Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary (2015)
Chapter: Appendix: Workshop Statement of Task and Agenda
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Workshop Summary
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
Workshop Statement of Task and Agenda
POLICY ISSUES IN THE DEVELOPMENT AND ADOPTION OF MOLECULARLY TARGETED THERAPIES FOR CANCER
An ad hoc committee will plan and host a 1.5-day public workshop that will feature panel discussions and invited presentations. Workshop participants will explore the challenges in developing molecularly targeted therapies and the associated biomarker tests within the traditional research and development paradigm as well as the challenges in implementing treatments and biomarker tests in clinical practice. A major goal of the workshop will be to facilitate discussion about potential strategies and actions to address those challenges.
Participants will be invited to discuss topics that may include:
- Clinical trial designs, the role of registries, and the “N-of-1” approach to evidence development;
- Evidentiary needs, regulatory processes, and ethical/legal considerations;
- The logistics and funding of multisite studies, including patient participation and coverage of experimental costs (biospecimen acquisition, biomarker test and drug costs) in clinical research; and
- Clinical decision-making tools for appropriate implementation in clinical practice.
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
The committee will develop the agenda for the workshop sessions, select and invite speakers and discussants, and moderate the discussions. An individually authored workshop summary will be prepared by a designated rapporteur based on the information gathered and the discussions held during the workshop in accordance with institutional policy and procedures.
AGENDA
National Cancer Policy Forum Workshop Agenda: Policy Issues in the Development and Adoption of Molecularly Targeted Therapies for Cancer
| November 10, 2014 | |
| 7:45 am | Registration |
| 8:00 am | Welcome from the Institute of Medicine’s National Cancer Policy Forum: Michael Caligiuri, James Cancer Hospital and Solove Research Institute, Ohio State University’s Comprehensive Cancer Center |
| Overview of the Workshop: Adrian Senderowicz, Oncology Drug Development, LLC | |
| 8:15 am | Session 1: Challenges in Developing Clinical Biomarker Tests Moderator: Samir Khleif, Georgia Regents University Cancer Center |
| Lessons Learned from Single Analyte Tests Bruce Johnson, Dana-Farber Cancer Institute |
|
| New Challenges with Next Generation Sequencing (NGS) Mia Levy, Vanderbilt University |
|
| Challenges in Analytical Validation of NGS Tests for Clinical Trials Mickey Williams, National Cancer Institute (NCI) |
|
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
| Tests for Circulating Tumor DNA Matthias Holdhoff, Johns Hopkins University |
|
| RNAseq Tests Neil Hayes, University of North Carolina at Chapel Hill |
|
| Group Discussion | |
| 10:30 am | Break |
| 10:45 am | Session 2A: Evidentiary Standards: Regulatory Science Moderator: Adrian Senderowicz, Oncology Drug Development, LLC |
| Overview of Food and Drug Administration (FDA) Regulations for Diagnostics Adrian Senderowicz, Oncology Drug Development, LLC |
|
| Evolving Paradigm for Companion Diagnostics and Other Diagnostic Tests at FDA David Litwack, FDA |
|
| Clinical Utility of Diagnostic Tests David Eberhard, University of North Carolina at Chapel Hill |
|
| Group Discussion | |
| 12:15 pm | Lunch Break |
| 1:00 pm | Session 2B: Evidentiary Standards: Reimbursement Moderator: Robert McDonough, Aetna |
| MolDX Approach Dane Dickson, Palmetto, Teton Cancer Institute |
|
| Payer’s Perspectives Donna Messner, Center for Medical Technology Policy (CMTP) |
|
| Group Discussion |
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
| 2:00 pm | Session 3A: Generating Evidence: Clinical Trial Designs Moderator: Barbara Conley, NCI |
| Lung-MAP Roy Herbst, Yale University |
|
| Matching Drugs to Mutations for Treating Advanced Cancer Lilian Siu, Princess Margaret Hospital, Ontario Cancer Institute |
|
| Evaluation of Next Generation Sequencing for Companion Diagnostics Use Anne-Marie Martin, GlaxoSmithKline |
|
| Group Discussion | |
| 3:20 pm | Break |
| 3:30 pm | Session 3B: Generating Evidence: Other Mechanisms Moderator: Richard Schilsky, American Society of Clinical Oncology |
| Actionable Genome Consortium David Solit, Memorial Sloan Kettering Cancer Center |
|
| Coverage with Evidence Development Sean Tunis, CMTP |
|
| Facilitated Drug Access Program and Registry Richard Schilsky, American Society of Clinical Oncology |
|
| Benefits and Limitations/Challenges of Registries/Databases Garnet Anderson, Fred Hutchinson Cancer Research Center, University of Washington School of Public Health |
|
| Group Discussion | |
| 5:15 pm | Wrap Up Day 1 and Adjourn |
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
| November 11, 2014 | |
| 7:30 am | Registration |
| 8:00 am | Session 4: Practice Guidelines and Implementation into Clinical Practice Moderator: Roy Herbst, Yale University |
| Guidelines Development William Gradishar, Northwestern University |
|
| Treatment Pathways Jennifer Malin, WellPoint |
|
| Adoption of Genomics in Oncology Care Kathryn Phillips, University of California, San Francisco |
|
| Return of Sequencing Results to Patients Patricia LoRusso, Yale University |
|
| Group Discussion | |
| 10:00 am | Break |
| 10:15 am | Session 5: The Business Model for Test Development Moderator: Lisa McShane, NCI |
| Karen Long, Abbott Molecular | |
| Federico Monzon, Invitae | |
| Group Discussion | |
| 11:30 am | Workshop Wrap-Up |
| 11:45 am | Adjourn |
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
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Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
Suggested Citation:
"Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2015. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies: Workshop Summary. Washington, DC: The National Academies Press.
doi: 10.17226/21692.
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