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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 AM Registration and Continental Breakfast

9:00 AMWelcome/Opening Remarks

Gary Burin, Ph.D.

President, NCAC-SOT

Donna Mendrick, Ph.D.

Vice-President, NCAC-SOT and Program Chair

9:10 AM 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 AM Experience with a Biomarker Consortium

William Mattes, Ph.D., D.A.B.T.

Director of Toxicology

The Critical Path Institute

Rockville, MD

10:50 AM Break

11:10 AM 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 PM Lunch (Box lunch and beverage included in registration fee)

1:00 PM 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 PM Break

2:10 PM 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 PM 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 PMClosing Remarks

Donna Mendrick, Ph.D.

Vice-President, NCAC-SOT and Program Chair

4:00 PM Meeting Adjourned

SPEAKER SLIDE PRESENTATIONS (In Adobe Acrobat®)

 

 

 

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