sergio earned his medical degree from the Universidad Nacional de Colombia and his specialization in Healthcare Auditing and Administration at the Santo Tomas University in Bogota, Colombia. He practiced general medicine in different clinical settings, also serving as Professor of Medicine at UDCA University and as a Medical Auditor at a large University Hospital in his home city of Bogota, Colombia.

On a personal note, Sergio lives in Morrisville, PA, loves music, cultural activities and social networking. He is married and with his husband, they enjoy traveling, eating out (real foodies!) and taking care of their three flurry “children”, their cats Tony, Orea and Mono!

Brian Fulling, PhD, IRT Global Oversight Team, Support Team Director, Pfizer Brian Fulling, PhD is the IRT Support Group Lead in the Digital Business Operations (DBO) division of Pfizer Global Clinical Supply (GCS). In this role, Brian manages a global team that provides 24/7/365 help desk support for Pfizer clinical trials using Pfizer’s internal Interactive Response Technology (IRT) systems, delivering continued excellence in customer service and patient focus to ensure studies are effectively supported and system capabilities meet dynamic portfolio timelines and demands.

Brian has over 21 years of pharmacy and the biopharmaceutical industry experience having held prior roles as a hospital oncology pharmacist and an investigational drug pharmacist followed by Clinical Research Pharmacy (CRP) positions at both Genzyme and Pfizer. As a CRP, he supported IRT activities, including being a member of the IRT Protocol Assessment Group (IPAG) and provided site facing perspective on the Impala 2.0 project. At the beginning of 2018, Brian accepted a secondment opportunity in Clinical Supply Logistics (CSL) as a U.S. Distribution team lead and later transitioned to the Import/Export and External Vendor Inventory Management team lead role.

Brian is originally from Rantoul, IL, and obtained both his undergraduate degree (Pharmaceutical Sciences) and Doctor of Pharmacy degree from the University of Toledo in Ohio. He and his wife Anne have four kids ages 6 to 15, so naturally they spend most of their “free time” driving one or more of their kids to activities. When time permits, Brian enjoys swimming and traveling with his family.

Bob Gambogi, PhD, Senior Director and Fellow, Johnson & Johnson Consumer Healthcare Bob leads the Global Oral Care Upstream Innovation team within the Johnson & Johnson Consumer Products organization. During his 10 years with J&J, he has led the OC Upstream Innovation team to deliver clinically validated technologies designed to address the needs of the consumer. These technologies included the development of the first clinically effective alcohol-free mouthwash (Listerine Zero), a mouthwash designed to help treat and prevent dentinal sensitivity (Listerine Advanced Defense Sensitive) and the first mouthwash as a medical device designed to prevent plaque and gingivitis (Listerine Advanced Defense Gum Therapy). In addition, he is passionate about developing the next generation of scientific leaders. He currently is the Chairman of the Fellows Steering Committee for the Consumer Products sector of J&J.

During Bob’s 25-year professional career he has held positions at Colgate-Palmolive and GlaxoSmithKline with significant product launches with each organization. He has been recognized by Colgate-Palmolive for his Excellence in Science and he was recognized with the Johnson Medal in 2014 at Johnson & Johnson. He has 9 granted US patents, 8 pending US applications, 12 peer reviewed papers and has coauthored 20+ external presentations. He is recognized in the dental research community as a technical expert. He represents J&J for ISO/TAG for Dentistry and is a member of the Consumer Home Products Association – Anti-Caries Task Force.

Steve Gendreau, PhD, Senior Director and Global Franchise Lead, Genentech Steve Gendreau, PhD joined Genentech in 2010 and is a Senior Director and Global Franchise Lead for the Biomarker Signaling Franchise in the Oncology Biomarker Development (OBD) department, which includes supporting programs and developing biomarker and PHC strategies for assets in Early- and Late-Stage Development. His teams are charged with driving translational science and biomarker development for many molecules across multiple disease and therapeutic areas. Steve is also the co-Lead of our Reverse Translation (RT) Team at Genentech. The RT team’s mission is to fully leverage the potential of our clinical and biomarker datasets to generate knowledge and insights that will enable discovery of novel drug targets that can feed RD pipeline in Discovery Research and support clinical combinations strategies for our programs in Development. Steve is also the co-sponsor of the ambitious Diversity and Inclusion Workstream in his home department of OBD.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 10 Website: www.icpdprograms.org Steve received his PhD in 1998 from the University of Wisconsin, Madison and joined Exelixis Inc. that same year and took on increasing responsibility as a Group Leader in Research and Oncology Discovery Project Team Leader. Steve joined Genentech initially as a Clinical Scientist Specialist in Exploratory Clinical Development (ECD) and transitioned to OBD in 2014. Steve is energized by the opportunity to lead teams that generate, validate and translate scientific insights to advance our portfolio through collaborations across functions and departments.

Richard George, MD, Senior Medical Director, Astra Zeneca Richard George, MD is a Senior Medical Director and leads AZ Cardiovascular in Early Clinical Development; Cardiovascular, Renal & Metabolic Diseases (CVRM). Richard has a degree in Animal Physiology from Cornell University and graduated with Summa Cum Laude honors from Jefferson Medical College. He completed his internal medicine residency at Massachusetts General Hospital and trained in Biostatistics and Epidemiology at the Harvard School of Public health in MGH’s clinical research track.

He spent 12 years at Johns Hopkins University where he completed his cardiovascular fellowship and joined the cardiology faculty thereafter. At Johns Hopkins, he spent about 1/3 of his time in patient care and the remainder in CV research, teaching, and administration. His research spanned across work in large preclinical models of ischemia and heart failure to single and multicenter clinical trials. His industry-, NIH-, and foundation-funded research focused on developing novel, multimodality imaging methods (CT, PET, SPECT, Echo, and MRI) in the areas of atherosclerosis, ischemia, heart failure, thrombosis, and cardiac innervation. He has published more than 100 publications and 7 patents. He has served on the board of directors for the Society of Cardiovascular CT, on the editorial boards of the Journal of Cardiovascular CT and the Journal of Nuclear Cardiology, as Guest Editor for Circulation Cardiovascular Imaging, and as a member of several NIH study sections. He also served on advisory boards for GE Healthcare, Astellas Pharma, Toshiba Medical Systems and as a consultant for ICON. While at Hopkins, he directed outpatient imaging programs in echocardiography and nuclear stress testing.

Richard joined MedImmune in 2015 to lead their cardiovascular clinical development programs. At MedImmune, he led clinical strategy development for multiple pre-IND, phase 1, and phase 2a/b assets for treating atherosclerosis and heart failure and was a member of the CVRM therapeutic area leadership team (IMED). In 2019, he transitioned to AstraZeneca and continues to lead clinical development programs in atherosclerosis and heart failure. His work spans clinical strategy across phase 1 to phase 3 planning. He is a key member of AZ corporate strategy workstreams in cardiovascular and heart failure and the Early Clinical Development Leadership Team.

Marian Gindy, PhD, Executive Director, PreClinical Development, Merck Marian Gindy, PhD is a pharmaceutical research and development executive experienced in leadership of drug product discovery and development organizations. Over her 20-year career, Marian has served in a variety of roles of increasing scope and responsibility. Currently, Marian is Executive Director of Pharmaceutical Sciences and Clinical Supplies within Merck Research Labs, leading an organization responsible for drug product formulation and process development of Merck’s portfolio of oral product candidates, from first-in-human testing through late-stage development. Previously, Marian served as Executive Director of Discovery Pharmaceutical Sciences, where she led a team responsible for drug delivery and formulation R&D across disease areas, drug modalities and dosage forms. Marian has also served as head of Sterile Product Development at Merck, leading an organization responsible for development of parenteral products, from preclinical stages to Phase 3 clinical trials. Earlier in her career, Marian served as head of RNA Therapeutics Formulation Sciences, where she led drug delivery research and manufacturing capability build in support of RNA therapeutics. Marian has also held leadership roles in small molecule drug substance process development and pilot plant operations. Dr. Gindy received her PhD in Chemical and Biological Engineering from Princeton University.

Kristen Goettner, PharmD, Senior Director, Medical Information & Knowledge Integration, Janssen Pharmaceuticals After receiving her Doctor of Pharmacy degree from University of the Sciences in Philadelphia, Kristin completed a post-doctoral fellowship in Medical Information with Rutgers University and Ortho-McNeil Pharmaceutical. Upon completion of her fellowship, Kristin joined the Johnson & Johnson family of companies as a member of the Medical Information Department at Centocor, Inc. For more than seventeen years, Kristin has held numerous positions within Medical Information and is currently Senior Director, Medical Information & Knowledge Integration at Janssen Scientific Affairs, LLC. Kristin is actively involved in Drug Information Association and PhactMI® and enjoys fostering the development of professionals in the scientific community. In her spare time, Kristin enjoys spending time with her husband and their three children.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 11 Website: www.icpdprograms.org Barbara Green, Senior Director and Fellow, Skin Health Translational Science, Johnson & Johnson Consumer Healthcare Barbara Green is Senior Director, Skin Health Translational Science where she leads the end-to-end R&D team that delivers global, upstream “Future of Skin Health” innovation, drives scientifically rigorous and novel consumer and claim activations, and drives external KOL execution through professional/scientific engagement. As a member of the Skin Health Innovation Board and R&D Leadership Teams she is responsible to lead initiatives that impact the growth strategy for Johnson & Johnson Consumer Health through innovation across skin aging, resilient skin, sunscreen/protected skin, acne and cleansing.

Barbara joined Johnson & Johnson in 2016 through the acquisition of NeoStrata Company, the dermo-cosmetic company that markets the iconic physician-dispensed brand NeoStrata® and the prestige brand Exuviance®. At NeoStrata, she had the unique opportunity to lead the development, commercialization and licensing of the company’s novel, patented skin care ingredients, including the revolutionary alpha-hydroxy acids (AHAs), polyhydroxy acids (PHAs), bionic acids and breakthrough NeoGlucosamine® and Aminofil®.

Barbara is a graduate of Rutgers University, College of Pharmacy, holds a Master of Science degree in Pharmaceutical Chemistry, and is a registered pharmacist in the state of New Jersey. She maintains an industrial advisory position with the Rutgers University Professional Science Master’s Program and is a proud advisor and mentor to WLI.

Joseph Grimsby, PhD, Global Project Leader, Astra Zeneca Joe Grimsby, PhD is Senior Project Leader in Cardiovascular, Renal & Metabolic Diseases (CVRM) iMED. Joe received his PhD degree in Molecular Pharmacology & Toxicology from the University of Southern California where he studied neurotransmitter metabolism. As a post-doctoral research fellow at Roche Pharmaceuticals, he elucidated the mechanism of action of a novel class of antidiabetic agents called glucokinase activators. During the span of his 15 years at Roche he served as the departments associate therapeutic area head for diabetes preclinical drug discovery, in vivo biology head and was a project leader responsible for bringing 5 different molecules from preclinical to clinical development. Joe joined MedImmune in 2011 and helped build CVRM’s preclinical drug discovery portfolio and research capabilities located at the Gaithersburg site. He continues his pursuit in developing innovative therapies to treat diabetes, obesity, NASH and cardiovascular disease as a Senior Project Leader and by mentoring the next generation drug hunters in CVRM. He has established and manages external partnerships (academic/industry) and has broad experience in-licensing and out-licensing assets. Joe has a strong track record in pharmaceutical drug discovery and an accomplished scientist with >60 publications and 5 patents.

