Mark McClellan, MD, PhD, is the Robert J. Margolis professor of business, medicine, and policy, and director of the Duke-Margolis Center for Health Policy at Duke University with offices at Duke and in Washington DC. In his roles of a doctor and an economist, his work has addressed a wide range of strategies and policy reforms to improve health care. Before coming to Duke, he served as a senior fellow in Economic Studies at the Brookings Institution, where he was director of the Health Care Innovation and Value Initiatives and led the Richard Merkin Initiative on Payment Reform and Clinical Leadership. He also has a highly distinguished record in public service and in academic research. Dr. McClellan is a former administrator of the Centers for Medicare & Medicaid Services (CMS) and former commissioner of the U.S. Food and Drug Administration (FDA), where he developed and implemented major reforms in health policy such as Medicare and Medicaid payment reforms, the FDA’s Critical Path Initiative, and public-private initiatives to develop better information on the quality and cost of care. He is the founding chair and a current board member of the Reagan-Udall Foundation for the FDA, is a member of the National Academy of Medicine and chairs the Academy’s Leadership Council for Value and Science-Driven Health care, co-chairs the guiding committee of the Health Care Payment Learning and Action Network, and is a research associate at the National Bureau of Economic Research. He has also previously served as a member of the President’s Council of Economic Advisers and senior director for health care policy at the White House, and as Deputy Assistant Secretary for Economic Policy at the Department of the Treasury. As a previous associate professor of economics and medicine with tenure at Stanford University, he has twice received the Kenneth Arrow Award for Outstanding Research in Health Economics.

John H. Alexander, MD, MHS, FACC, is a cardiologist and professor of medicine in the Department of Medicine and Division of Cardiology at Duke University, as well as the vice chief for Clinical Research in the Division of Cardiology. He is the director of cardiovascular research at the Duke Clinical Research Institute where he oversees a large group of clinical research faculty and a broad portfolio of cardiovascular clinical trials and other clinical research programs.

Dr. Alexander’s clinical interests are in acute and general cardiovascular disease, valvular heart disease, and echocardiology. His research focuses on the translation of novel therapeutic concepts into clinical data through clinical trials, specifically on the therapeutics of acute coronary syndromes and chronic coronary artery disease, on antithrombotic therapies, and on novel methodological approaches to clinical research.

Dr. Alexander has published extensively and has served on the steering committee and as the principal investigator of numerous multi-center clinical trials.

Jacqueline Corrigan-Curay, JD, MD, is director of the Office of Medical Policy (OMP) within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). She leads the development, coordination, and implementation of medical policy programs and strategic initiatives. She works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes. Prior to joining FDA, Dr. Corrigan-Curay served as supervisory medical officer with the Immediate Office of the Director, National Heart, Lung and Blood Institute, at National Institute of Health (NIH), where she focused on developing policies and procedures to enhance the clinical trial enterprise. She also served as the director of the Office of Biotechnology Activities, Office of Science Policy at NIH, where she was executive secretary of the NIH Recombinant DNA Advisory Committee. She has held positions as an attending physician with the VA Medical Center, a policy analyst with the Congressional Office of Technology Assessment, and a practicing attorney in Washington, D.C. Dr. Corrigan-Curay earned her law degree from Harvard Law School, her medical degree from University of Maryland School of Medicine, and a bachelor’s degree in history of science from Harvard/Radcliffe College in Cambridge, MA. She completed her training in internal medicine at Georgetown University Medical Center, where she also served as a clinical assistant professor of medicine. She continues to practice internal medicine part-time at the Veterans Affairs Medical Center in Washington, D.C. 

Donna R. Cryer, JD, has channeled her personal experience as an inflammatory bowel disease and liver transplant patient into professional advocacy. She is the president and chief executive officer of the Global Liver Institute. Ms. Cryer serves on the executive committee of the People-Centered Research Foundation, the boards of directors of the Society for Participatory Medicine and the Personalized Medicine Coalition, and as a patient representative to the U.S. Food and Drug Administration and the American Board of Internal Medicine’s Gastroenterology Specialty Board. Previously, Ms. Cryer served as the patient and consumer representative on the U.S. Government Accountability Office’s Health Information Technology Policy Committee, the federal advisory body to the National Coordinator for Health Information Technology, and as a merit reviewer for the Patient-Centered Outcomes Research Institute. She was also a member of the Stakeholder Advisory Group for the NIH Health Care Systems Research Collaboratory and a guidelines committee of the American Society of Clinical Oncology. Ms. Cryer has been named one of the Top Blacks in Healthcare by the Milken Institute School of Public Health at George Washington University and BlackDoctors.org, one of the Top 10 Patients Who Make an Impact by Health 2.0, and one of PharmaVoice’s 100 Most Inspiring People. She received a Juris Doctorate from the Georgetown University Law Center.

