® BACKGROUND
® OBJECTIVES
® ACCOMPLISHMENTS
® FUTURE ACTIVITIES
® ANTICIPATED IMPACT
® PROJECT COMMITTEE PARTICIPANTS
® LEADERSHIP AND INFORMATION
The mission of the HESI Subcommittee on Risk Assessment for Sensitive Populations is to aid the scientific characterization of sensitive populations by improving our ability to identify and define these populations. This mission includes evaluating the utility and adequacy of current and proposed methods for assessing risks to sensitive populations as well as identifying deficiencies. The Subcommittee seeks to improve the publicly available science to facilitate improved risk assessment for diverse sensitive populations in the future.
Sensitive populations result from age, medical conditions, genetics, and socioeconomic status. There is considerable concern and sound science to suggest that current risk assessment that is based largely on exposures in young, healthy adults may fail to provide adequate assessment of risk in such sensitive populations. In recognition of these concerns, the HESI Scientific Map also identified issues relating to assessment of sensitive populations as important areas for HESI focus in coming years.
Sensitive populations are also gaining increased attention as part of regulatory risk assessment via focus on mode-of-action, pharmacokinetics, age-specific issues, and genetic susceptibility assessment among other areas.
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The Subcommittee will consider the following questions:
· What scientific considerations should be included in defining or characterizing a sensitive population? (examples: exposure, PBPK, etc.)
· What is the adequacy of and/or gaps in current and proposed procedures and approaches to assess risk in sensitive populations (using children as an initial example of a sensitive population)?
· Can existing procedures and approaches to assessing risk in sensitive populations be extrapolated across different population types? If not, where are there needs for modification of these approaches?
The results of the analysis of these questions are anticipated to result in white papers, peer-reviewed publications, and workshops.
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n The Subcommittee was initiated in the summer of 2006 as part of HESI’s Emerging Issues process. The Subcommittee convened for the first time in October 2006 in Washington, D.C. The meeting resulted in a defined mission and proposed work plan for the Subcommittee.
n The Subcommittee organized a scientific session on sensitive populations as part of HESI’s Annual Meeting in January 2007.
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The Subcommittee will continue its review and evaluation of current literature on risk assessment of sensitive populations and will meet via teleconference and in person during 2007. The results of the literature analysis will be used as the basis for a publication and determination of next stesps.
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This multi-sector activity is well timed to provide input into evolving approaches for the risk assessment of sensitive populations.
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Subcommittee Participation
3M
Monsanto Company
Dow AgroSciences
Bayer CropScience
Public Participation
Dr. Ronald Hines, Medical College of Wisconsin
Dr. Robert Brent, Albert DuPont Hospital for Children
Dr. Elaine Faustman, University of Washington
Dr. Herman Autrup, University of Aarhus
U.S. Environmental Protection Agency
FDA/CDER Div. of Metabolism & Endocrinology Products
Federal Institute for Drugs and Medical Devices – BfArM
National Cancer Institute
National Center for Toxicological Research
NIEHS
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Chair.............................................. Dr. Ronald Hines
Vice-chair..................................... Ms. Dana Sargent
HESI Staff...................................... Ms. Syril D. Pettit
Ms. Regina Graham
For more information, please contact: Ms. Syril D. Pettit at 202-659-3306 or spettit@hesiglobal.org.
For more information, please contact: Dr. Michelle Embry, HESI Scientific Program Manager, at 202-659-3306 or membry@ilsi.org.
The Subcommittee was initiated in late 2006. New participants to the Subcommittee are welcome!
Please click here, to download a copy of the subcommittee fact sheet.