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New Approach Methods (NAMs) and In Vitro Alternatives

Achieve your goals ethically and sustainably using the newest methods, technologies and alternatives
Scientist holding up a petri dish observing the findings

Our shared commitment to the 3Rs

Your dedication to the development of meaningful breakthroughs means investing significant time, resources and hope into the products you bring to market every day. You deserve a lab partner who will treat that work with the utmost care and urgency while offering solutions that are rooted in the 3R principles of replacing, refining and reducing animal testing so together we can achieve our goals of improving health and improving lives.

Dropper over a petri dish

Clarity, data and insights through NAMs at Labcorp ​

Not sure which drug candidate is the right one to pursue? Need to submit safety data for the active ingredient(s) in your new chemical-based product? Need to make sure the materials that make up your medical device are safe? NAMs at Labcorp help optimize the efficacy and safety profiles of your products, therapies and drugs in their earliest stages, allowing for timely detection of potential issues or the ability to accelerate submission to regulatory bodies. Additionally, the comprehensive data obtained through these advanced methodologies equips you with actionable insights, facilitating decision-making and ensuring your program advances in an efficient way.

Scientist looking into a microscope at a lab

Benefits of NAMs

NAMs offer innovative technologies that can partially or completely replace the use of animals. From organ-on-a-chip microphysiological systems to computational modeling and in vitro testing, NAMs encompass a diverse range of technologies that can meet your specific needs and help you reach your goals. ​

Whether you’re looking to enhance predictivity, improve translatability, increase efficiency or reduce costs, we have the NAMs capabilities and know-how to help you get the answers you need to inform the decisions for your breakthrough therapy, drug, device or product all while positively impacting the 3Rs.

With scientific capabilities spanning a global cross-functional team, dependable high-quality data deliverables at scale and a dedication to delivering innovative non-animal alternative options for your program, we fully support your mission of advancing translational research to improve health, improve lives—faster, better, sooner. ​

Connect with our specialists to learn how you can: ​

  • Successfully submit for regulatory review and consideration​

  • Save time by leveraging in silico studies or computer modeling to avoid lengthy vivo models

  • Leveraging of NAMs for maximum efficiency in development

  • Potentially save costs by gaining data and insights early in discovery so you choose the best possible candidate for success​

NAMs by discipline and area of development

Pharmaceuticals

Ease the cost burden of early-stage drug development by having better insight into proper candidate selection and risk reduction via:
 

Crop protection and chemical

Assess the chemical properties and risk assessment on human health of your new industrial chemical or agrochemical product: In vitro, in silico and alternative testing methods are available to meet regulatory requirements.​
 

Medical device

Proving that your device materials and manufacturing processes are biologically compatible is a regulatory requirement of every device. You can expedite the proof points for this requirement via:​

 

*Cell-based in vitro alternatives also available

Partnership and solutions geared towards the success of your program

Expansive portfolio

Our NAMs offerings include immunotoxicology, irritation and corrosion, genetic toxicity (mode of action), endocrine disruption, carcinogenesis, in silico/QSAR, cardiovascular, respiratory, cytotoxicity, phototoxicity, sensitization and much more.​

Methodology range

Get answers to diverse scientific questions and support for complex regulatory requirements. Plus, obtain the highest quality of data and insights possible through our cutting-edge techniques and state-of-the-art technologies.

Comprehensive suite

Streamline your research and shorten development timelines while reducing costs. Our focus on innovation means we continuously update our offerings in line with the latest advancements to drive your program forward.

Extensive NAMs historical control data

You'll gain confidence and assurance in our decades of experience delivering in vitro testing solutions and alternative methods, approaches and technologies that are geared to give you the insightful answers needed to continue development effectively.

NAMs at Labcorp helps you navigate complex regulatory landscapes efficiently, so you can make better long-term decisions while saving time and costs. We offer:

  • Guidance on FDA, EMA, and other regulatory bodies' accepted NAMs

  • Optimal assay selection for discovery and IND stages

  • In vitro alternatives for biocompatibility and safety testing in preclinical device development

  • Streamlined submission for agrochemical and industrial chemical development

Organ-on-a-chip. This is a microfluidic device that simulates biological organs.

New Approach Methods (NAMs) educational resources

blog post

Understanding the Bhas 42 cell transformation assay: A first step in detecting carcinogenesis

blog post

New OECD TG 497: Interpretation and application of defined approaches for skin sensitization assessment

Info Sheet

New approach methods

Info Sheet

In vitro toxicology: Inhalation

Info Sheet

An in vitro microfluidic model of the human cardiovascular system for use in pharmaceutical screening applications

Info Sheet

In vitro toxicology assay development

Recordings

SOT 2023 Exhibitor-Hosted Session Recording - NAMs in Human Safety Testing

Ebook

Quantitative Structure Activity Relationships (QSAR) in Toxicity Testing

Poster

Roadmap: Labcorp's approach to next generation risk assessment

Frequently asked questions

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.

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