A Transformative Year: A Conversation with the FDA on COVID-19 and Medical Innovation for Older Adults in 2020
11:00 AM – 12:00 PM Eastern
The Food and Drug Administration (FDA) is having one of its most transformational years to date. The agency is working around the clock to address COVID-19, beginning negotiations for FDA Reauthorization Act (FDARA), releasing final guidance on Patient-Focused Drug Development (PFDD), and working to enhance the diversity of our clinical trial populations.
This panel will feature senior officials from the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) for a discussion on the agency’s response to the pandemic, the User Fee Agreements, and a discussion on its work to collect more meaningful data from patients and improve the inclusion of underrepresented groups in clinical trials, particularly older adults.
Susan Peschin, MHS, is president and CEO at the Alliance for Aging Research, the leading national non-profit organization dedicated to accelerating the pace of scientific discoveries and their application to improve the experience of aging and health. Since 2012, Ms. Peschin has been a driving force in the growth and success of the organization. As a thought leader on many aging-related issues, she has led the Alliance in efforts to: boost older adult immunization rates; increase NIH Alzheimer’s disease and aging research funding; raise awareness of geriatric cardiac issues; develop Talk NERDY to Me (NERDY-Nurturing Engagement in Research and Development with You), a PCORI-funded, older patient and family caregiver research engagement network; address costs of healthcare and value frameworks; and reform Medicare treatment access issues. She participates in major industry and policy symposiums around the country each year and has published opinion pieces in news outlets nationwide. Ms. Peschin currently serves on the Boards of Heart Valve Voice U.S. and the King Farm Neighbors Village; and on the National Advisory Council for the National Institute on Aging at the NIH.
Ms. Peschin earned a B.A. in Sociology from Brandeis University, and a M.H.S. degree in Health Policy from the Johns Hopkins University Bloomberg School of Public Health.
Jeffrey E. Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation.
“Our center experts and programs help get safe and effective technology to patients and health care professionals on a daily basis,” says Dr. Shuren. “Rapid technological advances enable us to approve such innovations as a diagnostic test for the H1N1 influenza virus, an expandable prosthetic rib for children with abnormal growth conditions, and a test that can help detect ovarian cancer.”
Dr. Shuren received his B.S. and M.D. degrees from Northwestern University under its Honors Program in Medical Education. He completed his medical internship at Beth Israel Hospital in Boston, his neurology residency at Tufts New England Medical Center, and a fellowship in behavioral neurology and neuropsychology at the University of Florida. He received his J.D. from the University of Michigan.
Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.
Dr. Shuren has served in a leadership role at FDA or on behalf of the agency on numerous initiatives, including
- reauthorization of the Medical Device User Fee Act, which dramatically shortens review times for device applications
- creation of the Sentinel Initiative, which works toward a national electronic system for monitoring medical product safety
- development of FDA’s Pandemic Influenza Preparedness Strategic Plan
- development of FDA’s Counterfeit Drug Task Force Report
- development of the Interagency Food Safety Working Report to the President
- implementation of FDA provisions of the Medicare Prescription Drug Improvement and Modernization Act
- development and implementation of the Interagency Import Safety Working Group’s Report to the President: Action Plan for Import Safety
From 1999 to 2000, Dr. Shuren served as a detailee on Senator Edward Kennedy’s staff on the Senate Health, Education, Labor, and Pensions Committee. From 1998 to 2003, he also was a staff volunteer in the National Institutes of Health’s Cognitive Neuroscience Section where he supervised and designed clinical studies on human reasoning.
As director of the Division of Items and Devices, Coverage and Analysis Group at the Centers for Medicare and Medicaid Services, Dr. Shuren oversaw the development of Medicare national coverage determinations for drugs, biologics, and non-implantable devices.
Patrizia Cavazzoni, M.D., is the Acting Center Director at FDA’s Center for Drug Evaluation and Research (CDER).
Dr. Cavazzoni received her medical degree at McGill University and completed a residency in psychiatry and a fellowship in mood disorders at the University of Ottawa. She subsequently joined the faculty of medicine at the University of Ottawa as an assistant professor, where she was engaged in clinical work, teaching, and research on genetic predictors of mood disorders, authoring numerous peer-reviewed scientific publications. Following this, Dr. Cavazzoni worked in the pharmaceutical industry for several years, and held senior leadership positions in clinical development, regulatory affairs, and safety surveillance.
Dr. Cavazzoni is certified by the American Board of Neurology and Psychiatry, and she is a fellow of the Canadian Royal College of Physician and Surgeons, a member of the Canadian College of Neuropsychopharmacology, and recipient of the American College of Psychiatrists’ Laughlin Fellowship.
Dr. Kersten is the Divisional Vice President, Global Regulatory Services for Abbott. He has over 30 years experience working in the Biotechnology, Pharmaceutical and Medical Device industries. He has extensive regulatory experience in various stages of product development.
He is responsible for International Regulatory Affairs and Global Regulatory Operations for Abbott’s medical device business units and related activities including establishing policy and strategy for the business units, overseeing the process of preparing all international product submissions; managing regulatory submission process through approvals; and ensuring compliance with all international regulatory and quality requirements including Cybersecurity.
Prior to joining Abbott, Dr. Kersten held several senior leadership positions within the healthcare industry, most recently as Vice President, Regulatory Affairs and Quality Assurance/Analytical Sciences at Nuvelo, Inc.
Dr. Kersten holds a bachelor’s degree in Chemistry from the University of Michigan, Dearborn, Michigan and a doctorate degree in Chemistry from Wayne State University in Detroit, Michigan.