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Making a Decision on Drug Metabolism Data – Go or No Go
Monday, November 12
2:00 pm – 4:00 pm
Roundtable
ACPE #073-999-07-539-L04
The new FDA Guidance on Safety Testing of Drug Metabolites puts an increased focus on the identification and quantitative determination of drug metabolites formed in humans. Quantitative and qualitative differences in metabolite profiles are important when comparing exposure and safety of a drug in a nonclinical species relative to humans during risk assessment. Metabolic profiles and metabolite concentrations can vary across species, and there are cases when clinically relevant metabolites have not been identified or adequately evaluated during nonclinical safety studies. Metabolites may be unique to formation in humans or present at much higher levels in humans compared to animal species used during standard toxicity testing. While this can be perceived as an increased risk from an industry perspective at late stages in drug development, major metabolites with pharmacological activity can also be considered as an opportunity for developing improved drug candidates in drug discovery. This roundtable tries to provide an overview of this increasingly important aspect in drug discovery and development, both from an industry and regulatory point of view.
Moderators
Raimund M. Peter, Ph.D.
AstraZeneca
Dhiren Thakker, Ph.D.
University of North Carolina
Human-specific Metabolites – Industry Perspective
Kevin Bateman
Merck Frosst
Human-specific Metabolites – Industry Perspective
Volker Fischer, Ph.D.
Abbott Laboratories
Human-specific Metabolites – Regulators' Perspective
Shiew-Mei Huang, Ph.D.
U.S. Food and Drug Administration