February 1, 2024

Statement on catalyzing the development of novel alternative methods

Major leaps in science are often driven by the invention of new technologies and approaches. For example, while genome editing technologies have been around for decades, the novel approach used by the CRISPR-CAS system transformed researchers’ capabilities to solve previously intractable problems. By harnessing this new technological approach, we now have our first FDA-approved gene editing therapy for patients suffering from Sickle Cell Disease(link is external).

We also are seeing dramatic leaps in technologies that allow researchers to use complementary, non-animal-based approaches to study biological functions and human disease. These so called “novel alternative methods” or NAMs, which include computational modeling and predictive technologies, cell-free methods and assays and cell-based culture models, hold tremendous promise when applied to the appropriate scientific inquiry.

With the explosion of work being done in developing and using NAMs, NIH charged a working group of the Advisory Committee to the Director (ACD) to assess the challenges and opportunities for NAMs, as well as provide recommendations to the ACD for priority investments to catalyze their use and development in biomedical research. The working group consulted with experts in the field and reviewed input from the community to deliver its report to the ACD during the Dec. 14, 2023, meeting. 

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