The rapid acceleration in R&D on a new Covid-19 pipeline has been met with a fast response by the FDA. This has changed the rules around drug development, allowing biopharmas to significantly advance their pipeline projects. We’ll talk to experts about what’s changing, what’s likely to stick and the long term implications for the industry.
Roy Baynes is Senior Vice President Global Clinical Development and Chief Medical Officer at Merck Research Laboratories in Rahway, New Jersey. He was previously Senior Vice President of Oncology, Inflammation and Respiratory Therapeutics at Gilead Sciences and prior to that was Vice President Global Clinical Development and Therapeutic Area (TA) Head for Hematology / Oncology, at Amgen Inc. In the early years of his tenure at Amgen before becoming TA head of Hematology / Oncology in Clinical Development he was TA head for Hematology / Oncology in Global Medical Affairs.
He graduated as a Medical Doctor and obtained a Master of Medicine and Doctor of Philosophy from the University of the Witwatersrand, Johannesburg, South Africa. He has had a long and distinguished career in the haematology-oncology-and stem cell transplantation fields, including drug development, basic research, clinical practice, clinical research, teaching and administration. He is a member of many international societies, including the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO), and has authored some 150 publications. He has been recurrently named among America’s top physicians. Before joining Amgen in 2002, he was the Charles Martin Professor of Cancer Research at the Barbara Ann Karmanos Cancer Institute, an NCI designated Comprehensive Cancer Center, at Wayne State University, Detroit, Michigan, USA.
Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest. Before founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute.
From 2002-2004 Peter was FDA's Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised the FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency's obesity working group and counterfeit drug taskforce.
His book, Become Strategic or Die, is widely recognized as a cutting edge study of how leadership, to be successful over the long term, must be combined with strategic vision and ethical practice. He is the editor of the book, Coincidence or Crisis, a discussion of global prescription medicine counterfeiting. His latest book is Common Sense Healthcare Policy for Common Sense Americans (Cognito Press, August 2019)
Mr. Pitts currently serves as a Visiting Professor at the University of Paris School of Medicine.
Samit Hirawat, M.D., joined Bristol Myers Squibb in June 2019 as Chief Medical Officer, Global Drug Development.
Samit is a highly collaborative leader who brings extensive drug development experience to the role. Prior to joining Bristol Myers Squibb, Samit most recently served as Executive Vice President and Head of Oncology Global Development at Novartis. Samit also led clinical development programs in multiple indications at PTC Therapeutics and Pfizer/Pharmacia Corporation.
Samit received his Bachelor of Medicine and Bachelor of Surgery (M.B; B.S.) from the Sawai Man Singh Medical College in India, and completed his Internal Medicine Residency and Medical Oncology Training at North Shore University Hospital, New York. He is an author of several manuscripts and abstracts published in peer-reviewed journals and presented at major conferences. Samit is a recipient of several government grants, academic and corporate awards.
Rod MacKenzie, PhD, is Chief Development Officer and Executive Vice President for Pfizer. Rod leads the Global Product Development organization, which is responsible for the clinical development and advancement of Pfizer’s pipeline of innovative medicines. Rod joined Pfizer in Sandwich, UK as a Research Scientist and conducted medicinal chemistry research.
Prior to this role, Rod has held positions including Head of PharmaTherapeutics Research and Development, served as Site Director of the Groton, Connecticut laboratories, a series of research leadership positions, including Senior Vice President and Head of Worldwide Research, Head of Discovery Chemistry, Head of the Discovery Technology Center.
Rod graduated from the University of Glasgow with a 1st Class Honors degree in chemistry and completed his PhD at Imperial College, London. He was awarded a NATO Postdoctoral Research Fellowship and spent two years at Columbia University, New York working in the area of molecular recognition with Professor W.C. Still.
Liza C. O’Dowd, MD is Vice President Global Regulatory Affairs - Immunology, Regulatory Policy and Intelligence, and North America Liaison at Janssen Research & Development, LLC. Prior to joining Global Regulatory Affairs in 2015, she was the Vice President, Disease Area (DASL) and Clinical Leader for Pulmonary. Previously, she had a successful 13-year career at AstraZeneca with positions of increasing global responsibility in multiple Therapeutic Areas. Liza led the oversight of integrated global product strategies including global and U.S. regulatory submissions for inhaled small molecule therapeutics.
She is board-certified in Internal Medicine, Pulmonology and Critical Care Medicine, and completed a fellowship in Allergy and Immunology. Liza has a MS in Biostatistics and Epidemiology from the University of Pennsylvania, and a MD from the University of Pennsylvania.
Liza received her B.A. from Wellesley. She continues to hold the position of Adjunct Assistant Professor, Department of Medicine at the University of Pennsylvania.
Jeremy Chadwick, Ph.D., is SVP and Head of the Global Development Office at Takeda Pharmaceutical Company Ltd. and a member of the R&D Management Committee. In his role, he oversees Global Regulatory Affairs, Global Patient Safety Evaluation and Clinical Development Operations.
Prior to this role, Dr. Chadwick held positions including: Group VP Clinical Development Operations at Shire, VP Clinical Operations and Program Management at the Medicines Company; SVP regulatory affairs, quality, development operations, program management and drug safety at Synta Pharmaceuticals; VP Development Operations at Vertex Pharmaceuticals; COO Foliage Software and VP Biostatistics and Data Management at Parexel and roles in GlaxoSmithKline UK in biostatistics and data management.
Dr. Chadwick earned his Ph.D. and M.S. in statistics from the University of London and B.S. in mathematics from DeMontfort University, United Kingdom.
Alok is the Vice President of Life Sciences at Egnyte where he is responsible for building and executing the company's strategy for the life sciences market segment. Alok works across the organization to verticalize our marketing, sales, product, compliance, and account management practices for this domain. Before joining Egnyte, Alok was a YCombinator-backed entrepreneur and started two vertical software-as-a-service companies. He was honored with a 20 under 40 award by Endpoints News in 2018. Prior to his career in software, Alok spent over 15 years as a scientist: he took part in postdoctoral work at Harvard University with George Whitesides, and has published papers in Nature and Nature Chemistry. Alok holds a PhD from Northwestern University and BS from Cornell University.
John D. Carroll is a biotech analyst and writer with decades of prize-winning experience in journalism. A co-founder of Endpoints News, he has covered biopharma for the past 15 years. Aside from his previous daily industry coverage at FierceBiotech, where he was named editor in 2003, leaving in 2016, Carroll has been a regular speaker at biotech events around the globe. He’s been quoted by The New York Times, The New Yorker, Financial Times, The Times of London and more. He’s also keynoted at biotech gatherings around the world and addressed student audiences at MIT and Harvard.