As a postdoctoral fellow in the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Research Participation Program, Pratistha Tamrakar, Ph.D., seized the opportunity to build upon her education and forged a pathway to her future in pharmaceutical regulatory work. Today, she examines preclinical data in drug applications as a pharmacology toxicology reviewer at the Office of New Drugs (OND) Center for Drug Evaluation and Research (CDER).
The Oak Ridge Institute for Science and Education (ORISE) Research Participation Training Program for CBER provides scientific training for participants having an interest in medical, biological, chemical, toxicological, mathematical/statistical or other related sciences. With her background in neuroscience and pharmacology, Tamrakar was excited about the future possibilities the ORISE fellowship represented for her aspirations to directly impact public health safety and support FDA regulatory decisions.
Having earned her doctorate in pharmacy from the University of Louisiana at Monroe in 2015, Tamrakar set her sights on regulatory pharmaceutical work and began taking steps to realize her career goals. “The fellowship helped me decide my career path. As a research participant, I gained a sense of how the agency functions and learned about various aspects of the work performed at FDA,” she explained.
With her mentor, chemist Luisa Gregori, Ph.D., Tamrakar contributed to research projects within the Office of Blood Research and Review (OBBR) at CBER. “Our project was focused on determining whether the routine storage of blood and blood components reliably eliminates the risk of transfusion-transmitted syphilis,” Tamrakar said. “We studied the infectivity of stored whole blood and platelets spiked with Treponema pallidum, a spirochete bacterium and the causative agent of syphilis.”
This project gave Tamrakar the opportunity to train on new techniques and contribute to a research project with potential regulatory implications for public health. “I was very excited to take up this opportunity because the project addressed FDA’s public heath safety mission and supported its regulatory decisions,” Tamrakar said.
Tamrakar spent 17 months in her ORISE fellowship and recently transitioned into her new role as a senior staff fellow at OND CDER. She expressed appreciation for the collaborative nature of the agency and its focus on cultivating stronger scientific teams.
“The CBER Research Participation Program is an excellent opportunity,” she said. “You will meet many knowledgeable people who are dedicated and passionate about public health safety.”
The CBER Research Participation Training Program is administered through the Oak Ridge Institute for Science and Education (ORISE) under an agreement between the FDA and the U.S. Department of Energy (DOE). ORISE is managed for DOE by Oak Ridge Associated Universities.