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Innovation Theatre: The US NIH Perspective on the Priority of New Approach Methodologies (NAMs) in Biomedical Research, Regulatory Acceptance and Widespread Adoption

Thursday, July 16, 2026
10:40 AM - 11:10 AM

Details

Dan Tagle will provide an overview on the evolving role of New Approach Methodologies (NAMs) in medical product development. His presentation will highlight recent developments in the regulatory landscape increased use of organoids, microphysiological systems and AI enabled tools, and emerging guidance on how NAM data may be considered within regulatory submissions. He will also touch on how regulators, researchers and industry are working together to accelerate the uptake of these approaches in future development pathways.


Speaker

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Dr Dan Tagle
Independent Expert on NAMsFormer Director, Office of Special Initiatives; Senior Scientific Advisor for Regulatory Scien

Presenter

Biography

Danilo Tagle is currently Senior Scientific Advisor on Regulatory and Translational Research at the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). He recently retired as Director, Office of Special Initiatives where he led efforts in developing innovative tools and technologies that can greatly accelerate development of diagnostics and therapeutics. These programs involve interdisciplinary collaborations between intramural and extramural components of NIH, and entail partnerships with other agencies, such as FDA, NASA, and DARPA, as well as with private sector. Some of the programs include tissue chips, 3D bioprinting, automated chemistry, electronic nose technology for disease diagnosis, quantum technologies, and the isolation and analyses of exosomes for biomarker and therapy development. He has served on numerous advisory and review committees, including the Biological and Physical Sciences Federal Advisory Committee, the White House OSTP Microgravity Science and Technology Interagency Working Group, and more recently on the LabCorp NAM Scientific Advisory Board. Dan obtained his PhD and MS in molecular biology and genetics from Wayne State University School of Medicine. He was an NIH National Research Service Award postdoctoral fellow in human genetics at the University of Michigan. Dan has authored many scientific publications and has garnered numerous awards, including several NIH Director’s Award, and more recently the Roscoe O. Brady Award for Innovation and Accomplishment; the Henry J. Heimlich Award for Innovative Medicine; the Department of Health and Human Services Secretary's Award for Distinguished Service: Rapid Acceleration of Diagnostics (RADx) Initiative, and the NASA Silver Group Achievement Award.
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