ISSCR/CIRM/ISCT Regulatory Workshop

Stem Cell Therapies in Clinical Trials – Best Practices and the Need for Harmonization
Tuesday, June 15, 8:30 a.m. – 5:30 p.m.
San Francisco Marriott Marquis

This session is full.

A day-long workshop examining the issues involved in harmonizing regulatory features internationally so that clinical trials are registered and conducted under common minimum standards accepted by global and national government regulators.

Preliminary Agenda
8:30 - 8:45 a.m.
Introduction: Challenges and Successes in Advancing Stem Cell Therapies into the Clinic – A Worldwide Perspective 
George Q. Daley, MD, PhD, Children's Hospital Boston

8:45 - 10:15 a.m.
Experiences Around the Globe
Moderator: Thomas Okarma, PhD, MD, Geron

•Alan Trounson, MSc, PhD, CIRM
•Olle Lindvall, MD, PhD, University of Lund, Wallenberg Neuroscience Center
•Wise Young, MD, PhD, Rutgers University

10:30 a.m. - 12:00 p.m.
Developing Regulatory Frameworks for Stem Cell Trials
Moderator: R.Alta Charo, JD, School of Law, University of Wisconsin

•ARGENTINA: Gustavo Sevlever, MD, Institute for Neurological Research Raúl Carrea (FLENI)  
•INDIA: Alok Srivastava, MD, FRACP, FRCPA, FRCP, Chairman, National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT)
•CHINA:  TBD

12:00 - 1:15 p.m.
Lunch ~ Keynote Address

1:15 - 2:15 p.m.
Regulatory Agency Overview – Harmonizing Regulatory Issues
Moderator: Ed Penhoet, PhD, Alta Partners

•U.S. Food and Drug Administration: Celia M. Witten, MD, PhD, Director of Cellular, Tissue, and Gene Therapy, Center for Biologics Evaluation and Research
•JAPAN:  Hiroki Tanabe, MD, PhD, Assistant Director, Research & Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare
•European Medicines Agency (EMA): Christopher A. Bravery, PhD, Consulting on Advanced Biologicals Ltd. 

2:15 - 3:30 p.m.
Meeting the Challenges – Shaping a Balanced and Protective Regulatory Regime
Moderator: Mary J. Laughlin, MD, Associate Professor of Medicine, Case Western Reserve University; Medical Director, Cleveland Cord Blood Center; President, International Society of Cellular Therapy-ISCT
Hypothetical case study - panel discussion

•GERMANY:  Frank-Roman Lauter, PhD, Berlin-Brandenburg Center for Regenerative Therapies (BCRT)
•CHINA: Duanqing Pei, PhD, Guangzhou Institute of Biomedicine and Health, Chinese Academy of Sciences
•USA: Darin J. Weber, PhD, Biologics Consulting Group, Inc.
•European Medicines Agency (EMA): Veronika Jekerle, PhD, Quality of Medicines, European Medicines Agency

3:45 - 5:00 p.m.
World View: International Bodies that May Play a Role in Harmonization in Standards Development
Moderator: Kurt C. Gunter, MD, Hospire Inc./International Society of Cellular Therapy-ISCT

•National Institute of Standards and Technology: Anne L. Plant, PhD, Cell Systems Science Group, Biochemical Science Division, National Institute of Standards and Technology
•ISSCR: Patrick Taylor, JD, Children's Hospital Boston, ISSCR Guidelines/Task Force on Unproven Stem Cell Therapies
•CIOMS:  Alexander M. Capron, LLB, University of Southern California

5:00 - 5:30 p.m.
Closing summary:  George Q. Daley, MD, PhD, Children's Hospital Boston

Updated May 28, 2010