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



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OCR for page 57
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 57

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58 THERAPEUTIC AND DIAGNOSTIC CO-DEVELOPMENT 8:40–10:05 A.M. SESSION I: CO-DEVELOPMENT Moderator: Pratt Victoria 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.– SESSION II: CHALLENGES AND OPPORTUNITIES 12:05 P.M. Stakeholder Input on the Current Co-Development 10:20–10:40 A.M.  Paradigm Robert McCormack Head, Technology Innovation and Strategy Veridex LLC

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APPENDIX A 59 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.– Discussion with Speakers and Attendees 12:05 P.M. 12:05–12:55 P.M. WORKING LUNCH 12:55–1:45 P.M. Stakeholder Presentations (10 minutes each) Discussion Moderator: Terry Patrick Founder PXE International

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60 THERAPEUTIC AND DIAGNOSTIC CO-DEVELOPMENT Regulatory and Legal Oversight Gutman Steven Strategic Advisor Myraqa, Inc. Bradley Thompson Member of the Firm Epstein Becker & Green, P.C. Payers Quinn Bruce Senior Health Policy Advisor Foley Hoag, LLP Armstrong Joanne 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 Pfeifer John Vice Chair for Clinical Affairs, Pathology and Immunology Professor, Pathology and Immunology Professor, Obstetrics and Gynecology Washington University School of Medicine

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APPENDIX A 61 Clinical End Users F. Terry Sharon 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 L. Swatkowski Pamela Director, Regulatory Affairs Abbott Molecular Inc. Richard Buller Vice President, Translational Oncology Oncology Business Unit Pfizer Inc.

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62 THERAPEUTIC AND DIAGNOSTIC CO-DEVELOPMENT 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 Robson Mark 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