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Agenda: EDRN FDA Education Workshop
The purpose of this workshop was to open dialogue between FDA staff that provide oversight for review of in vitro diagnostic applications and EDRN scientists currently performing clinical validation studies on cancer biomarkers. Issues related to FDA review of diagnostic tests were presented by FDA personnel. Representatives from EDRN provided details on supporting data of their validation studies and the resources developed within EDRN to facilitate such research for FDA compliance. The agenda provided here provides links to the presentations by each speaker.
EDRN FDA Education Workshop
Natcher Conference Center
National Institutes of Health
Bethesda, MD
February 15, 2007
- 9:00 – 9:05 am Welcome
- Paul Wagner, Ph.D., National Cancer Institute
- Francis Kalush, Ph.D., Food and Drug Administration
- 9:05 – 9:30 am
- Sudhir Srivastava, Ph.D., M.P.H., National Cancer Institute
- Overview of NCI’s Early Detection Research Network
- 9:30 – 9:40 am Questions
- 9:40 – 10:10 am
- Steve Gutman, M.D., Food and Drug Administration
- FDA Overview of Molecular Diagnostics and Critical Path Initiative
- 10:10 – 10:20 am Questions
- 10:20 – 10:35 am Coffee Break
- 10:35 – 11:05 am
- Margaret Pepe, Ph.D, Fred Hutchinson Cancer Research Center
- EDRN Approach to Biomarker Validation: Statistical Approaches, Designs, and Parameters for Evaluation Early Detection Biomarkers
- 11:05 – 11:15 am Questions
- 11:15 – 11:55 am
- Robert Becker, M.D, Ph.D., Food and Drug Administration
- Establishment of an In Vitro Diagnostic (IVD) Claim
- Greg Campbell, Ph.D., Food and Drug Administration
- Statistical Approaches, Clinical Study Designs, and Parameters for Evaluation of IVD Biomarkers: FDA Regulatory Requirements
- 11:55 – 12:05 pm Questions
- 12:05 – 12:25 pm
- Jackie Dahlgren, Fred Hutchinson Cancer Research Center
- Validation Study Management System: A Category 5 Software System for Managing EDRN Validation Studies
- 12:25 – 12:35 pm Questions
- 12:35 – 1:30 pm Lunch
- 1:30 – 2:00 pm
- Jorge Marrero, M.D., University of Michigan
- DCP for Hepatocellular Carcinoma Validation Trial
- 2:00 – 2:30 pm
- Mark Schoenberg, M. D., Johns Hopkins University
- MSA for Bladder Cancer Validation Trial (Part 1)
- Mark Thornquist, Ph.D., Fred Hutchinson Cancer Research Center
- MSA for Bladder Cancer Validation Trial (Part 2)
- 2:30 – 3:00 pm Questions and discussion
- Jorge Marrero, M.D., Ziding Feng, Ph.D., Mark Schoenberg, M.D., Mark Thornquist Ph.D., Maria Chan, Ph.D., and Gene Penello, Ph.D
- Moderator: Paul Wagner, Ph.D., NCI
- 3:00 – 3:10 pm Break
- 3:10 – 3:40 pm
- Daniel Cramer, M.D., Brigham and Women’s Hospital
- Panel of Protein Markers for Ovarian Cancer
- 3:40 – 4:10
- Alla Ivanova, M.D., New York University School of Medicine
- Protein Markers for Mesothelioma
- Mark Thornquist, Ph.D., Fred Hutchinson Cancer Research Center
- Statistical Considerations for Mesothelioma
- 4:10 – 4:40 pm Questions and discussion
- Daniel Cramer, M.D., Mark Thornquist, Ph.D., Alla Ivanova, M.D., Dave Li, M.D., and Estelle Russek-Cohen, Ph.D.
- Moderator: Francis Kalush, Ph.D., FDA
- 4:40 – 5:00 pm General Discussion
- Lead by: Sudhir Srivastava, Ph.D., M.P.H., NCI and Larry Kessler, Sc.D., FDA
