With Broad Appeal, FDA’s Workshop on Reducing Animal Testing Hears from Experts on More Humane and Human-Relevant Testing Methods
By Erin Peabody, OII Writer-Editor
Pressing forward on its earlier announced plan and roadmap to phase out the animal testing requirement for monoclonal antibodies and other drugs, the FDA hosted an expert panel workshop on July 7 at its White Oak campus, which was also livestreamed to the public.
Commissioner Dr. Martin Makary opened the event, elaborating on the win-win nature of the transformative initiative, given its potential to help advance a number of agency priorities simultaneously: faster delivery of cures and treatments to patients; reduced R&D costs, which can translate into lower drug costs for Americans; enhanced innovation; and, of course, more humane and ethical treatment of animals.
A Top Priority
The goal has been a clear priority for the Commissioner. Within only weeks of taking office, Dr. Makary instigated the gathering of experts needed to begin work on a roadmap whose goal, he says, is to “reduce animal testing in a way that’s meaningful and continues to protect public safety.“
The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of modern approaches, including AI-based computational models of toxicity and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies, or NAMs, data).
Bringing People Together
The Commissioner noted the broad bipartisan interest the initiative has generated. “I am so moved at how uniting of a topic this is,” and that it’s “bringing people together.”
The topic has had such broad appeal—in-person seats for the event filled up within hours—that Dr. Makary humorously compared its popularity to a Taylor Swift concert. To accommodate all interested in viewing, the agency livestreamed the event, as it has other expert panels and workshops, on FDA’s YouTube channel.
Before wrapping up his welcoming remarks, the Commissioner highlighted the contributions of two specific individuals, whose work has been integral to recent efforts to reduce animal testing at the FDA and NIH:
- Tracy Beth Høeg, M.D., Ph.D.,
Senior Advisor for Clinical Sciences, Office of the Commissioner and Center for Biologics Evaluation and Research. - Nicole Kleinstreuer, Ph.D,
Acting NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives.
Dr. Makary also acknowledged and thanked the event’s other distinguished speakers who included:
- Jacqueline Corrigan-Curay, J.D, M.D.
Acting Director, Center for Drug Evaluation and Research (CDER) - Haleh Saber, Ph.D.
Division Director of Hematology, Oncology and Toxicology (DHOT), Center for Drug Evaluation and Research - Steven Musser, Ph.D.
Associate Commissioner for Human Foods Research - Jeremy Walsh
Chief Artificial Intelligence Officer - Tucker Patterson, Ph.D.
Director, National Center for Toxicological Research, NCTR - Steve Kozlowski, M.D.
Acting Chief Scientist
- Tracy Chen, Ph.D., D.A.B.T.
Senior Advisor, Regulatory Science Collaborative Community, Office of the Chief Scientist - Warren Casey, Ph.D., DABT
Director of Strategic Partnerships in the Office of Portfolio Strategy and Research Management, Division of Translational Toxicology, National Institute of Environmental Health Sciences, National Institutes of Health - Brian Cholewa, Ph.D.
Senior Toxicologist/Program Director, Chemopreventive Agent Development Research Group, National Cancer Institute, National Institutes of Health - Andrew Kilianski, Ph.D.
Acting Deputy Director, Health Science Futures, Advanced Research Projects Agency for Health (ARPA-H)
Why Animal Testing?
Dr. Tracy Beth Høeg described for listeners, especially those new to the topic, how the 1937 sulfanilamide disaster, responsible for the deaths of at least 105 Americans, including children, helped trigger the need for drug testing (as well as the 1938 Federal Food, Drug, and Cosmetic Act). Animal testing soon became the default standard.
But why animal testing, this many decades later? Dr. Høeg went on to describe the limitations of animal testing for human drugs and other treatments.
What Are NAMS, or New Approach Methodologies?
In addition to elaborating on CDER’s use of NAMS, Dr. Jacqueline Corrigan-Curay also named some of the alternative methods that qualify as new approach methodologies:
- Systems biology
- Engineered Tissues
- AI
- Alternative Organisms
- Microphysiological systems, such as organs-on-chips
Dr. Høeg outlined how some of those approaches can be employed right now.
Oncology
Haleh Saber stressed DHOT’s commitment to reducing animal testing, including through streamlined approaches in oncology—including weight-of-evidence risk assessments, modeling approaches paired with pharmacology data, and the formation of a new Bioinformatics Unit in DHOT.
She also noted some regulatory challenges that could be addressed, including enhanced approval pathways.
Foods, A Different Space
Steven Musser echoed the importance of the initiative, also describing HFP’s past engagement with NAMS. Foods do have some distinctions from drugs that need to be considered when evaluating them, including their post-market consumption and the unpredictable way in which most consumers are exposed to a given food product (versus a medication they might take at the same time every day).
Power of Data
While organ-on-a-chip and organoids were common topics at the workshop, in silico computational modeling was also mentioned as holding great promise, including as an approach to address more complicated toxicology issues and foods.
The agency’s Chief AI Officer Jeremy Walsh spoke with bold optimism about the potential for data and AI to reduce animal testing. The agency is rich with data but much of it, he says, remains unstructured and nonstandardized. The good news: AI tools have the capacity to convert those reams and decades’ worth of data into meaningful knowledge that can advance our understanding of toxicology and replace the need for animal testing.
Our Current Moment and the Value of Champions
A couple of speakers reminded listeners of the progress that’s already made by the agency and its federal collaborators, and how the current moment, as prioritized by the Commissioner, can catapult real progress when it comes to reducing animal testing.
Chief Scientist Dr. Steve Kozlowski invoked the metaphor of planting bamboo seeds. While they may not flourish for a long time; if tended to, they will flourish and spread vigorously.
Dr. Jacqueline Corrigan-Curay explained the classic curve that regulatory agencies often experience in implementing novel regulatory approaches—noting, in phase three, the importance of growing championships and developing business processes and regulatory guidances.
You can view the recording of the workshop at: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-nih-workshop-reducing-animal-testing-07072025.