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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
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Appendix A


Workshop Agenda

Refining Processes for the Co-Development of Genome-Based Therapeutics
and Companion Diagnostic Tests: A Workshop


February 27, 2013

The Keck Center of the National Academies
500 Fifth Street, NW
Washington, DC 20001



Workshop Objective:

•   To examine and discuss challenges and potential solutions for the co-development of targeted therapeutics and companion molecular tests for prediction of drug response.


8:30–8:35 a.m. WELCOMING REMARKS
 

Wylie Burke, Roundtable Co-Chair

 

Professor and Chair

 

Department of Bioethics and Humanities

 

University of Washington

 

Sharon F. Terry, Roundtable Co-Chair

 

President and Chief Executive Officer

 

Genetic Alliance

8:35–8:40 A.M.

Charge to Workshop Speakers and Participants

 

Robert McCormack, Workshop Co-Chair

 

Head, Technology Innovation and Strategy

 

Veridex LLC

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
8:40–10:05 A.M. SESSION I: CO-DEVELOPMENT
   
  Moderator:
   
 

Victoria Pratt

 

Chief Director, Molecular Genetics

 

Quest Diagnostics Nichols Institute

8:40–9:00 A.M. Effectiveness of Co-Development
   
 

Felix Frueh

 

Entrepreneur-in-Residence

 

Third Rock Ventures

9:00–9:20 A.M. FDA Review of Co-Development to Date
   
 

Elizabeth Mansfield

 

Director, Personalized Medicine Staff

 

Office of In Vitro Diagnostics and Radiological Health

 

Center for Devices and Radiological Health

 

U.S. Food and Drug Administration

9:20–10:05 A.M. Discussion with Speakers and Attendees
   
10:05–10:20 A.M. BREAK
   
10:20 A.M.–12:05 P.M. SESSION II: CHALLENGES AND OPPORTUNITIES
   
10:20–10:40 A.M. Stakeholder Input on the Current Co-Development Paradigm
   
 

Robert McCormack

 

Head, Technology Innovation and Strategy

 

Veridex LLC

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
10:40–11:20 A.M. Stakeholder Presentations (10 minutes each)
   
  Discussion Moderator:
   
 

Geoffrey Ginsburg

 

Director, Center for Genomic Medicine Institute for Genomic Sciences & Policy

 

Duke University

  In Vitro Diagnostic Developers
   
 

Walter Koch

 

Vice President, Global Research

 

Roche Molecular Systems, Inc.

 

Pamela L. Swatkowski

 

Director, Regulatory Affairs

 

Abbott Molecular Inc.

  Pharmaceuticals Developers
   
 

Scott Patterson

 

Executive Director, Medical Sciences

 

Amgen Inc.

 

Richard Buller

 

Vice President, Translational Oncology

 

Oncology Business Unit

 

Pfizer Inc.

11:20 A.M.–12:05 P.M. Discussion with Speakers and Attendees
   
12:05–12:55 P.M. WORKING LUNCH
   
12:55–1:45 P.M. Stakeholder Presentations (10 minutes each)
   
  Discussion Moderator:
   
 

Patrick Terry

 

Founder

 

PXE International

   
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Regulatory and Legal Oversight
   
 

Steven Gutman

 

Strategic Advisor

 

Myraqa, Inc.

 

Bradley Thompson

 

Member of the Firm

 

Epstein Becker & Green, P.C.

  Payers
   
 

Bruce Quinn

 

Senior Health Policy Advisor

 

Foley Hoag, LLP

 

Joanne Armstrong

 

Senior Medical Director

 

Head, Women’s Health

 

Aetna

1:45–2:40 P.M. Discussion with Speakers and Attendees
   
2:40–3:10 P.M. Stakeholder Presentations (10 minutes each)
   
  Discussion Moderator:
   
 

Muin Khoury

 

Director

 

National Office of Public Health Genomics

 

Centers for Disease Control and Prevention

  Laboratory End Users
   
 

John Pfeifer

 

Vice Chair for Clinical Affairs, Pathology and Immunology

 

