Appendix A
Workshop Agenda

National Cancer Policy Forum

Workshop on

Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment:

The State of the Science, Evaluation, Implementation, and Economics


National Academy of Sciences Building Auditorium

2101 Constitution Avenue, N.W.

Washington, DC


Agenda

2.5 days, March 20-22, 2006


Day 1—March 20, 2006


8:30 am Welcome and introductory remarks

Hal Moses, MD (Vanderbilt University, Chair, National Cancer Policy Forum)


8:45-10:15 am Session 1

Brief overview of technologies

Moderator: Howard Schulman



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Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics Appendix A Workshop Agenda National Cancer Policy Forum Workshop on Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics National Academy of Sciences Building Auditorium 2101 Constitution Avenue, N.W. Washington, DC Agenda 2.5 days, March 20-22, 2006 Day 1—March 20, 2006 8:30 am Welcome and introductory remarks Hal Moses, MD (Vanderbilt University, Chair, National Cancer Policy Forum) 8:45-10:15 am Session 1 Brief overview of technologies Moderator: Howard Schulman

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Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics Presentations: Genomics-based technologies (including DNA microarrays, CGH, and sequencing technologies) Todd Golub, MD (The Broad Institute of Harvard and MIT) Proteomics and metabolomics technologies Howard Schulman, PhD (PPD Biomarker Discovery Sciences) Technologies for physiological characterization (including functional imaging) Michael Phelps, PhD (University of California, Los Angeles) 10:30 am-12:00 noon Session II Overcoming the technical obstacles Moderator: Charles Sawyers Presentations: Informatics and data standards John Quackenbush, PhD (Harvard) Biomarker validation David Ransohof, MD (University of North Carolina) Biomarker qualification: Fitness for use John Wagner, MD, PhD (Merck and Co., Inc.) 12:00 noon-1:00 pm Lunch break 1:00-3:00 pm Session III Coordinating the development of biomarkers and targeted therapies Moderator: David Parkinson

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Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics Presentations: Therapeutics industry perspective/realities (examples of successes and difficulties/failures of targeted therapy) Paul Waring, PhD (Genentech) Diagnostics industry perspective (industry mission/business models/marketing strategies, & IP) Robert Lipshutz, PhD (Affymetrix) NCI/NIH perspective (goals and funding initiatives) James Doroshow, MD (National Cancer Institute) Clinical investigator perspective Charles Sawyers, MD (University of California, Los Angeles) 3:15-5:45 pm Small Group Discussions Policy implications surrounding biomarker development— prioritizing problems and solutions 1) Strategies for implementing standardized biorepositories Moderators—Carolyn Compton, Brent Zanke, Hal Moses Invited Discussants—Edith Perez, Margaret Spitz, B. Melina Cimler, Indra Poola, Ann Zauber 2) Strategies for determining analytic validity and clinical utility of biomarkers Moderators—Janet Woodcock, Howard Schulman, John Wagner Invited Discussants—Walter Koch, Zoltan Szallasi, Scott Patterson, Ronald Hendrickson, David Carbone, Laura Reid 3) Clinical development strategies for biomarker utilization Moderators—Charles Sawyers, Stephen Friend, David Parkinson, Richard Simon Invited Discussants—Richard Schilsky, David Agus, Barbara Weber, Richard Frank, Robert Gillies

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Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics 4) Strategies to develop biomarkers for early detection Moderators—Scott Ramsey, David Ransohof Invited Discussants—Jean-Pierre Wery, Kathryn Phillips, Larry Norton, Hongyue Dai, David Muddiman 5:45 pm Adjourn Day 1 Day 2—March 21, 2006 8:30 am Welcome—Opening remarks Hal Moses 8:45-10:15 am Session IV Biomarker development and regulatory oversight Moderator: Janet Woodcock Presentations: FDA Critical Path Initiative Janet Woodcock, MD (Food and Drug Administration) Clinical laboratory diagnostic tests: Oversight for analytical and clinical validation Mark Heller, JD (Wilmer Cutler Pickering Hale and Dorr) Clinical trial design and biomarker-based tumor classification systems Richard Simon, DSc (National Cancer Institute) 10:30 am-12:00 noon Session V Adoption of biomarker-based technologies Moderator: Alfred Berg Presentations: CMS strategies for biomarker coverage Jim Rollins, MD, PhD (Centers for Medicare & Medicaid Services)

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Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics Insurance coverage and practice guidelines William McGivney, PhD (National Comprehensive Cancer Network) Technolgy assessment and clinical decision making Alfred Berg, MD, MPH (University of Washington) 12:00 noon-1:00 pm Lunch Break 1:00-2:30 pm Session VI Economic impact of biomarker technologies Moderator: Scott Ramsey Presentations: Cost-effectiveness analysis and technology adoption in the UK Andrew Stevens, MD (UK National Institute for Health and Clinical Excellence) Cost-effectiveness analysis and the value of research David Meltzer, MD, PhD (University of Chicago) The payer perspective Naomi Aronson, PhD (BlueCross BlueShield Technology Evaluation Center) 2:45-5:15 pm Small Group Discussions Policy implications surrounding biomarker adoption—prioritizing problems and solutions 1) Mechanisms for developing an evidence base Moderators—Janet Woodcock, David Parkinson, Charles Sawyers Invited Discussants—Walter Koch, Indra Poola, Laura Reid, Richard Frank

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Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics 2) Evaluation of evidence in decision making Moderators—Naomi Aronson, Scott Ramsey Invited Discussants—Ronald Hendrickson, Ann Zauber, Kathryn Phillips, Barbara Weber, Robert Gillies 3) Incorporating biomarker evidence into clinical practice Moderators—Robert McDonough, William McGivney Invited Discussants—David Carbone, David Agus, Hongyue Dai, Mark Fendrick, Judith Hellerstein, Judith Wagner 5:15 pm Adjourn Day 2 Day 3—March 22, 2006 Reports from small group discussions 8:30-10:00 am Reports from day 1 group leaders 10:15 am-12:15 pm Reports from day 2 group leaders 12:15 pm Wrap up/summary Hal Moses 12:30 pm Lunch—Adjourn