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Genomics at FDA
Presentations from FDA, DIA, PhRMA,
BIO, & PWG Workshop on
“Applications and Validation of Genomic Biomarkers for Use
in Drug Development and Regulatory Decision Making”
Bethesda, MD, October 6 – 7, 2005
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zip file of all presentations (6.71 MB)
Download Full Program [PDF]
Presentations: Day
One
Introduction
[PDF]
Felix W. Frueh, Ph.D.
Associate Director for Genomics, Office of Clinical Pharmacology and
Biopharmaceutics, FDA/CDER
Importance of Genomic Biomarker
Validation in the Context of Pharmacogenomic Initiatives at the FDA
[PDF]
Janet Woodcock, M.D.
Deputy Commissioner for Operations, FDA
Current and Anticipated Use of
Genomic Biomarkers in Drug Development
[no slides available]
Klaus Lindpaintner, M.D.
Vice President, Research Head, Roche Genetics and Roche Center for
Medical Genomics
Qualification of Toxicogenomic
Biomarkers for Applications to Early Drug Development
[PDF]
Frank Sistare, Ph.D.
Executive Director, Laboratory Sciences and Investigative
Toxicology, Merck
Biomarkers from a Diagnostic
Perspective
P. Mickey Williams, Ph.D.
Director, Pharmacogenetics Department, Roche Molecular Systems, Inc.
The Use of Efficacy Biomarkers in
Drug Development
Stephen A. Williams, Ph.D.
Head of Worldwide Clinical Technology, Pfizer
Efficacy/Risk Assessment
[PDF]
Douglas C. Throckmorton, M.D.
Deputy Center Director, FDA/CDER
Case Studies in Electronic
Submissions for Toxicogenomics: Update on the HL-7 Toxicogenomics
Electronic Submission Workgroup
Joseph Sina, Ph.D., Merck - Toxicogenomic Investigation of
Compound-induced GI Toxicity [PDF]
Thomas Papoian, Ph.D., FDA/CDER - Use of Microarray Data in
Support of a Hypothetical Drug Submission: Attenuation of
Ventricular Remodeling Associated with Heart Failure in an Animal
Model [PDF]
William B Mattes, PhD, Gene Logic - The Nofatatol Submission
Example
Breakout Session 1: Standards for
Safety and Efficacy Biomarkers
Case Study [PDF
(Background),
PDF (Slides)]
Breakout Session 2: Validation of
Safety and Efficacy Biomarkers
Case Study [PDF
(Background_Safety),
PDF (Background_Efficacy),
PDF (Slides)]
Introducing Genomic Biomarkers into
Drug Development to Improve Safety and Efficacy
[PDF]
Jacky Vonderscher, Ph.D.
Vice President, Head of the Novartis-GNF Discovery Science Office,
Novartis
Presentations: Day
Two
Opening Remarks
[PDF]
Mark Watson, Ph.D.
Clinical Pharmacogenetics, GlaxoSmithKline
Use of Genomic Biomarkers in a
Regulatory Environment [PDF]
Robert J. Temple, M.D.
Director, Office of Medical Policy, FDA/CDER
Regulatory Experience with
Voluntary Genomic Data Submissions and Collaborations: Do They Help
Us to Qualify Genomic Biomarkers?
[PPT]
Robert J. Meyer, M.D.
Director, Office of Drug Evaluation II, FDA/CDER
Regulatory Pathways to Qualify
Genomic Biomarkers: What Do We Need?
[PDF]
Christopher Webster, Ph.D.
Director, Regulatory Strategy and Intelligence, Millennium
Pharmaceuticals
(Representing PhRMA)
Current Experience with
Pre-Clinical Safety Biomarker Qualification
[PDF]
Gerard Maurer, Ph.D.
Senior Expert, Exploratory Development, Novartis
Transcriptional Biomarker Discovery
in a Phase II Clinical Trial and Prospects for Phase III Validation
[PDF]
Andy Dorner, Ph.D.
Senior Director, Molecular Profiling and Biomarker Discovery, Wyeth
Developing and Validating Genomic
Classifiers [PDF]
Richard Simon, D.Sc.
Chief, Biometric Research Branch, National Cancer Institute
Breakout Session 3: How to
Incorporate and Use Genomic Biomarkers for Regulatory Decision
Making
Case Study [PDF
(slides)]
Luis Parodi, Ph.D., Pfizer - Optimizing Irinotecan
Safety/Efficacy Profile with UGT1A1 Genotypes [PDF]
Breakout Session 4: Database
Development for Safety and Efficacy Biomarkers
Case Study [PDF
(Background),
PDF (slides)]
Usha Reddy, Ph.D., IBM Lifesciences - HL7 Clinical Genomics
Special Interest Group [PDF]
Weida Tong, Ph.D., FDA - Analysis of VGDS Data Using ArrayTrack
[PDF]
Shashi Amur, Ph.D., FDA - Biological Interpretation of
Differentially Expressed Gene Lists Generated by ArrayTrack [PDF]
Jennifer Fostel, Ph.D., NIH - CEBS: Chemical Effects in
Biological Systems – Integrating Biology with Microarray/Proteomics
Data [PDF]
Closing Remarks
[PDF]
Felix W. Frueh, Ph.D.
Associate Director for Genomics, Office of Clinical Pharmacology and
Biopharmaceutics, FDA/CDER
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Date created: November 1, 2005 |
