Transitioning to Human-Centered Science: An Off-Ramp and Transition Plan
By Paul Locke | September 4th, 2025
In April 2025, FDA published its “Roadmap for Reducing Animal Testing in Pre-Clinical Safety Studies.” The first sentence boldly launches a strategic, stepwise approach to reduce animal testing by using new approach methods (NAMs), with the dual goals of reducing animal testing and improving science. The Roadmap goes on to explain how FDA will begin this effort by focusing on monoclonal antibody development and eventually expand to other areas. Since April, other federal agencies and departments, including the EPA and the NIH, have issued statements that embrace the vision illuminating the FDA Roadmap.
Animal models had underpinned scientific research for more than half a century. The insights gained from them have led to lifesaving discoveries, treatments and cures. While it is important to acknowledge these contributions, it is equally as important to recognize that we are bumping up against the scientific limits of what animal models can tell us. If we are going to solve the public health and medical problems that confront us now and will challenge us in the future, human centered, non-animal techniques -- those that closely align with human biology – are needed.
For those of us who have been advocating for the development, use and adoption of human centered NAMs, the Roadmap and these announcements are a breath of fresh air. It seems that – finally – the federal government has turned the corner. But talking the talk is not enough. The transition to human centered science and away from animal testing needs an implementation plan, centered around 6 pillars.
Scale up support for the development, use and validation of NAMs. The NIH and other public health agencies need to substantially increase their investment in these promising technologies. To date, based on the data available, it appears that less than one tenth of one percent of NIH’s budget is dedicated to NAMs. That number should be closer to 10%.
Right size current purpose bred animal populations and develop a plan to shrink numbers over time. As NAMs are increasingly used for research, there will be less need for live animals. Planning must include a reduction in breeding and, eventually, a closure of federally supported facilities that breed research animals, especially non-human primates.
Build up the capacity of sanctuaries and improve and expand adoption programs. Unfortunately, many animals used in research are sacrificed at the end of experiments. Those that are not – especially for longer lived species such as cats, dogs and non-human primates – deserve to live out their lives in dignity. At present there are not enough sanctuaries and adoption programs for these animals. It is our responsibility to care for these creatures and support them after they leave the lab.
Support animal care workers and emerging scientists. Those working with animals in labs will continue to be instrumental in humanely caring for animals, as well as preparing them for their lives after research. In addition, we need to educate regulators so they understand the strengths and weaknesses of NAMs, and train the next generation of scientists who will bring NAMs to the next level.
Align laws and regulations to support the use of NAMs and increase transparency. The public wants to know more about how animals are used in laboratory settings. Basic information, such as how many animals are used, is not readily available. In addition, provisions in laws and regulations that require the use of animals must be removed and replaced by statutes and regulations that set standards for validation and regulatory acceptance of NAMs. Our federal laws and regulations that cover laboratory animals should be amended by adding provisions that require disclosure of such information.
Communicate progress on implementation. Proactive transmission of information is crucial. This plan and its milestones must be publicized. Information about the development and validation of NAMs should be part of every communication effort. A comprehensive census of the type and numbers of different animals should be maintained, regularly updated and published so that reduction in animal use can be measured.
Now that the need for NAMs has been acknowledged and embraced by the federal government, it is time to build the platform to carry this much needed change into the future. With thoughtful planning we can reach the twin goals of eliminating nearly all animal use and creating a stronger scientific basis on which to develop cures and treatments for people and healthier communities.
The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.
