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Rethinking Drug Development: How science is taking a more human-relevant approach with support from Thermo Fisher Scientific

The longstanding process to bring promising new therapies through the regulatory process took an important turn in late 2025 when a San Diego-based company secured the first-ever investigational new drug (IND) approval from the U.S. Food and Drug Administration (FDA) using efficacy data derived solely from human organoids instead of traditional lab animal models.

It’s a signal of something bigger than a single program. Regulators and drug developers are increasingly rallying around New Approach Methodologies (NAMs), a growing toolkit of human-relevant, non-animal use approaches that can help predict how therapies will perform in people earlier in development. The FDA made the announcement in 2025 to begin to phase out animal testing in the development of monoclonal antibodies and other drugs.

Under the policy, IND developers are now encouraged to include NAM-derived data, setting the stage for an unprecedented change in how preclinical safety and efficacy are evaluated. Lab-grown organoids or tumoroids, mini version of organs or tumors designed to help scientists test drugs more realistically, play a crucial role in generating human-relevant data.

Multiplexed, spatial immuno-flourescence imaging of a lab-grown lung organoid stem cell model that enables researchers to better understand and treat rare congenital lung diseases.

NAMs hold the potential to accelerate drug development, reduce R&D costs, enhance patient safety and minimize ethical concerns. For customers in academia and biopharma, the path forward may not require the use of lab models in the future, but it will demand rigorous validation and adoption of modern science, which Thermo Fisher Scientific is well-positioned to provide.

We spoke with John Bishop, director of project management, Research and Development, to learn more about what’s driving the shift toward NAMs and how Thermo Fisher’s ongoing innovation in cell-based modeling and analysis tools will help enable its customers to leverage this evolving development and bring new therapies to market sooner.

Can you explain what is involved in New Approach Methodologies (NAMs), and why are they gaining momentum now?

New Approach Methodologies, or NAMs, encompass a range of non-animal-based approaches for evaluating drug safety and efficacy. These include in vitro human cell–based models, in chemico assays, and in silico computational modeling. While many of these technologies have been under development for decades, momentum accelerated significantly in 2025 when major regulatory and funding bodies—including the FDA, NIH, and international counterparts in Europe and Asia—issued new guidance aimed at encouraging their adoption. This alignment between regulators, academia, and industry has created a pivotal inflection point for NAMs.

John Bishop

Tell us more about the alignment we’re now seeing in the industry. How does it differ from a historical perspective?

Pharmaceutical companies have been working to develop NAMs for many years. They know that most drugs that succeed in animal testing oftentimes fail during human clinical trials. This highlights a fundamental limitation - animal biology frequently does not accurately predict human outcomes - which results in longer timelines and high costs. But given the historical requirement of animal-derived efficacy data for IND submissions, NAMs have not been fully pursued. However, NAMs offer a compelling alternative by generating data that is often more human-relevant, faster to obtain, and more cost-effective in the long run.

Regulators are now actively engaging with industry on how NAM-generated data can be validated and accepted. This signals that NAMs are no longer theoretical. They are beginning to influence real regulatory decisions. And Thermo Fisher fits in that conversation because we provide many of the tools that pharmaceutical companies will use to help develop and mature their NAMs programs.

How is Thermo Fisher Scientific uniquely positioned to support NAMs adoption?

Thermo Fisher plays a foundational role by enabling NAMs workflows across key capability areas. At its core, the company provides cell lines, culture media, reagents and basic labware that are used to grow and develop cells for clinical research. These are supported with other essential lab infrastructure tools, such as incubators, centrifuges and other consumables.

Through our Gibco™ line of products, Thermo Fisher has positioned itself as a prominent player in the cell biology space for decades. But then there are complex co-culture systems such as patient-derived organoids and tumoroids. The company leads here as well with highly custom approaches needed to grow and manage these cells to get them to do what our customers want. Through this expertise, Thermo Fisher is enabling development of these in vitro, human-relevant testing models that are used to test drug candidates and generate pre-clinical data for NAMs initiatives.

And finally, there’s our analytical capabilities. I’m not aware of any other company that has the breadth of next generation sequencing, mass spectrometry, qPCR and Olink proteomics panels to drive genomics, transcriptomics and proteomics analysis. We also have cellular analysis and visualization capabilities, including flow cytometry, high-content cellular imaging systems, and our Cryo Electron Microscopy platforms. So, this multi-omics analysis of complex cellular systems is really compelling and highly relevant for early-stage discovery and safety assessment in the NAMs space.

How is Thermo Fisher engaging with customers to advance NAMs solutions?

To date, many customers are using Thermo Fisher products within NAMs-like workflows already. But to further evolve existing solutions and co-develop new capabilities in ways that help meet our customers’ specific needs, we are engaging them directly. You don't know what to make until you ask your customer, right? And if you don't ask the right questions, you won't get the right answers. This approach helps us innovate new capabilities, such as novel cell types, antibodies, or validated analytical methods that are tailored to NAMs-specific challenges.

Cardiac organoids grown from induced pluripotent stem cells (iPSC) to model heart physiology in 3D models.

Are there particular diseases where the use of NAMs can be especially effective to help accelerate development of new therapies?

Any disease state is potentially relevant. Obviously most pharmaceutical companies are focusing on the most impactful diseases, but there is a tremendous number of targets that could be impacted by NAMs. But, honestly, any disease could be relevant here. Cancer is an important one, but so is Alzheimer's disease. And of course, using NAMs for toxicological modeling of drug-induced liver damage is applicable across drug programs targeting essentially any disease.

How do you expect the NAMs landscape to evolve over the next few years?

NAMs are not a short-term trend. I see this as a multi-year transformation. Momentum from regulators, pharmaceutical companies, and academia will continue to build, especially in preclinical research. The challenge will be in garnering a sufficient level of control over NAMs systems to consistently achieve the sufficient level accuracy and reproducibly to gain the trust of regulators.

So, while the ongoing dialogue between all the parties is a very positive sign, the industry is now implementing simple workflows as we work to build more complex NAMs systems for more challenging applications. It’s possible that some applications may always require animal models, but many others will likely shift decisively toward human-relevant systems in the near future. The grand vision of completely replacing animal testing for absolutely every application is likely multiple years away. That’s very challenging, but we shouldn't let the more complicated challenges stop us from moving forward.

To learn more about NAMS resources, visit our website.