Shalini Gupta, PhD, Director Pre-clinical, Amgen Shalini Gupta, PhD is a Director in the Translational Safety & Bioanalytical Sciences Department at Amgen, Inc., Thousand Oaks, CA. She received her PhD in Biochemistry from Lucknow University, India. Subsequently, she completed postdoctoral fellowships at Cornell University, Ithaca, New York and UCLA where she studied growth factor receptor signaling pathways in mammalian cells and T and B cell signal transduction mechanisms. In Fall 1994, Shalini joined Athena Neurosciences, Inc. where she developed and validated cell- based potency assays. In 1996, she joined Amgen where she leads a group that develops and validates PK, immunogenicity and cell-based bioassays aimed for measuring drug and immune responses towards Amgen’s biological therapeutics. She has been an active member of the American Association of Pharmaceutical Scientists (AAPS) since 1998 and leads a committee that writes whitepapers for harmonizing approaches for evaluating the immunogenicity of protein-based therapeutics. She also served on the USP Immunogenicity Experts Panel from 2010-2015.

Jennifer Hayes, PhD, Director of Medical Alignment, Astra Zeneca Jennifer Hayes, PhD is a Director of Medical Alignment in US Medical Affairs (USMA) Oncology at AstraZeneca. She is driven by a passion to improve healthcare delivery, access and the quality of life and outcomes for patients. Through her public and private sector experience in oncology, Jen has developed expertise in leading diverse groups of stakeholders in cross-matrix environments, industry launches and product lifecycle management, strategic planning, developing innovative approaches to achieve objectives, managing multi- million-dollar biomedical research funding programs, and collaborating with diverse groups of experts to successfully execute multi-disciplinary projects. At AstraZeneca, Jen is a member of the USMA Inclusion & Diversity Committee, the Medical Affairs Women’s Leadership Initiative and leads a Digital Health & Therapeutics workstream.

Before joining AstraZeneca, Jen worked as a Program Director for the National Cancer Institute (NCI) Breast Cancer Steering Committee and played key roles in developing and leading the NCI Cancer Clinical Investigator Team Leadership Award Program. Prior to the NCI, Jen was a Program Manager and Scientific Officer at the Congressionally Directed Medical Research Programs, a component of the Department of Defense US Army Medical Research and Materiel Command which Congress tasks with annually administering approximately $1 billion for extramural biomedical research directed towards specific diseases and medical conditions.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 12 Website: www.icpdprograms.org

Jen holds a PhD in cell biology from Cornell University and a BA in biological sciences from Rutgers University. A love of math and curiosity about Wall Street led her to a few years in the financial sector at Goldman Sachs and JPMorgan Chase. A desire to be closer to the science and impacting patients’ lives brought her down her current path to AstraZeneca.

Stan Hemsley, MD, MBA, Senior Product Vigilance Physician, Johnson & Johnson office of the Chief Medical Officer Stan is currently responsible globally for all aspects of ICSR medical review and related functions. He joined J&J and the pharmaceutical industry as a medical safety officer in 2007 at J&J’s Janssen Pharmaceutical after several decades of clinical practice including more than a decade as a clinical assistant professor of Pediatrics/Adolescent Medicine at the University of Pennsylvania and Temple University’s Schools of Medicine. Since joining J&J, he has held additional positions within the Janssen Pharmaceutical and Consumer Health safety organizations of increasing responsibility culminating in his current position as Head of Product Vigilance Physician Operations.

Stan holds a B.S. in Biology from Bates College, a M.D. from Harvard University, School of Medicine, and a M.B.A from Temple University’s Fox School of Business. His medical training in pediatrics occurred at St. Christopher’s Hospital for Children, Temple School of Medicine and medical fellowship in adolescent medicine with focus in eating disorders occurred at the Children’s Hospital of Philadelphia, University of Pennsylvania, School of Medicine. He has also completed coursework at McMaster University, Canada, in the area of Evidence Based Medicine. He is board certified in Pediatrics and sub-board certified in adolescent and maintains a license to practice medicine in Pennsylvania.

Stan and his wife Kathy are the parent of 5 children and live in Pennsylvania.

Miguel Herrera, MBA, Senior Director, R&D Global Package Development, Johnson & Johnson Consumer Healthcare Miguel Herrera, MBA is the Senior Director for Global Package Development at Johnson & Johnson Consumer Health in Skillman, NJ. He joined J&J in 2015 and earned an MBA from Xavier University in Cincinnati, OH. Miguel’s expertise includes package, product and material design and development; consumer-driven technology/innovation management; strategy development; packaging/product equipment and processes supplier/partner relationship management and organizational development and management. Miguel is a NA RDLT member. He is married to Veruska, they have a son (Andres) and daughter (Isabella)

Beth Hinkle, PhD, Senior Scientific Director, Preclinical, Janssen R&D Beth Hinkle, PhD is a Preclinical Director in the Comparative Biology and Safety Sciences department at Amgen Inc. She has over 16 years of experience in the biotechnology and pharmaceutical industry where Beth has most recently focused on Oncology therapeutics. Her work involves developing and implementing the nonclinical safety strategy for therapeutic drug candidates, including small molecules, monoclonal antibodies, recombinant proteins, antibody drug conjugates, and CD3-directed bi-specific antibodies.

Prior to joining Amgen Inc., Beth lead the New Drug Screening group at Miravant Pharmaceuticals, where she directed the evaluation of small molecule therapeutics for toxicity, pharmacodynamics, and efficacy. Beth was a postdoctoral research fellow at the University of Connecticut Health Center. She earned her PhD in Biochemistry & Molecular Biology from the University of California Santa Barbara and her B.A. from the University of Denver.

Sonal Humane, Director, Project Management, Merck Sonal studied biology at Rutgers University. She has been at Merck for 28 years and has held various roles within the research division of Merck (Merck Research Labs) within GCTO. Prior to this, her role involved meetings, as she was a Program Manager for various drug and vaccine clinical studies.

Since 2007, Sonal been the head of the GCTO Meeting Management group which plans and delivers 500+ industry leading meetings in the Clinical Trials space in a consistent and compliant manner that promotes the highest degree of excellence in the execution of Merck clinical trials.

Outside of work, Sonal is a mother of 2 children (20-year boy and 23-year girl). She loves to spend time with family, cooking, traveling and listening to music. She can speak 5 different languages and would love to learn a few more!

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 13 Website: www.icpdprograms.org Simon Jackson, PhD, Executive Director Research, Amgen Simon received his PhD in Biochemistry from the University of Manchester, UK, in 1986, completed postdoctoral training at UCLA and served as Adjunct Assistant Professor at the same institution from 1996 to 2000. Simon joined the Tularik Biology group in South San Francisco in 2000 working on small molecule inhibitors of an obesity target. He subsequently became part of the Metabolic Disorders group of Amgen Inc in 2004 following the Tularik acquisition. At Amgen Simon has worked on the biology of PCSK9 and the antibody program for inhibiting PCSK9, leading to the launch of Repatha for the treatment of hypercholesterolemia in high-risk patients with atherosclerotic cardiovascular disease. Currently, Simon is the lead for the Atherosclerosis and Vascular Biology group in the Cardiometabolic Disorders Therapeutic Area.

Annette John-Baptiste, PhD, Director, Pfizer Annette began her career as an entry-level scientist in Clinical Pathology and worked her way up to supervisor and eventually managing both Clinical and Anatomic laboratories supporting both preclinical (GLP) and clinical (GCP) at Pharmacia. She returned to graduate school to hone her management skills in an MBA program and soon afterward began mentoring high school students in her laboratory. When she transitioned to Pfizer La Jolla as the DSRD Biomarker Lead in 2003, she continued mentoring but extended her mentorship to disadvantaged undergraduate students of color to consider pursuing careers in Pharma. Several of her mentees, have completed PhD programs in medicinal chemistry, organic chemistry, and pathology and currently work in Pharma. Annette continues to mentor both colleagues (locally and globally) and students of color (grammar school through undergrad) in her current role on leadership, people management, career development, and the pursuit of science as a career in Pharma among our youth. She returned to graduate school and completed a PhD in Organizational Development and is currently the Scientific Ops Lead (Scientific & Operational Effectiveness {SOE} Group) in Drug Safety R&D where is a strategic partner to the SOE Head, DSRDs Chief Toxicology Scientist, and other line leaders enabling them to increase the scientific performance of DSRD and its partners.

Carl Erwin Johnson, MD, EdM, MS Director-Outcomes Research, Merck Office of the Chief Patent Officer Carl Erwin Johnson, MD, EdM, MS is a pediatrician trained at Boston Children’s Hospital. Before joining Merck, Carl spent the last decade as a physician executive in the healthcare information technology and healthcare analytics industries; most recently at Optum, prior to Optum, Cerner Corporation. He is a graduate of The Mount Sinai School of Medicine in New York City and has held faculty positions at Harvard Medical School, The University of California at San Francisco, The Ohio State University, and The Mount Sinai School of Medicine as a health services researcher applying mixed methodology studies to answer real world questions in primary care settings. Carl also has experience in medical education and faculty development working with physicians to help them learn and apply new tools for success in contemporary healthcare. He believes that healthcare can be transformed with real world research collaborations that focus on the right data and right questions.

When not helping to transform healthcare, Carl can be found playing tennis, cooking, improving his French (and traveling to France), taking photographs, reading historical fiction, listening to music (jazz, opera, classical, R & B, lounge), and watching Ohio State Football.

Renu Juneja, PhD, Head Scientific Evidence & Communications, Oncology US Medical Affairs, Janssen Oncology Medical Affairs Renu Juneja, PhD is Head of Scientific Evidence and Communications at Janssen Biotechnology Inc (JBI). She leads a team responsible for development and execution of publication strategy, medical education, KOL engagement, medical booth at scientific congresses, MSL materials/tools & training, Cooperative groups studies strategy, and Clinical Operations for US Medical Affairs studies, Investigator Initiated Studies (IIS) & Cooperative group studies. Before joining Janssen, Renu was head of the Medical Communications group at MedImmune (the worldwide biologics research and development arm of AstraZeneca). Her group had the responsibility for both regulatory documents and development & execution of strategic publication plans. Her team supported all therapeutic areas including Immuno-oncology, respiratory, inflammation, CVMD, infectious diseases and vaccines.

Previously, she led the Strategic Scientific Communication (SSC) group at Novo Nordisk Inc. (NNI). She also had the opportunity to lead the Information & Education group at NNI and was responsible for the company’s library and for Independent Medical Education (IMEs) programs. Renu started her career in Novo Nordisk as a medical writer. After finishing her PhD in Reproductive Biology & Biochemistry from the Post-Graduate Institute of Medical Education & Research (PGIMER) in India, Renu joined the Population Council in NY as a Postdoctoral fellow. Two years later, she received an independent research grant from the Lalor Foundation and joined the department of Molecular Biology at the Princeton University. She has over 30 publications in peer- reviewed journals and has presented at various national and international conferences.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 14 Website: www.icpdprograms.org Renu has presented and conducted workshops at the annual meetings of various professional organizations e.g. ISMPP, TIPPA, CBI, and Q1 productions. Since July 2020, she is leading the Medical Communications workstream for the Medical Affairs Professional Society (MAPS)

John Knighton, MBA, Vice President, Head Large Molecule API, Janssen R&D John is the Vice President of BioTherapeutic Development Cell & Gene Therapy API in Janssen’s Pharmaceutical R&D and has been with Janssen for 16 years. With 30 years of biopharmaceutical development experience, John leads a diverse and dedicated team of scientists and engineers in biopharmaceutical viral vector drug substance and CAR-T process development and global technology transfer. John started his career at GlaxoSmithKline in various roles of biopharmaceutical research and development. John also is the Chair of the Advisory Board for Jefferson Institute of Bioprocessing.

