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.
Jan. 30, 2026
10am PT | 1pm ET | 19:00 CET
FDA & Industry Virtual Panel on NAMs: Moving Beyond Promise to Application
Join Us Live (Only) for an Online Roundtable Discussing the Barriers, Breakthroughs and Road to Adoption for New Approach Methodologies (NAMs)
This virtual panel will feature representatives from FDA, industry and NAM development for a unique, candid conversation about what’s working, what’s missing, and what comes next for the implementation of NAMs in research and development.
Regulatory agencies and industry innovators are accelerating the push to utilize scientifically validated New Approach Methodologies (NAMs), which aim to provide more human-relevant preclinical drug safety and efficacy data while eliminating unnecessary animal testing. Over the past decade, we’ve seen rapid scientific progress in the development of NAMs, but we are now entering a pivotal phase as we transition into implementation.
This event will explore scientific, operational, and regulatory steps needed to integrate NAMs into modern drug development. The panel will discuss the scientific readiness of NAMs, the barriers that remain, the value of collaborative frameworks, and look at what it will take for these models to scale across the industry. We’ll close with audience Q&A.
This discussion will not be recorded for distribution. Please plan ahead to join us live.
Dr. Rhiannon Hardwick is a Scientific Director in Discovery Toxicology at Bristol Myers Squibb where she serves as a project toxicologist supporting discovery programs through candidate nomination. She also leads a laboratory team and coordinates a complex in vitro model and microphysiological system working group focused on model characterization and qualification for specific contexts of use for toxicology applications. Rhiannon is a Diplomate of the American Board of Toxicology, an active member of the Society of Toxicology, serves on the European Organ on a Chip Society Industrial Advisory Board and the Washington State University College of Pharmacy and Pharmaceutical Sciences Industry Advisory Board, and is a BMS representative to the IQ Consortium MPS Affiliate. She received her PhD in pharmacology and toxicology from the University of Arizona and completed postdoctoral training at the University of North Carolina-Chapel Hill.
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.
Dr. Joshua Apgar is VP and Head of Quantitative Systems Pharmacology Software at Certara, where he leads the design and development of large-scale modeling platforms for translational and clinical decision-making. He co-founded Applied BioMath, advancing industry adoption of QSP through innovative model-informed strategies and collaborative partnerships. His work focuses on building credible, scalable biosimulation tools that help teams integrate complex biology with practical, real-world drug development decisions. Josh received his PhD in biomedical engineering from Massachusetts Institute of Technology.
Dr. Murat Cirit is a bioengineer and the co-founder & CEO of Javelin Biotech. He specializes in developing and commercializing New Approach Methodologies (NAMs), including MPS-based and computational platforms, to improve preclinical R&D productivity and clinical outcomes. With over a decade of experience in microphysiological systems, Murat has led several groundbreaking initiatives. Prior to founding Javelin, he was the founding Principal Investigator of the NIH-funded Translational Center of Tissue Chip Technologies at MIT, managing major programs like DARPA's Human Body on a Chip and NASA’s Tissue Chips in Space. Previously, as a computational biologist at Merrimack Pharmaceuticals, he provided computational guidance for oncology drug programs. Murat received his PhD in Chemical and Biomolecular Engineering from North Carolina State University and a bachelor's degree in Chemical Engineering from Middle East Technical University in Turkey.
Register To Attend
Jan. 30, 2026
10am PT | 1pm ET | 19:00 CET
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