Agenda - Institute of Medicine

Committee on Policy Issues in the Clinical Development and Use of
Biomarkers for Molecularly Targeted Therapies
The Keck Center of the National Academies
500 Fifth Street, NW
Washington, DC 20001
April 1, 2015
Room 201
8:00 a.m.
Welcome and Opening Remarks
Hal Moses, Committee Chair
8:05 a.m. – Panel One: Clinical Practice Issues
10:05 a.m.
Moderator: Edith Perez, M.D., Committee Member
William W. Stead, M.D.
Associate Vice-Chancellor for Health Affairs; Chief Strategy Officer
McKesson Foundation Professor of Biomedical Informatics, Professor of Medicine
Vanderbilt University Medical Center
Laurence J. Meyer, M.D., Ph.D.
Professor of Dermatology and Internal Medicine
University of Utah Health Sciences Center
Associate Chief of Staff, Research, SLC Veterans Administration Medical Center
National Director Genomic Medicine, Veterans Health Administration
Marc S. Williams, M.D.
Director, Genomic Medicine Institute
Geisinger Health System
Jonathan W. Heusel, M.D., Ph.D.
Associate Professor of Pathology and Immunology and of Genetics
Chief Medical Officer, Genomics and Pathology Services
Department of Pathology and Immunology
Department of Genetics
Medical Director of the Clinical Laboratory
The Genome Institute of Washington University
Washington University School of Medicine in St. Louis
10:05 a.m.
Panel Two: Payment/Reimbursement Issues
Moderator: Sean Tunis, M.D., M.Sc., Committee Member
12:15 p.m.
Joseph Chin, M.D., M.S.
Senior Medical Advisor/Acting Deputy Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Scott Ramsey, M.D., Ph.D.
Fred Hutchinson Cancer Research Center
Professor, School of Medicine, School of Pharmacy, and the Institute for Public Health Genetics
University of Washington
Lee N. Newcomer, M.D., M.H.A.
Senior Vice President, Oncology, Genetics and Women’s Health
Brian Carey, J.D.
Partner, Foley Hoag, LLP
12:15 p.m.
1:30 p.m.
1:30 p.m.
Committee Working Lunch
(served in meeting room for committee members only)
1:30 p.m.— Panel Three: Evolving Regulatory Environment
Moderator: Debra Leonard, M.D., Ph.D., Committee Member
3:45 p.m.
Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration
Elizabeth Mansfield, Ph.D.
Deputy Office Director for Personalized Medicine
Office of In Vitro Diagnostics and Radiological Health/
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration
Curtis Hanson, M.D.
Professor of Laboratory Medicine and Pathology
Chief Medical Officer, Mayo Medical Laboratories
Mayo Clinic
Sheila Walcoff, J.D.
CEO and Founder, Goldbug Strategies, LLC
Marisa Papaluca, M.D.
Senior Scientific Advisor, Human Medicines Research& Development Support Division
European Medicines Agency
3:45 p.m.— Panel Four: Future Directions
Moderator: Hal Moses, M.D., Committee Chair
5:30 p.m.
Samuel Aronson, M.A.
Executive Director, IT
Partners Personalized Medicine
Suzanne Topalian, M.D.
Professor of Surgery and Oncology
Director, Melanoma Program, Sidney Kimmel Comprehensive Cancer Center
Johns Hopkins University
John A. Wagner, M.D., Ph.D., FCP, FAAPS
Senior Vice President, Head of Clinical and Translational Sciences
Takeda Pharmaceuticals
Robert Califf, M.D.
Deputy Commissioner for Medical Products and Tobacco
U.S. Food and Drug Administration
5:30 p.m.
Closing Remarks/ADJOURN