{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T23:49:48Z","timestamp":1759362588214,"version":"3.37.3"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"Supplement_1","funder":[{"DOI":"10.13039\/100000049","name":"National Institute on Aging","doi-asserted-by":"publisher","award":["P30 AG048785"],"award-info":[{"award-number":["P30 AG048785"]}],"id":[{"id":"10.13039\/100000049","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000069","name":"National Institute of Arthritis and Musculoskeletal and Skin Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000069","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009210","name":"Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009210","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000016","name":"U.S. Department of Health and Human Services","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000016","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,6,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Functional limitations and physical disabilities associated with aging and chronic disease are major concerns for human societies and expeditious development of function-promoting therapies is a public health priority.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Expert panel discussion.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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, professional societies, patients and patient advocacy organizations, the pharmaceutical and biotechnology industry, and the U.S. Food and Drug Administration.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/gerona\/glad028","type":"journal-article","created":{"date-parts":[[2023,6,16]],"date-time":"2023-06-16T07:44:09Z","timestamp":1686901449000},"page":"94-100","source":"Crossref","is-referenced-by-count":2,"title":["Synergistic Strategies to Accelerate the Development of Function-Promoting Therapies: Lessons From Operation Warp Speed and Oncology Drug Development"],"prefix":"10.1093","volume":"78","author":[{"given":"Rosaly","family":"Correa-de Araujo","sequence":"first","affiliation":[{"name":"National Institute on Aging, National Institutes of Health, U.S. Department of Health and Human Services , Bethesda, Maryland , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William J","family":"Evans","sequence":"additional","affiliation":[{"name":"Department of Nutritional Science and Toxicology, University of California at Berkely , Berkely, California , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roger A","family":"Fielding","sequence":"additional","affiliation":[{"name":"Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University , Boston, Massachusetts , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Venkatesh","family":"Krishnan","sequence":"additional","affiliation":[{"name":"Eli Lilly, Inc. , Indianapolis, Indiana , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7300-6700","authenticated-orcid":false,"given":"Robert H","family":"Carter","sequence":"additional","affiliation":[{"name":"National Institute of Arthritis, Musculoskeletal and Skin Diseases, National Institutes of Health, U.S. Department of Health and Human Services , Bethesda, Maryland , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Appleby","sequence":"additional","affiliation":[{"name":"Gerontological Society of America (GSA) , Washington, District of Columbia , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jack","family":"Guralnik","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Public Health, University of Maryland School of Medicine , Baltimore, Maryland , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lloyd B","family":"Klickstein","sequence":"additional","affiliation":[{"name":"Versanis Bio, Inc. , Oakland, California , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5619-4404","authenticated-orcid":false,"given":"Peter","family":"Marks","sequence":"additional","affiliation":[{"name":"U.S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services , Silver Spring, Maryland , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alison A","family":"Moore","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of California, San Diego , San Diego, California , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sue","family":"Peschin","sequence":"additional","affiliation":[{"name":"Alliance for Aging Research, Aging in Motion , Washington, District of Columbia , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3982-6200","authenticated-orcid":false,"given":"Shalender","family":"Bhasin","sequence":"additional","affiliation":[{"name":"Research Program in Men\u2019s Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women\u2019s Hospital, Harvard Medical School , Boston, Massachusetts , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2023,6,16]]},"reference":[{"key":"2023061607430845100_CIT0001","doi-asserted-by":"crossref","first-page":"E151","DOI":"10.5888\/pcd13.160174","article-title":"Multimorbidity and functional limitations among adults 65 or older, NHANES 2005-2012","volume":"13","author":"Jindai","year":"2016","journal-title":"Prev Chronic Dis."