A

Workshop Agenda

STEM CELL THERAPIES:
OPPORTUNITIES FOR ENSURING THE QUALITY AND
SAFETY OF UNREGULATED CLINICAL OFFERINGS

A WORKSHOP

November 18, 2013

National Academy of Sciences Building, Room 125
2101 Constitution Avenue, NW, Washington, DC

Workshop Objectives:

  • Discuss the current environment in which patients are receiving unregulated stem cell offerings.
  • Examine the stem cell treatments that are being offered.
  • Assess the potential benefits and risks to individual health.
  • Consider the evidence base needed to substantiate the clinical application of stem cell technologies.
  • Evaluate legal hurdles for establishing standards and criteria to govern stem cell trials and treatments.
  • Discuss potential solutions for assuring the quality of stem cell offerings.


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A Workshop Agenda STEM CELL THERAPIES: OPPORTUNITIES FOR ENSURING THE QUALITY AND SAFETY OF UNREGULATED CLINICAL OFFERINGS A WORKSHOP November 18, 2013 National Academy of Sciences Building, Room 125 2101 Constitution Avenue, NW, Washington, DC Workshop Objectives: • Discuss the current environment in which patients are receiving unregulated stem cell offerings. • Examine the stem cell treatments that are being offered. • Assess the potential benefits and risks to individual health. • Consider the evidence base needed to substantiate the clinical application of stem cell technologies. • Evaluate legal hurdles for establishing standards and criteria to govern stem cell trials and treatments. • Discuss potential solutions for assuring the quality of stem cell offerings. 61

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62 STEM CELL THERAPIES 8:30 – 8:45 A.M. Welcome, Introduction of Moderators, Meeting Goals, and Charge to Participants Alta Charo, Workshop Chair University of Wisconsin–Madison 8:45 – 10:20 STEM CELL THERAPIES: KNOWNS AND UNKNOWNS Session Moderator: Ralph J. Cicerone National Academy of Sciences 8:45 – 9:10 Stem Cells as Regulated Therapeutics John Wagner University of Minnesota 9:10 – 9:25 Clinical Offerings That Use Stem Cells Timothy Caulfield University of Alberta 9:25 – 9:40 Patients Seeking Unproven or Unregulated Treatments: Why and How Alan Petersen Monash University 9:40 – 10:20 Moderated Panel Discussion Panelists: John Wagner, Timothy Caulfield, Alan Petersen 10:20 – 10:35 BREAK 10:35 A.M. – QUALITY ASSURANCE—PART I 12:30 P.M. Session Moderator Ellen Feigal California Institute for Regenerative Medicine 10:35 – 10:50 Regulatory and Legal Frameworks for Offering Stem Cell Therapies in the United States Margaret Foster Riley University of Virginia School of Law

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APPENDIX A 63 10:50 – 11:05 Regulatory and Legal Frameworks for Offering Stem Cell Therapies in Italy Paolo Bianco Sapienza Universita di Roma 11:05 – 11:20 Regulatory and Legal Frameworks for Offering Stem Cell Therapies in Japan Toshio Miyata Health and Global Policy Institute 11:20 – 11:35 Regulatory and Legal Frameworks for Offering Stem Cell Therapies in Mexico María de Jesús Medina Arellano Universidad Autonoma de Nayarit 11:35 – 11:50 Regulatory and Legal Frameworks for Offering Stem Cell Therapies in China Qi Zhou Institute of Zoology Chinese Academy of Sciences 11:50 A.M. – Moderated Panel Discussion 12:30 P.M. Panelists: Margaret Foster Riley, Paolo Bianco, Toshio Miyata, María de Jesús Medina Arellano, Qi Zhou 12:30 – 2:15 P.M. LUNCH SEMINAR 12:30 – 12:50 BREAK 12:50 – 1:00 Introductory Comments Irving Weissman Stanford University School of Medicine 1:00 – 1:15 A Patient’s Story Michael Phelan 1:15 – 1:45 Medical Tourism: Patients Seeking Stem Cell Treatments I. Glenn Cohen Harvard University Law School

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64 STEM CELL THERAPIES 1:45 – 2:00 Discussion 2:00 – 2:15 BREAK 2:15 – 3:55 QUALITY ASSURANCE—PART II Session Moderator Amy Comstock Rick Parkinson’s Action Network 2:15 – 2:30 Quality of Information: Advertising David Vladeck Georgetown University 2:30 – 2:45 Quality of Information: ISSCR Statements and Guidelines George Daley Harvard University 2:45 – 3:15 Quality of Professional Services: Medical and Society-Based Accreditation Professional Society Efforts Calling for Evidence- Based Medicine and Appropriate Independent Oversight Douglas Sipp International Society for Cellular Therapy Professional Society Efforts in Parallel with Government Regulation Glenn L. Schattman Society for Assisted Reproductive Technology 3:15 – 3:55 Moderated Panel Discussion Panelists: David Vladeck, George Daley, Douglas Sipp, and Glenn L. Schattman 3:55 – 4:10 BREAK

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APPENDIX A 65 4:10 – 5:10 MOVING FORWARD Session Moderator Harvey V. Fineberg Institute of Medicine 4:10 – 5:10 Moderated Panel Discussion Panelists: Glenn L. Schattman, David Vladeck, María de Jesús Medina Arellano, Timothy Caulfield, Michael Phelan, Gil Van Bokkelen 5:10 – 5:25 FINAL REMARKS 5:10 – 5:25 Summary of Salient Points and Final Words Alta Charo University of Wisconsin–Madison Harvey V. Fineberg Institute of Medicine Ralph J. Cicerone National Academy of Sciences 5:25 ADJOURN

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