Nonclinical Safety Studies for Investigational New Drug and New Drug Application Filing for Small Mo

Nonclinical Safety Studies for Investigational New Drug and New Drug Application Filing for Small Molecules Part 1: Overview and Safety Pharmacology

Friday, October 18, 2024

12:00 Noon to 1:30 PM (US EDT, UTC -4)

Hosted by: The SOT Women in Toxicology Special Interest Group and the Drug Discovery Toxicology Specialty Section

Registration required for this free webinar.

In two parts, this webinar will cover the different types of toxicology studies conducted to support Investigational New Drug (IND) and New Drug Application (NDA) filings for small molecules, including an overview of the nonclinical modules, safety pharmacology, genetic toxicology, carcinogenicity, and reproductive and developmental toxicology. This webinar will cover best practices and example case studies from leaders in the field. Part 1 is in collaboration with the Drug Discovery Toxicology Specialty Section and Part 2 is with the Carcinogenesis Specialty Section.

Speakers:

• Smita Salian-Mehta, PhD, DABT, ERT, Senior Project Toxicologist, Gilead Sciences
• Dinah Misner, PhD, DABT, DSP, Vice President, Aligos Therapeutics
• Toufan Parman, PhD, DABT, Senior Director of Nonclinical Safety Evaluation, Sangamo Therapeutics
• Ellen McGlinchey, PhD, Senior Project Toxicologist, Gilead Sciences

Registration required for this free webinar.