},{"year":"2019","author":"United Nations DoEaSA,","article-title":"Population Division","key":"2023061607430845100_CIT0002"},{"year":"2022","author":"Centers for Medicare & Medicaid Services.","key":"2023061607430845100_CIT0003"},{"issue":"4","key":"2023061607430845100_CIT0004","doi-asserted-by":"crossref","first-page":"501","DOI":"10.1007\/s12603-017-0951-y","article-title":"Muscle weakness and physical disability in older americans: longitudinal findings from the U.S. Health and Retirement Study","volume":"22","author":"Duchowny","year":"2018","journal-title":"J Nutr Health Aging"},{"issue":"12","key":"2023061607430845100_CIT0005","doi-asserted-by":"crossref","first-page":"1160","DOI":"10.1016\/j.cels.2021.09.001","article-title":"NAD(+) flux is maintained in aged mice despite lower tissue concentrations","volume":"12","author":"McReynolds","year":"2021","journal-title":"Cell Syst"},{"issue":"1","key":"2023061607430845100_CIT0006","doi-asserted-by":"crossref","first-page":"S41","DOI":"10.1093\/geronb\/55.1.S41","article-title":"Sex differences in the prevalence of mobility disability in old age: the dynamics of incidence, recovery, and mortality","volume":"55","author":"Leveille","year":"2000","journal-title":"J Gerontol B Psychol Sci Soc Sci"},{"issue":"9","key":"2023061607430845100_CIT0007","doi-asserted-by":"crossref","first-page":"987","DOI":"10.1177\/0898264319872309","article-title":"Impact of physical and functional limitations on health care utilization in older cancer survivors: a medicare current beneficiary survey","volume":"32","author":"Chavan","year":"2020","journal-title":"J Aging Health."},{"issue":"1","key":"2023061607430845100_CIT0008","doi-asserted-by":"crossref","first-page":"701","DOI":"10.1186\/s12913-022-08017-y","article-title":"How does the onset of physical disability or dementia in older adults affect economic wellbeing and co-payments for health care? The impact of gender","volume":"22","author":"Hu","year":"2022","journal-title":"BMC Health Serv Res."},{"issue":"9","key":"2023061607430845100_CIT0009","doi-asserted-by":"crossref","first-page":"1532","DOI":"10.1016\/j.apmr.2009.02.020","article-title":"Health care expenditures of living with a disability: total expenditures, out-of-pocket expenses, and burden, 1996 to 2004","volume":"90","author":"Mitra","year":"2009","journal-title":"Arch Phys Med Rehabil."},{"issue":"10","key":"2023061607430845100_CIT0010","doi-asserted-by":"crossref","first-page":"1059","DOI":"10.1093\/gerona\/61.10.1059","article-title":"The loss of skeletal muscle strength, mass, and quality in older adults: the health, aging and body composition study","volume":"61","author":"Goodpaster","year":"2006","journal-title":"J Gerontol A Biol Sci Med Sci."},{"issue":"3","key":"2023061607430845100_CIT0011","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1042\/cs0820321","article-title":"Leg extensor power and functional performance in very old men and women","volume":"82","author":"Bassey","year":"1992","journal-title":"Clin Sci (Lond)"},{"key":"2023061607430845100_CIT0012","doi-asserted-by":"crossref","first-page":"111714","DOI":"10.1016\/j.exger.2022.111714","article-title":"Osteoporotic Fractures in Men Study G. Factor analysis to determine relative contributions of strength, physical performance, body composition and muscle mass to disability and mobility disability outcomes in older men","volume":"161","author":"Zanker","year":"2022","journal-title":"Exp Gerontol."},{"issue":"1","key":"2023061607430845100_CIT0013","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1093\/gerona\/glaa111","article-title":"Muscle mass assessed by the D3-creatine dilution method and incident self-reported disability and mortality in a prospective observational study of community-dwelling older men","volume":"76","author":"Cawthon","year":"2021","journal-title":"J Gerontol A Biol Sci Med Sci."},{"issue":"16","key":"2023061607430845100_CIT0014","doi-asserted-by":"crossref","first-page":"1772","DOI":"10.1001\/jama.297.16.1772-b","article-title":"Effect of 10 days of bed rest on skeletal muscle in healthy older adults","volume":"297","author":"Kortebein","year":"2007","journal-title":"JAMA."},{"issue":"10","key":"2023061607430845100_CIT0015","doi-asserted-by":"crossref","first-page":"1076","DOI":"10.1093\/gerona\/63.10.1076","article-title":"Functional impact of 10 days of bed rest in healthy older adults","volume":"63","author":"Kortebein","year":"2008","journal-title":"J Gerontol A Biol Sci Med Sci."},{"issue":"4","key":"2023061607430845100_CIT0016","doi-asserted-by":"crossref","first-page":"243","DOI":"10.1038\/s41574-021-00626-7","article-title":"Mitochondrial and metabolic dysfunction in ageing and age-related diseases","volume":"18","author":"Amorim","year":"2022","journal-title":"Nat Rev Endocrinol."},{"issue":"5","key":"2023061607430845100_CIT0017","doi-asserted-by":"crossref","first-page":"641","DOI":"10.1007\/s40279-015-0305-z","article-title":"Muscle quality in aging: a multi-dimensional approach to muscle functioning with applications for treatment","volume":"45","author":"Fragala","year":"2015","journal-title":"Sports Med."