John holds his BS degree in Microbiology from The Pennsylvania State University, an MBA from Villanova University, and a Doctorate from Temple.

Courtney Leo, Director, Integrated Medical Operations Services, Pfizer Courtney has 25 years of pharmaceutical industry experience which includes leading global teams, system administration, financial management, medical publication planning, and vendor relationships. She is a strategic and achievement-oriented Operations Leader offering a distinguished career in leveraging highly refined analytical talents and strong business acumen. An experienced leader directing financial operations and process controls, publications planning and management, and business technology. Courtney is a conceptual decision-maker possessing ability to lead change by identifying deficiencies, creating corrective action plans, and providing focus to succeed. Her strong presentation and communication skills complimented by ability to build consensus across all functional areas.

Courtney Leo serves as the Director/Team Leader of Integrated Medical Operations Services in the Worldwide Medical & Safety organization. In this role, her responsibility is to ensure operational efficiencies for the Pure Compound Grants, Clinical Trial Disclosure Study requests, U.S. External Funding, and Publications Operations, including compliance with financial and contractual transactions, vendor negotiations, and publications management system.

Courtney began her pharmaceutical career in 1996 with experience across manufacturing, marketing, and medical at both Wyeth and Pfizer. In Courtney’s prior role, she was a Publications Director supporting several publication subcommittees in Oncology and Vaccines. In addition, she led the publications technology team, where she was responsible for vendor management, overseeing the publications management system, and design and implementation of a financial module which allows for accurate monitoring and recording of publication budgets and transfer of value to authors for external reporting.

From an educational perspective, Courtney graduated from Immaculata University with degrees in Business Administration and Organizational Dynamics. She is a Certified Medical Publications Professional (CMPP) and certified project manager, and has held certification as an International Privacy Professional (CIPP). Courtney serves on the International Society of Medical Publication Professionals (ISMPP) society as Treasurer for the Board of Trustees.

Aston Liu, PhD, Senior Director, SFC, CMC Analytical, GSK Aston Liu, PhD is currently a Senior Director in CMC Analytical in GlaxoSmithKline, managing a global organization providing analytical support for small molecule and biologics portfolios. Prior to joining GlaxoSmithKline, Aston was Head of Analytical Development in Tanox, Inc which was acquired by Genentech/Roche. Before that, Aston spent several years working with Pfizer Biopharma and Agenus, Inc, assuming increasing responsibilities with the last role as Director of Analytical Chemistry. Aston was also a founding investor and a member of the Board of Directors of Hypromatrix, Inc.

Aston received his PhD from University of Minnesota and postdoctoral training at Pacific Northwest National Laboratory. He went on to receive additional training in Business Management at Boston University School of Management. Aston published more than 20 peer-reviewed journal articles and book chapters and is a frequent speaker at national and international conferences. Aston holds three US & international patents and received numerous awards including the prestigious R&D 100 Awards recognizing the 100 best innovations of the year worldwide.

Pingli Liu, PhD, Executive Director, Process Chemistry, Incyte Corporation Pingli Liu is a PhD organic chemist by training. He has been working in small molecular process chemistry for more than 20 years in the pharmaceutical industry. He has been managing internal and external teams of multidisciplinary professionals to make drug substance economically, efficiently, safely, environmental friendly and timely. He also responsible for drafting and finalizing FDA and EMA filling documents for process chemistry. His responsibility is to work with internal and external process chemists, chemical engineers, quality controls, regulary affaires, clinical material managements, and others professionals, to ensure the quality of the drug substances that are manufactured and complied with regulations.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 15 Website: www.icpdprograms.org Christina Loefgren, MD PhD, Senior Global Medical Affairs Leader, Janssen Pharmaceuticals Christina Loefgren, MD PhD is a Swedish hematologist. She completed her Medical Degree at the Karolinska Institute, Stockholm, Sweden, with board certification in Hematology and Internal Medicine. Christina also completed a PhD from the Karolinska Institute, exploring new pharmacological and clinical methods to improve cytostatic treatment of AML.

Between 1998 and 2006 Christina held a variety of clinical hematology roles at Huddinge University Hospital which merged with the Karolinska Hospital, where she specialized in allogenic stem cell transplantation, with a clinical focus on CML and acute leukemia’s. Christina was the director of hematology residency training at the Karolinska, with a focus on mentorship and building personal development plans. For several years Christina coordinated and led the training in internal medicine for students at the Karolinska Institute faculty of Dentistry. She led leadership training courses for residents and students at the Karolinska Institute as well as created cases for and led Case Based Learning at the faculty of Medicine, Huddinge. Christina then worked at Bristol Myers Squibb for 8 years in a variety of Medical Affairs positions, culminating in leading the European Medical Affairs hematology team.

Prior to joining Janssen in 2016, Christina had returned to the Karolinska University Hospital, where she was Head of the Hematology Department, in Stockholm. In that position she led all operational aspects of the Hematology department at the Karolinska University Hospital, including medical activities, budget and >200 staff. In her current position Christina partners closely with the myeloid Global Medical Affairs Strategy & execution, Strategy Leader, Regional Medical TA/product leaders and Clinical Development Leader to develop integrated global medical affairs perspectives, strategies and plans.

In Jan 2018 Christina relocated to Newtown Pennsylvania, where she lives with her husband, their youngest daughter and two Lagotto Romagnolo dogs. She enjoys spending time with family and friends playing a round of golf, cooking and DIY around the house.

Nikki Longwell, PhD, Sr Director, MSLs -Immunology, Janssen Pharmaceuticals Nikki Longwell, PhD is a Senior Director, Medical Science Liaisons - Immunology within the Janssen Immunology Medical Affairs organization. Nikki will be responsible for leading the development and execution of the U.S. Immunology MSL strategies and tactics as well as the strategic oversight of the MSL Communications Group and of the training lead for the Medical Affairs department.

Most recently, Nikki was the National Director for the Immunology MSLs in the US Medical Affairs team at Genentech within the Immunology and Ophthalmology Division. While at Genentech, she oversaw the strategy and execution for field medical for Rituxan, Xolair, Esbriet and Actemra and the MSL-led activities for the gastroenterology pipeline.

Nikki entered the pharmaceutical industry in clinical operations but soon moved into Medical Affairs while at Cubist Pharmaceutical during the launch of Cubicin. She has been in Medical Affairs for over 18 years with increasing roles of responsibility at Sepracor while launching Lunesta (now Sunovion) and at Questcor (now Mallinckodt). Nikki started working at Questcor as the MSL in New England while simultaneously starting the Medical Information function at the company. She had progressively larger responsibilities and was responsible for growing the MSL team from two individuals covering all therapeutic areas to a team of five therapeutically aligned teams, MSL training and Payer MSLs with 70 members.

Nikki received her bachelor's degree from Wesleyan University and received her PhD in Psychopharmacology from Tufts University. She completed her post-doctoral training in pre-clinical and clinical pharmacology at Harvard Medical School.

Nikki is married to Brian Longwell and has a 20-year-old son, Levi, who is a freshman at Elon University and a 35-year-old stepdaughter, Jennifer. Nikki enjoys reading, dancing, working out, relaxing with her favorite TV series and in the ‘old days' entertaining friends at home, which she hopes to resume soon.

Matthew Lorenzi, PhD, VP-Disease Area Stronghold ST3, Janssen R&D Matthew V. Lorenzi, PhD is Vice President, Oncology Ventures & Scientific Innovation, Oncology Therapeutic Area, Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. In this role, Matthew is responsible for the direction and execution external innovation strategies for the oncology therapeutic area for Western North America. In addition, Matthew is leading an effort to create new platform companies for externalization. Prior to his current role Matt led the Solid Tumor Targeted Therapy Disease Area in Janssen Oncology focused on therapeutically targeting the key genetic defects and resistance mechanisms underlying solid tumor pathobiology. During his tenure at Janssen, Matthew advanced strong discovery and translational research to deliver a robust preclinical and clinical pipeline of novel immunotherapy and targeted agents leading to the approval of BALVERSA (erdafitinib) and RYBREVANT (amivantamab) targeting the oncogenic drivers FGFR and EGFR, respectively.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 16 Website: www.icpdprograms.org

Prior to joining Janssen, Matthew was a senior oncology leader at Bristol-Myers Squibb where he directed teams focused on small molecule and biologics-based drug discovery and development. Within these roles, he brought strong scientific and strategic leadership to successfully deliver multiple agents into and through clinical development.

Matthew received his PhD from the University of Miami in Molecular Pharmacology where he was a PhRMA Foundation Pre- Doctoral Fellow. He conducted his post-doctoral fellowship at the National Cancer Institute in Bethesda, MD where he continued as a tenure-track Senior Staff Fellow. Matthew’s research on the molecular events underlying cancer development have led to the identification of new cancer driver pathways and novel therapeutics for cancer patients.

Suman Luthra, PhD, Director Discovery Pharmaceutical Sciences, Merck Suman was born in India where she earned a Bachelor and master’s degree in Pharmaceutical Sciences from the University of Delhi. She then moved to Storrs, Connecticut to pursue a PhD in Pharmaceutical Sciences at University of Connecticut. Her research was focused on stabilization of lyophilized amorphous materials. Along with dissertation project, Suman took various courses in drug discovery, protein stability, biochemistry, drug delivery and aspired to work in Biopharmaceutical industry. Her first job was within small molecules Drug Product Design at Pfizer where she delivered drug product strategy of multiple preclinical and clinical programs and learned about the importance of networking and mentoring. She currently works for Merck at the Boston site and leads Discovery pharmaceutical sciences team. Merck's vision is to be the premier, research-intensive biopharmaceutical company to save and improve lives of patients across the world. Suman has a continuous growth mindset and advocates that identifying opportunities to be a better person and do the job better is very important. She is passionate about enabling colleagues achieve their career goals and aspirations. In her free time, Suman prefers to be outdoors riding bike and hiking in nature with her family and friends.

Ricardo Macarron, PhD, Vice President, Applied Technology Group, Incyte Corporation Ricardo Macarron, PhD is Vice-President of Applied Technologies at Incyte, a group within the Discovery Biology department responsible for compound management, molecular biology, structural biology, biochemical and cellular assay development and screening for hit identification and lead optimization. Prior to joining Incyte, he worked in different GlaxoSmithKline drug discovery groups from 1992 to 2019. In 2007 he co- founded a start-up, ID Diagnostics, closed in 2010.

Ricardo received both bachelor’s degree in Biology (1987) and PhD in Biochemistry (1992) from the University Complutense of Madrid (Spain). He also completed a Master’s degree in Technology Management from the University of Pennsylvania (2006).

Seema Malkani, PhD, MBA, Director, Medical Affairs, Merck Seema Malkani, PhD, MBA, brings 20+ years of R&D and Global Medical Affairs experience across Diabetes and CNS therapeutic areas within the biopharmaceutical industry. Over the past 16 years at Merck and Takeda Pharmaceuticals, Inc., Seema has held positions of increasing responsibilities both within US and Global Medical Affairs organization and has led regional/global teams in the development and implementation of medical affairs strategies to support prioritized global assets across 15+ regions and functions.

