Director, Toxicology Regeneron Seattle, Washington, United States
Nonclinical studies have an impact on the development timeline for a program. There are opportunities through regulatory interactions to adjust the nonclinical development strategy for new molecular entities (NMEs). This talk will present case studies highlighting the nonclinical toxicity component of the regulatory interaction involving requesting study waivers (i.e, a TQT clinical pharmacology study waiver, a developmental and reproductive toxicity (DART) study waiver, a waiver to conduct a rodent carcinogenicity study). The audience will be asked to discuss the options presented, identify any additional information needed, and provide recommendations for the strategy they might apply in the regulatory interaction. Learning objectives: 1) understand points to consider when presenting the weight of evidence (WoE) approach for requesting a study waiver, 2) understand that each NME should be evaluated on a case-by-case basis, and 3) understand the importance of having the interactions with different regulatory agencies early during development.
