Marks: Reviewing AI-Driven Cancer Vaccines ‘May Be A Little Bit Of A Step Ahead’ For FDA

FDA is struggling to review Moderna and Merck’s mRNA-4157 melanoma cancer vaccine candidate as the companies used artificial intelligence (AI) to determine the formulation of the individualized vaccine. FDA biologics chief Peter Marks suggests FDA may not yet be in a position to address whether AI algorithm alterations make a vaccine an entirely new product. FDA commissioner Robert Califf told Inside Health Policy Wednesday (May 8) that it’s an open question how the agency tackles drugs developed using AI...