In her current role as Global Director Medical Affairs, Seema supports the development of the scientific and medical affairs plans and drives execution of plans with regional and country medical affairs colleagues. Prior to joining Merck, she was the Global Scientific Director at Takeda where she led Global Medical Strategy Teams for Diabetes and CNS franchises, and drove implementation of numerous medical affairs deliverables while building strong internal and external networks globally. She oversaw the development and alignment of global medical affairs strategies including consolidation of medical priorities across the global organization, implementation of KOL engagement strategy/plans, scientific communications, medical education strategy, launch planning, competitive intelligence, publication planning, alliance management, and overall market development. She also implemented numerous training programs in US, Europe, and Emerging Markets across multiple TAs.

Prior to joining Takeda, Seema worked as a Neuroscientist within Neuroscience Discovery at Eli Lilly and Company and completed her post-doctoral training at Harvard Medical School at the Center for Neurological Diseases. Seema holds a PhD in Neuroscience and a Masters of Business Administration (MBA) from the University of Chicago Booth School of Business. Seema has authored numerous peer-reviewed papers in high-profile journals and presented at multiple international congresses. In her free time, she enjoys traveling with her husband and 3-year-old son.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 17 Website: www.icpdprograms.org Carlos Martinez, Leader for the Biocatalysis Center of Excellence, Pfizer Carlos is the Leader for the Biocatalysis Center of Excellence (BCE), within the Chemical Research and Development Department in the Pharmaceutical Science Small Molecule organization in WRDM. In his current role, he is responsible for leading the development of new Biocatalysis technologies and the implementation of those in the manufacture of Active Pharmaceutical Ingredients (API). Carlos has contributed to establishing Biocatalysis as an important technology in API manufacture, including the acceleration of multiple clinical candidates and the implementation in commercial processes such as Lyrica, Lipitor and Xalkori.

Carlos obtained a BSc in Chemistry from the Universidad del Valle in Cali Colombia and obtained a PhD in Chemistry from the University of Florida. He then worked as a Postdoctoral Fellow at the California institute of Technology in Frances Arnold’s lab. Carlos joined Pfizer in 2001 and participated in the creation of a Biocatalysis group in La Jolla, soon after starting his career at Pfizer. In 2006, Carlos moved to Groton to participate in the creation of the BCE. He became the leader of the BCE in 2016. Carlos’s passion involves learning and developing solutions to complex problems. He is also passionate about discovering ways to inspire, coach and enable the development of colleagues while delivering value to Pfizer. Carlos was born in Cali, Colombia and has lived in the US for the last 24 years. He lives in Waterford, CT with his wife and 2 kids and in addition to spending time with the family, he enjoys outdoor activities like soccer, running, golf, kayaking & surfing, learning to play the Piano and water gardening.

Rahn McKeown, Scientific Director, GSK Rahn was part of the 3rd graduating class at Rowan University’s Chemical Engineering program in New Jersey. While at Rowan, he spent his summers interning at GlaxoSmithKline between 1999 and 2002. After graduating, he attended Clemson University but left prior to finishing a PhD to pursue a career at GSK. Rahn has been at GSK ever since starting with a bench role and gradually taking on roles of increasing responsibility. He is currently the US Director of the Materials Science group in R&D, which tailors the API’s physical and chemical properties to meet the needs of the patients that GSK serves. In his spare time, Rahn enjoys competitive scrabble, basketball, and designing puzzles for his side hustle (an Escape Room business).

Lloyd Miller,MD, PhD, Vice President, Immuno Derm DAS - IMM, Janssen Research & Development Lloyd S. Miller, M.D., PhD, joined Janssen Immunology in January 2020 as Vice President, Immunodermatology Disease Area Stronghold (DAS) Leader. In this role, his primary objective is to drive the scientific leadership in dermatology and set the strategy to meet the needs of millions of patients living with immune-mediated skin diseases who have inadequate available treatments. In this role, he serves as a member of the Janssen Immunology Core Leadership Team and Immunology Portfolio Committee and is based in Pennsylvania.

Lloyd earned his B.A. in biology at Johns Hopkins University and received his M.D. and PhD degrees from the State University of New York Downstate Medical Center in Brooklyn. His dermatology residency and post-doctoral research fellowship were completed in the Specialty Training and Advanced Research (STAR) program at the University of California Los Angeles (UCLA). At UCLA, he started his basic science and translational research program that involved the study of skin infections and inflammation, the skin microbiome and wound healing responses. In 2012, Lloyd moved his research program to the Johns Hopkins Department of Dermatology, where he served as Vice Chair for Research in Dermatology and Professor of Dermatology, Infectious Diseases, Orthopedic Surgery and Materials Science and Engineering at the Johns Hopkins University School of Medicine. Over the years, Lloyd has published more than 100 peer-reviewed manuscripts, review articles, book chapters and editorials and has given over 100 oral presentations at national and international scientific programs and meetings. In addition, he has received several NIH grants, in addition to private foundation and industry funding awards for his research. Throughout his career, he practiced both general dermatology and specialized wound care.

Lloyd also served as a standing roster member on the Arthritis, Connective Tissue and Skin (ACTS) NIH study section, the Medical and Scientific Review Committee for the Dermatology Foundation, the Scientific Program Committee for the Society for Investigative Dermatology and was elected to the American Society of Clinical Investigation. He is certified by the American Board of Dermatology.

Audrey Mosley, Director Clinical Operations, Merck Audrey Mosley is a Director and Therapeutic Area Lead for Infectious Diseases (ID) and Vaccines within Clinical Sciences and Study Management. In this role, Audrey provides and manages operational and scientific strategy, design, budget, and execution for multiple programs. She is responsible for ensuring operational and scientific consistency, quality development and execution, as well as continued evaluation of clinical development plans across multiple programs.

Audrey has been at Merck since 1990. Over her tenure, all within MRL, she has taken on increasing responsibilities in various roles. She has significant experience as a people manager. Her experience extends to directing clinical and operational aspects of vaccines and infectious disease trials and programs, including HIV, Zostavax, Heat Inactivated Zostavax, Pneumococcal Conjugate, Rotateq, Zinplava, Cubicin, Zepatier, CMV Vaccine, Gardisil, and Vaxelis.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 18 Website: www.icpdprograms.org Audrey is a certified Project Management Professional (PMP®) and earned a Bachelor of Arts degree in Biology from Temple University. She resides in the Greater Philadelphia area with her husband. She is the mother of two daughters and two awesome dogs. She spends her spare time knitting, praise dancing, and performing community service with her sorority.

Ayad Mudarris, PhD, Medical Science Liaison, Janssen Pharmaceuticals Ayad Mudarris, PhD is Pharmacist with a Master’s degree in Medical Technology and a PhD in Biochemistry by education and Clinical Chemistry/Toxicology training with a career path encompassing directing diagnostic clinical laboratories and forensic toxicology laboratories involved in toxicology/drug of abuse testing and clinical chemistry. He has held several roles in the pharmaceutical industry with the current position being a Principal Medical Science Liaison with Janssen Pharmaceutical Medical Affairs. Ayad’s interests include reading, movies, and travel.

Fran Muller, PhD, Executive Director, Pharmaceutical Development, Incyte Corporation Fran Muller, PhD is an executive director of Pharmaceutical Development at Incyte Corporation. Fran received both his Bachelor's Degree in Pharmacy and his PhD in Pharmaceutical Science from the University of Maryland. Prior to joining Incyte, he worked for GlaxoSmithKline Pharmaceuticals for 21 years. In his current role, Fran leads a team of scientists that perform pre-formulation characterization, formulation development and analytical testing. His research interests include solid state characterization, powder flow and compaction behavior, and particle engineering. Fran has numerous presentations and publications in these areas.

Heather Myler, PhD, Medical Science Liaison, Janssen Pharmaceuticals Heather Myler, PhD received her PhD in Biochemistry and Cell Biology at Rice University and completed her post-doctoral training at Pfizer in Drug Safety Evaluation, later holding positions of increasing responsibility at Amgen, Merck and BMS supporting PK, immunogenicity and biomarker bioanalysis with an expertise in biologics. Heather currently serves as the Senior Director of R&D, Immunochemistry at PPD leading a group of scientists responsible for bioanalytical (PK, ADA, Nab) and biomarker method development, validation and automation supporting gene and cell therapies, biosimilars and novel biologics. Heather has a strong external scientific presence, serving as past-chair of the Bioanalytical Community within AAPS and chair of the Community Forum. Heather is also leading an AAPS team focused on the Harmonization of ADA and Nab validation testing and reporting, comprised of over 60 KOL from across industry and from various health authority agencies with a strong FDA presence.

Chimeremma Nnadi, MD, PhD, Senior Medical Director, U.S. Vaccine Medical Affairs, Janssen Pharmaceuticals Chimeremma Nnadi, MD, PhD is Senior Medical Director, U.S. Vaccine Medical Affairs at the Janssen Pharmaceutical Companies of Johnson & Johnson. In this role, Chime oversees U.S. Medical Affairs efforts to prepare for the potential introduction of vaccines across multiple disease areas, including our investigational COVID-19 vaccine. Prior to joining Janssen, Chime served as Medical Director for Vaccine Confidence and the Global Medical Director for New Vaccines at Merck.

Chime is a physician by training and obtained a PhD in Public Health from the University of Pittsburgh. He also studied Vaccinology at the Pasteur Institute in Paris. Prior to his industry career, he worked as a Medical Officer and Vaccine Preventable Disease Epidemiologist at the U.S. Centers for Disease Control and Prevention, where he conducted immunization policy and programs research. He also worked on implementing vaccines delivery in different parts of the world.

Chris Nuñez, PhD, GMAF Strat And Exec Lead Multi Myeloma, Janssen Pharmaceuticals Chris Nuñez, PhD has been working at Johnson & Johnson for over 15 years and in his current role serves as the Global Medical Affairs Strategy and Execution Leader with responsibility for the Multiple Myeloma Portfolio within the Janssen Oncology team. Chris initially joined Janssen in 2016 where he successfully led the development and implementation of the Janssen secondary data governance model and partnered with the RWE LT and key stakeholders to roll-out of the Methods Review process within Janssen GCSO and across all regions.

Prior to Janssen, Chris worked at Johnson & Johnson Consumer after the Pfizer Consumer Healthcare acquisition in 2006. At J&J Consumer, he held various roles including serving as the Medical/Clinical lead for Wound Care/Topical Healthcare portfolio – supporting iconic OTC brands such as Neosporin®, Band-aid®, BenGay®, Compeed®, Benadryl® and Visine®. He also supported the Baby franchise, leading medical affairs strategy for the Baby Franchise (Johnson’s® and Aveeno® Baby Brands). Prior to joining J&J Consumer, Chris held various clinical research positions at Pfizer, Inc and Cadbury Schweppes, plc.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 19 Website: www.icpdprograms.org Throughout his career, Chris has been a strong advocate of diversity, equity and inclusion initiatives. In various Leadership roles within our Hispanic and Latino Organization for Leadership and Achievement (HOLA) Employee Resource Group, he has advanced key programs supporting talent development and external programs serving our underserved communities.

Chris earned his Bachelor of Science degree in Nutrition at Cornell University and his Doctorate Degree in Applied Physiology from Columbia University. Chris and his wife, Janette, live in East Brunswick, NJ along with their daughter, Katianah and sons, Ryan, Daniel and Kristian. Outside of work, Chris enjoys exercising and participating in CrossFit, playing basketball and spending time outdoors with his family.

Kathryn Packman, PhD, Senior Director, Scientific Discovery, Janssen Research & Development Kathryn Packman PhD is the Senior Scientific Director and Global Head of Tumor Biology at Janssen Research & Development. She leads a group of ~25 oncology pharmacologists located in Spring House, PA and Beerse, Belgium, to support discovery- and development-stage research programs. Their mission is to rapidly bring new medicines to cancer patients by integrating cutting edge technologies and deep biological insight through internal research and collaborations with world-class academic and biotechnology research organizations.

