Profile: Seema Nayak, MD


Director, Office of Clinical Research Resources, Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and serves on the IDCRC Collaboration and Publications Key Function Committee

Dr. Nayak oversees clinical operations, grants and contracts on Phase 1-3 interventional clinical trials across a variety of pathogens such as SARS-CoV-2, influenza, malaria, gonorrhea, RSV and others along with therapeutics, vaccines, diagnostics and devices.

Tell us about your path to NIAID

I began my career in infectious diseases on the faculty of Johns Hopkins University where I ran an interventional clinical trials program, under the mentorship of Jonathan Zenilman, MD. We started with Phase 1 clinical trials in new therapeutics, with an initial focus in sexually transmitted infections, and quickly branched into vaccines and Phase 2/3 trials. My team expanded to start operationalizing trials for other groups at Hopkins in a variety of medical and surgical specialties. The position at NIAID was a natural progression and increase in scope for me; it provided me with a fantastic opportunity to make the biggest impact on science that I could.

How long have you worked with Vaccine & Therapeutics Evaluation Units (VTEUs) and/or IDCRC?

I’ve worked with the VTEUs since I joined NIAID in January 2018, and with the IDCRC since before its inception. I was the lead author on the RFA.

What has been the most impactful or highlight of your IDCRC work?

The impact the IDCRC has had in its significant contributions to the Covid-19 research response is definitely the highlight for me, from the Phase 1 Moderna trial to the Adaptive Covid-19 Treatment Trials (ACTT 1-4) and the Phase 3 vaccine trials, to answering important public health questions through the data gathered in Mix-n-Match and MOMI-Vax. The IDCRC will continue to lead the research community in answering questions of public health importance around Covid-19. View all IDCRC studies

What is a strength or example of the importance of the IDCRC?

The strength of the IDCRC is the components of the network itself. The investigators and their teams, who do high-quality interventional trials every day, and are now training the next generation of infectious disease researchers. The mentorship programs at the IDCRC and growth opportunities for young investigators will continue the legacy of the IDCRC.