Triangle CERSI Presents:
Previous Sessions
Session 6 Date: July 14, 2026 | 12:00 Noon - 1:00 PM EDT
Topic: May the NAMs Be With You: Considerations for Traditional vs Alternative Approaches
This session addresses various considerations and responsibilities, including ethical considerations, that are embedded in advancing NAMs in the context of various use cases.
Speakers:
Namandjé N. Bumpus, PhD
Steven J. Bulera, PhD, DABT
Matthew Hewitt, BA, PhD
About the Session 6 Featured Speakers:
Dr. Namandjé N. Bumpus joined Charles River Laboratories in 2026 as Senior Vice President, Chief Scientific and Innovation Officer. In this role, Dr. Bumpus leads the Company’s scientific strategy, oversees research and development initiatives, and advances innovation to support clients in accelerating the drug development process. She also leads the Company’s Scientific Advisory Board, which provides guidance to strengthen its commercial and regulatory strategy, and is also focused on developing and accelerating the adoption of NAMs across the biopharmaceutical industry. Prior to joining Charles River, Dr. Bumpus joined the U.S. Food and Drug Administration (FDA) in 2022 as Chief Scientist and later served as the agency’s Principal Deputy Commissioner through 2024. Before joining the FDA, she was Professor and Director of the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. Dr. Bumpus has received several honors, including the Presidential Early Career Award, the John J. Abel Award, and the Leon I. Goldberg Award, and is a past president of the American Society for Pharmacology and Experimental Therapeutics, a fellow of the American Association for the Advancement of Science, and a member of the National Academy of Medicine. Dr. Bumpus holds a B.A. in Biology from Occidental College and a Ph.D. in Pharmacology from the University of Michigan Medical School.
Dr. Steven Bulera has >25 years in the pharmaceutical industry. He has been at Charles River (CR) since 2007 and has served as the Head of Toxicology at both the Shrewsbury, MA and Reno, NV sites, and as the Global Head of Toxicology. Currently, Steven is the Chief Scientific Officer for Discovery and Safety Assessment. Prior to CR, Steven held positions at 3 pharmaceutical companies: Parke-Davis, Pfizer, and Bristol-Myers Squibb. He has experience as a in vivo study director, has been the Head of Genetic Toxicology, and has led an investigational toxicology group with experience in the panomic technologies (toxicogenomics, proteomics, metabonomics). He also has experience in drug development and worked on numerous drug candidates being developed for oncology and anti-HIV therapies. Steven holds degrees in biochemistry from Canisius College (B.A.) and The University of Connecticut (M.S./Ph.D.). Steven was a postdoctoral fellow in Dr. Henry Pitot’s laboratory at the McArdle Laboratory for Cancer Research at the University of Wisconsin. He is a current member of the American College of Toxicology and the Society of Toxicology. Steven has been a Diplomat of the American Board of Toxicology since 1998.
Dr. Matthew Hewitt currently serves as Vice President, Chief Technical Officer for the Manufacturing Business Division at Charles River Laboratories (CRL). In this role, Matt leads multiple initiatives across Charles River’s manufacturing portfolio for CDMO, Testing, and Microbial Solutions to assist partners moving assets to clinic and commercial. Matt is also responsible for leading conversations relating to CRL’s strategic approach. Before joining the company, Matt was Head of R&D and Clinical Development for Lonza’s Personalized Medicine Business Unit where he was responsible for the Cocoon Platform, a closed, automated, scalable cell therapy manufacturing solution. He led the R&D Innovation groups (Biology, Engineering, and Software) and worked with numerous cell and gene therapy programs to accelerate clinical development timelines. These collaborations included a lead program in Israel, culminating in dosing the first patients with a cell therapy manufactured in the Cocoon. In addition, Matt oversaw numerous academic and industry collaborations including an analytics initiative to better understand cell therapy products, enhance clinical efficacy, and manufacturing process robustness. Prior to Lonza, Matt led the Tumor Immunology and Microenvironment program at Bellicum Pharmaceuticals focused on improving cell therapy efficacy in solid tumors. He led the Immunology group at the University of Pennsylvania’s Gene Therapy Program under Dr. James Wilson, leading numerous AAV gene therapy programs. Matt received his B.A in Molecular Biology from Goucher College, PhD in Biophysics and Physiology from the University of Alabama at Birmingham and completed his post-doctoral fellowship at Johns Hopkins University.