Collectively her laboratories have supported the advancement of over 20 drugs into clinical investigation, including CD3 T-cell bispecific antibodies teclistamab (BCMA/CD3), talquetamab (GPCR5D/CD3), JNJ-67571244 (CD33/CD3), JNJ-63898081 (PSMA/CD3), AR antagonist JNJ-63576253 (TRACON TRC253), PRMT5 inhibitor JNJ-64619178, MALT-1 inhibitor JNJ-67856633, and cetrelimab (anti-PD-1). They have also provided translational support for erdafitinib (FGFR inhibitor), bispecific EGFR/MET antibody amivantamab, PARP inhibitor Niraparib, FDA-approved AR antagonist apalutamide (ERLEADA), and anti-CD38 antibody daratumumab (DAZARLEX).

Kathryn is an in vivo pharmacology leader with extensive preclinical drug discovery experience. Prior to her current role, she led academic and biotechnology research collaborations for the Oncology therapeutic area at Janssen, including the Belfer Institute at Dana Farber Cancer Institute/ Harvard Medical School and MD Anderson Moon Shots Program immunotherapy platform.

Prior to joining Janssen, Kathryn was head of preclinical oncology research at the Roche Translational and Clinical Research Center, she also led preclinical tumor biology at Roche Pharmaceuticals for 10 years, where her laboratory examined drug efficacy and biological mechanisms of action in vivo. This work culminated in the advancement of ten drugs with companion biomarkers into clinical investigation, including first-in-class p53-MDM2 antagonists RG7112, Idasanutlin, and pegylated Idasanutlin, and the marketed BRAFV600 inhibitor vemurafenib (ZELBORAF). Kathryn’s lab also focused on modulation of dose, schedule, and combination therapy to optimize tumor apoptotic response while limiting drug toxicity. Their work provided the basis for clinical investigation of the dose-dense regimen for the marketed drug capecitabine (XELODA) in breast and colorectal cancer, as well as intermittent schedules for idasanutlin.

Kathryn has published over 40 peer-reviewed research articles and 6 patents. She also served as an Adjunct Professor in the Graduate School of Biomedical Sciences at the Rutgers New Jersey Medical and Dental School for 10 years. Kathryn earned her BSc. Degree in Biology at the State University of New York at Geneseo, and a PhD in Cellular and Molecular Biology at the University of Notre Dame.

Jacqueline Panigel, Scientific Manager Innate Immunity, GSK Jacqui started her career in the pharmaceutical industry soon after completing her Bachelor’s Degree in Life Sciences/Pre-Medicine at The Pennsylvania State University. She worked in an ion channel lab and trained as an electrophysiologist. Soon after joining Merck she started working on her Master’s Degree in Molecular Biology at Lehigh University. After 8 years at Merck she saw an opportunity for career growth at GlaxoSmithKline, where she joined in 2013. There she worked in several different departments spanning the fields of Respiratory, Neuroscience, Muscle Metabolism and now Innate Immunology. She currently leads a team of 6 scientists who are focused on identifying and validating novel targets with strong human genetic evidence. She is currently also pursuing her PhD at Northeastern University. Jacqui is passionate about the impact strong mentorship relationships can have in one’s career and is excited and motivated to have a part in guiding the next generation of talented scientists.

Dhaval Patel, PhD, Senior Director of Vaccines Development, Pfizer Dhaval Patel, PhD joins Pfizer Vaccines as a Senior Director of Vaccines Development and brings with him over 15 years of vaccine development experience from early discovery to late development. Dhaval previously held positions of increasing responsibility at Sanofi Pasteur US R&D. Dhaval joined Sanofi Pasteur as a Research Scientist where is served on numerous project teams as a CMC lead. Dhaval was subsequently promoted to Senior Scientist, where he managed the development of immunological assays to support vaccine characterization, before joining Global Clinical Immunology at Sanofi Pasteur as a Deputy Director. He was subsequently promoted to be the lead of the group. The role of the group was to serve on several New Vaccine project and clinical teams. Group was responsible for managing serological and diagnostic testing and for providing scientific expertise to the programs. In his role he has directly supported several projects including C.difficile Toxoid Vaccine development.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 20 Website: www.icpdprograms.org Prior to Sanofi Pasteur, Dhaval worked at Abbott Laboratories in Worcester, MA, as a Post-doctoral Fellow focused on early discovery autoimmune projects.

Dhaval holds a Doctorate of Philosophy (PhD) in microbiology and immunology from East Carolina University and an MBA from Fairleigh Dickinson University. Dhaval is married to Kinjal, and has three boys, Kirtan age 17, Keshav age 9, and Moksh age 4. He enjoys spending time with his family and friends, as well as coaching baseball and soccer teams for his sons.

Marjorie Peraza, PhD, Regulatory and Project Toxicologist, Drug Safety R&D, Pfizer Marjorie A. Peraza, PhD, is a toxicologist and nonclinical Regulatory Strategy Lead within Drug Safety R&D (DSRD) at the Kendall Square site in Cambridge, MA. Marjorie has more than 14 years of drug development experience in the pharmaceutical industry as a project toxicologist on drug development teams for a variety of therapeutic areas and modalities, from early stage research to late stage development and registration.

Marjorie is a DSRD Talent Ambassador, representing DSRD as a Talent and D&I Champion both internally and externally. She is also a Pfizer representative to the Society of Toxicology (SOT) Hispanic Organization of Toxicology Special Interest Group. Through these efforts Marjorie seeks to leverage, expand, and build networks at the SOT and other conferences, identify and build long-term relationships with key talent, and help build the Pfizer talent pipeline for future hires.

Prior to joining Pfizer, Marjorie completed her graduate work on mechanisms of arsenic toxicity at the University of Arizona in Tucson. Her postdoctoral work on the role of peroxisome proliferator-activated receptors in general mechanisms of toxicity and of carcinogenesis was conducted at Pennsylvania State University in State College. Marjorie has published several peer-reviewed scientific papers and book chapters, is a speaker in the American College of Toxicology’s course on “Toxicology for Pharmaceutical and Regulatory Scientists” and is a member of the SOT.

Marjorie is passionate about encouraging STEM careers for underrepresented groups. She plays the violin and volunteers for the Kendall Square Orchestra, whose goal is to unite STEM colleagues through music and philanthropy, which has empowered her to combine several of her passions. Marjorie also volunteered in the 2020 Professional Pathways Event between Pfizer and youth in the Year Up Program, to help empower and close the opportunity gap facing many low-income young adults in the community by engaging these students through informational interviews, resume workshops, and networking sessions.

Cornel Phillip, PhD, Senior Medical Science Liaison, AstraZeneca Cornel Phillip is currently a Senior Oncology Medical Science Liaison at AstraZeneca on the Thoracic and Immuno-Oncology who is responsible for Georgia, South Carolina, and Puerto Rico. He has a PhD in Cancer Biology/Pharmacology from the University of Texas Houston Health Science Center, M.D. Anderson Cancer Center that he earned in 2009 and a Bachelor of Science degree in Biology from the University of the Virgin Islands in 2002.

Prior to joining AstraZeneca, Cornel worked as a medical writer for 6 years supporting the development of fair and balanced medical content and marketing strategies in hematologic malignancies, solid tumors, and inflammatory bowel disease at Nucleus Global. Cornel also spent 2 years as a postdoctoral fellow at Emory University where he conducted biologic, translational, and bioinformatics research on prostate cancer to identify novel therapeutic strategies and targets.

Steffi Pluschkell, PhD, Head of Business Strategy and Operations and Chief of Staff for the Biotherapeutics Pharmaceutical Sciences, Pfizer Stefanie Pluschkell PhD is currently Head of Business Strategy and Operations and Chief of Staff for the Biotherapeutics Pharmaceutical Sciences (BTxPS) organization at Pfizer Inc, based in Groton, Connecticut. In this role, she leads the execution of the 5-year strategic and annual business plans via matrix leadership across Pharmaceutical Sciences, Worldwide Research & Development (WRDM) and commercial Business Units, as well as commercial manufacturing (Pfizer Global Supply, PGS). Her team delivers financial forecasting, ensures BTxPS meets budget targets, and leads capacity modeling and resource planning to drive maximum efficiency and output from BTxPS and outsourcing partners in support of customers and new technology initiatives. This work is critically important to maintaining and growing a state of the art BTxPS organization (currently approx. 1100 employees across four main sites) that delivers clinical supplies and robust, commercializable processes for a highly diverse and complex product portfolio, including vaccines, monoclonal antibodies, other therapeutic proteins, and advanced therapies such as gene therapy. Stefanie’s team manages all facilities (laboratory, non-GMP and GMP pilot plants) across the BTxPS network globally and provides the digital transformation and knowledge management strategy for BTxPS. Stefanie also leads continuous improvement efforts across BTxPS and drives external benchmarking to evaluate how BTxPS is performing relative to peer large Biotech organizations as well as other technology companies. She coordinates the talent management process within BTxPS and serves as a sounding board and coach to BTxPS colleagues at all levels.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 21 Website: www.icpdprograms.org Prior to her current role, Stefanie was Senior Director in Pharmaceutical Sciences, Global Chemistry and Manufacturing Controls (GCMC) at Pfizer. Her experience as a leader in regulatory CMC spans a period of over 10 years. After initially supporting both biotherapeutics and small molecules, she focused primarily on biotherapeutics, vaccines and advanced therapies in recent years. In her team leader and advisory role, Stefanie was responsible for developing global regulatory strategies for quality and manufacturing aspects of biologics in pre- and post-approval stages. Stefanie has a long track record of and continues to be actively engaged at the external interface with regulators and industry in support of innovation as it relates to the R＆D pipeline and commercial products. She has served on multiple US-based and international working groups and has delivered podium presentations globally on topics including supply chain complexities, post-approval changes, Quality by Design, biosimilars, etc. Stefanie has been a Pfizer representative to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA, based in Geneva, Switzerland), and has represented the biopharmaceutical industry at WHO workshops and at the WHO Expert Committee for Biological Standardization on multiple occasions.

Stefanie first joined Pfizer in 1999, as a research scientist in the Pharmaceutical Sciences department of Bioprocess Development. For several years, she focused on developing processes for the manufacture of therapeutic proteins and monoclonal antibodies for use in clinical trials, including the scale-up and technology transfer to external partners.

Stefanie's educational background includes a PhD in Chemical Engineering from the University of Minnesota and an executive MBA from Massachusetts Institute of Technology. In addition, she holds a MS degree in Biotechnology from the Technical University of Braunschweig, Germany. Stefanie's path from Germany to the United States began as a Fulbright scholar in 1992, and she continues to be passionate about supporting cultural exchange and international education.

Naomi Rajapaksa, PhD, Senior Scientist and Team Leader, Genentech Naomi is a Senior Scientist and Team Leader in the Genentech Small Molecule Discovery Chemistry department. She received her Bachelor’s degree in Chemistry from Stanford University and a PhD from Harvard University, where she studied asymmetric catalytic methods and total synthesis under the direction of Professor Eric N. Jacobsen.

After two years as a medicinal chemist at Novartis, Naomi joined the Genentech Discovery Chemistry department. In her current role, she is involved in the design and development of small molecules to modulate biological pathways. Naomi feels fortunate to be part of an interdisciplinary team of dedicated scientists that aims to address unmet medical needs. Over the past year, she’s enjoyed watching too many Netflix shows and growing a collection of indoor plants. Looking forward, I'm excited to connect with people in person and travel again.

