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ARS Home » Northeast Area » Boston, Massachusetts » Jean Mayer Human Nutrition Research Center On Aging » Research » Publications at this Location » Publication #403488
Research Project: Nutrition, Sarcopenia, Physical Function, and Skeletal Muscle Capacity During Aging

Location: Jean Mayer Human Nutrition Research Center On Aging

Title: Synergistic strategies to accelerate the development of function promoting therapies: Lessons from operation warp speed and oncology drug development

Author
item CORREA-DE-ARAUJO, ROSALYN - National Institutes Of Health (NIH)
item EVANS, WILLIAM - University Of California Berkeley
item FIELDING, ROGER - Jean Mayer Human Nutrition Research Center On Aging At Tufts University
item KRISHNAN, VENKATESH - Eli Lilly & Company
item CARTER, ROBERT - National Institutes Of Health (NIH)
item APPLEBY, JAMES - Gerontological Society Of America
item GURALNIK, JACK - University Of Maryland
item KLICKSTEIN, LLOYD - Versanis Bio, Inc
item MARKS, PETER - Us Food & Drug Administration (FDA)
item MOORE, ALISON - University Of California, San Diego
item PESCHIN, SUSAN - Alliance For Aging Research
item SHALENDER, BHASIN - Brigham & Women'S Hospital

Submitted to: Journal of Gerontology Medical Science
Publication Type: Review Article
Publication Acceptance Date: 1/18/2023
Publication Date: 6/16/2023
Citation: Correa-De-Araujo, R., Evans, W.J., Fielding, R.A., Krishnan, V., Carter, R., Appleby, J., Guralnik, J., Klickstein, L.B., Marks, P., Moore, A., Peschin, S., Shalender, B. 2023. Synergistic strategies to accelerate the development of function promoting therapies: Lessons from operation warp speed and oncology drug development. Journal of Gerontology Medical Science. https://doi.org/10.1093/gerona/glad028.
DOI: https://doi.org/10.1093/gerona/glad028

Interpretive Summary:

Technical Abstract: Background: Functional limitations and physical disabilities associated with aging and chronic disease are a major concern of human societies and expeditious development of function-promoting therapies is a public health priority. Methods: Expert panel discussion. Results: The remarkable success of Operation Warp Speed for the rapid development of COVID-19 vaccines, COVID-19-therapeutics, and of oncology drug development programs over the past decade have taught us that complex public health problems such as the development of function-promoting therapies will require collaboration among many stakeholders, including academic investigators, the National Institutes of Health (NIH), professional societies, patients and patient advocacy organizations, the pharmaceutical and biotechnology industry, and the U.S. Food and Drug Administration (FDA). Conclusions: There was agreement that the success of well designed, adequately powered clinical trials will require careful definitions of indication/s, study population, and patient-important endpoints that can be reliably measured using validated instruments; commensurate resource allocation; and versatile organizational structures such as those used in Operation Warp Speed.