September 19th 12pm – 1:30pm ET (lunch will be served) at 902 Hart Senate Office Building
Regenerative cellular therapies represent the next generation of groundbreaking treatments that are showing great promise in cardiology, neurology, oncology, orthopedics, ophthalmology, and other areas. Several well-designed clinical trials are being conducted under FDA investigational new drug (IND) protocols. At the same time, a handful of clinics have caused patient harm or made questionable claims, taking advantage of vulnerable patients and casting a negative light on this emerging science and industry.
The 21st Century Cures Act contained several provisions to make safe and effective regenerative cellular therapies available to patients, including extending Food and Drug Administration (FDA) expedited programs to include regenerative therapies and providing funds for research through the National Institutes of Health.
Join us for a discussion on regenerative cell therapies, including promising research for diseases for which there is no cure, the importance of cell characterization and quality controls in manufacturing, and the actions that the FDA is taking to both advance and support the science and address “bad actors.”
- Amy P. Patterson, MD, Chief Science Advisor and Director of Scientific Research Programs, Policy, and Strategic Initiatives, National Heart, Lung, and Blood Institute, National Institutes of Health
- Peter Marks, MD, Director, Center for Biologic Evaluation and Research, Food and Drug Administration
- Anthony Atala, MD, Chair and Professor, Urology; Director and Professor, Institute for Regenerative Medicine, Wake Forest School of Medicine
- Joanne Kurtzberg, MD, Professor of Pediatrics and Pathology; Director, Marcus Center for Cellular Cures; Director, Pediatric Blood and Marrow Transplant Program; Director, Carolinas Cord Blood Bank; Duke University Medical Center.
- David Pearce, PhD, President of Innovation and Research and Scientist, Pediatrics and Rare Diseases Group, Sanford Health; Professor, Department of Pediatrics, Sanford School of Medicine of the University of South Dakota
- Krishnendu Roy, PhD, Robert A. Milton Chair; Director, NSF Engineering Research Center for Cell Manufacturing Technologies; Director, Marcus Center for Cell-Therapy Characterization and Manufacturing; Technical Lead, National Cell Manufacturing Consortium; Director, Center for ImmunoEngineering, Georgia Institute of Technology
- Fred Sanfilippo, MD, PhD, Professor, Health Policy and Management, Rollins School of Public Health, Emory University; Director, Emory-Georgia Tech Healthcare Innovation Program; Medical Director, The Marcus Foundation
- Bernard Siegel, Executive Director, Regenerative Medicine Foundation
- Janet Marchibroda, President, Alliance for Cell Therapy Now; Senior Vice President, Health Policy, Bockorny Group; and Fellow, Bipartisan Policy Center
This briefing is a widely attended educational event as defined by the House and Senate ethics rules.