September 2020 Policy Conference

Exploring Public Policy: Regenerative Medicine and Cell Therapies

Event Date: September 16, 2020, Virtual Conference

Co-Hosted by Alliance for Cell Therapy Now, Regenerative Medicine Foundation, and Cord Blood Association

 

1. Opening Remarks

Janet Marchibroda, President, Alliance for Cell Therapy Now

Bernard Siegel, Executive Director, Regenerative Medicine Foundation; Founder and Chair, World Stem Cell Summit

2. Overview of the Landscape: Regenerative Medicine and Cell Therapies

Julie Allickson, PhD, Chief, Manufacturing Development Center Officer, Wake Forest Institute for Regenerative Medicine

Colleen Delaney, MD, Founder, Chief Scientific Officer and Executive Vice President of Research and Development, Deverra Therapeutics and Professor, Department of Pediatrics, Division of Pediatric Hematology/Oncology, University of Washington

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; President, Cord Blood Association

Moderated by:

Max Gomez, MD, Award-Winning Broadcast Journalist, CBS News Medical Correspondent

3. Insights on Outcomes from Use of MSCs for Patients with COVID-19

Joshua M. Hare, MD, FACC, FAHA, Louis Lemberg Professor of Medicine, Founding Director, Interdisciplinary Stem Cell Institute, University of Miami, Miller School of Medicine

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; President, Cord Blood Association

Wenchun Qu, MD, PhD, Associate Professor of Anesthesiology; Associate Professor of Physical Medicine and Rehabilitation; Physiatrist and Pain Specialist, Director, Mayo Allogeneic Cell Therapy Program, Mayo Clinic

Michael Matthay, MD, Professor in Residence, Associate Director, Critical Care Medicine; Research Lab Director, Acute Lung Injury and ARDS: Research and Clinical Trials, University of California – San Francisco

Moderated by:

Fred Sanfilippo, MD, PhD, Professor of Pathology and Laboratory Medicine, and Health Policy and Management, Emory University; Director, Emory-Georgia Tech Healthcare Innovation Program; Medical Director, The Marcus Foundation

4. The Role of Government in Advancing Clinical Trials and Research

Steven Becker, PhD, Director, Office of Regenerative Medicine, National Eye Institute, National Institutes of Health

Maria T. Millan, MD, President and CEO, California Institute for Regenerative Medicine

Audrey Kusiak, PhD, Scientific Program Manager, Rehabilitation Research and Development Service, Office of Research and Development, Department of Veterans Affairs

Moderated by:

Anthony Atala, MD, G. Link Professor and Director, Wake Forest Institute for Regenerative Medicine and the W. Boyce Professor and Chair of Urology, Wake Forest School of Medicine

5. Virtual Fireside Chat with Current and Former Administration Leaders

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

Robert M. Califf, MD, PhD, Head of Health Strategy and Policy, Google and Verily Health; Former Commissioner, Food and Drug Administration

Andrew von Eschenbach, MD, President, Samaritan Health Initiatives, Inc.; Adjunct Professor, University of Texas MD Anderson Cancer Center; Former Commissioner, Food and Drug Administration; Former Director, National Cancer Institute

Moderated by:

Mark McClellan, MD, PhD, Robert J. Margolis Professor of Business, Medicine, and Health Policy, and founding Director of the Duke-Margolis Center for Health Policy at Duke University; Former Commissioner, Food and Drug Administration; Former Administrator, Centers for Medicare and Medicaid Services

6. Conversation with Industry Leader

David Oxley, Senior Vice President, Business Development and Licensing, Mesoblast

Moderated by:

Bernard Siegel, Executive Director, Regenerative Medicine; Founder and Chair, World Stem Cell Summit

7. Update from Capitol Hill

Garrett Devenney, Office of Senator Patty Murray (D-WA), Ranking Member, Senate Health, Education, Labor, and Pensions Committee

Andrew Vogt, Office of Senator Lamar Alexander (R-TN), Chairman, Senate Health, Education, Labor, and Pensions Committee

Moderated by:

Janet Marchibroda, President, Alliance for Cell Therapy Now

8. Scaling Manufacturing of Cell Therapies: Current Capabilities, Key Strategies for Moving Forward

John McMannis, PhD, Executive Vice President, Manufacturing, Mesoblast

Lisa McClain-Moss, Senior Director, Manufacturing, Longeveron

Jon A. Rowley, PhD, Founder and Chief Product Officer, RoosterBio Inc.

Moderated by:

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

9. Examining Workforce: Where We Are Today; Key Actions Needed

Gary M. Green, EdD, Chief Workforce Development Officer, RegenMed Development Organization, Wake Forest Institute for Regenerative Medicine

Moderated by:

Bernard Siegel, Executive Director, Regenerative Medicine Foundation

10. Roundtable Discussion: Policy Actions Needed to Advance Regenerative Medicine and Cell Therapies

Julie G. Allickson, PhD, Chief, Manufacturing Development Center Officer, Wake Forest Institute for Regenerative Medicine

Arnold Caplan, PhD, Professor of Biology and the Director of the Skeletal Research Center, Case Western Reserve University

Keith March, MD, PhD, Director, University of Florida Center for Regenerative Medicine; Vice Chief, Cardiology Research; and Professor in the UF Division of Cardiovascular Medicine and UF Department of Medicine

David A. Pearce, PhD, President of Innovation, Research, and World Clinic, Sanford Health; Senior Scientist, Sanford Children’s Health Research Center; Professor of Pediatrics, University of South Dakota Sanford School of Medicine

Ricardo Rodriguez, MD, Medical Director, Cosmeticsurg.net; Member, Regenerative Medicine Task Force, American Society of Plastic Surgeons; Former President, International Federation for Adipose Therapeutics and Science (IFATS)

Moderated by:

Robin L. Smith, MD, MBA, President and Chair, Stem for Life and Cura Foundation

11. NFL Alumni’s Work in Regenerative Medicine and Cell Therapies

Billy Davis, Co-Director, Healthcare Initiatives, NFL Alumni; Former Player, NFL

Tiffany Facile, Director of Clinical Regenerative Medicine, Sanford Health

Jaime R. Garza, MD, DDS, FACS, Professor of Orthopedic Surgery, Professor of Otolaryngology, and Director of Human Regenerative Cell Trials at Tulane University School of Medicine; Professor of Surgery and Professor of Otolaryngology, University of Texas – San Antonio

Kyle Richardson, Board Member, Co-Director, Healthcare Initiatives, NFL Alumni; Former Player, NFL

Moderated by:

Janet Marchibroda, President, Alliance for Cell Therapy Now

12. Closing Remarks and Adjourn

Joanne Kurtzberg, MD, President, Cord Blood Association

Bernard Siegel, Executive Director, Regenerative Medicine Foundation; Founder and Chair, World Stem Cell Summit

Janet Marchibroda, President, Alliance for Cell Therapy Now