Program - Society of Toxicology

44 th Annual Meeting
and ToxExpo
Program Description
Wednesday Afternoon, March 9
1:30 PM to 4:30 PM
Room 207
Wednesday Afternoon, March 9
1:30 PM to 4:30 PM
Room 220
WEDNESDAY
WORKSHOP SESSION: CONFLICT OF INTEREST
Chairperson(s): Jacques Maurissen, The Dow Chemical Company, Midland,
MI and Steven Gilbert, Institute of Neurotoxicology and Neurological
Disorders, Seattle, WA.
Endorsed by:
Board of Publications
Ethical Legal and Social Issues SS*
Regulatory Affairs and Legislative Assistance Committee
Regulatory and Safety Evaluation SS
The conflict of interest issue has recently been the subject of much attention
from the points of view of editorial policy and electoral policy to scientific advisory
boards. The perception is that some scientists performing or evaluating
research may be tempted to overlook an adverse effect in a research project
(hoping to please the sponsor and to secure future funding from the same
source); likewise, other scientists may be tempted to overemphasize the significance
of a positive result in their research (to gain access to additional grant
support from private or institutional foundations or to favor donations from the
general public). A number of scientific journals (including Toxicological
Sciences) have recently addressed or reviewed the issue of conflict of interest.
Similarly, a number of institutions have also codified their policy to help in the
selection of members for scientific advisory boards. A number of questions can
be asked around several themes: What is a financial conflict of interest? What
about grant renewal, university tenure? What is the importance of non-financial
conflicts of interest in the decision process, e.g., number of publications,
academic competition, public/professional visibility, satisfaction of accomplishment,
loyalty? When does a conflict start and stop being a conflict, apparent or
real? Should a scientist with a real conflict of interest be prevented from
publishing an editorial or a review paper on the basis of a conflict of interest?
What if the conflict is not real but perceived? Should a perceived conflict of
interest be enough to disqualify an otherwise competent scientist from election
to a panel? What is the role of full disclosure in a successful conflict of interest
policy? A group of five panelists (from diverse backgrounds) will present their
views concerning the conflict of interest.
#1678 1:30 CONFLICT OF INTEREST. J. P. Maurissen 2 and S.
G. Gilbert 1 . 1 INND, Seattle, WA and 2 Neurotoxicology,
Dow Chemical Company, Midland, MI.
#1679 1:45 WHAT IS A “CONFLICT OF INTEREST”? T. L.
Beauchamp. Kennedy Institute of Ethics, Georgetown
University, Washington, DC. Sponsor: S. Gilbert.
#1680 2:15 CONFLICT OF INTEREST IN THE
PUBLICATION PROCESS. L. D. Lehman-
McKeeman. Bristol Myers Squibb Co., Princeton, NJ.
#1681 2:45 ROLE OF GOVERNMENT OVERSIGHT. B. A.
Schwetz. Office for Human Research Protections,
Rockville, MD.
#1682 3:15 MANAGING CONFLICTS OF INTEREST: DOES
DISCLOSURE GO FAR ENOUGH? M. Goozner.
Cntr for Sciences. in the Public Intrst, Washington, DC.
Sponsor: S. Gilbert.
#1683 3:45 CONFLICT OF INTEREST AND BIAS: A
VIEWPOINT FROM INDUSTRY. C. Barrow. Dow
Chemical Company, Washington, DC.
WORKSHOP SESSION: DOSIMETRY AND POTENTIAL IMPACTS
ON REPRODUCTIVE/DEVELOPMENTAL STUDY DESIGN AND
INTERPRETATION FOR RISK OR SAFETY ASSESSMENT
Chairperson(s): Hugh Barton, U.S. EPA, Research Triangle Park, NC and Ed
Carney, Dow Chemical Company, Midland, MI.
Endorsed by:
Biological Modeling SS
Regulatory and Safety Evaluation SS
Risk Assessment SS
Student Advisory Committee
Reproductive and developmental toxicity studies in animals are utilized in
assessing the potential adverse effects of chemicals and drugs in pregnant
women, nursing infants, and children. The results of these studies are extrapolated
to humans primarily based on the dose or the exposure in the mother due
to the complexity of describing the dose, pharmacokinetics, and tissue
dosimetry of chemicals during pregnancy, lactation, and postweaning periods.
Transporters are increasingly recognized as a key factor in dosimetry during
early life along with development of metabolism and other clearance processes.
For pharmaceuticals, measurement of maternal blood levels, and sometimes
placental and lactational transfer, are addressed for safety assessment. Classical
and physiologically-based pharmacokinetic analyses are increasingly being
applied across these life stages of reproduction. Identification of the critical
window of sensitivity, and how this critical period and its associated pharmacokinetics
correlates with humans, is a significant challenge. This workshop will
present approaches to characterizing measures of internal dose in reproductive
and developmental toxicity studies, and how this impacts study designs and
applications for safety and risk assessment.
#1684 1:30 DOSIMETRY AND
REPRODUCTIVE/DEVELOPMENTAL STUDY
DESIGN AND INTERPRETATION FOR RISK OR
SAFETY ASSESSMENT. E. Carney 2 and H. A.
Barton 1 . 1 U.S. EPA, Research Triangle Park, NC and
2 Toxicology & Environmental Research & Consulting,
Dow Chemical Company, Midland, MI.
#1685 1:40 LIFE-STAGE DEPENDENT DOSIMETRY AND
POTENTIAL IMPACTS ON RISK ASSESSMENT.
H. A. Barton. U.S. EPA, Research Triangle Park, NC.
#1686 2:10 INCORPORATING DOSIMETRY IN
DEVELOPMENTAL TOXICITY ASSESSMENTS:
STUDY DESIGN AND DATA INTERPRETATION.
E. Mylchreest and S. A. Gannon. DuPont Haskell
Laboratory, Newark, DE.
#1687 2:40 TRANSPORTERS DURING DEVELOPMENT. C.
D. Klaassen. Pharmacology, U Kansas Med. Ctr,
Kansas City, KS.
#1688 3:10 PHARMACEUTICAL PERSPECTIVE ON
DOSIMETRY IN REPRODUCTIVE AND
DEVELOPMENTAL STUDIES AND THE IMPACT
ON DRUG DEVELOPMENT. G. Pastino. Drug
Metabolism and Pharmacokinetics, Schering Plough
Research Institute, Lafayette, NJ.
#1689 3:40 PBPK MODELING OF EARLY LIFESTAGES AND
ESTIMATION OF DOSIMETRY FOR RISK
ASSESSMENT. H. Clewell 1 and R. Clewell 2 .
1 2 ENVIRON, Ruston, LA and CIIT Centers for Health
Research, Research TrianglePark, NC.
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SOT’s 44 th Annual Meeting