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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
New Funding Opportunity: Biomarker Development Laboratories for the Early Detection Network: Applications Due May 23

Update: Pre-application webinar information now available.

The National Cancer Institute's Division of Cancer Prevention has released a new funding opportunity to solicit organ-specific applications for Biomarker Developmental Laboratories (BDLs), one of the four scientific units of the recently funded Early Detection Research Network (EDRN). The EDRN is a national infrastructure funded to discover, develop, and validate biomarkers for risk assessment, detection, and molecular diagnosis and prognosis of early cancer. BDLs are responsible for the discovery, development, characterization, and testing of new, or the refinement of existing, biomarkers and biomarker assays for risk assessment, detection, and molecular diagnosis and prognosis of cancers.

The existing BDLs are primarily focused on ovary and gastrointestinal cancers. The proposed BDLs (to be supported under this funding opportunity) should be focused on one or more of the following cancers: breast, prostate and other genitourinary organs, or lung. In addition, cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers, and/or cancers with unique etiology, e.g., mesothelioma, will be considered.

The newly funded units of the Early Detection Research Network will be announced later in April. Successful applicants have already been notified. Those researchers who were not successful during the last round of applications are encouraged to apply to this opportunity.