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CHI's BioPharma Strategy Series' Phase III Clinical Trials Conference - Speaker Biographies

Declan Doogan, M.D., CMO, Amarin

Dr. Declan Doogan MD has been Chief Medical Officer at Amarin Corporation plc since August 2010. Dr. Doogan is a Venture Partner at Beacon Bioventures and joined it in October 2007. Dr. Doogan has been in pharmaceutical research and development for most of his professional life, starting first in the Netherlands as a Project Physician. Dr. Doogan has more than 30 years' experience of the global pharmaceuticals industry including more than 20 years with Pfizer. Dr. Doogan joined Amarin in 2007 as Head of R&D. He served as Chief Medical Officer and Executive Vice President of Prometheus Laboratories Inc. since September 2010. He joined Pfizer in 1982, where Dr. Doogan was In Charge of the sertraline(R) (Zoloft) clinical development program. He has held a number of senior positions in research and development in Pfizer in the United States, United Kingdom, and Japan, where he served as Medical Director and Head of its development organization. He served at Pfizer Global Research & Development until April 2007, where Dr. Doogan served as the Senior Vice President and Head of World Development. He served as the President of Research & Development of Amarin Corp.

PLC since April 10, 2007 and Interim Chief Executive Officer from 2009 to 2010. He has been Non-Executive Chairman at Spinifex Pharmaceuticals Pty Limited since December 2011. Dr. Doogan holds a number of non-executive directorships including Board Member of Sosei Group Corporation, Alimentary Health Limited, and Odyssey UK. He serves as External Director of Sosei Co. Ltd. Dr. Doogan served as a Director of Amarin Corp. Plc since December 19, 2007 until May 16, 2008. He holds a number of Board appointments principally in pharmaceutical research and development. Dr. Doogan is also involved in charities such as the Haitian Health Foundation, the Pulmonary Vascular Research Institute, and Odessey. He is Visiting Professor at Harvard School of Public Health, Glasgow University Medical School, and Kitasato University (Tokyo). He is a Fellow of the Royal College of Physicians and the Faculty of Pharmaceutical Medicine in the United Kingdom. Dr. Doogan received his Medical degree from Glasgow University in 1975.

Joga Gobburu, Ph.D., M.B.A., Professor, Schools of Pharmacy, Medicine; Executive Director, Institute for Translational Medicine, University of Maryland

Gobburu obtained a BPharm and an MSc in chemistry from the Birla Institute of Technology and Science in Pilani, India, in 1992. He earned a PhD in pharmaceutical sciences from North Dakota State University in 1996 and completed two postdoctoral fellowships, one at the University at Buffalo, the State University of New York; and another at the Center for Drug Development Science, Georgetown University in Washington, D.C., and the FDA. Most recently, he received an MBA from Johns Hopkins University.

He has received numerous FDA awards such as the Outstanding Achievement Award. In 2008, he received the Outstanding Leadership Award from the American Conference on Pharmacometrics and the Tanabe’s Young Investigator Award from the American College of Clinical Pharmacology. Gobburu is on the editorial boards of the journal Clinical Pharmacology & Therapeutics and the Journal of Clinical Pharmacology. He has published more than 60 papers and book chapters, and has directed the doctoral research of two graduate students and mentored 16 postdoctoral fellows. He is a frequent speaker at national and international scientific conferences.

Charles Knirsch, M.D., M.P.H., Vice President, Clinical Affairs Head, Specialty Therapeutics, Pfizer, Inc.

Charles Knirsch, MD, MPH is Vice President, NY Site Head, Clinical Research & Development, Pfizer Inc. and Adjunct Clinical Professor of Medicine, Columbia University. Chuck completed medical school at McGill University in Montreal, Canada and a Masters in Public Health at Columbia University. He completed residency and infectious diseases training at Columbia Presbyterian Medical Center, and post-doctoral fellowship training at The London School of Hygiene and Tropical Medicine.

Chuck has worked in the Public-Private-Partnership model to collaborate on a number of disease control programs. This has involved work on addressing information management for tuberculosis patient treatment protocols and hospital epidemiology in New York to more recent international private sector collaborations with The National Institutes of Health and The Centers for Disease Control and Prevention on malaria. Chuck currently works extensively with The World Health Organization and The International Trachoma Initiative on a program to eliminate blinding trachoma by the year 2020.
Chuck’s publications include many randomised controlled trials, the epidemiology of drug resistant tuberculosis, medical informatics applications in hospital epidemiology, molecular diagnostic tests, travel medicine and he is also co-author of the 4th and 5th Editions of the textbook Parasitic Diseases.

Michael Krams, M.D., Vice President, Research & Development; Head, Neurology Franchise, Johnson & Johnson

He is recognized as an expert in designing, implementing and executing adaptive designs, enabling real-time learning in Learn and Confirm studies. He has built an industry leading cross-functional team of drug developers, applying Modeling&Simulation techniques and integrating input from clinical, translational medicine, biostatistics, discovery and commercial. The emphasis is on applying innovative designs across therapeutic areas, including small molecules, vaccines and biologics.  Mike co-chairs clinical review committees and continuously challenges teams to apply scientific rigor to decision problems without losing sight of the business case.

