Biomarkers of Drug Safety: Discovery
and Regulatory Aspects
National Capital Area Chapter
Society of Toxicology
Fall Symposium
November 6, 2007
Lister
Hill Auditorium
National
Library of Medicine
Bethesda, MD
Program
8:30 a.m. Registration and Continental Breakfast
9:00 a.m. Welcome/Opening
Remarks
Gary Burin, Ph.D.
President, NCAC-SOT
Donna Mendrick, Ph.D.
Vice-President, NCAC-SOT and Program Chair
9:10 a.m. Computational Framework to Predict Toxicity and Prioritize Testing of Environmental Chemicals
Thomas B. Knudsen, Ph.D.
Developmental Systems Biologist (title 42)
National Center for Computational Toxicology
Office of Research & Development
U.S. Environmental Protection Agency
Research Triangle Park, NC
10:00 a.m. Experience with a Biomarker Consortium
William Mattes, Ph.D., D.A.B.T.
Director of Toxicology
The Critical Path Institute
Rockville, MD
10:50 a.m. Break
11:10 a.m. A Year of Working through a Biomarker Qualification Pilot Process at the FDA
Federico Goodsaid, Ph.D.
Genomics Group
Office of Clinical Pharmacology
Office of Translational Science
Center for Drug Evaluation and Research. U.S. Food and Drug Administration
Silver Spring, MD
12:00 p.m. Lunch (Box lunch and beverage included in registration fee)
1:00 p.m. Bridging Exploratory Biomarkers into Drug Development
Joseph Sina, Ph.D.
Senior Scientific Director, Systems Toxicology
Department of Safety Assessment
Mereck & Co., Inc.
West Point, PA
1:50 p.m. Break
2:10 p.m. Thinking About How a Preclinical Program Can Translate into the Clinic
Jerry M. Collins, Ph.D.
Associate Director for Developmental Therapeutics
Division of Cancer Treatment and Diagnosis, NCI, NIH
Bethesda, MD
3:00 p.m. Monitoring Genetic Toxicity Indicators in Clinical Trials: Pros and Cons
David Jacobson-Kram, Ph.D., D.A.B.T.
Associate Director for Pharmacology and Toxicology
Office of New Drugs
Center for Drug Evaluation and Research
Silver Spring, MD 20993
3:50 p.m. Closing Remarks
Donna Mendrick, Ph.D.
Vice-President, NCAC-SOT and Program Chair
4:00 p.m. Meeting Adjourned