My Thoughts on NAMs and the Future of Drug Development: Progress Demands Leadership
Donna Robinson, Chief Commercial Officer, Instem
New ideas, methods, and technologies appear all the time, especially in the biomedical space. While the hype is often well-earned, many developments remain “on the horizon” rather than making a difference where it counts. As with so many things, real progress begins when somebody raises their hand and says “Yes, I believe in this, let’s go with it,” long before all the tools and roadmaps for implementation are in place.
We’re quickly approaching a tipping point in drug discovery towards a reduction in use of animals in research via new approach methodologies (NAMs). In this post, let’s take a closer look at what NAMs are and the factors driving the conversation around their implementation.
NAMs for Reducing Animal Use
NAMs include alternative approaches to animal models for generating toxicological data in drug development, and include in silico and computational modeling, in chemico assays, and in vitro assays.
- In silico analyses: A broad set of tools, including qualitative structure-activity relationship (QSAR) models that predict toxicity from chemical features, and physiologically based pharmacokinetic (PBPK) models that predict effects on ADME (absorption, distribution, metabolism, and excretion)1.
Instem’s computational toxicology platform, Leadscope Model Applier™ deserves a mention here, which includes models developed under a research collaboration agreement with the FDA and automatically generates regulatory-ready reports. Additionally, Instem’s Predict solution is used to generate a WoE (weight of evidence) package that eliminates the need for 2 – year rodent studies. We have customers getting acceptance from the FDA using Predict which saves time, money and supports animal welfare.
- In chemico assays: These methods assess therapeutic reactivity in an abiotic setting and are often applied in skin sensitivity and hepatotoxicity studies2.
- In vitro assays: These include organ-on-chip models such as mini-brain-on-chip, gut-on-chip, and heart-on-chip. Microphysiological systems that connect multiple organ models via fluidics systems are emerging and help to assess the interplay of drug metabolism, distribution, and toxicity3.
While the promise of reduced animal testing drives much of the enthusiasm for NAMs, it isn’t the whole story. NAMs have the potential to deliver more efficient safety assessments, enabling faster and more confident development decisions while also supporting more ethical drug development.
Another factor driving the conversation around NAMs is the clear interest and enthusiasm from regulatory bodies. In the UK, the Replacing animals in science strategy references the implementation of alternative methods to animal use in research and includes £75 million in funding for developing these methods4. The FDA and EMA have also signaled a clear intent to shift away from animal testing in drug development, with increasing support for NAMs as more effective and ethically sound alternatives5-7. There is genuine momentum building behind NAMs, and the engagement of major regulatory bodies lends even further weight. However, meaningful change ultimately begins with individuals, and the experiences and values that shape their approach.
Why This Matters to Me
Concern for animal welfare has always been woven into my identity. For instance, it played a huge part in the trajectory of my early career. Advanced Biology involves a lot of animal dissection, and to put it plainly, I couldn’t stand it, especially when the subjects were fetal pigs and cats. I went so far as to beg my lab partner to do my dissections and I did the data documentation and lab reports for both of us. When I made the decision not to follow in my sister’s footsteps and pursue medical school, my aversion to animal dissection was a major contributing factor! I’m also a vegetarian, which is a choice closely linked to my enthusiasm for NAMs and their promise for replacing the use of animals in research. Values are enough to get me, and many others, hopeful and excited about NAMs but answering the practical questions about their implementation requires more.
The Reality Check and What to Do About It
Drug development teams and leaders constantly face the challenge of distinguishing hype from methods that are truly ready for early adoption. Many are hesitant to take the first step, and understandably so. While there is growing consensus on the limitations and ethical shortcomings of animal models, NAMs still present several risks, including a lack of definitive guidance, unclear timelines, and the absence of established implementation playbooks. For me, we are still a few years away from full implementation of NAMs. However, it’s crucial that NAMs being “not ready yet” does not result in inaction. The big question leaders should be asking themselves is “What can we do in the meantime?”
Moving Forward Thoughtfully: What Leaders Can Do Now
In my view, leadership should push companies to be the first movers in adopting NAMs and replacing animal models. Though this transition feels inevitable, it won’t be easy. Teams will certainly face challenges balancing the implementation of NAMs with the standards for accuracy and translatability demanded by toxicology studies. They may feel stranded, waiting for fully developed tools and implementation roadmaps to emerge while remaining hesitant to try new approaches. Waiting slows progress but moving recklessly creates risk. So how can effective leaders make the most of the shift towards NAMs?
Leadership can use this period where uncertainty is high to test new approaches, to pilot different experimental setups, and to seize the opportunity to shape best practices like using Instem’s Predict solution for WoE in the submission process. It’s important to strike a balance between blind enthusiasm and being paralyzed by uncertainty. At the very least, educating teams about regulatory direction can prepare them to troubleshoot effectively and anticipate challenges that may emerge during early adoption.
Conclusion: Leadership Is About Moving Forward Without Perfect Answers
NAMs represent a real opportunity to advance drug development in ways that are more predictive, efficient, and ethically responsible. But progress will not come from waiting for perfect clarity. It will come from leaders willing to move forward thoughtfully, balancing innovation with structure, and hope with evidence. Leadership is not about having all the answers today. It is about creating momentum, asking better questions, and shaping the future while the answers are still taking form.
Drug development methodologies aren’t just the domain of researchers and regulators. Leadership perspectives matter now more than ever. I’d love to hear yours.
Comment your thoughts on my recent post on LinkedIn here: Read Post
Thanks for reading!
References
1. Ram RN, Gadaleta D, Allen TEH. The role of ‘big data’ and ‘in silico’ New Approach Methodologies (NAMs) in ending animal use – A commentary on progress. Computational Toxicology. 2022;23:100232. doi:10.1016/j.comtox.2022.100232
2. Asturiol D, Worth A. The Use of Chemical Reactivity Assays in Toxicity Prediction. JRC Publications Repository. 2011. doi:10.2788/32962
3. Beilmann M, Adkins K, Boonen HCM, et al. Application of new approach methodologies for nonclinical safety assessment of drug candidates. Nat Rev Drug Discov. 2025;24(9):705-725. doi:10.1038/s41573-025-01182-9
4. Animal testing to be phased out faster as UK unveils roadmap for alternative methods. GOV.UK. Accessed February 6, 2026. https://www.gov.uk/government/news/animal-testing-to-be-phased-out-faster-as-uk-unveils-roadmap-for-alternative-methods
5. Research C for DE and. CDER/Office of New Drugs Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs). FDA. December 29, 2025. Accessed February 6, 2026. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cderoffice-new-drugs-streamlined-nonclinical-studies-and-acceptable-new-approach-methodologies-nams
6. Commissioner O of the. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. FDA. May 28, 2025. Accessed July 31, 2025. https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs
7. Ethical use of animals in medicine testing | European Medicines Agency (EMA). April 20, 2018. Accessed February 6, 2026. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/ethical-use-animals-medicine-testing