Corrine Reimer, PhD, Director-Oncology Bioscience, AstraZeneca Corinne Reimer PhD is the Director of Oncology in Vivo Biosciences at AstraZeneca’s early oncology research site located in Waltham MA. Corinne leads a team of 30 drug discovery research scientists supporting in vivo pharmacology and molecular pathology to support the development of new oncology therapeutics for many different cancer types including leukemia, lymphoma, lung and breast cancers. Corinne is passionate about improving the translation and predictability of preclinical data by developing and using disease models of cancer that closely resemble the patients’ clinical disease. She draws from her experience playing and coaching team sports (swimming and ice hockey) to build talented and successful teams of research scientists, known for their ability to master the most complex aspects of in vivo disease modeling and pharmacology studies.

Corinne holds a PhD in Anatomy and Developmental Biology from the University of British Columbia Canada and moved to Boston for her postdoctoral studies at Harvard Medical School, where her career in cancer research began. She has over 20 years industry experience in oncology drug discovery, at 3 companies. During her free time, she keeps herself busy renovating her colonial style house and playing the guitar and violin.

Jeremy Roach, PhD, Senior Research Investigator, Chemistry, Incyte Corporation Jeremy Roach is an organic chemist and a Senior Research Investigator at Incyte. He graduated from the University of North Carolina with a bachelor of science degree in chemistry and mathematics, and earned a PhD from The Scripps Research Institute. As a graduate researcher, he designed and synthesized a new analog of salvinorin, a non-addictive, painkilling, and psychoactive opioid. He counts cooking, baking, dog training, rock climbing, chess, sports, and listening to podcasts among his myriad hobbies and interests.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 22 Website: www.icpdprograms.org Brooke Rock, PhD, Director Pre-clinical, Amgen Brooke Rock PhD is a Director in the Pharmacokinetics and Drug Metabolism at Amgen Inc. Brooke received her PhD degree from University of Washington, School of Pharmacy in medicinal chemistry. Her research has focused on in vitro-in vivo drug metabolism, enzymology, in silico kinetic modeling, clinical DDI predictions and pharmacokinetics.

Dan Rock, Scientific AVP, Pharmacokinetics, Merck Insert Dan’s bio here

Astrid Reufli-Brasse, PhD, Vice President Tumor Biology, Pfizer Dr. Astrid Ruefli-Brasse is currently Vice President of Tumor Biology, Oncology at Pfizer R&D where she leads a large team focused on early target identification, validation and drug discovery. Prior to joining Pfizer, Astrid was the Vice President and Head of Discovery and Translational Research at 23andme. In this capacity, she led all target identification and pre-clinical drug discovery activities through IND filing for 23andMe Therapeutics research projects. During her three-year tenure at 23andMe, she grew the Therapeutics division from 35 employees to over 100, delivering two immune-oncology programs from target identification to early development. She also served as Company Chair of the Joint Research Committee on the strategic collaboration between 23andMe and GlaxoSmithKline, providing strategic and operational leadership for the joint scientific team focused on target and drug discovery through IND filings.

From 2015-2018, Astrid was the Senior Group Leader of Molecular Targeted Therapy at F. Hoffman-La Roche, where she was a member of the Pharma Research and Early Development (pRED) Discovery Oncology extended leadership team led. There she led collaborative efforts across pRED core functions such as medicinal chemistry, pharmaceutical sciences and bioinformatics, focused on driving forward small molecule cancer immunotherapy and molecular targeted oncology programs, including targets for a degrader platform. Prior to her time at F. Hoffman-La Roche, Astrid was with Amgen Inc., which she joined in 2004, advancing to a Principal Scientist position in 2010. In this role, she led a target discovery work force consisting of PhD level scientists from Oncology, Lead Discovery, and Bioinformatics to vet and bring forward proposals for new platform-based approaches to oncology drug discovery.

Astrid completed her postdoctoral fellowship at Genentech with Vishva Dixit following a PhD at the Peter MacCallum Cancer Institute in 2001 with Ricky Johnstone and Mark Smyth, where her research focused on the role of the multi-drug resistance protein, P-glycoprotein in regulating cell death induced by chemotherapeutic drugs. She holds a B.A. from the University of Rochester and spent a year in the United States Peace Corps in the Islamic Republic of Mauritania, where she collaborated with the World Health Organization supporting programs for the eradication of Dracunculiasis (guinea worm) and childhood vaccinations. Astrid holds four patents, has authored more than 25 scientific publications, and is a member of the American Association of Cancer Research and Healthcare Businesswomen’s Association.

Astrid is an outdoor enthusiast and loves swimming, biking and hiking, and especially enjoys traveling with her husband, Daniel, and two children, Mayah (17yrs old) and Sophie (13yrs old). In her spare time, Astrid also enjoys volunteering at her local schools to support STEM initiatives and at community foodbanks, especially during the pandemic when need is so great.

Puja Sapras, PhD, VP Discovery, Tumor Targeted Delivery, AstraZeneca Puja Sapra, PhD is the Vice President, Tumor Targeted Delivery, in the Oncology Research and Development at AstraZeneca. In this role, she leads the group responsible for tumor-targeting technology platforms, including Antibody-drug conjugates (ADCs), nanoparticles, radioimmunoconjugates and Oncolytic viruses. She manages the extensive portfolio on tumor targeting candidates from target conception to clinic. Prior to joining AstraZeneca, she was the VP and CSO at Pfizer Inc., where her contributions help build industry leading platforms and a diversified pipeline in the tumor-targeted arena. Prior to joining Pfizer, Dr. Sapra led Pharmacology groups at Enzon Pharmaceuticals, NJ and Immunomedics Inc. NJ and developed several oncology-based targeted therapeutics.

Puja has broad expertise in tumor-targeting strategies and biotherapeutics including immunotherapeutics, liposomal drug delivery system, nanoparticles, antisense oligonucleotide delivery and pegylation technologies. She is a well-recognized expert in the targeted therapeutics, especially in the ADC arena and has given numerous lectures at national and international meetings. She had

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 23 Website: www.icpdprograms.org notable success in the ADC arena and contributed to two approved agents including Mylotarg and Besponsa, while developing platforms and progressing several ADCs in clinic.

Puja received her Bachelor’s degree from the premier medical college of India, All India Institute of Medical Sciences. She was one of the two Indians selected to be awarded the prestigious British Chevening scholarship. She received PhD in Pharmacology from University of Alberta. Puja is an author of >50 scientific publications, book chapters and inventor/ co-inventor on >25 patents. She is a member of several scientific and medical societies including American Association for Cancer Research and also serves as the Deputy Editor of Molecular Cancer Therapeutics. In 2017, she was recognized as Healthcare Business Women Association Rising Star.

Gopi Shankar, PhD, MBA, FAAPS, Vice President Biologics Development, Janssen R&D Gopi Shankar, M.S., PhD, MBA, FAAPS, is Vice President and Head of Biologics Development Sciences (BDS) within Janssen BioTherapeutics (JBIO), Janssen Research & Development (JRD). He leads a global team of scientists who contribute to scientific and operational deliverables across the areas of biophysics, translational pharmacology and model-guided drug design, and bioanalytical sciences. He is based in Spring House, PA.

Gopi earned an M.S. in Molecular Biology from Oklahoma State University, a PhD in Immunology from University of Kentucky, a Certificate in Biomedical Regulatory Affairs from the University of Washington, and an MBA in Leadership and General Management from Drexel University. Following a post-doctoral tenure, he managed Quality Control & Immune Monitoring at Northwest Biotherapeutics (Seattle, WA) from 1999 to 2002. He then joined Centocor as a Senior Research Scientist overseeing clinical immunogenicity. Subsequently he assumed progressively greater responsibilities for immunogenicity and the bioanalytical laboratory, supporting biologics development at JRD - from preclinical through post-market studies.

A world-renowned expert in the field of immunogenicity, Gopi has published in the areas of basic immunological research and technical, strategic and regulatory best practices. He has led or contributed to several highly cited articles on immunogenicity, including 6 industry whitepapers and a chapter in the United States Pharmacopeia.

During his career, Gopi has focused on the development of fit-for-purpose solutions to scientific problems. He has also built consensus for and harmonized scientific practices within drug development, many of which have been adopted by regulatory agencies in their public scientific guidance documents. These approaches include anti-drug antibody detection methods development and validation, resolution of assay interferences to improve accuracy, quality control of bioanalytical reagents, and the establishment of terminology and analytical approaches for clinical immunogenicity. His research, consensus-building efforts and best-practice publications, both independently and via AAPS, have transformed the thinking and tactical processes related to immunogenicity around the globe.

For his contributions to pharmaceutical science, the American Association of Pharmaceutical Scientists (AAPS) conferred Fellow status to him in 2015. In 2019 he was elected as a Member-at-Large to serve on the AAPS Board of Directors.

Hilary Sheevers, PhD, Global Head NonClinical Submission - DPDS, Janssen Research & Development Hilary Sheevers currently is Global Submissions head at Janssen. She received her PhD in Pharmacology and Toxicology from the University of Arizona in 1994. Hilary joined the FDA in 1995, where she was a reviewer and then a supervisor in the Center for Drugs. After FDA, Hilary was an active consultant in drug development across indications, for both small and large molecules. She co-founded the women-owned and diverse consulting firm Aclairo in 2001, which she presided over as president or executive vice president for 16 years. Some of her most compelling projects included drugs for rare diseases including Dravet Syndrome, Huntington’s Disease and sickle cell anemia, and break through drugs in the areas of pulmonary, oncology and neuropharmacology. In 2016, Aclairo was sold to EPL, Inc. an employee-owned company specializing in veterinary pathology. Hilary retired from EPL, Inc. in May 2020, and continues to actively work in the drug development arena at Janssen. She remains an active member of the Society of Toxicology and the American College of Toxicology, where she has organized many sessions and presentations.

John Shirley, MBA, Director, Pfizer John Shirley is a director in Pfizer’s Worldwide Research Development & Medical (WRDM) division. Prior to spending the last 15 years in a drug portfolio management role, John identified clinical candidates for asthma and other inflammatory diseases as a Research Biologist and provided IT support for research teams at Pfizer. Before joining Pfizer in 1985, he spent 3 years as a Research Assistant at the University of Connecticut Health Center in Farmington, CT. John graduated from Trinity College in Hartford, CT in 1982 and earned his MBA from UConn in 2001.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 24 Website: www.icpdprograms.org Angus Sinclair, PhD, VP of Immuno-Oncology, IGM Biosciences Angus Sinclair PhD is the Vice President Immuno-oncology Research at IGM Biosciences Inc with over 19 years experience in the biotech industry. Prior to joining IGM Biosciences, Angus was the Senior Director of Oncology at Northern Biologics Inc, Toronto, Canada, and a Scientific Director of Oncology at Amgen. During his tenure in biotech, Angus progressed multiple antibody-based and small molecule therapeutics through preclinical research and development to the clinic. Before joining Amgen, Angus held several academic positions at UT Southwestern Medical Center, Texas; University of Cambridge, UK and UCSD, California.

Susan Smith, PhD, Senior Director, Translational Sciences, Incyte Corporation Susan Smith, PhD is an immunologist and translational scientist. She received her PhD in immunology from The University of Pennsylvania in Philadelphia and continued her training with a fellowship at the Max-Planck Institute of Immunobiology in Freiberg, Germany and a postdoc appointment Duke University Medical School in Durham, NC. Sue’s adventure in industry started in 2011, where she contributed to drug discovery efforts focused on novel treatments for inflammatory skin disease. She joined Incyte’s Translational Sciences team in December of 2020 and is loving every minute! Sue likes to be out in nature, travel just about anywhere (when there isn’t a pandemic going on), and spend time with her family. She is passionate about developing people and teams, and is usually working to grow herself as well. Sue has taken on several formal mentoring and coaching roles in addition to her various industry positions and is an avid reader on leadership, personal growth and poetry.

