Jeff Roberts | Associate Director For Scientific Affairs
FDA
Dr. Jeff Roberts is the Associate Director for Scientific Affairs in the Office of Vaccines Research and Review. 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, Dr. Roberts’ 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.
Appearances:
Day 2, April 8 @ 09:10
Clinical trials of the future
- Use of real-world evidence for vaccine efficacy
- How to get information from the field to a database
- Regulatory perspective in new development areas
Day 2, April 8 @ 17:10
Vaccine safety surveillance: what can we do to improve surveillance studies and databases?
- Evaluating vaccine safety in children and other at-risk populations
- E.g. RSV and Pertussis, Live attenuated vs subunit
- What are the benefits of RCTs and large databases and how can they be improved?
- How can we ensure we are taking all parameters into account e.g. what time of year is the vaccine given?
- How do we decide which signals are meaningful?
- Do we need to revisit the influenza & narcolepsy issue?
- The need for better databases in LMICs – how do you recognize safety signals? How can they be implemented?
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