BioIVT Leads Charge as FDA Ushers in New Era of Drug Testing

WOODBURY, NY – March 19, 2026 – As the pharmaceutical industry stands on the cusp of a regulatory-driven transformation, biospecimen solutions provider BioIVT is positioning itself at the forefront of the shift toward advanced, non-animal testing methods. The company has announced a series of high-profile scientific presentations and collaborative forums for spring 2026, aimed directly at addressing the U.S. Food and Drug Administration's recent and decisive push for the adoption of New Approach Methodologies (NAMs) in drug development.

This strategic initiative, highlighted by a significant presence at the upcoming 65th Annual Society of Toxicology (SOT) Meeting and a company-hosted symposium, comes just as the FDA solidifies its commitment to modernizing preclinical safety assessment. The convergence of these events signals a pivotal moment for the industry, moving the conversation around NAMs from theoretical promise to practical, widespread application.

The Regulatory Revolution: FDA Charts a New Course

The landscape of drug development was irrevocably altered by the passage of the FDA Modernization Act 2.0 in late 2022, which removed the long-standing mandate for animal testing. Building on this legislative foundation, the agency has accelerated its efforts to champion human-relevant alternatives. Just this week, on March 18, 2026, the FDA released a highly anticipated draft guidance, "General Considerations for the Use of New Approach Methodologies (NAMs) in Drug Development."

This document provides the clearest roadmap yet for drug sponsors, outlining four key principles for validating NAMs: defining a clear context of use, demonstrating human biological relevance, ensuring robust technical characterization, and confirming the model is fit-for-purpose. The guidance explicitly encourages the use of a diverse range of technologies, including organoids, organs-on-chips, and sophisticated in silico computer models, to replace animal studies that have shown a notoriously poor track record in predicting human safety and efficacy.

This regulatory sea change creates both a challenge and an opportunity for the pharmaceutical sector. While the goal is to develop safer, more effective drugs faster, the transition requires a new ecosystem of validated tools, reliable biological materials, and collaborative expertise—a gap that companies like BioIVT are strategically moving to fill.

BioIVT's Scientific and Collaborative Offensive

In response to this evolving environment, BioIVT is launching a multi-pronged effort to showcase its capabilities and foster industry-wide dialogue. The company's activities will kick off at the SOT Meeting and ToxExpo in San Diego, from March 22–25, where it will engage with the toxicology community on several fronts.

Beyond its exhibitor presence, BioIVT will host a session featuring Dr. Rhiannon N. Hardwick of Bristol Myers Squibb, focusing on the critical need for baseline characterization in qualifying NAMs. This highlights a core theme: the success of these new models depends entirely on the quality and understanding of their biological components.

Furthermore, the company and its collaborators will present compelling new research through a series of scientific posters. These include:

• Immune-Mediated Liver Injury: A presentation by BioIVT's Dr. Karissa Cottier on integrating immune cells into their HEPATOPAC® co-culture liver model to better detect a complex and dangerous form of drug toxicity.
• Automation and AI: A collaboration with DeNovix Inc. showcasing how novel machine learning algorithms can automate the counting of primary hepatocyte samples, improving accuracy and efficiency in a foundational lab process.
• In Vitro Clearance Trends: An analysis from BioIVT's Dr. Tina Mueller on drug clearance data from microsomes and hepatocytes, offering insights to improve the predictive power of these key in vitro test systems.

Following the SOT meeting, BioIVT will convene a panel of experts in April for an in-person symposium in Boston titled, “Elevating Drug Development with NAMs: Meeting the FDA’s Call for Change.” This event will feature speakers from Harvard Medical School, Bristol Myers Squibb, and several innovative biotech firms. Crucially, the initiative will culminate in a virtual roundtable on April 14, bringing together industry leaders and FDA experts to discuss the path forward.

“There’s undeniable growing momentum around how researchers are utilizing NAMs and working to meet evolving regulatory expectations,” said Dr. Kent Grindstaff, Consulting Director at BioIVT. “We're looking forward to engaging with drug development researchers, model developers, and regulatory authorities... to highlight how BioIVT’s high-quality biological inputs can support these new methodologies and facilitate real-world drug development workflows.”

The Foundational Role of Biospecimens in the NAMs Era

The promise of NAMs—from complex 3D organoids to microphysiological systems—rests on a simple but critical foundation: they must accurately reflect human biology. This is where BioIVT's core business of providing high-quality, deeply-characterized human and animal biospecimens becomes central to the entire endeavor. The most sophisticated organ-on-a-chip is only as good as the cells it contains.

The research being presented at SOT underscores this point. The ability to create a functional, long-term liver model that includes HLA-typed immune cells is a significant step toward predicting immune-mediated drug-induced liver injury (DILI), a major cause of drug failure that is poorly modeled in animals. This work directly addresses the FDA's call for more human-relevant data.

By providing the essential raw materials—from control and disease-state tissues to isolated primary cells and biofluids—the company enables researchers in academia and industry to build, validate, and deploy the very models the FDA is now encouraging. This positions the firm not merely as a supplier, but as a critical partner in building the infrastructure for the next generation of toxicology and drug discovery. The events in San Diego and Boston are designed to cement this role, moving beyond product supply to actively shaping the scientific and regulatory dialogue and helping to solve the complex challenges of NAM implementation. The focus on collaboration, bringing together regulators, established pharma, and nimble biotech innovators, demonstrates an understanding that navigating this new landscape requires a collective effort.