Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jul 25;148(4):309-311.
doi: 10.1161/CIRCULATIONAHA.123.065585. Epub 2023 Jul 24.

FDA Modernization Act 2.0 Paves the Way to Computational Biology and Clinical Trials in a Dish

Syed Mukhtar Ahmed  1   2 , Rabindra V Shivnaraine  3   2 , Joseph C Wu  1   4
Affiliations

FDA Modernization Act 2.0 Paves the Way to Computational Biology and Clinical Trials in a Dish

Syed Mukhtar Ahmed et al. Circulation. .
No abstract available

Keywords: animal use alternative; artificial intelligence; clinical trials as topic; drug development; drug discovery; induced pluripotent stem cells.

PubMed Disclaimer

Conflict of interest statement

Disclosures Dr Wu is a co-founder of Greenstone Biosciences. Drs Ahmed and Shivnaraine are senior scientists at Greenstone Biosciences, a company that engages in drug discovery using clinical genomics, computational modeling, and iPSC technology.

Figures

Figure.
Figure.
Integration of AI and “Clinical Trials in Dishes” using iPSC-derived models in the drug discovery and development pipeline. The FDA Modernization Act 2.0 facilitates the adoption of innovative approaches for conducting safer and more efficient clinical trials. Created with BioRender.com.
See this image and copyright information in PMC

References

    1. Wax PM. Elixirs, diluents, and the passage of the 1938 federal food, drug and cosmetic act. Ann Intern Med. 1995; 122:456–461. - PubMed
    1. Mullard A. 2022 FDA approvals. Nat Rev Drug Discov. 2023; 22:83–88. - PubMed
    1. Cho S, Discher DE, Leong KW, Vunjak-Novakovic G, Wu JC. Challenges and opportunities for the next generation of cardiovascular tissue engineering. Nat Methods. 2022; 19:1064–1071. - PubMed
    1. Zhang A, Xing L, Zou J, Wu JC. Shifting machine learning for healthcare from development to deployment and from models to data. Nat Biomed Eng. 2022; 6:1330–1345. - PubMed
    1. Sayed N, Liu C, Ameen M, Himmati F, Zhang JZ, Khanamiri S, Moonen JR, Wnorowski A, Cheng L, Rhee JW, Gaddam S, Wang KC, Sallam K, Boyd JH, Woo YJ, Rabinovitch M, Wu JC. Clinical trial in a dish using iPSCs shows lovastatin improves endothelial dysfunction and cellular cross-talk in LMNA cardiomyopathy. Sci Transl Med. 2020; 12:eaax9276. - PMC - PubMed