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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Appendix A

Workshop Agenda

Navigating the Manufacturing Process and Ensuring the Quality of
Regenerative Medicine Therapies:
A Workshop

June 26, 2017
National Academy of Sciences Building
Lecture Room
2101 Constitution Avenue NW
Washington, DC 20418

8:30 a.m. Opening Remarks

R. ALTA CHARO, Forum Co-Chair

Warren P. Knowles Professor of Law

University of Wisconsin–Madison

JAY P. SIEGEL, Forum Co-Chair

Chief Biotechnology Officer

Head, Scientific Strategy and Policy

Johnson & Johnson

8:35 a.m. Charge to Workshop Speakers and Participants

CLAUDIA ZYLBERBERG, Workshop Co-Chair

Founder and Chief Executive Officer

Akron Biotech

STEVEN OH, Workshop Co-Chair

Acting Deputy Director, Division of Cellular and Gene Therapies

Office of Tissues and Advanced Therapies

Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
8:45 a.m. Opening Keynote

ADRIAN GEE

Professor of Cell and Gene Therapy

Baylor College of Medicine

SESSION I: TRANSITIONING FROM DISCOVERY AND DEVELOPMENT TO MANUFACTURING FOR REGENERATIVE THERAPIES

Session Objectives:

  • To discuss challenges and opportunities associated with bringing new discoveries from the lab to manufacturing and navigating the process of scaling up the manufacturing of new therapies.
  • To learn about methods and capabilities for manufacturing and quality control data collection for the purpose of informing the transition from research and development (R&D) to the implementation of good manufacturing practices (GMPs).
  • To illuminate potential opportunities and models to reach scale and commercialization with current infrastructure and to assess probable future needs.
Moderator: Krishanu Saha, Assistant Professor, University of Wisconsin–Madison
9:10–9:55 a.m. Speakers:

BRUCE LEVINE

Barbara and Edward Netter Professor in Cancer Gene Therapy

University of Pennsylvania Perelman School of Medicine

LAURA NIKLASON

Professor of Anesthesiology and Biomedical Engineering

Yale University

BOB PRETI

President and Chief Executive Officer

PCT Cell Therapy Services, LLC

Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
9:55–10:30 a.m. Discussion with Workshop Participants
10:30–10:45 a.m. BREAK

SESSION II: IDENTIFYING AND MEASURING CRITICAL QUALITY ATTRIBUTES OF REGENERATIVE MEDICINE PRODUCTS AND SOURCE CELLS

Session Objectives:

  • To examine methods and processes used to identify and measure critical quality attributes for raw materials and regenerative medicine products.
  • To discuss measurement methodology and how to ensure that measurements are accurate and reproducible.
  • To survey technologies and future needs in the measurement of critical quality attributes.
Moderator: Martha Somerman, Director, National Institute of Dental and Craniofacial Research, National Institutes of Health
10:45–11:30 a.m. Speakers:

ANNE PLANT

Chief of the Biosystems and Biomaterials Division

National Institute of Standards and Technology

LINDA KELLEY

Director, Cell Therapies Processing Facility

Moffitt Cancer Center

ROBERT DEANS

Chief Technology Officer

BlueRock Therapeutics

11:30 a.m.–noon Discussion with Workshop Participants
Noon–1:00 p.m. WORKING LUNCH
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

SESSION III: DESIGNING TECHNOLOGIES TO MEET THE MANUFACTURING NEEDS OF NEW REGENERATIVE THERAPIES

Session Objectives:

  • To explore existing technologies that facilitate the efficient and cost-effective development of products that meet manufacturing and regulatory standards.
  • To illuminate opportunities for new technologies and manufacturing models to increase efficiency and quality.
  • To discuss novel and more precise in-process and final release testing technologies.
  • To review existing infrastructure such as GMP facilities in academic centers and the commercial sector.
  • To understand the open and closed systems models applicable to the manufacturing setting and information technology support.
Moderator: Thomas Petersen, Vice President, Regenerative Medicine, United Therapeutics Corporation
1:00–1:45 p.m. Speakers:

ISABELLE RIVIÈRE

Director, Cell Therapy and Cell Engineering Facility

Memorial Sloan Kettering Cancer Center

RODNEY RIETZE

Lead, cGMP Process Automation for Cell and Gene Therapies

Novartis

PHILIP VANEK

General Manager, Cell Therapy Technologies

GE Healthcare

1:45–2:15 p.m. Discussion with Workshop Participants
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

SESSION IV: REGULATORY CHALLENGES AND OPPORTUNITIES FOR REGENERATIVE MEDICINE THERAPIES

Session Objective:

  • To consider the regulatory landscape for regenerative medicine, including
    • developing standards
    • enforcing regulation
    • meeting the needs of patients
Moderator: Jiwen Zhang, Senior Director, Regulatory Affairs, Cell Therapy and Regenerative Medicine, GE Healthcare
2:15–3:00 p.m. Speakers:

ROBERT MCBURNEY

President and Chief Executive Officer

Accelerated Cures Project for Multiple Sclerosis

Co-Principal Investigator

iConquerMS Patient-Powered Research Network

STEVEN BAUER

Chief, Cellular and Tissue Therapy Branch

Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

KATHERINE TSOKAS

Senior Director, Global Regulatory Affairs

Johnson & Johnson

3:00–3:35 p.m. Discussion with Workshop Participants
3:35–3:50 p.m. BREAK
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

SESSION V: CLOSING KEYNOTE AND PANEL

Session Objectives:

  • To summarize the lessons learned and topics discussed throughout the workshop day.
  • To discuss ways forward to support the development, manufacture, and regulation of safe and effective regenerative medicine therapies.
Moderator: Krishnendu Roy, Robert A. Milton Chair and Professor and Technical Lead, National Cell Manufacturing Consortium, Georgia Institute of Technology
3:50–4:10 p.m. Closing Keynote:

DEAN KAMEN

Advanced Regenerative Manufacturing Institute

DEKA Research & Development Corporation

4:10–4:30 p.m. Panelist Reflections

BOB PRETI

President and Chief Executive Officer

PCT Cell Therapy Services, LLC

ANNE PLANT

Chief of the Biosystems and Biomaterials Division

National Institute of Standards and Technology

PHILIP VANEK

General Manager, Cell Therapy Technologies

GE Healthcare

ROBERT MCBURNEY

President and Chief Executive Officer

Accelerated Cures Project for Multiple Sclerosis

Co-Principal Investigator

iConquerMS Patient-Powered Research Network

4:30–5:00 p.m. Discussion with Workshop Participants
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
5:00 p.m. Final Remarks from Workshop Co-Chairs

CLAUDIA ZYLBERBERG, Workshop Co-Chair

Founder and Chief Executive Officer

Akron Biotech

STEVEN OH, Workshop Co-Chair

Acting Deputy Director, Division of Cellular and Gene Therapies

Office of Tissues and Advanced Therapies

Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

5:15 p.m. Adjourn
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 81
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 82
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 83
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 84
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 85
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 86
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 87
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Page 88
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On June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes. The workshop also addressed the challenges of designing and adhering to standards as a way of helping those who are working to scale up processes and techniques from a research laboratory to the manufacturing environment. This publication summarizes the presentations and discussions from the workshop.

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