FDA Evaluates AI-Driven Cancer Vaccine

The FDA’s ongoing review of a cancer vaccine raises critical questions about FDA’s approach to the use of AI to develop drugs, biologics and vaccines. Moderna and Merck used AI to determine the formulation of the individualized vaccine for their mRNA-4157 cancer vaccine, for which the FDA granted breakthrough therapy designation in February 2023. Peter Marks, M.D., PhD., director of the Center for Biologics Evaluation and Research (CBER), which is charged with reviewing the vaccine, indicated that review of the AI component of the vaccine may be “a step ahead” for the FDA. Specifically, the agency may not yet be ready to address what degree of modification to an AI algorithm is permissible before the change makes the vaccine an entirely new product. Director of the Center for Drugs Evaluation and Research (CDER), Patrizia Cavazzoni, M.D., said that the FDA is also finding that they need additional computational capacity and resources to adequately assess algorithms like these and a private-public framework to allow for exchange of data may be necessary.

• Artificial Intelligence & Machine Learning
• Technology

• https://investors.modernatx.com/
• https://www.fda.gov/
• https://friendsofcancerresearch.org/
• https://acrobat.adobe.com/