September 2019 Capitol Hill Briefing

Regenerative Cell Therapies: Making Safe and Effective Treatments Available to Patients

Event Date: September 19, 2019 at the Hart Senate Office Building

Summary of Alliance for Cell Therapy Capitol Hill Briefing 09.19.19

Agenda: Congressional Briefing on Regenerative Cell Therapies

Alliance for Cell Therapy Now Overview

Opening Remarks

Janet Marchibroda, President, Alliance for Cell Therapy Now

Regenerative Cell Therapy Research: Current Clinical Trials and the Promise for Patients

Anthony Atala, MD, G. Link Professor, and Director, Wake Forest Institute for Regenerative Medicine, Wake Forest University School of Medicine

David Pearce, PhD, President of Innovation and Research, Sanford Health; Scientist, Pediatrics and Rare Diseases Group; Professor, Department of Pediatrics, Sanford School of Medicine of the University of South Dakota

Joanne Kurtzberg, MD, Jerome Harris Distinguished Professor of Pediatrics; Professor of Pathology; Director, Marcus Center for Cellular Cures; Director, Pediatric Blood and Marrow Transplant Program; Director, Carolinas Cord Blood Bank; Co-Director, Stem Cell Transplant Laboratory; Duke University Medical Center

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 (Moderator)

Cell Characterization and Scalable Manufacturing: Assuring Quality Control and Improving Access for Cell Therapies

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 (moderator)

Protecting Patients Through Rigorous Science and Safety

Bernard Siegel, JD, Executive Director, Regenerative Medicine Foundation

Amy Patterson, MD, Chief Science Advisor and Director of Scientific Research Programs, Policy, and Strategic Initiatives, Immediate Office of the Director, National Heart, Lung, and Blood Institute, National Institutes of Health

Peter Marks, MD, PhD, Director, Center for Biologic Evaluation and Research, Food and Drug Administration

Janet Marchibroda (moderator)

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 that is currently being conducted under well-designed clinical trials to address conditions for which there is no cure, the importance of cell characterization and scalable manufacturing, and the important actions that the FDA and NIH are taking to advance the science and bring safe and effective therapies to patients, while also protecting patients from stem cell clinics who are causing patient harm.

Alliance for Cell Therapy Now and its leaders thank Senator David Perdue for his support for this event.

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