Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary (2014)
Chapter: 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 |
| 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 |
| 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 | |
| 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 |
| 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. | |
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 |
