FDA & Industry Roundtable Discussion on NAMs: From Application to Scientific Justification

Dr. Nakissa Sadrieh joined FDA 29 years ago and has held many positions including reviewer, supervisor, associate director and director within FDA. Her current job is that of senior advisor for new approach methodologies in the office of new drugs in CDER, where she works on projects to facilitate the implementation of NAMs in regulatory decision making and prediction of drug safety. Nakissa has a PhD in toxicology from Rutgers University and did a postdoc at the National Cancer Institute at NIH.

PJ Devine is a Scientific Director in Discovery Toxicology in the department of Pharmaceutical Candidate Optimization at Bristol Myers Squibb. PJ worked in Preclinical Safety at Novartis from 2010-2022, initially focusing on investigating endocrine and reproductive toxicity, and has expanded his focus over the years. He joined Discovery Toxicology at Bristol Myers Squibb in March of 2022. PJ helps drug discovery teams select the best drug candidates to move forward, driving the safety evaluations leading to first-in-human studies. Research has involved using both simple and complex in vitro models, as well in vivo models, derisking potential target liabilities and examining mechanisms of toxicity that have been seen in preclinical studies or the clinic. PJ is involved in cross-industry consortia involving evaluating complex in vitro models (IQ MPS) and safety aspects of targeted protein degraders (HESI TPD).

Dr. Bhagwat Prasad is a Professor of Pediatrics and Division Director of Translational and Clinical Pharmacology at Cincinnati Children’s Hospital Medical Center, and the founder and CSO of Precision Quantomics, Inc. He leads federally and industry-funded research programs on interindividual variability and IVIVE of drug transport, metabolism, and response, and directs the PRINCE consortium focused on non-conserved enzymes in drug metabolism. Previously a tenured professor at Washington State University and faculty at the University of Washington, he has published over 150 peer-reviewed articles and delivered more than 125 invited talks. His accomplishments have earned major recognitions, leadership roles in ASPET and ISSX, multiple editorial appointments, and awards, and he completed his MS/PhD at NIPER, postdoctoral training at UW, and a Visiting Faculty Fellowship at the U.S. FDA.

Shiny Rajan serves as Senior Director of Platform Development at Javelin Biotech, where she leads the development of human-relevant tissue models that are reshaping how drugs are evaluated before reaching the clinic. With a background in biomedical engineering and dual training in science and business (Ph.D./MBA, Virginia Tech–Wake Forest University), she brings both technical expertise and strategic vision to her role. Her early work in engineering, a six-organ integrated human tissue platform set the stage for her current leadership in advancing multi-tissue chips for drug metabolism, pharmacokinetics, and disease applications. At Javelin, she combines innovation in tissue engineering with collaborative partnerships across academia and industry to deliver predictive models that bridge preclinical research and human health outcomes.