Professor, Pathology and Immunology

 

Professor, Obstetrics and Gynecology

 

Washington University School of Medicine

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Clinical End Users
   
 

Sharon F. Terry

 

President and Chief Executive Officer

 

Genetic Alliance

   
 

Mark Robson

 

Clinic Director, Clinical Genetics Service

 

Department of Human Genetics

 

Memorial Sloan–Kettering Cancer Center

   
3:10–3:25 P.M. BREAK
   
3:25–4:10 P.M. Discussion with Speakers and Attendees
   
4:10–5:40 P.M. SESSION III: POTENTIAL PATHS FORWARD
   
4:10–4:25 P.M. Pathways Toward Progress: Overview of Themes from the Day
   
 

Debra Leonard, Workshop Co-Chair

 

Professor and Vice Chair for Laboratory Medicine

 

Director of the Clinical Laboratories

 

Weill Cornell Medical Center of Cornell University

   
4:25–5:40 P.M. Advancing Co-Development
   
  Discussion Moderator:
   
 

Wylie Burke, Roundtable Co-Chair

 

Professor and Chair

 

Department of Bioethics and Humanities

 

University of Washington

   
  Respondents
   
 

Pamela L. Swatkowski

 

Director, Regulatory Affairs

 

Abbott Molecular Inc.

   
 

Richard Buller

 

Vice President, Translational Oncology

 

Oncology Business Unit

 

Pfizer Inc.

   
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×

Steven Gutman

 

Strategic Advisor

 

Myraqa, Inc.

 

Joanne Armstrong

 

Senior Medical Director

 

Head, Women’s Health

 

Aetna

 

John Pfeifer

 

Vice Chair for Clinical Affairs, Pathology and Immunology

 

Professor, Pathology and Immunology

 

Professor, Obstetrics and Gynecology

 

Washington University School of Medicine

 

Mark Robson

 

Clinic Director, Clinical Genetics Service

 

Department of Human Genetics

 

Memorial Sloan–Kettering Cancer Center

   
5:40–5:50 P.M. SESSION IV: CONCLUSION
   
5:40–5:50 P.M. Concluding Remarks
   
 

Robert McCormack, Workshop Co-Chair

 

Head, Technology Innovation and Strategy

 

Veridex LLC

 

Debra Leonard, Workshop Co-Chair

 

Professor and Vice Chair for Laboratory Medicine

 

Director of the Clinical Laboratories

 

Weill Cornell Medical Center of Cornell University

5:50 P.M. ADJOURN
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 57
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 58
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 59
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 60
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 61
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 62
Next: Appendix B: Speaker Biographical Sketches »
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Many drug developers have examined new strategies for creating efficiencies in their development processes, including the adoption of genomics-based approaches. Genomic data can identify new drug targets for both common and rare diseases, can predict which patients are likely to respond to a specific treatment, and has the potential to significantly reduce the cost of clinical trials by reducing the number of patients that must be enrolled in order to demonstrate safety and efficacy. A key component of the approval of targeted therapeutics is the ability to identify the population of patients who will benefit from treatment, and this has largely hinged on the co-development and co-submission to the FDA of a companion diagnostic test.The co-development process, or the development of the test and drug for the simultaneous submission to FDA, has led to a major alteration in the way that drugs are being developed, with traditionally separate entities—pharmaceutical and diagnostic companies—now working in close collaboration.

Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests is the summary of a workshop held by the Roundtable on Translating Genomic-Based Research for Health on February 27, 2013 to examine and discuss challenges and potential solutions for the codevelopment of targeted therapeutics and companion molecular tests for the prediction of drug response. Prior to the workshop, key stakeholders, including laboratory and medical professional societies, were individually asked to provide possible solutions to resolve the concerns raised about co-development of companion diagnostic tests and therapies. Workshop speakers were charged with addressing these solutions in their presentations by providing insight on (1) whether the proposed solutions address the problems described, (2) whether there are other solutions to propose, and (3) what steps could be taken to effectively implement the proposed solutions.
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