Jessica Tang, Ph.D., joined the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Research Participation Program following a three year postdoctoral residency at the National Institutes of Health (NIH).
During the NIH residency, her interest in infectious diseases and vaccines rose to the surface, and she sought research opportunities to redirect her career path. Tang, who earned a doctorate in molecular and cellular biology from the University of Maryland, transitioned from NIH to CBER.
The CBER Research Participation Program at FDA is an educational and training program designed to provide college students, recent graduates and university faculty opportunities to connect with the unique resources of FDA. Specifically, the program provides temporary scientific training for participants having a background or interest in medical, biological, chemical, toxicological, mathematical/statistical or other related sciences.
Tang was appointed to the Division of Vaccine Products (DVP), and she participated in research initiatives under the guidance of her mentors Surender Khurana, Ph.D., and Hana Golding, Ph.D. Located within the Office of Vaccines Research and Review (OVRR), DVP supports OVVR’s mission to protect and enhance public health by assuring the availability of safe and effective vaccines, allergenic extracts and other related products.
“Our research focused on the efficacy and safety of vaccines and therapeutic drugs using antibodies,” she said. “Specifically, we were looking at the antibody-dependent enhancement (ADE) effect in influenza viral infection.”
The ADE of virus infection is a phenomenon in which virus-specific antibodies enhance the entry of a virus, and in some cases the replication of a virus, into monocytes and other target cells.
“The goal of our research was to assess the possible ADE of several influenza monoclonal antibodies and to use the characterized antibodies to establish animal models and in vitro assays that can facilitate the assessment of ADE effects,” Tang said. “Certain flu antibodies, especially the non-neutralizing antibodies, could cause more severe disease in the animal models and human tissues, especially in the lungs. So we need to be extremely careful to assess the safety of any vaccines or anti-viral treatments related to flu antibodies,” she said.
“Every year, there are 100,000 hospitalizations and more than 10,000 deaths caused by influenza virus infection, or the flu,” Tang explained. “Many vaccines and therapeutic antibody treatments are being developed. To make sure these products are preventing diseases and not harming the population, we are conducting research to examine the efficacy and possible safety issues for these products. My research will provide essential scientific support for regulatory officials and the public at large.”
Tang said her fellowship at CBER has been a valuable collaborative learning experience, and it has allowed her to expand on skills she fostered during her NIH residency. “My favorite part of the program has been being involved in research that could directly provide essential information for regulatory issues, potentially showing an impact on the public health,” she said.
As a CBER fellow, Tang has had the opportunity to look at important public health issues while learning unique approaches to solving public health concerns with scientific tools and procedures. “First, through this experience, I have gained knowledge concerning the efficacy and safety of influenza antibodies,” she said. “Secondly, I have been exposed to seminars and work-in-progress meetings, where I learned to understand more practical perspectives on how science can support the public health decisions being made,” she said.
“This has been an enriching program which broadened my view of what science can do,” Tang said. Her research has been the subject of a paper she co-authored in Proceedings of the National Academy of Sciences (PNAS) in 2019.
Tang recommended the program to researchers who want to expand on their knowledge of biologics. “I am fortunate to conduct research in my main areas of interest and use my skills to benefit public health,” she said.
The CBER Research Participation Training Program is administered through the Oak Ridge Institute for Science and Education (ORISE) under an agreement between FDA and the U.S. Department of Energy (DOE). ORISE is managed for DOE by Oak Ridge Associated Universities.