Tackling the challenges of new approach methods for predicting drug effects from model systems

The passage of the FDA Modernization Act 2.0 in 2022 has provided additional impetus to develop new approach methods for predicting the effects of drug candidates in humans from models such as microphysiological systems based on human-derived induced pluripotent stem cells. Here, we highlight progress in the field and strategies to address various challenges, including the application of artificial intelligence tools.

By
• Paul D. Pang0 ,
• Syed Mukhtar Ahmed1 ,
• Masataka Nishiga2 ,
• Norman L. Stockbridge3 &
• …
• Joseph C. Wu4

1. Paul D. Pang
   1. Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA, USA; Greenstone Biosciences, Palo Alto, CA, USA. *These authors contributed equally.

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   1. Greenstone Biosciences, Palo Alto, CA, USA. *These authors contributed equally.

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   1. Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA, USA.

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   1. US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.

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   1. Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA, USA; Greenstone Biosciences, Palo Alto, CA, USA.

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