On Sunday afternoon, I attended the Continuing Education course titled “Detecting Cancer Risk in Drugs: Design, Conduct, and Interpretation of Carcinogenicity Studies for Regulatory Approvals.” It was endorsed by the Carcinogenesis and Regulatory and Safety Evaluation Specialty Sections. The course featured five speakers.
Owen G. McMaster, PhD, US Food and Drug Administration (US FDA), provided a brief introduction and stated the course objectives and what participants could expect from the course. Dr. McMaster then asked the audience to raise their hands if they were directly or indirectly involved in carcinogenicity studies. At least 50% of the audience raised their hands. This course was designed to provide an overview of the practical aspects of the design, conduct, and interpretation of the US FDA-required carcinogenicity assessments. Dr. McMaster opened the course with an overview of current procedures of carcinogenicity testing of drugs to be marketed in US. He provided some case studies and explained why carcinogenicity studies are conducted.
James A. Popp, DVM, PhD, Stratoxon, LLC, discussed the standard design and conduct of a typical two-year rodent carcinogenicity study. Dr. Popp discussed acceptable approaches for dose selection. He stressed the importance of careful design, planning, and performance of these studies.
Mark A. Morse, PhD, Charles River Laboratories, presented information on the planning, conduct, and interpretation of studies to assess cancer risk using a six-month TgrasH2 assay. The TgrasH2 mouse model has proved to be a good alternative to the two-year rodent assay.
Timothy J. McGovern, PhD, US FDA, presented a US FDA reviewer’s perspective on carcinogenicity studies. He described the point of view of the pharmacology/toxicology review, the review division, and that of the US FDA Center for Drug Evaluation and Research (CDER)’s Executive Carcinogenicity Assessment Committee.
Finally, Todd Bourcier, PhD, US FDA, presented the status of the ICH S1 expert working group. He discussed how the weight-of-evidence approach could be used as an alternative to the S1 in the future.
The talks prompted a number of questions and resulted in a good discussion at the end of each presentation.