The Scientific Liaison Coalition (SLC) will continue its webinar series on animal models of disease for toxicity prediction on Tuesday, May 31 with a presentation by Sruthi King, PhD, on the Regulatory Perspective on the Use of Animal Models of Disease in Drug Development. The webinar will be held from 11:00 am-12:30 pm ET USA. This live webinar is open only to members of the partnering societies of the SLC listed on the SLC website, and you must register to attend.
Dr. King is the 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, she 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.
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.
An SLC Work Group comprised of Mary Jeanne Kallman, Safety Pharmacology Society; Donna Mendrick, Society of Toxicology; and Arun Pandiri, Society of Toxicologic Pathology, developed this Use of Animal Models of Disease for Toxicity Prediction Webinar Series, the first of which was held on Tuesday, May 17 presented by Diann Blanset, PhD, DABT, Boehringer Ingelheim. This series provides pharmaceutical industry and regulatory perspectives on this topic and will conclude with a webinar presented by Sherry Morgan, AbbVie, Inc., on June 21. All of these webinars will be recorded and posted to the SLC website.
The mission of the SLC is to serve as “A partnership of scientific societies with the goal of improving public health through a collaborative interdisciplinary approach.”
- Strengthening partnerships among scientific and health-based organizations to increase awareness of the impact of toxicology and related subjects on human health.
For more information on the SLC, please contact Marcia Lawson.