Dr. Jeffrey Roberts is the associate director for scientific affairs in the Office of Vaccines Research and Review at the US Food and Drug Administration (FDA). He came to FDA in 2008, serving first as a medical officer then as clinical branch chief in the Division of Vaccines and Related Product Applications before assuming the associate director role in 2019.
During his initial tenure at FDA, Dr. Roberts reviewed the clinical data for multiple vaccine programs at all phases of development. As clinical branch chief, he managed the clinical review of a wide variety of products, including vaccines, allergenic products, phage therapy, and live biotherapeutics. As associate director, his focus now includes emerging disease threats and medical countermeasures, use of alternative clinical trial designs and real world evidence to support product development/licensure, and coordinating discussions on vaccine development with other regulatory authorities.
Jeffrey N. Roberts, MD Presentations
June 18, 2020 at 12:30 PM - 1:45 PM
It is getting more difficult for some vaccines to be licensed on the basis of traditional randomized controlled trial demonstrations of efficacy against disease. This session will cover the latest thinking about clinical trial designs and approaches to demonstrate vaccine effectiveness to support licensure (including use of biomarkers predictive of protection, human challenge studies, and real world evidence).