Plenary 1– Global Trends in Biotech Industry (B)
Date: 22 July (Wednesday) 10:30 – 12:10 (GMT+8)
Venue: 701EF, 7F, TaiNEX2 / Online event platform
Dr. Steven K. Galson, senior vice president, Global Regulatory Affairs and Safety, joined Amgen in 2010 as vice president, Global Regulatory Affairs.
Prior to Amgen, 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.
Galson began his Public Health Service (PHS) 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. Prior to his arrival at the FDA, Galson was director of the EPA’s Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances.
Galson holds a B.S. from Stony Brook University, an M.D. from Mt. Sinai School of Medicine, and an M.P.H. 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. In 2018 Galson was named the Health Leader of the Year from the Commissioned Officers Association of the United States Public Health Service. Galson is a member of the Clinical Trials Transformation Initiative Executive Committee, a trustee on the PHS Commissioned Officers Foundation and on the board of trustees for the Keck Graduate Institute.
Speech title & Synopsis
Although COVID-19 resulted in social distancing, quarantine, and isolation for people around the world, global health authorities are collaborating better than ever during this pandemic. Regulators are sharing information about their experiences and best practices, and are making appropriate modifications to the regulatory requirements that govern interactions with industry.
Some of the regulatory requirements that were relaxed or lifted, at least temporarily, in response to this crisis could be made permanent, with great benefit to patients. Regulatory approaches that allowed for new ways to execute and monitor clinical trials, deliver medicines, and use digital tools could reduce costs, increase efficiency, and enable regulators to make decisions more effectively.
We will explore the lessons learned from the COVID-19 pandemic and consider what the future might look like if we implement those lessons long-term.