Session 6 Slides
Session 6 Blog Post
Watch Session 6, linked here or embedded below.
Session 5 Date: June 22, 2026 | 12:00 Noon - 1:00 PM EDT
Topic: AI, Evidence and Trust: A Conversation on the Next Frontier of the NAMolution
In this session, we sit down with two internationally recognized leaders working at the intersection of artificial intelligence, computational science, and trustworthy innovation in healthcare and regulatory science.
Speakers:
Alejandro Frangi, FREng FIEEE
Tina Morrison, PhD
About the Session 5 Featured Speakers:
Alejandro Frangi, FREng FIEEE is Royal Academy Chair in Computational Medicine and serves as Executive Director of the UK CEiRSI Centre of Excellence on In Silico Regulatory Science and Innovation. He is also Lead for Digital Infrastructure at the NIHR Manchester Biomedical Research Centre and holds appointments as Bicentennial Turing Chair in Computational Medicine within both the Division of Informatics, Imaging & Data Sciences and the Machine Learning and Robotics Centre at The University of Manchester. His work sits at the crossroads of AI, computational physiology, medical image analysis, and in silico clinical trials, with a particular focus on developing digital and computational approaches that can support regulatory-grade evidence generation. Across academia, engineering, and translational medicine, he has been a leading international voice advancing how AI and simulation technologies can accelerate safer, more efficient, and more predictive healthcare innovation.
Tina Morrison, PhD is VP, Scientific Strategy at EQTY Lab and a recognized leader in trustworthy AI, computational modeling, and digital governance frameworks for emerging technologies. Her career has spanned standards development, regulatory science, AI assurance, and the responsible deployment of advanced technologies in high-consequence settings. Prior to founding EQTY Lab, she directed the Office of Regulatory Science and Innovation at the U.S. Food and Drug Administration before transitioning to serve as Senior Executive and Science Advisor to the FDA Chief Scientist. Dr. Morrison also serves on the AI and the Administration of Clinical Research Task Force for the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, leads the Global Harmonization Task Force for Avienna Alliance, and frequently advises scientific initiatives and emerging technology companies. She is widely known for helping shape credibility and verification frameworks for computational models and AI systems, including work related to standards development, AI governance, and regulatory trust in emerging technologies.
Session 5 Blog Post forthcoming.
Watch Session 5, linked here or embedded below.
Session 4 Date: May 4, 2026
Speaker: Will Proctor, PhD, DABT, Senior Director, Toxicologist - Preclinical Sciences, GSK
Topic: NAMs in Drug Discovery and Development: An Industry Perspective
About the Session 4 Featured Speaker
Will Proctor, PhD, DABT is a Senior Director and Toxicology Program Specialist at GSK, supporting discovery and development programs. He earned his BS in Chemistry from Trinity College and his PhD in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill, followed by postdoctoral training at the National Institutes of Health studying immune mechanisms of drug-induced liver injury. Dr. Proctor began his industry career at Genentech in 2013, where he spent eight years advancing to Senior Director and Head of Predictive Toxicology, overseeing investigative toxicology, complex in vitro systems, and small molecule discovery toxicology. He later joined Kymera Therapeutics as Senior Director of Preclinical Safety before joining GSK in 2023. He has been actively involved in the development and application of microphysiological systems (MPS) since 2014 and helped build industry capabilities for using complex in vitro models in nonclinical safety assessment. Dr. Proctor was also a founding member and inaugural chair of the IQ MPS Affiliate, a cross-industry consortium focused on advancing collaboration and data sharing to support the implementation and qualification of MPS technologies.
Our speaker will provide a contemporary view on how NAMs are being applied in the pharmaceutical industry, with focus on nonclinical safety assessment. This talk will address many opportunities, challenges, and misconceptions associated with NAMs from the perspective of the end-user as it relates to both internal and regulatory decisions.
Session 4 Slides
Session 4 Blog Post
Watch Session 4, linked here or embedded below.
