New Approach Methods (NAMs) and In Vitro Alternatives

We define NAMs as methods for testing the safety of new medicines, chemicals or medical devices that completely or partially replace the use of animals, and includes in silico, in chemico, in vitro, and ex vivo approaches.

Yes. There are a multitude of NAMs that are used to understand biology in basic research; or to assess specific characteristics or liabilities in translational science particularly. NAMs are also used in varying degrees depending on industry in regulatory safety testing assessments.

Some NAMs are already recognized as replacements to the use of animals in testing by regulatory authorities. This includes elements such as in vitro skin corrosion/irritation/sensitization as well as eye hazard identification assays for chemicals and the utilization of in vitro assays to replace the rabbit pyrogenicity testing of pharmaceuticals.

NAMs can be used in many circumstances where animals are currently used. They are routinely used for screening and ranking of compounds prior to selection for further development and testing. This allows a higher throughput of compounds for decision making more quickly, and reducing animals used early in the decision-making process. Animal studies are then used only where NAMs cannot be used.

NAMs do not currently provide the complexity of the toxicity safety endpoints that regulators require to allow authorization of a product, and so without using animals, important risks to humans may be missed.

It is very difficult to put a timeframe on the replacement of all animals for scientific research, since NAMs cannot currently recapitulate the complexity of biology in the whole body of living mammals. NAMs can replicate very specific processes or endpoints, and therefore it is likely that NAMs will gradually be developed and validated for specific purposes and supplement animal use in the first instance. As the science and confidence behind NAMs evolves, so will use and acceptance by global regulatory authorities.

Despite significant progress made in recent years, the transition from animal studies to NAMs still faces multiple technological, industry, regulatory, and commercial challenges. Labcorp believes these challenges can be overcome jointly, through collaboration between industry stakeholders and regulators, supported by appropriate investment.

Labcorp, like other industry stakeholders, is committed to the investment in NAMs and we are continuing our journey in collaboration with government and regulatory bodies. Investment is crucial to ensure a continued and permanent move towards NAMs. For instance, in the last two decades, the European Union has funded over 300 projects to support the development of alternatives to animal testing in the pharmaceutical sector and other sectors such as food, chemicals and pesticides. The UK government committed to doubling investment in research to achieve the 3Rs and develop non-animal alternatives. Similarly, in the U.S., the National Institutes of Health (NIH) has confirmed its commitment to continuing its investment in building a robust suite of tools for researchers to study human biology and disease, including investment in NAM projects. It is vital that this investment now makes its way through to NAM development and validation.

Labcorp continues to lead the transition to NAMs, by driving the technology, development, utilization, uptake, and regulatory guidance through extensive and wide-reaching collaborations. NAMs are already helping stakeholders deliver on their commitments to the 3Rs, while creating robust scientific data to support decision making without the need for animal tests in preliminary scientific research. Further government investment, international collaboration, global standardization and updated regulatory frameworks will be required to enable gaps to be filled, and for NAMs to fulfil their full potential to replace in vivo models through the widespread adoption of commercial assays at scale.