As you all are likely aware of by now, the FDA recently announced their plan to phase out animal testing requirements for monoclonal antibodies to give way to new approach methodologies (NAMs), which includes in vitro, in chemico, in silico methods to replace the usual animal models that have been employed in nonclinical drug research (Reference: https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs#:~:text=The%20FDA's%20animal%20testing%20requirement,Approach%20Methodologies%20or%20NAMs%20data).
While this announcement sent shockwaves through the business side of pharmaceutical/nonclinical research, the truth is this validates what has already been in consideration in the nonclinical space for quite some time. The significant amount of research that goes into reducing, refining, and/or replacing animal models with NAMs has been ongoing in the research community (to call out one, the company I am employed by, Charles River Laboratories, has an entire team dedicated to NAMs: Alternative Methods Advancement Project).
The main challenge with NAMs has been and likely will continue to be translatability: how well does the alternative method capture the applicability to humans, and how well does the data gathered translate into understanding the potential therapeutic from a human standpoint? A recent publication from Shenton et al (https://www.sciencedirect.com/science/article/pii/S1359644625000418#s0060) does a great job highlighting the applicability, utilization, and future consideration of NAMs for nonclinical pharmaceutical research. As stated in the concluding remarks by the authors, efforts to bring NAMs to a point of scientific justification and recognition for their capability to facilitate robust nonclinical safety assessment require collaborative efforts between those employed in the regulatory, scientific, and industrial arenas. It will be quite interesting to see where the progress of NAMs takes nonclinical research over the next decade, and perhaps we will see a day where "alternative" methods become standard.
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Bo Tokarski Ph.D.
Manager, Analytical Chemistry
Charles River Laboratories Ashland LLC
Ashland OH
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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