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

HomeCirculationVol. 148, No. 4FDA Modernization Act 2.0 Paves the Way to Computational Biology and Clinical Trials in a Dish No AccessArticle CommentaryRequest AccessFull TextAboutView Full TextView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toNo AccessArticle CommentaryRequest AccessFull TextFDA Modernization Act 2.0 Paves the Way to Computational Biology and Clinical Trials in a Dish Syed Mukhtar Ahmed, Rabindra V. Shivnaraine and Joseph C. Wu Syed Mukhtar AhmedSyed Mukhtar Ahmed https://orcid.org/0000-0002-9183-9957 Stanford Cardiovascular Institute, Stanford, CA (S.M.A., J.C.W.). Greenstone Biosciences, Palo Alto, CA (S.M.A., R.V.S.). Search for more papers by this author , Rabindra V. ShivnaraineRabindra V. Shivnaraine https://orcid.org/0000-0002-1478-5422 Departments of Molecular and Cellular Physiology (R.V.S), Stanford University School of Medicine, Stanford, CA. Greenstone Biosciences, Palo Alto, CA (S.M.A., R.V.S.). Search for more papers by this author and Joseph C. WuJoseph C. Wu Correspondence to: Joseph C. Wu, MD, PhD, 265 Campus Drive G1120B, Stanford, CA 94305, Email E-mail Address: [email protected]; or Mukhtar Ahmed, PhD, 3160 Porter Dr, Suite 140, Palo Alto, CA 94304, Email E-mail Address: [email protected] https://orcid.org/0000-0002-6068-8041 Stanford Cardiovascular Institute, Stanford, CA (S.M.A., J.C.W.). Medicine, Division of Cardiovascular Medicine (J.C.W.), Stanford University School of Medicine, Stanford, CA. Search for more papers by this author Originally published24 Jul 2023https://doi.org/10.1161/CIRCULATIONAHA.123.065585Circulation. 2023;148:309–311FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.For Sources of Funding and Disclosures, see page 311.Circulation is available at www.ahajournals.org/journal/circCorrespondence to: Joseph C. Wu, MD, PhD, 265 Campus Drive G1120B, Stanford, CA 94305, Email joewu@stanford.edu; or Mukhtar Ahmed, PhD, 3160 Porter Dr, Suite 140, Palo Alto, CA 94304, Email mukhtarahmed@greenstonebio.comREFERENCES1. Wax PM. Elixirs, diluents, and the passage of the 1938 federal food, drug and cosmetic act.Ann Intern Med. 1995; 122:456–461. doi: 10.7326/0003-4819-122-6-199503150-00009CrossrefMedlineGoogle Scholar2. Mullard A. 2022 FDA approvals.Nat Rev Drug Discov. 2023; 22:83–88. doi: 10.1038/d41573-023-00001-3CrossrefMedlineGoogle Scholar3. 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. doi: 10.1038/s41592-022-01591-3CrossrefMedlineGoogle Scholar4. 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. doi: 10.1038/s41551-022-00898-yCrossrefMedlineGoogle Scholar5. Sayed N, Liu C, Ameen M, Himmati F, Zhang JZ, Khanamiri S, Moonen JR, Wnorowski A, Cheng L, Rhee JW, et al. 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. doi: 10.1126/scitranslmed.aax9276CrossrefMedlineGoogle Scholar eLetters(0)eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. Authors of the article cited in the comment will be invited to reply, as appropriate.Comments and feedback on AHA/ASA Scientific Statements and Guidelines should be directed to the AHA/ASA Manuscript Oversight Committee via its Correspondence page.Sign In to Submit a Response to This Article Previous Back to top Next FiguresReferencesRelatedDetailsCited ByKuehn B (2023) Introducing AHA's New President: Joseph C. Wu, MD, PhD, FAHA, Journal of the American Heart Association, 12:15, Online publication date: 1-Aug-2023. July 25, 2023Vol 148, Issue 4 Advertisement Article InformationMetrics © 2023 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.123.065585PMID: 37486997 Originally publishedJuly 24, 2023 Keywordsdrug developmentdrug discoveryartificial intelligenceanimal use alternativeclinical trials as topicinduced pluripotent stem cellsPDF download Advertisement SubjectsBig Data and Data StandardsClinical StudiesComputational BiologyStem Cells