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FORUM HOME
Emerging Safety Sciece
April 23-24, 2007
FDA White Oak Conference Center
Silver Spring, MD
Click on a speaker's name to see their slides. Please note that not all speakers gave permission to post their slides.
Monday, April 23: The Biology of Adverse Events
8:30-8:35 Welcome and Opening Remarks
- ED HOLMES, Workshop Chair
Co-Chair, Forum on Drug Discovery, Development, and Translation
Executive Deputy Chairman
A*Star Biomedical Research Council, Singapore
8:35-8:45 Meeting Objectives: Merging New Science and Drug Review
- STEVE GALSON
Member, Forum on Drug Discovery, Development, and Translation
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration
- JANET WOODCOCK
Member, Forum on Drug Discovery, Development, and Translation
Deputy Commissioner and Chief Medical Officer
U.S. Food and Drug Administration
8:45-9:40 Human Cell System-Based Approaches to Signaling and Biology
- Moderator: DAVID JACOBSON-KRAM
Associate Director for Pharmacology and Toxicology
Office of New Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
20 min. Drug Evaluation in Human Cell-Systems: Biology Based Models of Physiology and Disease.
- EUGENE BUTCHER
Co-founder and Chair of the Scientific Advisory Board, Bioseek
Professor, Department of Pathology
Stanford University School of Medicine
20 min. High Throughput, High Content Cellular Screening for Definition of Drug Mechanisms, Selectivity and Safety.
15 min. DISCUSSION
9:40-12:30 Biomarkers of Toxicity in Drug Discovery and Development
- Moderator: FEDERICO GOODSAID
Senior Staff Scientist in Genomics
Office of Clinical Pharmacology, Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
20 min. Toxicogenomics and assessment of drug pharmacology using microarrays.
- MARK COCKETT
Vice President, Applied Genomics
Bristol-Myers Squibb Company
20 min. Application of Toxicogenomics to Drug Discovery and to Preclinical Safety Assessment.
- DON HALBERT
Executive Vice President Research and Development
Iconix Pharmaceuticals
10:20-10:35 Break
20 min. Practical Application of Toxicogenomics in Early Drug Discovery.
- BRIAN SPEAR
Director, Genomic and Proteomic Technologies
Abbott Laboratories
20 min. Gene Expression Profiling in Rat Exploratory Toxicology Studies: Why and Where is it Useful?
- ERIC BLOMME
Project Leader, Cell and Molecular Toxicology
Abbott Laboratories
20 min. Integration of Preclinical, Clinical, and Post Marketing Safety Data.
20 min. Qualification of Drug Induced Nephrotoxicity Biomarkers
20 min. The Transition from Pre-Clinical to Clinical Application of Safety Related Genomics.
- FELIX FRUEH
Associate Director for Genomics
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
15 min. DISCUSSION
12:30-1:30 Lunch
1:30-2:25 Metabolomics in Drug Safety
- Moderator: SHIEW-MEI HUANG
Deputy Director
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
20 min. Mx as an Emerging Technology in Drug Safety Assessment.
20 min. Targeted Metabolomics in Pharmacodynamics and Toxicology
- KLAUS WEINBERGER
Chief Scientific Officer
BIOCRATES Life Sciences GmbH
- 15 min. DISCUSSION
2:25-3:20 Targeted Therapy
- Moderator: GEORGE ROCHESTER
Lead Mathematical Statistician
Quantitative Safety & Pharmacoepidemiology Group
Office of Biostatistics
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
20 min. ALK5: Targeted Investigations of a Targeted Therapy - Using Laser Capture Microdissection, Flow Cytometry, Immunohistochemical Approaches and Genomics.
- KEN FRAZIER
Director of Cellular & Molecular Pathology
GlaxoSmithKline, Safety Assessment
15 min. DISCUSSION
3:20-3:35 Break
3:35-4:15 Abacavir: A Working Example of PGx Investigation of Drug-Related Adverse Events
- Moderator: DEBRA BIRNKRANT
Medical Team Leader, Division of Antiviral Products
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
30 min. Abacavir: A Working Example of PGx Investigation of Drug-Related Adverse Events.
- ERIC LAI
Vice President
PGx Experimental Project Coordination and Analysis
GlaxoSmithKline
10 min. DISCUSSION
4:15- 4:45 Where is the science taking us?
Drug Forum Panel Discussion:
- JANET WOODCOCK, U.S. Food and Drug Administration
- MIKHAIL GISHIZKY, Entelos, Inc.
- PETER CORR, Pfizer, Inc. (retired)
- THOMAS CASKEY, University of Texas HSC at Houston
Tuesday, April 24: Datamining from Medical Experience
8:30-8:45 Welcome and Opening Remarks
- ED HOLMES, Workshop Chair
Co-chair, Forum on Drug Discovery, Development, and Translation
Executive Deputy Chairman
A*Star Biomedical Research Council, Singapore
- JANET WOODCOCK
Member, Forum on Drug Discovery, Development, and Translation
Deputy Commissioner and Chief Medical Officer
U.S. Food and Drug Administration
8:45-11:00 Approaches to Pharmacovigilance and Signal Detection
Moderators:
- PAUL SELIGMAN
Associate Director for Safety Policy and Communication
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
- GERALD DAL PAN
Director, Office of Surveillance and Epidemiology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
30 min. Signal Management through the Product Life Cycle.
- JUNE S. ALMENOFF
Vice-President, Safety Evaluation and Risk Management
Global Clinical Safety and Pharmacovigilance
GlaxoSmithKline
30 min. Statistical Issues in the Analysis of Spontaneous Report Databases.
30 min. Active Surveillance for Anticipated Adverse Events: Opportunities and Challenges.
- RICHARD PLATT
Professor and Chair
Harvard Medical School and Harvard Pilgrim Health Care
10:15-10:30 Break
30 min. Panel Discussion
- JUNE ALMENOFF, GlaxoSmithKline
- WILLIAM DUMOUCHEL, Lincoln Technologies
- RICHARD PLATT, Harvard Medical School
- ANA SZARFMAN, U.S. Food and Drug Administration
- JUDITH RACOOSIN, U.S. Food and Drug Administration
11:00-12:00 Where is the science taking us?
30 min. Summing Up: Improving Safety Science to Make Better Medicines.
- RON KRALL
Member, Forum on Drug Discovery, Development, and Translation
Senior Vice President and Chief Medical Officer
GlaxoSmithKline
11:30-12:00 Panel Discussion
- JANET WOODCOCK, U.S. Food and Drug Administration
- PAUL SELIGMAN, U.S. Food and Drug Administration
- RON KRALL, GlaxoSmithKline
- JOHN JENKINS, U.S. Food and Drug Administration
- MARY PRINCE PANACCIO, Merck
12:00 Adjourn
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