The next installment of the Scientific Liaison Coalition Use of Animal Models of Disease for Toxicity Prediction Webinar Series will take place May 31 at 11:00 am ET and will feature Sruthi King, US Food and Drug Administration.
This webinar series debuted May 17 with the first installment featuring Diann Blanset, Boehringer Ingelheim. A recording will be available soon.
The third installment is scheduled for June 21 and will feature Sherry Morgan, AbbVie, Inc.
Regulatory Perspective on the Use of Animal Models of Disease in Drug Development
Tuesday, May 31, 2016, 11:00 AM–12:30 PM ET
Presented by: Sruthi King, PhD, Pharmacology/Toxicology Team Leader in the Division of Clinical Review in the Office of Generic Drugs within the Center for Drug Evaluation and Research at the US Food and Drug Administration (CDER/FDA). Prior to her current role, Dr. King was a primary nonclinical reviewer for seven years in the Division of Gastroenterology and Inborn Errors Products in the Office of New Drugs within CDER/FDA. She has spoken on the topic of using animal models for nonclinical safety assessment and their utility in supporting rare disease drug development, most recently at the 2015 Annual Meeting of the American College of Toxicology. Dr. King also has co-authored a chapter on this topic in second edition of Pediatric Drug Development: Concepts and Applications. The objective of this presentation is to highlight current regulatory practices within CDER/FDA with case studies in which animal models of disease were used in nonclinical safety studies. At this time, the FDA recommends the use of animal models of disease be used in “proof of concept” studies, unless the sponsor provides acceptable justification that the animal model is the most relevant species for pharmacology and toxicology testing. However, the use of animal models, particularly for rare disease drugs, is increasing and regulators are tasked with determining whether the data generated in these models are adequate to support drug development and approval of safe and effective therapies, with limited clinical trial data. In general, nonclinical studies to support clinical trial initiation and ongoing development of small molecules and biologics are guided by ICH M3 and ICH S6; however, review divisions may apply regulatory flexibility.
This webinar is open to members of the Teratology Society through our membership in the SLC. You must register to attend using the link above.
Recordings of previous SLC webinars are available in the Educational Webinars File Library on BDR Connection.