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Industry Leaders Signal a Turning Point in Drug Development
New Approach Methodologies improve speed, safety, and human relevance
At LSX 2025, Charles River hosted a forward-looking panel discussion that brought together biotech innovators, AI experts, and regulatory leaders to explore a transformative shift in drug development: the rise of New Approach Methodologies (NAMs) and the potential for animal-free programs from discovery through nonclinical development.
Moderated by our Chief Scientific Officer, the session focused on how recent FDA guidance is reshaping the landscape and what biotech and pharma companies can do to stay ahead.
This is a genuinely strategic turning point for our industry. Technology is coming together, sponsors are coming together, and regulators are coming together. This is a unique moment in time.”
Julie Frearson, SVP, Chief Scientific Officer
Why This Matters for Drug Developers
The FDA's push to reduce the reliance on animals, starting with monoclonal antibodies (mAbs), signals a broader shift enabling biopharma companies to accelerate timelines, improve human relevance, and increase the probability of success. Panelists emphasized that this is not just a regulatory shift, but a strategic opportunity for sponsors to lead the change.
This administration wants a win. They’re looking for the right partners to successfully translate the use of NAMs into the drug development space. The climate is ripe for innovation.”
Tina Morrison, LSX panelist, former FDA leader, VP Scientific Strategy, EQTY Lab
From the industry side, companies are already adapting their research strategies to align with this new direction.
We’ve been on a journey to transform our research into a more human-centric approach. It’s about avoiding false positives in rodents and making smarter decisions earlier."
Sara Toftegaard Hjuler, LSX panelist and Director, Microphysiological Systems, Novo Nordisk
AI and Data: The Translational Bridge
As the conversation turned to technology, panelists explored how artificial intelligence is helping bridge the gap between complex in vitro models and clinical relevance. AI is not just a tool; it’s becoming the connective tissue between data and decision-making for nonclinical, clinical, and regulatory domains.
The biggest impact of AI lies in translating complex data generated by in vitro assays to clinical language. It’s about connecting the dots and making sense of the biology.”
Amir Bein, SVP Biology, Quris AI and LSX panelist
This sentiment was echoed by those working at the intersection of data science and drug discovery.
Across the industry, we’ll start to see more mechanistic insights into safety issues and better candidates. New Approach Methodologies give us tools to understand what’s happening earlier in the cycle.”
Stephen MacKinnon, Vice President, Applied Machine Learning, Recursion and LSX panelist
The Future of NAMs: A Paradigm Shift in Progress
While science is advancing rapidly, panelists agreed that collaboration across industry, academia, and regulators is essential to scaling the adoption of NAMs. Programs like NIH’s Complement-ARIE are creating shared infrastructure to support validation, qualification, and data sharing.
No single organization can drive this transformation alone; trust, transparency, and shared goals will be key. While full animal-free programs may not be routine in the immediate future, the momentum is undeniable, and the shift is already underway. The panel consensus was clear: early adopters will benefit most, and those who invest now in NAMs will be better positioned for regulatory alignment and clinical success and can drive future adoption pathways.
As the regulatory landscape evolves, we are committed to helping clients navigate this shift. We offer expertise in advanced in vitro systems, in silico tools, safety assessment, and regulatory strategy. Our teams are ready to support sponsors in designing, validating, and integrating NAMs into their development programs. Whether you’re a startup looking to accelerate IND submission or a global pharma exploring alternatives to animal testing, we’re here to help you lead the change.
Maximize Safer, Targeted Biologic Development with Smarter NAMs-Based Off-Target Screening
Join us for a case-based webinar showcasing how the Retrogenix platform empowers smarter, earlier decisions across biologic formats. Learn how this platform aligns with evolving regulatory support for NAMs and the shift toward reduced reliance on animals.
Watch the Webinar