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This article is the first in a series in the IIAM Newsletter regarding Novel Alternative Methods in medical research and how it will change the nature of how medical research creates new treatments for humans in a more translatable manner with shorter development timelines.
In 2023, the FDA included the first funding in its budget to spur the development of Novel Alternative Methods (NAMs) in medical research. The FDA’s initial goals with this were to:
Through this initiative, FDA will:
- Expand processes to qualify alternative methods for regulatory use
- Provide clear guidelines to external stakeholders developing alternative methods
- Fill information gaps with applied research to advance new policy and guidance development
Since that time, the NIH has also started providing numerous grants and programs to support the development of NAMs, all while the medical research industry has seen the benefits and are actively pursuing these valuable research models to advance both the timelines and the translatability of research into real treatments for people.
But what are NAMs? The FDA and NIH are actively promoting novel alternative methods (NAMs) in medical research to reduce reliance on animal testing and improve the predictivity of nonclinical testing. These methods include:
- Computational modeling and predictive technologies: These tools help in understanding biological functions and human diseases without the need for animal testing.
- Cell-free methods and assays: These methods allow researchers to study biological processes in a non-animal setting.
- This includes the use of donated human organs and tissue, a direct model of working in human systems without testing in live humans!
- Cell-based culture models: These models replicate some features of organs and can be used to study various biological processes.
- Biochemical screening and assays: These methods assess potential toxicities, risks, safety, and effectiveness of drugs and other medical products.
These NAMs are expected to enhance the accuracy of preclinical safety studies, leading to safer treatments for patients faster and more reliably. They also aim to reduce research costs and improve the efficiency of drug development.
As a great summary of the expectation of NAMs in research, read the NIH’s summary statement on them here. Statement on catalyzing the development of novel alternative methods | National Institutes of Health (NIH)
Watch for more information on how NAM’s will change the nature and the outcomes of medical research moving forward in future IIAM newsletters.