The Scientific Liaison Coalition (SLC), of which the Teratology Society is a member, will begin a new Use of Animal Models of Disease for Toxicity Prediction Webinar Series on May 17. This series will provide pharmaceutical industry, and regulatory perspectives on this topic. The dates and speakers are listed below. All webinars will be held from 11:00 am–12:30 pm ET.
- May 17: Diann Blanset, Boehringer Ingelheim
- May 31: Sruthi King, US Food and Drug Administration
- June 21: Sherry Morgan, AbbieVie
The Use of Animal Models of Disease in Safety Assessments
Tuesday, May 17, 2016, 11:00 AM–12:30 PM
Presented by: Diann L. Blanset, PhD, DABT, Boehringer Ingelheim: Preclinical safety studies for proposed pharmaceutical products are usually conducted in healthy animals. The appropriate species for these studies are selected based on the relative pharmacological activity/potency and metabolite profiles between the proposed species and humans. The studies are then designed to mimic the clinical dosing regimen with respect to the route of administration, duration of treatment, and dosing interval. As these studies are conducted in healthy animals, they generally mimic the characteristics of the clinical population for first in human (FIH) Phase I trials in normal subjects (healthy volunteers). However, they do not mimic the characteristics of subjects in later clinical trials or in FIH Phase I trials conducted in subjects with disease. This deviation from the principle of mimicking the clinical conditions of use can be very important in certain disease indications where the disease condition can dramatically affect the safety of the pharmaceutical. The aim of this webinar is to review the use of animal models of disease in the evaluation of exaggerated pharmacology and toxicity to improve the relevance and extrapolation of the assessments to the intended disease population. The basic principles of the use of animal models of disease will be reviewed as well as the advantages and disadvantages of these models. In addition, specific examples of the use of these models in safety assessments will be presented.
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.