Food and The administration of the drug met OPENAI To discuss the use of AI by the agency, according to sources with knowledge of meetings. Meetings seem to be part of a wider effort at the FDA to use this technology to speed up the drug approval process.
“Why does he take over 10 years for a new medication to arrive on the market?” wrote the FDA commissioner Marty Makary on X Wednesday. “Why are we not modernized with AI and other things? We have just finished our first scientific review assisted by AI for a product and this is only the beginning.”
The remarks followed an annual meeting of the American Hospital Association earlier this week, where Makary spoke of the potential of the AI to help the approval of new treatments for diabetes and certain types of cancer.
Makary did not specify that Optai was part of this initiative. But sources close to the project indicate that a small team of Openai has met the FDA and two partners of the so-called Elon Musk government's effectiveness several times in recent weeks. The group discussed a project called CDERGPT, which probably represents Medicines evaluation centerwho regulates over-the-counter and prescription drugs in the United States, and search for GPT. Jeremy Walsh, who was recently appointed as the first FDA AI officer, led the discussions. So far, no contract has been signed.
Openai refused to comment.
Walsh has also met Peter Bowman-Davis, a first cycle on Yale's leave, who is currently the acting AI chief at the Ministry of Health and Social Services, to discuss the AI ambitions of the FDA. Politico first noted the appointment of Bowman-Davis, which is part by Andreessen Horowitz American dynamism team.
On Wednesday by e-mail, Robert Califf, who was a commissioner of the FDA from 2016 to 2017 and again from 2022 to January, said that the agency's exam teams have been using AI for several years. “It will be interesting to hear the details of the parts of the” helped “examination and what it means,” he says. “There has always been a quest to shorten the revision times and a large consensus that AI could help.”
Before Califf left the agency, he said that the FDA was considering the various ways in which AI could be used in internal operations. “The final examinations for approval are only part of a much more important opportunity,” he says.
To be clear, the use of AI to help the final exams of drugs would represent a chance to compress a small part of the calendar for the development of notoriously long drugs. The vast majority of drugs fail before showing off for an FDA review.
Rafael Rosengarten, CEO of Genéalis, a precision oncology company and co -founder and member of the Board of Directors of the Alliance for AI in Health Care, says that it is favorable to the automation of certain tasks related to the drug review process, but says that there should be political advice around which type of data is used to form AI models and what type of model performance is considerable. “These machines are incredibly able to learn information, but they must be formed in a way so that they learn what we want them to learn,” he said.
