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 |