As co-chair of PhRMA's working group on adaptive designs Mike has contributed to an ongoing debate with regulatory agencies, with a goal to establish a common position on "Good Adaptive Practices". A neurologist by training, Mike has a background in functional brain imaging and worked with Dick Passingham and Richard Frackowiak at the Wellcome Dept Cognitive Neurology in London.

Holly C. Kimko, Ph.D., Research Fellow, Johnson & Johnson Pharmaceutical Research & Development L.L.C.; author of “Clinical Trial Simulations

Holly H.C. Kimko, PhD is a senior pharmacometrics leader (Research Fellow) at the Department of Advanced Modeling & Simulation in Johnson & Johnson Pharmaceutical Research & Development, LLC, New Jersey, and Adjunct Professor in the faculty of the Pharmacy School of Rutgers University, New Jersey. She was previously Assistant Professor in the Center for Drug Development Science in Georgetown University Medical School, Washington DC. Trained in biochemistry and pharmacy, Dr. Kimko earned her Ph.D. degree in Pharmaceutical Science from the State University of New York, Buffalo. She has published key papers on indirect response modeling and applications of CTS, and co-edited Simulation for Designing Clinical Trials. Carl C. Peck, MDis Adjunct Professor, Center for Drug Development Science in the Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco, California. He was previously Director of the FDA Center for Drug Evaluation and Research, Assistant U.S. Surgeon General, and President of the American Society for Clinical Pharmacology and Therapeutics. Dr. Peck has also held professorial appointments in the faculties of UCSF, USUHS, and Georgetown University. He is an author of more than 150 original research papers, chapters and books concerning advanced concepts and techniques of quantitative pharmacology, trial designs, and pharmaco-statistical modeling and simulation.

Eric Olson, PhD, Vice President and Program Leader, Vertex Pharmaceuticals Incorporated

Eric Olson, PhD, is a Vice President and Program Leader at Vertex Pharmaceuticals Incorporated in Cambridge, MA, where he works on cystic fibrosis and antibiotic drug discovery and development programs. He co-leads the Vertex and the CF Foundation Therapeutics Joint Development Committee that provides oversight and strategy for development of two CF compounds: VX-770, a CFTR potentiator currently in Phase 2, and VX-809, a CFTR corrector currently in Phase 1. Prior to joining Vertex, he was at Warner-Lambert (now Pfizer) for 11 years and Upjohn Pharmaceuticals (now Pfizer) for six years, focusing on bacterial gene expression and new antibiotic discovery. His formal training is in Microbiology with a BS from the University of Minnesota, a PhD from the University of Michigan, and post-doctoral studies at McGill University.

Badri Rengarajan, M.D., Medical Director, Archimedes, Inc.

 At Archimdes, he is responsible for leading consulting engagements, providing clinical input to Model development efforts, and building relationships with clinical research leaders. Dr. Rengarajan has over ten years of healthcare industry experience including roles in product development strategy and new product planning, regulatory affairs, market research, and business development. Dr. Rengarajan was previously a director of business development and market research at Nodality (personalized/predictive medicine), regulatory team leader at Genentech, and an engagement manager at McKinsey. Dr. Rengarajan earned an A.B. in biology and public policy.

Doina Roman, M.D., Senior Medical Director, Translational Medicine Sciences, Takeda Global Research & Development, Inc.

Doina Roman, MD, is Senior Medical Director in Translational Medicine Sciences at Takeda Global Research & Development. In her role Dr. Roman leads and develops translational medicine and early clinical development strategies across multiple therapeutic areas utilizing relevant modalities such as biomarker driven development decision, modeling, imaging, emerging new technologies and statistical approaches. Before Joining Takeda Pharmaceuticals North America, Inc. Dr. Roman held several director positions at Pfizer Global Research and Development, most recently in the Clinical Development Group developing drugs in the pain and inflammation therapeutic areas. Prior to Pfizer she worked for Parke-Davis/ Warner Lambert, in the Clinical Pharmacology and Experimental Medicine Department. Dr. Roman is a graduate in Medicine from the Medical School University of Targu- Mures, Romania. Following training in Internal Medicine, she began her career in the pharmaceutical field at the Ohio State University, Clinical Pharmacology Department. In her career to date, Dr. Roman has a strong focus on translational medicine research by facilitating and improving drug development.

Stephen A. Williams, M.D., Ph.D., Chief Medical Officer, SomaLogic

Dr. Williams joined SomaLogic 2009 as Chief Medical Officer. Steve trained as a physician at Charing Cross and Westminster medical school, University of London, and following his internships returned to the same institution for a PhD in medicine and physiology. He subsequently performed 3 years residency in diagnostic imaging at the University of Newcastle Upon Tyne. He joined Pfizer in the UK in 1989 in Experimental Medicine, and worked on a variety of programs including asthma, irritable bowel syndrome, migraine [eletriptan], depression [sertraline] and urinary incontinence [darifenacin]. He moved to the USA in 1993 still at Pfizer and worked in inflammatory bowel disease, stroke, psychosis [ziprasidone] and head-injury. He created the Clinical Technology group in 1997, which became a worldwide function on 5 research sites with the objective of validating clinical biomarkers and measurements, and was made VP in 2006. In process initiatives, he led or co-led initiatives in diagnostics, biomarkers, quality of drug candidates and guidelines for development teams to make the decision to start phase III.

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