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Location:

FDA White Oak Campus, Room 2031, Building 2. 10903 New Hampshire Avenue, Silver Spring.

Background:

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Health & Environmental Sciences Institute (HESI) Global agree to co-sponsor the Nitrosamine Ames Data Review and Method Development Workshop that convenes subject matter experts to review data and discuss recommended test conditions for the Enhanced Ames Testing for nitrosamines. Both FDA and HESI have a mutual interest in addressing this scientific problem and publicly disseminating scientific knowledge under the terms set out below. 

This workshop will review the nitrosamines Ames data generated by the US Food and Drug Administration/National Center for Toxicological Research (US FDA/NCTR), European Medicines Agency’s (EMA) MutaMind project and through the collaborative HESI Genetic Toxicology Technical Committee (GTTC) ring trial, each of which have been testing nitrosamine compounds across various Ames assay conditions. Key aspects of the Ames assay as it pertains to nitrosamines will be addressed through data presentations and panel discussions from these three research programs and additional invited speakers.

Goals and Objectives:

• To provide a forum for open discussion between regulators and industry on the data generated using enhanced Ames assay methodologies to assess the mutagenic potential of nitrosamines.
• Present and hold open discussions on specific questions related to the generated data.
• Discuss recommendations on the relevant and most predictive test conditions of the Ames test for more reliable prediction of the mutagenic potential of nitrosamines.
• Discuss the correlation of Ames assay results for nitrosamine drug substance related impurities (NDSRIs) and in vivo carcinogenicity/mutagenicity.
• Generate recommendations for publication in a scientific journal and make them publicly available.

Who Should Attend:

This workshop is intended for scientists from organizations (EMA, FDA, HESI, Industry, Contract Research Organizations) and from other Regulatory Agencies who have been directly involved in generating and evaluating Ames assay data for nitrosamines across various assay conditions. The primary audience includes leading academic experts, interested pharmaceutical companies, regulatory agencies, non-profit organizations, scientists involved in the assessment of nitrosamine impurities in those same industries, and regulatory scientists who have conducted research on Ames assay assessment of nitrosamines or who evaluate this data.  Attendance is limited to invited participants involved in generating data related to enhanced Ames testing.

Contact:

If to HESI:           

Connie Chen, Senior Scientific Program Manager
Health & Environmental Sciences Institute (HESI)
740 15th Street NW, Suite 600
Washington, DC 20005
Tel: 202-652-8404

If to FDA:

Aisar Atrakchi, Supervisor Pharmacology Toxicology
CDER/Office of New Drugs
Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 22
Silver Spring, MD 21029
Tel: 301-796-1036
Email: aisar.atrakchi@fda.hhs.gov

Timothy J. McGovern, Associate Director, Pharmacology/Toxicology
CDER/Office of New Drugs
Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 22
Silver Spring, MD 21029
Tel: 240.402.0477
Email: timothy.mcgovern@fda.hhs.gov