Does AI Hold the Potential to Reduce Reliance on NHPs in Drug Development? This National Academies of Science, Engineering & Medicine Report Concludes “Yes.”

‍By VeriSIM Life Chief Scientific Officer Dr. Szczepan Baran, who served on the committee appointed by the National Academies of Science, Engineering & Medicine that recently released the report, “Nonhuman Primate Models in Biomedical Research: State of the Science and Future Needs (2023).”‍

Non-human primates (NHPs) still hold undeniable value for the pharmaceutical and biotechnology industries, but with ethical and practical issues posing increasing challenges, it is clear that we need a smarter approach to utilizing NHPs. For this reason and in response to a request from Congress, a committee of experts organized by the National Academies of Science, Engineering & Medicine recently released a report on the usage of NHPs in biomedical research. This report's conclusions serve as guidance for subsequent action by the NIH to address the current critical NHP shortage.

While developed to provide conclusions for the NIH, the report can and should also act as a call to action to other stakeholders of the industry to apply these conclusions to their drug development process. The growing shortage of NHPs, worsened by COVID-19 and by recent additional regulations, poses these challenges not only to NIH, but to many drug developers as well.

One of the most important takeaways of this report to drug developers should be that while NHPs are indispensable in certain scenarios, they are not the answer for every research question. We as an industry need to be smarter about the questions we are asking so that we can reduce our reliance on NHPs. Conclusion 3-4 of the report states, “Biomedical and public health research in the United States is threatened by dependence on imported nonhuman primates (NHPs). This reliance on external resources is unsustainable and undermines the security of the U.S. biomedical research enterprise.” Indeed, what the industry needs now is new additions to our toolbox that will alleviate the severity of reliance on NHP usage. 

For many drug developers, this will mean accelerating the exploration of New Approach Methodologies (NAMs) like using AI-enhanced computational models to reduce dependency on animal models. As noted in Conclusions 4-4 and 5-5 of the report, the FDA and other regulators support these emerging technologies and have expressed their approval of “continued development & validation of NAMs (in vitro and in silico model systems.)” The report also acknowledges that these technologies may even have the added benefit of lowering the costs associated with NHPs. 

With this positive business and scientific impact combined with the “go-ahead” from the FDA and other regulatory agencies to take advantage of developing technologies like AI, drug developers would be remiss not to acknowledge the incredible potential that lies in integrating such in silico tools into their existing R&D methodologies.