ACD Working Group on Catalyzing the Development and Use of Novel Alternative Methods to Advance Biomedical Research
Background
Biomedical researchers rely on a combination of innovative methods, models, and technologies to answer complex questions about human health and disease. The use of any given approach is based on its ability to answer the research question under study. While animal research remains researchers' best resource for addressing the complexity of human biology, rapid advances in technology are catalyzing the development and use of complementary, nonanimal based approaches. The development of these "novel alternative methods" hold tremendous promise for increasing the tools available to achieve the NIH mission and potentially reduce and refine the future use of animals in some areas of research in the future.
NIH investment in alternative methods, including in chemico, in vitro, and in silico approaches, has increased dramatically over the past 15 years. They have proven beneficial tools across basic and clinical research studies, being developed and applied to interrogate cancer, diabetes, cardiovascular disease, Alzheimer's disease, infectious disease, rare diseases, and more. Each approach has strengths and limitations that varies depending on the specific research question being addressed, and utility may be variable in terms of insight that can be provided into certain aspects of human biology, behavior, and disease. NIH is seeking the assistance of the ACD in identifying areas in which the development and use of novel alternative methods provide the most value to biomedical research.
Charge
- Identify the types of alternative methods being developed for use in biomedical research and assess their general strengths and weaknesses for studying human biology, circuits, systems, and disease states
- Characterize the types of research, condition, or disease for which alternative methods are most applicable or beneficial
- Articulate high-priority areas for NIH investment in the use and development of novel alternative methods with human applicability to:
- Advance progress into understanding specific biological processes or states
- Augment the tools and capabilities for biomedical research to complement and/or potentially replace traditional models
Working Group Reports
- Catalyzing the Development and Use of Novel Alternative Methods (NAMs) to Advance Biomedical Research (PDF - 3.8MB)
- Catalyzing the Development & Use of Novel Alternative Methods (NAMs) (PDF - 1.5MB)
- Catalyzing the Development and Use of Novel Alternative Methods (PDF - 865KB)
- NIH Public Workshop on Catalyzing Development and Use of Novel Alternative Methods Meeting Summary (PDF - 404KB)
Related Resources
Public Workshop: NIH held a virtual workshop on August 21, 2023 on approaches, challenges, and opportunities relating to the development of Novel Alternative Methods (NAMs). The workshop also featured discussion on identifying incentives and barriers to successful implementation of NAMs technologies
Request for Information: The NIH posted a Request for Information (RFI) for the community to share insights on challenges and opportunities for the further development and use of novel alternative methods (NAMs) in biomedical research. Input received from this request informed the NIH and the development of the Advisory Committee to the NIH Director (ACD)'s recommendations on high-priority areas for future investment in NAMs. The RFI was open from June 12, 2023 to September 5th, 2023
- Catalyzing Development and use of Novel Alternative Methods: August 21, 2023 (PDF - 247KB)
- The Opportunities and Challenges for NAMs in Biomedical Research: August 21, 2023 (PDF - 5.79MB)
- Digital Twins and Alternative Clinical Trial Designs: August 21, 2023 (PDF - 1.6MB)
- (R)evolution in Validation: Establishing Scientific Confidence in NAMs: August 21, 2023 (PDF - 6.9MB)
- Discovering inter-individual differences in exposomic risk at biobank scale: August 21, 2023 (PDF - 2.3MB)
- Achieving Good Ethics and Equity in the Development and Application of Novel Technologies: August 21, 2023 (PDF - 1.5MB)
- Technical Framework for Enabling High-Quality Measurements in New Approach Methodologies (NAMs): August 21, 2023 (PDF - 944KB)
- Engaging Scientific Societies in Driving NAMs Use and Development: August 21, 2023 (PDF - 2.2MB)
- Workshop on Catalyzing the Development and use of Novel Alternative Methods: August 21, 2023 (PDF - 1.1MB)