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
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
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
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)
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
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
