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Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
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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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

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)

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
Page 93
Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
Page 94
Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
Page 95
Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
Page 96
Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
Page 97
Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
Page 98
Next: Appendix B Workshop Speakers, Moderators, Invited Discussants, and Participants »
Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary Get This Book
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Research has long sought to identify biomarkers that could detect cancer at an early stage, or predict the optimal cancer therapy for specific patients. Fueling interest in this research are recent technological advances in genomics, proteomics, and metabolomics that can enable researchers to capture the molecular fingerprints of specific cancers and fine-tune their classification according to the molecular defects they harbor. The discovery and development of new markers of cancer could potentially improve cancer screening, diagnosis, and treatment. Given the potential impact cancer biomarkers could have on the cost effectiveness of cancer detection and treatment, they could profoundly alter the economic burden of cancer as well.

Despite the promise of cancer biomarkers, few biomarker-based cancer tests have entered the market, and the translation of research findings on cancer biomarkers into clinically useful tests seems to be lagging. This is perhaps not surprising given the technical, financial, regulatory, and social challenges linked to the discovery, development, validation, and incorporation of biomarker tests into clinical practice.

To explore those challenges and ways to overcome them, the National Cancer Policy Forum held the conference "Developing Biomarker-Based Tools for Cancer Screening, Diagnosis and Treatment: The State of the Science, Evaluation, Implementation, and Economics" in Washington, D.C., from March 20 to 22, 2006.

At this conference, experts gave presentations in one of six sessions. In addition, seven small group discussions explored the policy implications surrounding biomarker development and adoption into clinical practice. Developing Biomarker-based Tools for Developing Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics-Workshop Summary presents the conference proceedings and will be used by an Institute of Medicine (IOM) committee to develop consensus-based recommendations for moving the field of cancer biomarkers forward.

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