New Approach Methodologies (NAMs) have been used in drug development for decades. Despite their widespread use and clear advantages for improving human health and reducing animal experimentation, NAMs have faced significant headwinds for use in regulatory submissions. Recent guidelines, public announcements, and policy changes have demonstrated that global regulators, led by the US FDA, are ready to change that dynamic. The most powerful example of this change is the FDA’s IS

Based on listening and talking with a diverse range of industry colleagues, attending several conferences, reading the FDA monoclonal antibodies (mAbs) announcement and roadmap, watching the FDA/NIH workshop on the state of phasing out the use of animal testing, and the FDA’s engagement with 3Rs, the world of in vitro toxicology has been speeding up faster than I've seen before, and it is clear New Approach Methods (NAMs) are playing a more central role in predictive toxicolo

The final day of WC13 may have been a half day, but it ended on a powerful note. The closing keynote speaker, Dr. Nicole Kleinstreuer,...

The 13th World Congress on Alternatives and the Use of Animals in the Life Sciences (WC13) is in full swing in Rio de Janeiro. Over the...