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



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 77
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 Registration and Continental breakfast 8:00 am Welcome from National Cancer Policy Forum and 8:30 am Overview of the Workshop David Parkinson, Nodality, Inc. Roy Herbst, M.D. Anderson Cancer Center Technological Hurdles: vignettes 8:45 am 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 

OCR for page 77
 PERSONALIZED MEDICINE IN ONCOLOGY 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 Regulatory Hurdles: Overview of Past Recommendations 1:45 pm 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 bREAK 2:45 pm Regulatory Hurdles: What Is the Status Quo? 3:00 pm 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 Adjourn Day 1 4:30 pm

OCR for page 77
 APPENDIX A DAy 2: TuESDAy, JuNE 9, 2009 Registration and Continental breakfast 8:00 am Regulatory Hurdles: Looking Forward 8:30 am am Why the Food and Drug Administration Should Do More Why Should – Robert Mass, Genentech, Inc. Robert 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 Adjourn Day 2 1:30 pm

OCR for page 77