FDA and NIH Accelerate Shift Away from Animal Testing in Drug Development

The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have announced significant plans to reduce reliance on animal testing in drug development, marking a pivotal shift in the pharmaceutical industry's approach to preclinical research. This move towards alternative testing methods has sparked both excitement and caution among scientists and industry professionals.

FDA's Bold Initiative and NIH's Support

Last month, FDA Commissioner Marty Makary unveiled ambitious plans to phase out animal testing requirements for certain therapies, including monoclonal antibodies. The agency aims to make animal research "the exception rather than the norm" for preclinical safety and toxicity testing within the next three to five years.

Following the FDA's lead, the NIH announced its own plans to prioritize grant proposals that adopt alternatives to animal research. The agency will establish the Office of Research Innovation, Validation, and Application (ORIVA) to coordinate efforts in developing and scaling non-animal approaches across its biomedical research portfolio.

Both agencies are encouraging the adoption of "human-relevant methods," including AI-based technologies, human organoids, and organ-on-a-chip models, alongside real-world population health data.

Industry Response and Challenges

The announcements have been met with enthusiasm from organoid manufacturers and animal rights advocates. Tomasz Kostrzewski, CSO of organ-on-a-chip manufacturer CN Bio, called the move "fantastic," while Joseph Wu, a cardiologist at Stanford Medicine and co-founder of Greenstone Biosciences, expressed excitement about the shift away from animal models.

However, some scientists warn that alternative technologies may not yet be advanced enough to completely eliminate animal research. Irving Loh, chief medical officer of AI-focused Infermedica, emphasized the need for extensive validation periods before these new technologies can fully replace animal models.

Key challenges in implementing this shift include:

1. Safety concerns: Current organoid models primarily focus on single organs, not accounting for complex inter-organ interactions.
2. Cost of adoption: Deploying new technologies in laboratory settings requires significant initial investment.
3. Workforce training: Students and scientists need to be educated on human-relevant testing methods.
4. Funding uncertainties: Recent cuts to NIH funding may impact the pace of adopting non-animal methods.

Industry Adaptation and Partnerships

Despite challenges, the biopharma industry has already begun adopting non-animal methods in R&D. Several major pharmaceutical companies have partnered with firms specializing in AI and organoid technology:

• Bristol Myers Squibb contracted with Tempus in 2023 for multimodal datasets and target validation.
• AstraZeneca partnered with Emulate in 2013 to develop multiple organoid models.
• Johnson & Johnson and Roche have also established partnerships with organ-on-a-chip companies.

While embracing these new approaches, some companies, like Roche, maintain that animal testing will remain an essential part of drug development in the near to mid-term future.

As the industry navigates this transition, the collaboration between pharmaceutical companies, technology providers, and regulatory agencies will be crucial in shaping the future of drug development and ensuring patient safety remains paramount.