FDA’s draft guidance on the validation of New Approach Methodologies (NAMs) is reshaping how nonclinical programs are designed and justified. This webinar explores how sponsors can apply NAMs to streamline development, improve human relevance, and support IND decision-making within a weight-of-evidence framework.
We break down FDA expectations for validation, including context of use and fit-for-purpose application, and show how to position NAMs effectively in regulatory interactions.
Through real-world case examples spanning in vitro, in silico, and data-driven approaches, you will gain practical insight into how NAMs can address data gaps, reduce reliance on traditional models, and strengthen nonclinical programs.
Key learning objectives:
- Understand FDA expectations for validating New Approach Methodologies (NAMs), including context of use, human relevance, and fit-for-purpose application
- Learn how to incorporate NAMs into nonclinical programs to support IND decision-making within a weight-of-evidence framework
- Identify strategies to address data gaps and reduce reliance on traditional models using in vitro, in silico, and data-driven approaches
- Gain practical insight into positioning NAMs in regulatory interactions, including when and how to engage with FDA review divisions
This webinar is ideal for:
- Nonclinical / Preclinical Scientists (toxicology, DMPK, pharmacology)
- Translational Scientists
- Modeling & Simulation / Quantitative Scientists
- Regulatory Affairs professionals (especially early development / IND-focused)
- Clinical pharmacology / early clinical teams
- Project leaders / program leads
- Biotech leadership / decision-makers in small–mid companies
演讲嘉宾：
- Helen-Marie Dunmore, MSc, Senior Director, Toxicology, Certara Drug Development Solutions
- Kevin Snyder, PhD, Director of Nonclinical Innovation and Emerging Technologies
- Marc Bailie, DVM, PhD, Vice President Toxicology, Certara Drug Development Solutions
- Georgi Kapitanov, PhD, Senior Director
- Fran Brown, PhD, Senior Vice President, Global Head, Drug Development Science