Pat Furlong is the founding president and chief executive officer of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States focused on Duchenne muscular dystrophy. PPMD works to end Duchenne, the most common fatal, genetic childhood disorder, by accelerating research, advocating for optimal patient care, and educating the global community about the disorder. After her two sons were diagnosed with Duchenne, Ms. Furlong joined other parents to found PPMD in 1994. She has served on the boards of the Genetic Alliance and the National Organization for Rare Disorders, the National Institutes of Health’s Muscular Dystrophy Coordinating Committee, the Institute of Medicine’s Committee on Pediatric Studies Conducted Under BPCA and PREA, and the U.S. Food and Drug Administration’s Molecular and Clinical Genetics Panel. For her leadership in changing the course of Duchenne, Ms. Furlong was named among the top 50 orphan drug thought leaders by the World Orphan Drug Congress in 2014. She received the 2012 Global Genes | RARE Champion of Hope Advocacy Award and the 2008 Research!America Advocacy Award.

Steven K. Galson, MD, MPH, is the senior vice president of Research & Development for Amgen. He joined the company in 2010 as vice president of Global Regulatory Affairs. Prior to Amgen, Dr. Galson was senior vice president for Civilian Health Operations and chief health scientist at Science Applications International Corporation. Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. Previously, he served as director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), where he provided leadership for the center’s broad national and international programs in pharmaceutical regulation. Dr. Galson began his Public Health Service career as an epidemiological investigator at the Centers for Disease Control and Prevention (CDC) after completing a residency in internal medicine at the Hospitals of the Medical College of Pennsylvania. He also held senior-level positions at the Environmental Protection Agency (EPA); the Department of Energy, where he was chief medical officer; and the Department of Health and Human Services. Dr. Galson holds a bachelor’s degree from Stony Brook University, a medical degree from Mt. Sinai School of Medicine, and a Master of Public Health degree from the Harvard School of Public Health. In 2008, Galson received an Honorary Doctor of Public Service Degree from Drexel University School of Public Health, and in 2015, he received the Jacobi Medallion Award from Icahn Mount Sinai School of Medicine. Most recently, he was named the 2018 Health Leader of the Year from the Commissioned Officers Association of the United States Public Health Service.

Patricia Hurley, MSc, CPHQ, is the Director of Strategic Research Initiatives in the American Society of Clinical Oncology (ASCO) Center for Research and Analytics. Patricia leads several ASCO Research Committee strategic initiatives to advance and improve oncology clinical research and ensure patients have equitable access to quality clinical trials. She is also the staff lead for ASCO’s Research Community Forum, which is a solution-oriented initiative to address clinical trial site challenges with conducting and managing clinical trials. Patricia represents ASCO on a variety of multi-stakeholder collaborations to advance clinical trials and is on working groups for the Clinical Trials Transformation Initiative (CTTI), American Cancer Society Cancer Action Network (ACS CAN), and Outcome Measures in Rheumatology Clinical Trials (OMERACT). She is currently serving a second term on the Board of Directors for the Sjogren’s Foundation. Patricia has a master’s degree in health research methodology from McMaster University’s Clinical Epidemiology and Biostatistics Department in Ontario, Canada. Her expertise is in research methodology, measurement design and evaluation, research operations, and data management. Patricia’s career reflects her commitment to research, evidence-based quality health care, and advocacy in a variety of areas, including oncology, rheumatology, pediatric rehabilitation, and child and maternal health.

Michael Kolodziej, MD, is vice president and chief innovation officer at ADVI Health, which he joined in 2017. He is a Fellow of the American College of Physicians. He has published and spoken extensively on payment reform, personalized medicine, and practice care delivery transformation in oncology. Prior to ADVI Health, Dr. Kolodziej served as Flatiron Health’s National Medical Director, Managed Care Strategy, where he applied the core tech and data capabilities of Flatiron to facilitate practice transformation and success in alternative payment models. Before Flatiron, Dr. Kolodziej worked at Aetna as National Medical Director, Oncology Solutions, where he directed Aetna’s oncology delivery reform pilots and was the architect of the Aetna Oncology Medical Home program. He was also active in Aetna’s pharmacy policy, condition analysis, and genetics subcommittees. He served as Medical Director for Oncology Services for U.S. Oncology from 2007 to 2011. In this role, he helped direct the implementation of the USON clinical pathways initiative, the integration of the USON EMR into this program, and the development of the USON disease management and advanced care planning programs, now known as Innovent Oncology. Prior to this role, Dr. Kolodziej served as a partner of New York Oncology from 1998 until 2012. During this time, he was an active member of the US Oncology Pharmacy and Therapeutics committee, on the executive committee from 2002-2011, and chairman from 2004-2011. Directly after his medical training, Dr. Kolodziej was an associate professor at the University of Oklahoma School of Medicine. He attended college and medical school at Washington University in St. Louis, where he was Phi Beta Kappa and Alpha Omega Alpha. He completed internal medicine and hematology-oncology training at the University of Pennsylvania in Philadelphia.

