|
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
SPEAKER SLIDE PRESENTATIONS
(In Adobe Acrobat®)
Past NCAC-SOT Symposia
(Click
on date to view program: not all programs available yet)
- Spring
2007
“The Role of Inflammation in Toxicity”
(includes
speaker abstracts and slide presentations)
- Fall
2006
“Computational Toxicology”
- Spring
2006 “Public
Health Concerns in Disaster Preparedness” (includes
speaker abstracts and slide presentations)
- Fall
2005
“Biological, Toxicological, and Regulatory Assessment of
Nano-Materials” (includes speaker abstracts)
- Spring
2005 “Toxicology
of Chemical Mixtures” (includes speaker
abstracts and slide presentations)
- Fall
2004 “Toxicology
of Dietary Supplements” (includes speaker
abstracts and slide presentations)
- Spring 2004 “Novel
Methods for Detecting Hepatotoxic Agents” (Includes
speaker abstracts and slide presentations)
- Fall 2003 “Animal Models for Safety and
Efficacy Testing of Agents that Cannot be Tested in Humans”
- Spring
2003
“Emerging Issues in Human and
Veterinary Pharmaceutical Contamination of Water Supplies”
- Fall
2002
“Potential Applications of
Noninvasive Techniques to Toxicology”
- Spring 2002 “The Dose Response – The
Cornerstone of Toxicology and Challenges for Risk Assessment”
- Fall 2001
- Spring 2001
- Fall
2000
“Computational Approaches for
Predicting the Toxicity of Chemicals”
- Spring 2000 “Translating Genomics and
Proteomics for Toxicology and Risk Assessment”
- Fall 1999 “Toxicology and Risk
Communication”
|
