Resource > Articles >
New Approach Methodologies (NAMs): Building more predictive drug development workflows in the changing landscape of NAMs
Filed under: General OOC and Regulatory
Preclinical drug development is going through its biggest change in decades. New Approach Methodologies (NAMs), the umbrella term for human-relevant, animal-free testing technologies, have moved from the edges of research into the center of how pharmaceutical and biotech companies de-risk their drug development pipelines. For developers under pressure to raise success rates and control spending, the question is no longer whether to adopt NAMs, but how best to integrate them to maximize drug development success.
Why traditional preclinical models hold pipelines back
For decades, animal studies anchored early drug testing. Yet the numbers tell a hard story: only around one in ten candidates that enter Phase I trials ever reaches approval. Much of that attrition traces back to biological differences between species, which limit how well animal data predicts human outcomes. The cost is wasted investment, delayed therapies, and avoidable animal use. Human-relevant models help close that gap by generating data from human biology itself, giving teams a clearer read on how a candidate will behave in patients.
Regulatory momentum is accelerating adoption during the changing landscape of NAMs
The policy landscape has shifted fast. Recent moves by the US FDA to phase out certain animal testing requirements, alongside the UK government’s roadmap for alternative methods, have pushed NAMs firmly into the mainstream. Initiatives such as the FDA’s ISTAND program give developers a route to qualify novel drug development tools and build the evidence base regulators need. Questions remain over exactly what NAMs data agencies will accept in IND filings, but every new submission strengthens the case for the next, and early adopters are already setting the benchmark.
Why the FDA animal testing phase-out for monoclonal antibodies? – Read the full Blog
UK plans to phase out animal testing faster in favor of alternative methods – Read the Full Blog
Unlocking new therapeutic modalities
NAMs are proving especially useful for emerging modalities such as cell and gene therapies, antibody-drug conjugates (ADCs), and PROTACs. Many of these target human-specific pathways that animal models cannot replicate. Human-relevant platforms let developers study mechanism, safety, and efficacy with far greater relevance, which is why advanced therapies may be the first area to win broad regulatory acceptance for NAMs.
3Rs project with FDA: Building Confidence in MPS for Regulatory Applications!
CN Bio is participating in a 3Rs Collaborative-led project with the FDA to build confidence in Liver MPS for DILI that is now ISTAND-accepted!
On-demand webinar: Building confidence for regulatory decision making with immune-competent liver models
Dr. Emily Richardson and Dr. Justina Then explores emerging immune-competent models designed to predict immune-mediated toxicity for newer therapies – Watch here
A cost-effective edge in a tight market
Funding pressure has made it harder for biotech companies to advance assets without strong, validated data. NAMs offer a more affordable route to generating that early proof of value. Applications spanning drug bioavailability, ADME, and organ-organ crosstalk let teams make confident decisions sooner, reduce reliance on animal studies, and present compelling evidence to partners and investors.
Redefining the future of drug development
Overall, NAMs are poised to reshape the future of drug development. By improving the translation of preclinical findings to clinical outcomes, reducing reliance on animal testing, and enabling more efficient and predictive research, these approaches are becoming a core component of modern life sciences. Continued collaboration between regulators, industry, and technology providers will be essential to sustain this momentum and fully realise the potential of NAMs in delivering safer, more effective therapies to patients.
Read the full perspective on the future of NAMs
Human-relevant science is reshaping how the most predictive pipelines are built, and the momentum behind NAMs shows no sign of slowing. For a deeper look at the regulatory shifts, AI integration, and market forces accelerating adoption, read the full article by Dr. Paul Brooks of CN Bio on MedCity News.
The full article was published in MedCity News through the MedCity Influencer program.
Dr. Paul Brooks
CEO
Dr. Brooks has held senior leadership positions in the USA and the UK, including Head of Business Operations and Managing Director of Horizon Discovery Ltd; Chief Commercial Officer and Executive Board member of Oxford Genetics Ltd; Head of Discovery Research Services at MilliporeSigma (Merck KGaA); and Global Marketing Manager at Sigma-Aldrich Corp. Dr Brooks has a BSc in Biochemistry from the University of Wales, a PhD in Molecular Biology from the University of Manchester Institute of Science and Technology (UMIST), and an MBA from the University of Nottingham Business School.