Dr. Theodore (Ted) Lystig is SVP, Chief Analytics Officer at BridgeBio, where he provides leadership and guidance in the use of robust statistical and research design methods throughout the company.  He also holds the position of Adjunct Assistant Professor within the Division of Biostatistics at the University of Minnesota.  Dr. Lystig is an elected Fellow of the American Statistical Association (ASA) and an elected member of the International Statistical Institute (ISI).  He received his B.A. degree in Mathematics from St. Olaf College in Northfield, Minnesota, his M.S. and Ph.D. degrees in Biostatistics from the University of Washington in Seattle and was a Postdoctoral Fellow at Chalmers Technical University in Gothenburg, Sweden, in statistical genetics.

Rod MacKenzie, PhD, is chief development officer and executive vice president for Pfizer. Dr. MacKenzie leads Global Product Development, which is responsible for the clinical development and advancement of Pfizer’s pipeline of innovative medicines, as well as regulatory affairs in support of Pfizer’s R&D pipeline and portfolio of marketed therapies. He is a member of Pfizer’s executive leadership team. Dr. MacKenzie represents Pfizer on the Board of Directors for ViiV Healthcare, a global specialist HIV company established by GlaxoSmithKline and Pfizer to deliver advances in treatment and care for people living with HIV. He also represents Pfizer on the board of TransCelerate, a non-profit biopharmaceutical industry collaborative formed to identify and solve common drug development challenges with the end goals of improving clinical trial quality and bringing new treatment to patients faster. Dr. MacKenzie first joined Pfizer in Sandwich, UK, as a research scientist and conducted medicinal chemistry research in several disease areas. He is the co-inventor of darifenacin, brand named Enablex™. He has held numerous senior leadership positions at Pfizer in research and development, spanning areas including discovery chemistry, drug safety, and worldwide research, and has led several of Pfizer’s major R&D sites and technology centers. Dr. MacKenzie 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 in New York working in the area of molecular recognition with Professor W.C. Still.

Pierre Meulien, PhD, is executive director of the Innovative Medicines Initiative (IMI), a €5 billion public-private partnership between the European Union and the European pharmaceutical industry. At IMI, he is responsible for the overall management of the program, which works to improve and accelerate the drug development process by facilitating collaboration between the key players involved in health research. Previously, Dr. Meulien was president and CEO of Genome Canada, where he raised money and oversaw the launch of novel projects and networks in the field of genomics-based technologies. Prior to that, he was chief scientific officer for Genome British Columbia and was the founding CEO of the Dublin Molecular Medicine Center. Dr. Meulien also worked with the French biotechnology company Transgene and with Aventis Pasteur (now Sanofi Pasteur). He has a Ph.D. in molecular biology from the University of Edinburgh and carried out a postdoctoral fellowship at the Institut Pasteur in Paris.

Dr. Temple has a long-standing interest in the design and conduct of clinical trials. He has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose-response, and trials using “enrichment” designs. Serving as CDER’s deputy center director for clinical science, and also acting deputy director of the Office of Drug Evaluation I (ODE-I..), he is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products. He is trained in internal medicine and clinical pharmacology. Early in his career, Dr. Temple joined the Clinical Endocrinology Branch of the National Institute of Arthritis, Metabolism, and Digestive Diseases, NIH. He was a reviewing medical officer in the Division of Metabolic and Endocrine Drug Products and became assistant to the director of the Bureau of Drugs later becoming the director of the Division of Cardio-Renal Drug Products. For several years he served director of the Office of Drug Research and Review. His contributions have been frequently recognized with numerous awards from professional societies and the government.

Spiros Vamvakas, MD, is the Scientific Lead/Scientific Adviser on Human Medicines at the European Medicines Agency and serves on the EMA core team for COVID-19 products and guidelines. He joined the EMA in 1999, where he was responsible for establishing the orphan drug designation and had roles in scientific advice/protocol assistance for the qualification of novel methodologies, and as an advisor to health technology assessment organizations and payers. Between 2003 and 2016 Dr. Vamvakas represented EMA in ICH, serving as EMA Coordinator, as a member of the Management Committee, and as leader of the New Topics Subcommittee.

Dr. Vamvakas received his medical degree at the University of Würzburg, Germany, and is a board-certified specialist in pharmacology and toxicology from the Bavarian Chamber of Physicians. He has an active teaching appointment at the University Clinic of Würzburg in the Department of Pharmacology and Toxicology and formerly taught at the University of Rochester Medical Center. Since 2019 he has been an associate editor of the journal Clinical Pharmacology and Therapeutics.

Director of the FDA division of cardiovascular devices for more than a decade, Dr. Zuckerman joined the FDA’s Division of Cardiovascular Devices as a medical officer earlier in his career and has been actively involved in clinical trial design for many new cardiovascular devices. Trained in internal medicine and cardiology, Dr. Zuckerman was involved in basic research in hemodynamics and practiced noninvasive and invasive cardiology prior to transitioning to a career with the FDA.