Michael Southhall, PhD, Director, Preclinical Strategy, Medical and Clinical Sciences, Johnson & Johnson Consumer Healthcare Michael has been with Johnson & Johnson since January 2002. During that time he has lead both preclinical and clinical research groups at Johnson & Johnson Consumer Companies ranging from development of consumer products, 510K medical devices, and dermatological drug candidates. In his current role as Research Director Pre-Clinical Strategy, Medical & Clinical Sciences at Johnson & Johnson Consumer Health he is responsible for bringing thought leadership and novel solutions that can help build new research models and scientific approaches to bridge our pre-clinical safety/tox and clinical body of knowledge with Real World Evidence. Prior to J&J, Michael spent 3 years in the biotech sector at Telios Pharmaceuticals in the department of protein chemistry focused on developing Integrin based peptides for healing diabetic stasis ulcers. He is the recipient of three Johnson Medals, the highest research recognition at Johnson and Johnson. He has authored over 60 peer-reviewed papers and book chapters on skin biology, and skin measurements and is an inventor on over 80 patents or patent applications. He is a Scientific Expert on the U.S. Technical Advisory Group for the American National Standards Institute and a member of the ISO technical committee TC217 WG4 and is a fellow in the American Academy of Dermatology.

Michael received his Bachelor of Science in Microbiology from the University of California, San Diego and his doctorate in Pharmacology & Toxicology from Indiana University School of Medicine. He was a postdoctoral fellow at Department of Dermatology, Indiana University School of Medicine where he completed a fellowship conducting research on psoriasis, eczema, and other inflammatory skin conditions.

Elena Spencer, Chief of Staff & Patient Engagement Lead, Inflammation and Immunology Research Unit, Pfizer Elena Spencer is Chief of Staff to the Chief Scientific Officer for the Inflammation & Immunology Research Unit at Pfizer in Cambridge, MA. She received her B.S. and M.S. degrees in Cellular & Molecular Biology from the University of Michigan, Ann Arbor, and her M.B.A. at the University of Massachusetts, Amherst. After 15 years as a bench scientist she made the pivot to R&D Strategy & Operations in 2016 where she has pursued roles of increasing responsibility culminating in her present role as Chief of Staff. Elena is also co-founder, President and CEO of Kendall Square Orchestra, a community organization that seeks to connect science and technology professionals through music to spark innovation and support causes related to healthcare, education & inclusivity. Elena serves on the advisory board for Boston, MA, based WEST (Women in the Enterprise of Science & Technology), and through this organization has received the “Woman of the Future” award (2018) “Making a Difference in the Community” award (2020). Originally from Detroit, Elena now resides in Hudson, MA, with her two school-age kids and dog and enjoys playing violin, cooking and spending time with friends and family.

Steven Stein, MD, EVP & Chief Medical Officer, Incyte Corporation Steven H. Stein, MD is the Chief Medical Officer at Incyte Corporation. In this role, his primary responsibility is leading all the medical and scientific activities involving clinical development, clinical operations, pharmacovigilance, clinical pharmacology, scientific communications and medical affairs at Incyte

Steven previously worked at Novartis Oncology as the Senior Vice President and Head of U.S. Clinical Development and Medical Affairs and prior to that at GlaxoSmithKline as Vice President, Global Oncology, Clinical Development and also as Head of Medicines Development for Hematology and Supportive Care.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 25 Website: www.icpdprograms.org Steven earned his MBBCH from the University of Witwatersrand in Johannesburg, South Africa. He has authored more than 100 scientific papers and presentations and is an Adjunct Assistant Professor in the School of Medicine, University of Pennsylvania. Steven is also an active member of several professional and scientific societies and academic committees.

Jesse Sullivan, PhD, Director Manufacturing, Amgen Jesse Sullivan (Director Manufacturing) was born and raised on Long Island, New York. He has a B.S. in Chemical Engineering from the Northeastern University in Boston and a PhD in Chemical and Biomolecular Engineering from the University of Notre Dame. He lives in the Thousand Oaks with his wife, daughter, and two boys. Most weekends he spends time with his family doing outdoor activities, watching The Simpsons, or supporting their favorite sports teams (Go Irish!).

Lynne Szczepania., Vice-president, Regulatory Affairs, Johnson & Johnson Consumer Healthcare Lynne Szczepaniak is Global Vice President and Head of Consumer Health Regulatory Affairs at Johnson & Johnson. Lynne leads an organization of more than 250 staff with responsibility for J&J’s Consumer products that are sold in more than 150 countries. The portfolio includes well-known OTC medicines such as Tylenol®, Motrin® and Benedryl®, Oral Care products including Listerine®, and a wide range of Consumer Products such as Aveeno® and Neutrogena®. Under Lynne’s leadership, the J&J Consumer regulatory team provides strategic and operational support across the product life-cycle, providing input to the innovation portfolio, development planning, and post- market activities ensuring that patients and consumers have access to safe and effective products that meet their diverse needs. Lynne’s career also encompasses clinical and regulatory responsibility for prescription medicines including the development of medicines for chronic diseases where she and her team focused on developing a deep understanding of patient behavior and uncovering insights that guided study design and communication to patients and health care professionals. This included the first medicine for the prevention and treatment of osteoporosis and the clinical development program that demonstrated the value of triple antibiotic therapy to eradicate H. pylori and prevent the recurrence of peptic ulcer disease. Lynne has four children together with her husband Don, all of whom like to spend time outdoors biking, skiing and hiking.

Lamont Terrell, PhD, Inclusion and Diversity Lead, GSK Lamont Terrell graduated salutatorian from Texas Southern University as a Fredrick Douglas honor scholar earning a B.S degree in chemistry in 1995. While at TSU, his life as a research scientist began doing undergraduate research focusing on the synthesis of inorganic compounds with environmental applications. He earned his PhD in 2001 in organic chemistry from Michigan State. His graduate studies consisted of the total synthesis of the antiluekemic natural product amphidinolide A and the development of catalytic tin hydride reactions. Upon completion of his graduate studies at MSU, he continued his synthetic training with a two-year postdoctoral stint at Stanford University. The focus of his postdoctoral studies was the development of a catalytic dinuclear zinc asymmetric Mannich reaction. He began his career in drug discovery as a medicinal chemist at GlaxoSmithKline in 2003 in their cardiovascular medicinal chemistry group. He spent 11 years doing small molecule lead optimization primarily focusing on cardiovascular disease targets. In 2014, Lamont joined the Flexible Discovery Unit Medicinal Chemistry Center of Excellence as a Team Leader to support late-stage high priority projects in reaching their drug discovery milestones. Throughout his career at GSK, he has been recognized for his scientific contribution and was awarded an Excellent Scientific Award on three occasions.

Outside of leading science, Lamont is passionately involved with community and outreach efforts. He has been involved with the recruitment of scientists at all levels into the chemistry community. He led the GSK chemistry recruitment team for minority conferences and served as the lead for the African American Alliance employee resource group in the Delaware Valley. This passion lead to a career pivot and eventually to his role as the Inclusion and Diversity Lead for Pharma R&D. He is responsible for developing and implementing the Inclusion & Diversity strategy for the global business.

Oliver Thiel, PhD, Executive Director Process Development, Amgen Oliver R. Thiel is the Executive Director for Drug Substance Technologies, Pivotal and Commercial Synthetics. He is located at the Amgen site in Cambridge, MA and his teams in Cambridge, MA and Thousand Oaks, CA support the commercial process development and commercialization of the Amgen small molecule portfolio. Oliver joined Amgen in 2003 and has held various positions in Process Development at Amgen, Thousand Oaks and Cambridge. Prior to his current role he has held various Director roles in Process Development, Drug Substance Technologies. His team have been accountable for commercial process development, technology transfers and commercial support across synthetic and biologic modalities. His teams supported multiple commercial products (Blincyto®, Carfilzomib®, Corlanor®, Imlygic®, Kanjinti®, Neulasta®, Parsabiv®, Sensipar®) and > 40 clinical development candidates. Oliver has an undergraduate degree in Chemistry from the Technical University Munich, and he completed a PhD from the Max- Planck-Institut für Kohlenforschung, Mülheim an der Ruhr. After postdoctoral studies at Stanford University he joined the Amgen Process Development organization. He also holds a business degree from the Fernuniversität Hagen.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 26 Website: www.icpdprograms.org Oliver has over 50 peer-reviewed publications and has presented over 20 invited lectures. Oliver has been engaged in external consortia (IQ, PhRMA and EFPIA) and currently is a member of the ICH M7 expert working group. In his free time enjoys spending time with his family (2 daughters) and being active outside (road biking, running).

Julie Thomas, PharmD, Senior Director, Scientific Communications, Janssen Pharmaceuticals Julie Thomas is currently the Senior Director of the Immunology Scientific Communications Department within Janssen Scientific Affairs. In this role, Julie oversees the execution of publications, including scientific meeting abstracts, posters, presentations, and manuscripts, based on results from clinical trials in rheumatology, dermatology, and gastroenterology.

Julie started her Johnson & Johnson journey in 2000 as a Medical Information Specialist supporting the immunology and cardiovascular therapeutic areas. After 6 years in Medical Information, Julie transitioned to different types of publication-related roles in the Medical Affairs Writing Group.

Julie earned a BSc Pharmacy degree from the University of Toronto, Toronto, ON, Canada and a Pharm D degree from Albany College of Pharmacy, Albany, New York. She completed a Pharmacy Practice Residency at St. Joseph’s Hospital, Hamilton, ON, Canada and a Drug Information/Investigational Drug Research Specialty Residency at Thomas Jefferson University Hospital, Philadelphia, PA.

In her free time, Julie enjoys relaxing with her family, travelling, exercising, and cooking (especially baking!).

Alejandro Toro, PhD, Executive Director Process Development, Amgen Manufacturing Limited Born and raised in Puerto Rico, Alejandro graduated with a chemistry degree from the Pontifical Catholic University of Puerto Rico. Alejandro later obtained a PhD in biological chemistry from the Chemistry Department at Rutgers University in New Jersey. His research focused on the study of structure/function relationships in bacterial signal transduction proteins as targets for the development of anti-microbial agents.

In 2005 Alejandro moved to work as a downstream scientist in the Process Development (PD) department at AML. Over the last 15 years he has held positions of increased responsibility within the organization. Alejandro is currently the Executive Director of Drug Substance Process Development, responsible for the site's Process Sciences, Attribute Sciences, Process Engineering (MS&T), Process Validation and Data Science & Analytics teams.

Alejandro’s most fulfilling aspect of his career at Amgen has been helping develop teams and mentoring staff. As such, he has been involved in Amgen initiatives in support of talent and staff development including the FUEL Early Talents Rotational and University Relations programs, SMDP, as well as participation in diversity Employee Resource Groups as a member of WE2 (Women Empowered to Excel).

During his free time Alejandro enjoys listening to music and playing guitar. He also likes sports, consumer technology and spending time with his wife and three daughters.

Nikola Trbovic, PhD, Partner, Pfizer Ventures Nikola Trbovic, PhD is a Partner at Pfizer Ventures, the venture capital arm of Pfizer Inc. Nikola is responsible for identifying, evaluating, making and managing equity investments aligned with the future directions of Pfizer. He currently has responsibility for Pfizer’s investments in Arrakis, Artios, Cydan, Jnana, Lodo, Mediar, Nimbus, Palleon, TRex, and Triplet.

