May 14, 2025
In the rapidly evolving world of drug development, industry leaders are carefully monitoring the recent FDA announcements concerning efforts to reduce the use of animal testing in preclinical research. While some public reactions and media headlines have suggested a sweeping change in regulatory expectations, those inside the pharmaceutical and biotech sectors know the reality is far more nuanced.
At Envol Biomedical, we are committed to staying at the forefront of industry conversations, ensuring our clients and partners understand not only the latest regulatory trends but also the true implications for nonhuman primate (NHP) research, pharmacokinetics, toxicology, and advanced therapeutic development.
To deepen this discussion, we spoke with C. Edwin Garner, founder of Mammoth Preclinical Consulting, Vice President of Modeling and Simulation at Resero Analytics, and a trusted adviser to Envol Biomedical. Garner offers unique insights on the FDA’s recent public comments, helping to separate media overstatement from the on-the-ground scientific and regulatory truth.
Understanding the FDA’s Shift: What Was Really Said?
The recent statements by FDA Commissioner Martin McKarry, which highlighted the agency’s desire to reduce animal use in drug testing, have caused notable ripples across the pharmaceutical and biotech industries. Stock prices of major preclinical research providers like Charles River Laboratories were affected, and public conversations erupted over the future role of animal testing in regulatory submissions and investigational new drug (IND) applications.
However, as Garner emphasizes, these discussions are not about eliminating animal testing altogether. Instead, they reflect an ongoing evolution within the regulatory space, one focused on leveraging scientific advances — including AI, modeling and simulation, and organoid systems — to optimize the use of in vivo studies where possible.
“It’s about refining how we approach preclinical work, not rewriting the rules entirely,” Garner explains.
“No one is going to introduce a new chemical entity into mammals or humans without robust, validated animal data to support safety and efficacy assessments.”
Why Focus on Monoclonal Antibodies?
A key point in the FDA’s statements focused on monoclonal antibodies, a class of biologics that has been extensively studied since the 1940s. Thanks to decades of research, the pharmacokinetics and pharmacodynamics of monoclonal antibodies are relatively well-characterized, allowing researchers to apply physiologically based pharmacokinetic (PBPK) modeling with greater confidence.
Garner notes that this makes monoclonal antibodies a reasonable test case for reducing certain animal studies — but only under very specific, controlled circumstances.
“For well-studied molecules like IgGs, we can often build accurate predictive models after a few small studies, but for novel biologics or chemical entities, there’s no replacement for animal data, particularly in species like nonhuman primates where human-relevant data are needed,” Garner emphasizes.
The Role of Nonhuman Primate Research Remains Critical
At Envol Biomedical, our specialized NHP testing services continue to play a vital role in drug development pipelines, especially for complex therapeutic modalities such as gene therapies, oligonucleotide constructs, and novel lipid nanoparticles. Garner underscores that these types of innovations cannot rely solely on in vitro or in silico models.
“Complex systems require real-world testing. You can’t extrapolate beyond what your models know, and that’s where in vivo pharmacology and toxicology studies remain irreplaceable,” says Garner.
Reducing unnecessary animal use has long been part of the industry’s ethical and scientific mission, but the fundamental need for carefully designed, scientifically rigorous animal studies will not disappear — particularly when safety risks, such as those famously exposed by the thalidomide tragedy, remain a constant concern.
Addressing Public Misperception and Media Sensationalism
Both Garner and Envol Biomedical CEO Jacob McDonald emphasize that the real challenge now is communication — ensuring that policymakers, pharmaceutical executives, and the public understand the limits and implications of the FDA’s statements.
“When public figures make broad statements, they can unintentionally trigger confusion inside large pharmaceutical organizations,” McDonald explains.
“This misinformation filters down through bureaucratic layers, potentially disrupting good science and slowing drug development timelines.”
Garner agrees:
“It’s our responsibility as scientists and drug development experts to clarify what’s truly changing and what isn’t. Cooler heads should prevail, and the public needs to understand that science advances carefully, with validation at every step.”
The Bottom Line: Drug Development Will Continue Evolving — Carefully
For pharmaceutical companies, biopharma innovators, and contract research organizations (CROs) partnering with Envol Biomedical, the message is clear: while tools like artificial intelligence, organ-on-chip systems, and PBPK models will continue improving, they are enhancements, not replacements, for preclinical animal testing in most drug development programs.
“The Pfizer-level organizations of the world are not about to halt NHP research or animal toxicology studies because of a single public comment,” says Garner.
“Instead, the industry will continue refining its approaches, reducing unnecessary animal use, and leveraging every available tool to bring safe, effective treatments to patients faster and more efficiently.”
At Envol Biomedical, we are proud to support this mission by providing high-quality, ethical, and scientifically robust nonhuman primate studies that help our clients navigate complex regulatory pathways, reduce development risk, and accelerate breakthrough therapies to market.
Stay Informed with Envol Biomedical
We remain committed to bringing you the latest insights on regulatory trends, scientific advances, and best practices in NHP research, pharmacology, and toxicology. If you missed it, be sure to check out our earlier blog featuring Jacob McDonald’s thoughts on this topic, and stay tuned for more expert commentary from our leadership team and collaborators.
For questions about how Envol Biomedical can support your next preclinical or nonclinical program — including strategies for optimizing your use of animal studies alongside cutting-edge modeling tools — contact our team today. Together, we can help shape the future of safe, ethical, and innovative drug development.