Transcript HESI Project Committee on Dose-Dependent

HESI
ILSI Health and Environmental Sciences Institute
HESI PROJECT COMMITTEE ON
DOSE-DEPENDENT TRANSITIONS
IN MECHANISMS OF TOXICITY
NANCY G. DOERRER, MS
HESI
[email protected]
SOT Risk Assessment Specialty Section Teleconference
February 9, 2005
HESI
ILSI Health and Environmental Sciences Institute
Project Committee Leadership
Chair:
DR. WILLIAM SLIKKER, JR.
US Food and Drug Administration
National Center for Toxicological Research
Vice Chair / Scientific Advisor:
DR. KENDALL WALLACE
University of Minnesota
HESI
ILSI Health and Environmental Sciences Institute
Project History
• 2001: Project Committee formed;
objectives defined
• 2002: Development of case examples to
demonstrate dose-dependent transitions
• 2003: Multi-stakeholder, multi-sector
workshop to build consensus on principles
and applications
• 2004: TAAP publications
• 2003-2005: Outreach
HESI
ILSI Health and Environmental Sciences Institute
Project Committee Participation
Government Participation: Agency for Toxic Substances and
Disease Registry, National Institute of Environmental Health
Sciences, US Environmental Protection Agency, US Food and
Drug Administration
Academic Participation: Clark University, University of
Kansas Medical Center, University of Minnesota, University of
North Carolina
Industry: The Dow Chemical Company, DuPont Haskell
Laboratory for Health and Environmental Sciences, Eastman
Kodak Company
Other Participants: CIIT Centers for Health Research, Gaylor
and Associates, LLC, ILSI RSI
HESI
ILSI Health and Environmental Sciences Institute
February 12-13, 2003, Workshop
Washington, DC
• Co-Sponsors: HESI, ATSDR, ACC, NIEHS,
SOT, and US EPA, with additional support from
Health Canada
• Purpose: to examine approaches to doseresponse analysis, learn from the case study
examples, and gather feedback on the impact of
dose-dependent transitions on the risk
assessment process.
• Participation: approximately 50 invited
scientists from government, academia, and
industry
HESI
ILSI Health and Environmental Sciences Institute
Workshop Organizing Committee
Melvin Andersen (CIIT)
Matthew Bogdanffy (DuPont)
James Bus (Dow)
Rory Conolly (CIIT)
Raymond David (Kodak)
Christopher DeRosa (ATSDR)
Nancy Doerrer (HESI)
John Doull (University of Kansas)
William Farland (EPA)
Penelope Fenner-Crisp (ILSI RSI)
David Gaylor (Gaylor and
Associates)
Dale Hattis (Clark University)
Gary Kimmel (EPA)
Christopher Portier (NIEHS)
Bernard Schwetz (FDA)
R. Woodrow Setzer, Jr. (EPA)
William Slikker, Jr. (FDA)
Bob Sonawane (EPA)
James Swenberg (University of NC)
Kendall Wallace (University of MN)
Mildred Williams-Johnson (ATSDR)
HESI
ILSI Health and Environmental Sciences Institute
Publications
Slikker, W., Jr., Andersen, M.E., Bogdanffy, M.S., Bus, J.S.,
Cohen, S.D., Conolly, R.B., David, R.M., Doerrer, N.G.,
Dorman, D.C., Gaylor, D.W., Hattis, D., Rogers, J.M.,
Setzer, R.W., Swenberg, J.A., Wallace, K., 2004a. Dosedependent transitions in mechanisms of toxicity. Toxicol.
Appl. Pharmacol. 201, 203-225.
Slikker, W., Jr., Andersen, M.E., Bogdanffy, M.S., Bus, J.S.,
Cohen, S.D., Conolly, R.B., David, R.M., Doerrer, N.G.,
Dorman, D.C., Gaylor, D.W., Hattis, D., Rogers, J.M.,
Setzer, R.W., Swenberg, J.A., Wallace, K., 2004b. Dosedependent transitions in mechanisms of toxicity: case
studies. Toxicol. Appl. Pharmacol. 201, 226-294
HESI
ILSI Health and Environmental Sciences Institute
Outreach
2003:
• Workshop, Society of Toxicology Annual Meeting,
Salt Lake City, UT
2005:
• February SOT/RASS Monthly Teleconference
• SOT/RASS Meeting, March Annual Meeting
• Poster, May FDA Science Forum
• Poster, May EPA Science Forum
• Session, November Annual Meeting of the
American College of Toxicology, Williamsburg, VA