Appendix A
Workshop Agenda
National Cancer Policy Forum
Workshop on Policy Issues in the Development of Personalized Medicine in Oncology
National Academy of Sciences Building – Lecture Room
2100 C Street, NW
Washington, DC 20001
DAY 1: MONDAY, JUNE 8, 2009
|
8:00 am |
Registration and Continental Breakfast |
|
8:30 am |
Welcome from National Cancer Policy Forum and Overview of the Workshop David Parkinson, Nodality, Inc. Roy Herbst, M.D. Anderson Cancer Center |
|
8:45 am |
Technological Hurdles: Vignettes Multiple Genetic Changes in Breast Cancer – Stephen Friend, Sage Bionetworks KRAS in Colorectal Cancer – Rafael Amado, GlaxoSmithKline EGFR in Lung Cancer – Bruce Johnson, Dana-Farber Cancer Institute FLT3 in Leukemia – Donald Small, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Pharmacogenomic Issues in Drug Development – Mark Ratain, University of Chicago Medical Center Moderator – Fred Appelbaum, Fred Hutchinson Cancer Research Center |
|
10:30 am |
BREAK |
|
10:45 am |
Technological Hurdles: Professional Perspectives Clinician Perspective – Richard Schilsky, University of Chicago; Cancer and Leukemia Group B Drug Developer Perspective – Robert Mass, Genentech, Inc. Diagnostic Developer Perspective – Steven Shak, Genomic Health, Inc. Patient Perspective – Amy Bonoff, National Breast Cancer Coalition Moderator – Richard Schilsky, University of Chicago; Cancer and Leukemia Group B |
|
12:45 pm |
LUNCH |
|
1:45 pm |
Regulatory Hurdles: Overview of Past Recommendations The Original Secretary’s Advisory Committee on Genetic Testing – Wylie Burke, University of Washington The Secretary’s Advisory Committee on Genomics, Health and Society – Andrea Ferreira-Gonzalez, Virginia Commonwealth University Moderator – Steven Gutman, University of Central Florida |
|
2:45 pm |
BREAK |
|
3:00 pm |
Regulatory Hurdles: What Is the Status Quo? What Is the Food and Drug Administration Currently Doing? – Alberto Gutierrez, Office of In Vitro Diagnostic Devices, Food and Drug Administration How Do the Clinical Laboratory Improvement Amendments Oversee Laboratory-Developed Tests? – Penelope Meyers, Division of Laboratory Services, Centers for Medicare & Medicaid Services What Can the Center for Disease Control and Prevention Do to Help in the Assessment of New Tests? – Ralph Coates, Coordinating Center for Health Promotion, Center for Disease Control and Prevention Moderator – Steven Gutman, University of Central Florida |
|
4:30 pm |
Adjourn Day 1 |
DAY 2: TUESDAY, JUNE 9, 2009
|
8:00 am |
Registration and Continental Breakfast |
|
8:30 am |
Regulatory Hurdles: Looking Forward Why the Food and Drug Administration Should Do More – Robert Mass, Genentech, Inc. Is the Status Quo Appropriate? – Debra Leonard, Weill Cornell Medical College Moderator – Steven Gutman, University of Central Florida |
|
10:00 am |
BREAK |
|
10:15 am |
Reimbursement Hurdles Medicare Coverage and Reimbursement – Jeffrey Roche, Coverage and Analysis Group, Centers for Medicare & Medicaid Services and Amy Bassano, Center for Medicare Management, Centers for Medicare & Medicaid Services Clinician Perspective – Daniel Hayes, University of Michigan Comprehensive Cancer Center Policy Perspective – Bruce Quinn, Foley Hoag, LLP Moderator – Peter Bach, Memorial Sloan-Kettering Cancer Center |
|
12:15 pm |
BREAK – Please Retrieve Prepared Lunch and Return for Working Lunch with Last Session |
|
12:30 pm |
Reactions to the Workshop Patient Perspective – Robert Erwin, Marti Nelson Cancer Foundation Industry Perspective – Stephen Friend, Merck & Co, Inc. and David Parkinson, Nodality, Inc. Clinician Perspective – Roy Herbst, M.D. Anderson Cancer Center Venture Capital Perspective – Risa Stack, Kleiner Perkins Caulfield and Byers Moderator – Gail Javitt, Genetics and Public Policy Center, Johns Hopkins University |
|
1:30 pm |
Adjourn Day 2 |
