The NAMs Revolution: Smarter, Safer, More Ethical Drug Testing

The virtual panel, moderated by Ray Dogum, explored the rise of New Approach Methodologies (NAMs) in drug development. Speakers included Dr. Samantha Atkins (organ-on-chip expert), Dr. Shashi Ramaiah (former Pfizer executive and founder of SPECCRO Inc.), and Dr. Zaher Nahle (founder of IVYCTORY Solutions).

Panelists highlighted the FDA Modernization Act 2.0 and growing regulatory interest in NAMs. Atkins described organ-on-a-chip systems for toxicity and efficacy screening, noting systemic toxicology remained a challenge. Ramaiah stressed regulatory clarity and global harmonization to integrate NAMs into GLP environments. Nahle criticized reliance on animal models, citing a 92% drug failure rate and calling NAMs essential for efficiency and democratization.

The panel addressed questions on predictive toxicology, efficacy modeling, and investment. Consensus centered on data sharing, reproducibility, and policy reform as keys to scaling NAMs. Speakers agreed the shift required collaboration and aspirational thinking—moving from evolution to revolution.