Prior to his current role, Nikola held responsibilities for R&D technology investments, R&D strategy and early clinical portfolio management in Worldwide Research & Development at Pfizer. Nikola joined Pfizer from McKinsey Co., where he served as an Associate Principal and senior member of the Pharmaceuticals Practice, advising top pharmaceutical, biotech, and healthcare companies on a range of strategy, corporate finance and commercial topics across geographies and therapeutic areas.

Nikola received a BS in Biochemistry from the University of Frankfurt, Germany, and holds a PhD in Biochemistry and Molecular Biophysics from Columbia University.

Nikola grew up in Serbia and Germany before moving to the United States. He lives in the suburbs of NYC with his wife and two children.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 27 Website: www.icpdprograms.org David (Viv) Tyndall, PhD, Senior Director, Global Research & Development, Johnson & Johnson Consumer Healthcare Viv Tyndall is Senior Director of R&D for Selfcare in the Johnson and Johnson Consumer company. He is originally from Ireland, where he competed all his formal education. A Pharmacist by training, Viv completed his PhD in Pharmaceutical Chemistry and worked in a number of Pharmaceutical companies in Ireland, in Manufacturing, Quality Assurance and R&D before moving to the US almost 20 years ago. Since his time in the US, he worked for Oral-B/ Proctor and Gamble, where he led teams exploring novel technologies in the Oral Care space, from novel scientific approaches in non-peroxide tooth whitening, to combination device/chemistry solutions for treatment of gingivitis. He later joined Johnson & Johnson Consumer Company and continued his R&D leadership across multiple therapeutic areas, leading upstream innovation, breakthrough discovery and product development teams in areas including Oral Care (Listerine), Therapeutical Hair regrowth (Rogaine) and Intimate Health (KY). For the past few years, Viv has led a team of scientists (incl PhD) and leaders in the areas of Pain Care, supporting scientific advancement and product development for our OTC pharmaceutical brands including Tylenol/Motrin. Viv also has considerable knowledge of Clinical affairs and Regulatory affairs and is passionate about finding new, innovative, science-based solutions for the millions of consumer and patients who use our products. However, his greatest passion is helping to develop our scientists and create meaningful careers, so he’s excited to be involved in the SMDP program.

Narayan Variankaval, PhD, Exec. Dir, Analytical R&D, Merck Narayan Variankaval, PhD is currently an Executive Director in Analytical R&D (AR&D) at Merck Research Labs in Rahway, NJ. In this role he is responsible for the strategy and leadership of the small molecule API analytical development function within AR&D from preclinical candidate selection to launch. This includes oversight of all development activities for small molecules, synthetic peptides, oligonucleotides, novel excipients and small molecule adjuvants used in vaccines in the development of innovative assays and methods, validation, stability studies, in-process testing, technical transfer to commercial sites/vendors/CMOs, authoring regulatory dossiers including INDs and NDAs.

Prior to this Narayan was a Director and Head of the Molecular and Materials Characterization group responsible for salt and polymorph screening, crystallization process development support and solid-state characterization for all early stage Merck compounds. He spent four years in the Pharmaceutical Sciences organization as a member of the Materials Characterization and Technology Assessment group involved in the development of amorphous solid dispersions and as a result of this effort garnered the Merck Research Labs Divisional Award in 2012 for leading the development of amorphous formulations at Merck. During this time he also led the formulation development of Belsomra. Narayan’s journey at Merck started in the Physical Measurements team where he gained significant experience in physical form and attributes-selection for drug molecules from discovery to late-stage. He earned an MS and PhD in Polymer Science and Engineering at the Georgia Institute of Technology where he was a Molecular Design Institute Fellow through the Office of Naval Research. Narayan has presented as invited lecturer at over 15 conferences, has published over 30 peer reviewed journal articles, 2 book chapters and is co-inventor on 7 patents including one as a lead inventor on solid dispersion formulations for Suvorexant. His publications include the first work on co-crystals that demonstrated an in-vivo bioavailability advantage and was profiled in C&E News. Narayan has served in the past as Chair of the Analytical Leadership Group of the IQ Consortium (2016/2017), was Co-Chair of the Gordon Conference on Preclinical Form and Formulation (2017) and currently on the Organizing Committee of the Land O’ Lakes Conference on Pharmaceutical Analysis.

Raghavan Venkat, PhD, Vice President, BPD, AstraZeneca Raghavan Venkat (Venkat in short) leads the Cell Culture and Fermentation Sciences team, Bioprocess technologies and engineering team, as well as the Flu MS&T team within Biopharmaceutical Development (BPD) at AstraZeneca. Venkat obtained his B. Tech. degree in Chemical Engineering at Anna University, Chennai, India and his M.S. and PhD degrees in Chemical Engineering at The Ohio State University, in the US. Venkat has worked in the biopharmaceutical industry for 25 years and has been with MedImmune / AstraZeneca for 14+ years.

Venkat’ s expertise is in the field of biopharmaceutical development with an emphasis on protein expression, cell biology and scale- up of biologics production processes. Venkat is a strong believer that production platforms are a competitive advantage and can enable most efficient product development. At MedImmune / AstraZeneca, he has led the development of industry leading cell culture production technologies, especially for production of monoclonal antibodies. In addition to leading functional teams, Venkat also leads efforts within BPD for advancing new process platforms for pDNA, mRNA, AAV and cell therapy, as well as cross functional product teams. Venkat is passionate in development and mentoring of scientists and helping young scientists unlock their potential.

Venkat is very active in the biotechnology research community and has chaired and presented at multiple international meetings and authored many publications. Most recently, Venkat chaired the ECI-Cell Culture Engineering Meeting in Tampa, FL, in May 2018. Venkat is very active in promoting STEM within the community and is the President and Board Member of Science Montgomery, which is a community organization dedicated to the cause of STEM education.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 28 Website: www.icpdprograms.org

Min Wan, PhD, Senior Principal Scientist, Pfizer Min Wan, PhD is a leader and expert on metabolic syndrome and rare diseases, currently leading preclinical programs for treating NASH and obesity. Had led small molecular programs, as well as biologics (peptides). Had led efforts to identify and validate drug targets for treating metabolic syndrome, manage external collaborations and build a CRISPR platform. Over a decade of experience in liver diseases, metabolic pathways, in vivo pharmacology and animal model generation. Has led projects through all pre-clinical stages, and contributed to advancing programs to later stages of drug discovery.

Frank Wiegand, MD, PhD, Vice President, GMAF NS, Janssen Global Medical Affairs Frank Wiegand is Head of Neurosciences Global Medical Affairs team and a member of the Neuroscience Therapeutic Area Senior Leadership Team, which sets the R&D strategy and manages the compound portfolio in the areas of Schizophrenia, Mood Disorders and Neurodegeneration.

His department is responsible for the generation of integrated global medical affairs strategies and the development of robust, efficient global data generation and publication plans which are proactively designed to meet prioritized regional and local market needs. The Global Medical Affairs team represents the medical affairs community on the compound development teams and collaborates closely with the R&D organization, the Strategic Marketing Team and the Market Access functions within Neuroscience and the Medical Affairs affiliates across all regions and countries worldwide.

Frank joined Johnson & Johnson in Germany in the year 2000 as Product Director Neurology, responsible for the marketing of Topiramate and later on Risperidone. In 2003, he moved to the US and was appointed Director Global Medical Marketing Neurology within PGSM, where he spearheaded the development and implementation of a Global Medical Affairs review process for phase IIIb/IV trials and investigator initiated trials and led the global medical affairs team for Topamax and Galantamine. Subsequently Frank worked as Director Clinical Development within the US medical affairs team for 3 years before he became Global Medical Affairs Leader Neurology in 2007.

Since 2010 Frank leads the Neuroscience Global Medical Affairs Team within J&J Pharmaceutical Services L.L.C. From 2015-2017 Frank also oversaw the Neuroscience Global Market Access team and from 2017-2018 he was assigned to be Country Medical Affairs Director in the UK, where he oversaw >70 employees in Medical Affairs, Regulatory, Quality and Pharmacovigilance and was member of the UK executive board.

Before joining Johnson & Johnson, Frank served as Neurologist at the University of Essen, Germany. He received his PhD and M.D. from the University of Düsseldorf, Germany. He also holds a Postgraduate Certificate of Business Administration from the Herriot Watt University in Edinburgh, Scotland.

Mark Wildgust, PhD, Vice President, GMAF Onc, Janssen Global Medical Affairs Mark Wildgust has spent more than 20 years in the pharmaceutical industry working primarily in oncology, hematology and virology. He completed his undergraduate degree in Biological Sciences at the University of Plymouth, UK, and his PhD in Trace Metal Toxicology at the University of Manchester, UK. He then spent a short time as a post-doctoral researcher at the University of Maryland in the United States. After leaving academia, Mark worked for Bristol Myers Squibb and Pfizer before joining the Janssen Pharmaceutical Companies of Johnson & Johnson. Mark has now been with Janssen for 15 years.

During Mark’s career, he has predominantly spent time in medical affairs leading and supporting the medical strategy for a variety of compounds, including the launch of many blockbuster therapies like IMBRUVICA® and DARZALEX®. Currently, Mark serves as the Vice President of Oncology Global Medical Affairs, Janssen, where he leads a team of scientists and physicians supporting the development of new oncology and hematology therapies. This robust portfolio includes breakthrough therapies for lung cancer, hematologic malignancies, prostate cancer and bladder cancer, and spans novel mechanisms, CAR-Ts and bispecific antibodies. Mark is a 2018 PharmaVOICE 100 awardee, recognized as a Change Agent in Global Medical Affairs and a leading voice in shaping this important function in evidence generation and evidence communications.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 29 Website: www.icpdprograms.org Anita Ziboh, PhD, Principal Medical Science Liaison, Janssen Pharmaceuticals Anita Ziboh PhD received her Bachelor of Science in Biochemistry from California State University, Chico, and her Doctor of Pharmacy degree from the University of the Pacific, Stockton, California. Her post graduate training included Pharmacy Practice Residency training from the University of Colorado, in Denver, Colorado and Postgraduate Certification in Pharmaceutical Economics. She also received her Board Certification as a Pharmacotherapy Specialist during this time.

Anita spent the early part of her career as a Clinical Pharmacy Specialist in Ambulatory Care, for the department of defense and for Kaiser, Permanente in Denver, Colorado. Then, her introduction into the Pharmaceutical Industry was in the role of Clinical Education Consultant (CEC) with Pfizer Pharmaceuticals. In this role, she worked with Population Health Decision Makers to identify and implement projects focused on improving the outcomes in targeted patient populations and therapeutic areas. Also, during this time, she developed and served as a primary preceptor for a collaborative Fellowship program with Florida A&M University School of Pharmacy and CIGNA Healthcare in Managed Care and Pharmacoeconomics.

Currently, Anita is a Principal Medical Science Liaison (MSL) for the Cardiovascular Metabolic Team of Janssen Pharmaceuticals. Her prior roles at Janssen, include Medical Project Scientist (MPS), which was a hybrid Home office and field facing role, in which she led multiple Medical Affairs activities that helped to execute the field launch readiness for Invokana, including management of pre- clinical study protocols, development and execution of Advisory Boards and manuscript generation.

Virtual SMDP Biotech Training Session, June 14-15, 2021 Page 30 Website: www.icpdprograms.org