David Madigan, Northeastern University, and Demissie Alemayehu, Pfizer
The Symposium on Risks and Opportunities of Artificial Intelligence in Pharmaceutical Medicine—co-sponsored by Pfizer, Northeastern University, and the American Statistical Association—was held June 10–11 in Boston, Massachusetts.
The annual event is intended to provide a forum for major stakeholders to have a dialogue about pertinent issues with policy implications for the proper implementation of this emerging technology.
Featuring presentations by thought leaders from sectors such as the US Food and Drug Administration, pharmaceutical industry, and academia, the theme of the symposium was Generative AI in Medical Research & Drug Development: Hype or Reality?
David Madigan, conference co-chair and provost of Northeastern University, and Ron Wasserstein, ASA executive director, opened the event with welcoming remarks, followed by Kannan Natarajan, head of biometrics and data management at Pfizer. Natarajan set the stage for the conference, underscoring the myths and realities of generative AI in drug development, and introduced keynote speaker Tala H. Fakhouri, associate director of policy analysis at the FDA’s Center for Drug Evaluation and Research Office of Medical Policy. Fakhouri’s talk, “Responsive Regulation of AI in Drug Development,” provided insights into the current thinking of the FDA, including ongoing initiatives and long-term goals.
A highlight of the symposium was a panel discussion moderated by David Sontag of MIT that included Robert Ball of the FDA, Brian Caffo of Johns Hopkins University, Subha Madhavan of Pfizer, Anthony Philippakis of MIT, and Hoifung Poon of Microsoft. The panelists exchanged ideas and opinions about issues surrounding the challenges and opportunities of leveraging generative AI in medical research and drug development.
New features of this year’s conference included a workshop and poster sessions. The workshop focused on AI application and real-world evidence generation in drug development.
The next symposium is expected to take place in Portland, Maine, in June 2025.

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