NAMs the acronym of the moment – What does it mean for you?

New Approach Methodologies (NAMs) have been around for a while, but recently they have been getting a lot more visibility thanks to recent FDA and NIH press release announcements and workshops.

So, what are NAMs? NAMs range from lower organisms (non-mammalian) used as models, in vitro models all the way to computational models (such as AI) with the goal ultimately to replace animal testing. This is clearly extremely broad in scope and covers use for pharmaceutical research, consumer products and environmental research one would imagine. This affects multi-billion-dollar industries (more on that later).

I am 100% supportive of NAMs research and have dedicated my whole career to it starting with my PhD. First, I worked on tissue slices, using these as an in vitro model to greatly reduce animal use for in vitro metabolism and toxicology studies. Then I worked on using human liver microsomes and recombinant enzymes to predict drug-drug interactions in humans. Over the last 29 years I have performed research on using computational and, more recently, AI approaches for predicting absorption, distribution, metabolism, excretion and toxicity (ADME/Tox) properties, leading to the development of software and models as well as publication of close to 400 papers, book chapters and books. You can find some of the recent papers resulting from my company here as well.

So, what are the effects on you? Well that really depends which industry you belong to. If you are the clinical research organizations that use animals for various preclinical studies, then you are going to take a massive hit as groups decrease their use – as one would expect based on these new government regulatory requirements. You are going to need a suite of NAMs offerings to bring any return close to the animal studies. If you have not figured this out by now, you can bet the competition is. Which small companies offer NAMs technologies and what are they worth? If you are in the pharma or the consumer products industry, you are also probably trying to make sense of this as well. What NAMs do you need? Where do you get them from? What expertise can you hire? If you are in academia and you have spent your whole career working on animal models, how do you suddenly pivot to find NAMs that work for you such that you can submit them in your funding proposals to the FDA? In the chaos and confusion all around, this is a massive opportunity for those working on NAMs – the time is now. Such companies working in this space may finally see interest from private equity, Venture Capital and others looking to fund an investment opportunity.

In all these situations if you need computational approaches (NAMs) for toxicity prediction then look no further, we have a commercial product called MegaTox with hundreds of models available! We also offer consulting so we can guide you through what this all means and how these models could help.

Is this the beginning of the end of animals in research and development or just the beginning of the next phase in the use of NAMs? Only time will tell.