TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying the clinical research process, today announced its participation in numerous sessions at the DIA 2025 Global Annual Meeting in Washington, D.C. from June 15–19.

In fact, according to a report by the independent Reagan-Udall Foundation, the CTP under the previous administration suffered from ineffective leadership, a lack of direction and a culture that stifles scientific integrity.

In 2024, a workshop cohosted by FDA and the Reagan-Udall Foundation for the FDA (Reagan-Udall) focusing on advancing psychedelic clinical study design. Also in 2024, a second workshop by Reagan-Udall focusing specifically on understanding potential therapeutic uses of ketamine.

A report in late 2024 indicated that retailers, suppliers, and distributors were not even aware of the sweeping traceability standard. The report, written by the nonprofit Reagan-Udall Foundation for the FDA, also expressed concerns about how data would be used and shared, technology, and the complexity of the process.

Mr. Diamantas first shared some background with attendees on where FDA is headed and the agency's vision for modernization. He spoke about the Reagan-Udall Foundation's December 2022 report of its independent review of FDA's Human Foods Program (HFP), which uncovered logistical and functional challenges. As a result of this review, the reorganization of the HFP was implemented in October 2024.

We will share key learnings related to the design of our Phase 2b PRIZM study in MELAS at the primary mitochondrial diseases public workshop, hosted by the Reagan-Udall Foundation for the FDA.

The agency’s lack of resources was documented in the Reagan Udall Foundation’s 2022 operational evaluation of the FDA’s Human Foods Program, an assessment former FDA Commissioner Robert Califf requested to help the agency make changes to better carry out its regulatory responsibilities.

Dr. David Fajgenbaum was a third-year medical student when he “got critically ill out of nowhere.

Dr. Sumbul Desai’s job is to think creatively about the different ways that technology can improve health.

Georges C. Benjamin, M.D., is a well – known health policy leader, practitioner and administrator. He currently serves as the executive director of the American Public Health Association, the nation’s oldest and largest organization of public health professionals.