FASEB Offers Recommendations on Novel Alternative MethodsBy: Naomi Charalambakis
Wednesday, August 9, 2023
On August 1, FASEB submitted comments to the National Institutes of Health (NIH) in response to a Request for Information (RFI) on Novel Alternative Methods (NAMs). The RFI stems from the recently established Advisory Committee to the Director Working Group on Catalyzing the Development and Use of NAMs to Advance Biomedical Research, which is charged with identifying the types of nonanimal methods used in biomedical research and articulating areas for future NIH investment. Feedback from the RFI will inform the working group’s final recommendations to NIH, slated for release in December.
Questions from the RFI centered on three key areas it relates to the development and use of NAMs, including how these methodologies are used to study human biology and disease, approaches for catalyzing their development and validation, and strategies for maximizing their research value. Given that NAMs are in the early stages of development, FASEB's comments emphasize that animal research remains the premier method for numerous areas of science. While NAMs are powerful tools to supplement this work, many gaps and challenges still exist. For example, NAMs are not yet sophisticated enough to study complex diseases affecting multiple organ systems of the body such as cystic fibrosis or autoimmune disorders. Furthermore, the research community lacks consistent guidelines for validating and reporting these methods, two aspects that are essential for ensuring a model is safe and efficacious enough for widespread use.
To address these challenges and advance biomedical research, FASEB identified three central themes to facilitate NIH’s efforts in outlining future areas of NAMs investment:
- Establish uniform validation guidelines and consider parallel investments in validation studies when funding NAMs to ensure new technologies are well-characterized with clear endpoints and metrics.
- Develop NAM-specific reporting and data sharing guidelines that acknowledge the rigor, reproducibility, and translatability challenges associated with nonanimal models.
- Strengthen partnerships between federal agencies, industry, scientific societies, and animal researchers to exchange best practices, minimize regulatory burden, and ensure equitable implementation.