Highlights
- PharmaVoice interviewed Michael Shuler, President and Cofounder of Hesperos, and Lawrence Florin, CEO of Hesperos, along with other pharma leaders, about the future of New Approach Methodologies (NAMs)
- They discussed the recent pronouncements from the U.S. Food and Drug Administration and the National Institutes of Health supporting a shift away from traditional animal testing
- Hesperos and other companies that use NAMs have achieved regulatory acceptance for efficacy data generated from their models
- As regulatory agencies plan to move away from animal testing, they plan to collaborate with the industry to advance NAMs
- Many pharmaceutical companies have begun using NAMs in efficacy studies
"We are leveraging advanced [NAMs], including organoids and microphysiological systems in combination with AI and systems modeling to closely mimic human biology and provide preclinical predictions for safety and efficacy,"
- AstraZeneca Spokesperson