Hosted by the American College of Toxicology in collaboration with the Teratology Society, British Toxicology Society, and Society of Toxicologic Pathology
This webinar took place Wednesday, September 20, 2017, at 11 am Eastern. A recording of this webinar is now available on BDR Connection for Teratology Society members. Link to Recorded Webinar
Jayanthi Wolf, PhD, Director, Global Regulatory Affairs, Merck & Co., Inc.
Karissa Adkins, PhD, Scientific Director, Vaccines Lead, Takeda Pharmaceuticals
David Clarke, PhD, DABT, Senior Director, Pfizer, Inc.
The approach for the nonclinical safety assessment of prophylactic vaccines for infectious diseases is well-established, with several regulatory guidelines and numerous examples of toxicology studies available in the literature and product approval packages. In contrast, there are few regulatory guidelines covering the nonclinical safety assessment of therapeutic vaccines and limited examples available in the public domain, although the number of therapeutic vaccines entering development continues to grow; including vaccines for cancer, Alzheimer’s disease, and other chronic conditions.
This webinar starts by providing an overview of the regulatory guidelines and general approach for the nonclinical safety assessment and toxicology studies designs for prophylactic vaccines. This is followed by a discussion highlighting the similarities and differences with the approach used for therapeutic vaccines. Case studies are used to illustrate points for consideration with respect to repeat dose and developmental and reproductive toxicity, and other evaluations that may be necessary based on modality and indication.