Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies MEETING 2 AGENDA The Keck Center of the National Academies 500 Fifth Street, NW Washington, DC 20001 April 1, 2015 Room 201 BEGIN OPEN SESSION 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. Break 10:15 a.m.— Panel Two: Payment/Reimbursement Issues Moderator: Sean Tunis, M.D., M.Sc., Committee Member 1 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 UnitedHealthCare Brian Carey, J.D. Partner, Foley Hoag, LLP 12:15 p.m. 12:15 p.m.— 1:30 p.m. 1:30 p.m. BEGIN CLOSED SESSION Committee Working Lunch (served in meeting room for committee members only) BEGIN OPEN SESSION 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 2 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 3