Workshop Design Team
Dr. James Bus (Acting Chair), Dow Chemical Company
Dr. Melvin Andersen, Chemical Industry Institute of Toxicology
Dr. Hugh Barton, U.S. Environmental Protection Agency
Dr. Janice Chambers (Scientific Advisor), Mississippi State University
Dr. Craig Farr, Arkema Inc.
Dr. James Gibson (Scientific Advisor), East Carolina State University
Dr. David Jacobson-Kram, U.S. Food and Drug Administration
Dr. Robert Lindenschmidt, Procter & Gamble
Dr. Ron Melnick, National Institute of Environmental Health Sciences
Dr. James Sanders, sanofi-aventis
Dr. Charles Timchalk, Batelle Northwest
Mr. J. David Sandler, Staff
Ms. Candice Hamilton, Staff
Why is HESI undertaking this exercise?
- Rapid advances in analytical sciences and pharmacokinetic modeling position chemical safety evaluations to include earlier and more comprehensive pharmacokinetic evaluations that provide critical study design and interpretive information.
- Some regulatory initiatives present potential for increased animal tests (e.g., HPV, REACH) while others seek to reduce or refine these tests (e.g., European Cosmetic Directive, SAR)
- Exposure/dose information from human biomonitoring programs must be placed in context with dosimetry information from animal studies to understand potential for human risk.
Also:
- Likely rapid increase in availability of pharmacokinetic information and methodologies indicate that efforts must be made to mutually understand their potential application and value
- Need to define and implement appropriately harmonized approaches.
The Workshop will identify…
- Key partners: industry, academia, government
- Critical research supporting proactive and rational role for use of pharmacokinetic data in design and interpretation of toxicology studies
- Opportunities to improve use of pharmacokinetic data in risk assessments, including evaluations of mode of action, interpreting biomonitoring results, and risks of low-dose exposures to mixtures
The Workshop will…
- Fully consider activities of current HESI projects, i.e., Agricultural Chemical Safety Assessment, DNA Adducts, Biomarkers, others.