Hosted by the SOT Association of Scientists of Indian Origin and Women in Toxicology Special Interest Groups and the SOT In Vitro and Alternative Methods Specialty Section
The integration of New Approach Methodologies (NAMs) is transforming the landscape of nonclinical toxicology, offering the potential to enhance human relevance while reducing reliance on animal testing. This webinar will explore the current scientific and industrial perspectives on NAMs, focusing on their evolving role in modern safety assessment and their trajectory toward broader regulatory acceptance.
The session will begin with an overview of the regulatory context, highlighting the implications of the FDA Modernization Acts 2.0 and 3.0 and recent FDA roadmaps and guidance that encourage the adoption of NAM-based strategies in drug development. These initiatives mark a pivotal policy shift supporting alternative models—ranging from high-content in vitro systems to computational and in silico platforms—as scientifically valid tools for hazard identification and risk characterization. From an industry standpoint, we will discuss where and how NAMs can be optimally integrated across the developmental timeline, from early target selection and candidate prioritization to mechanism-based safety risk de-risking and regulatory submissions.
Illustrative case studies will highlight successful applications of NAMs across modalities alongside retrospective analyses demonstrating the predictive value of CIVMs in assessing hepatotoxicity and neurotoxicity. Looking ahead, the session will examine future opportunities to embed NAMs into international regulatory frameworks, particularly within ongoing ICH revisions that seek to harmonize approaches for reducing animal use while maintaining robust safety assessments.
Speaker
Payal Rana, MS, MBA, PhD, DABT, Scientific Director, AbbVie