Session 3 Date: April 3, 2026
Speaker: Melissa Haendel, PhD, FACMI, Distinguished Professor at University of North Carolina at Chapel Hill; and Director of Precision Health and Translational Informatics, NC TraCS
Topic: AI-Driven Approaches to Validate NAMs and Reduce Animal Dependency in Biomedical Research: An Academic Perspective
About the Session 3 Featured Speaker
Melissa Haendel, PhD, FACMI, is the Sarah Graham Kenan Distinguished Professor at the University of North Carolina at Chapel Hill and Director of Precision Health and Translational Informatics. An internationally recognized leader in biomedical data science, her work focuses on building the data infrastructure that enables AI-driven biomedical discovery. Dr. Haendel is a principal investigator in the Monarch Initiative, an international consortium that develops global standards and semantic data integration technologies to connect diverse biomedical datasets. The Monarch platform brings together multiple open-source, open-access tools that integrate and interpret genetic, phenotypic, and disease data to advance precision medicine and diagnostics. By leveraging ontologies, knowledge graphs, and AI, Monarch enables researchers to identify the most appropriate biological models for studying human physiology and disease and is increasingly being adapted to do the same for NAMs.
Drawing on examples that combine organoids and microphysiological systems with in silico models and large-scale biomedical knowledge graphs, Dr. Haendel will discuss how AI-enabled triangulation of model organism and human data can improve model selection, increase translational confidence, and support quantitative validation of NAMs. Her work highlights how consistent reporting, predefined validation metrics, and integrated data frameworks can strengthen reproducibility, reduce animal dependency, and advance more reliable, human-relevant evidence for biomedical research and decision-making.
Session 3 Slides
Session 3 Blog Post
Learn more about Mondo, the world’s first standardized rare disease coding tool.
Watch Session 3
Session 2: March 2, 2026 from 12:00 Noon to 1:00 PM Eastern
Speaker: Dr. Nicole Kleinsteuer, NIH Deputy Director for Program Coordination, Planning and Strategic Initiatives (DPCPSI)
Topic: Advancing Human-Relevant Science: NIH’s Role in Accelerating the NAM Revolution
About the Session 2 Featured Speaker
Dr. Nicole C. Kleinstreuer serves as Deputy Director for Program Coordination, Planning, and Strategic Initiatives in the NIH Office of the Director, where she leads NIH-wide strategic research programs, including the Common Fund and multiple cross-cutting policy initiatives. An internationally recognized leader in human-relevant science, she has advanced new approach methodologies (NAMs), computational modeling, and AI-driven innovation to strengthen biomedical research and regulatory science. Previously, she directed NICEATM at NIEHS and led ICCVAM, helping coordinate U.S. and international efforts to modernize toxicology. Dr. Kleinstreuer has authored more than 180 publications and is widely honored for her contributions to public health and humane science innovation.
Session 2 Slides
Session 2 Unanswered Q&A; Blog Post Forthcoming
Watch Session 2
Session 1: February 3, 2026 from 12:00 Noon to 1:00 PM Eastern
Speaker: Steven Kozlowski, MD, Chief Scientist at the U.S. Food and Drug Administration
Topic: Integrating NAMs into FDA Regulatory Practice: Where We're At and Where We're Going
About the Session 1 Featured Speaker
Steven Kozlowski, M.D., is the FDA’s Chief Scientist, where he leads cross-cutting scientific initiatives that advance regulatory science, innovation, and research in support of the agency’s public health mission. He brings extensive experience in pharmaceutical quality, immunology, and regulatory science, with prior leadership roles in the FDA’s Center for Drug Evaluation and Research overseeing the quality of drugs and biological products. Dr. Kozlowski has published widely across areas central to FDA’s mission and holds an M.D. with distinction from Northwestern University, with pediatric training at the University of Illinois.
Session 1 Slides
Session 1 Blog Post
Watch Session 1 Recording
Funding Acknowledgement:
This Program is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award Center of Excellence in Regulatory Science and Innovation, U01FD007857. The contents are those of the author(s) and do not necessarily represent the official views, nor an endorsement by, FDA/HHS, or other U.S. Government.