},{"issue":"4","key":"2023061607430845100_CIT0018","doi-asserted-by":"crossref","first-page":"982","DOI":"10.1152\/japplphysiol.00475.2016","article-title":"The aging neuromuscular system and motor performance","volume":"121","author":"Hunter","year":"2016","journal-title":"J Appl Physiol."},{"issue":"3","key":"2023061607430845100_CIT0019","doi-asserted-by":"crossref","first-page":"146","DOI":"10.1038\/ncpendmet0120","article-title":"Drug insight: testosterone and selective androgen receptor modulators as anabolic therapies for chronic illness and aging","volume":"2","author":"Bhasin","year":"2006","journal-title":"Nat Clin Pract Endocrinol Metab."},{"issue":"3","key":"2023061607430845100_CIT0020","doi-asserted-by":"crossref","first-page":"313","DOI":"10.1164\/rccm.201802-0286OC","article-title":"Activin type II receptor blockade for treatment of muscle depletion in chronic obstructive pulmonary disease. a randomized trial","volume":"199","author":"Polkey","year":"2019","journal-title":"Am J Respir Crit Care Med."},{"issue":"5","key":"2023061607430845100_CIT0021","doi-asserted-by":"crossref","first-page":"e96921","DOI":"10.1371\/journal.pone.0096921","article-title":"Fast skeletal muscle troponin activator tirasemtiv increases muscle function and performance in the B6SJL-SOD1G93A ALS mouse model","volume":"9","author":"Hwee","year":"2014","journal-title":"PLoS One."},{"key":"2023061607430845100_CIT0022","doi-asserted-by":"crossref","DOI":"10.1093\/gerona\/glac049","article-title":"MIB-626, an oral formulation of a microcrystalline unique polymorph of beta-nicotinamide mononucleotide, increases circulating nicotinamide adenine dinucleotide and its metabolome in middle-aged and older adults","author":"Pencina","year":"2023;78(1):90\u201396","journal-title":"J Gerontol A Biol Sci Med Sci."},{"issue":"1","key":"2023061607430845100_CIT0023","doi-asserted-by":"crossref","first-page":"74","DOI":"10.1016\/j.cell.2018.02.008","article-title":"Impairment of an endothelial NAD(+)-H2S signaling network is a reversible cause of vascular aging","volume":"173","author":"Das","year":"2018","journal-title":"Cell."},{"issue":"7","key":"2023061607430845100_CIT0024","doi-asserted-by":"crossref","first-page":"1429","DOI":"10.1111\/jgs.16517","article-title":"Putative cut-points in sarcopenia components and incident adverse health outcomes: an SDOC analysis","volume":"68","author":"Cawthon","year":"2020","journal-title":"J Am Geriatr Soc."},{"issue":"7","key":"2023061607430845100_CIT0025","doi-asserted-by":"crossref","first-page":"1410","DOI":"10.1111\/jgs.16372","article-title":"Sarcopenia definition: the position statements of the sarcopenia definition and outcomes consortium","volume":"68","author":"Bhasin","year":"2020","journal-title":"J Am Geriatr Soc."},{"issue":"1","key":"2023061607430845100_CIT0026","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1186\/s13063-020-04998-5","article-title":"Testing the efficacy and safety of BIO101, for the prevention of respiratory deterioration, in patients with COVID-19 pneumonia (COVA study): a structured summary of a study protocol for a randomised controlled trial","volume":"22","author":"Dioh","year":"2021","journal-title":"Trials"},{"issue":"7","key":"2023061607430845100_CIT0027","doi-asserted-by":"crossref","first-page":"1213","DOI":"10.1002\/jbmr.4505","article-title":"Association between muscle mass determined by D3 -creatine dilution and incident fractures in a prospective cohort study of older men","volume":"37","author":"Cawthon","year":"2022","journal-title":"J Bone Miner Res."},{"issue":"8","key":"2023061607430845100_CIT0028","doi-asserted-by":"crossref","first-page":"e3254","DOI":"10.1210\/clinem\/dgac295","article-title":"Effects of testosterone on mixed-muscle protein synthesis and proteome dynamics during energy deficit","volume":"107","author":"Howard","year":"2022","journal-title":"J Clin Endocrinol Metab."},{"key":"2023061607430845100_CIT0029","doi-asserted-by":"crossref","first-page":"154","DOI":"10.1186\/s12877-015-0155-4","article-title":"Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials","volume":"15","author":"de Labra","year":"2015","journal-title":"BMC Geriatr."},{"issue":"8","key":"2023061607430845100_CIT0030","doi-asserted-by":"crossref","first-page":"870","DOI":"10.1164\/rccm.200305-617OC","article-title":"Effects of testosterone and resistance training in men with chronic obstructive pulmonary disease","volume":"170","author":"Casaburi","year":"2004","journal-title":"Am J Respir Crit Care Med."},{"issue":"10","key":"2023061607430845100_CIT0031","doi-asserted-by":"crossref","first-page":"965","DOI":"10.1056\/NEJMcibr1203160","article-title":"Targeting the skeletal muscle-metabolism axis in prostate-cancer therapy","volume":"367","author":"Basaria","year":"2012","journal-title":"N Engl J Med."},{"issue":"7","key":"2023061607430845100_CIT0032","doi-asserted-by":"crossref","first-page":"414","DOI":"10.1038\/nrendo.2013.73","article-title":"Risks and benefits of testosterone therapy in older men","volume":"9","author":"Spitzer","year":"2013","journal-title":"Nat Rev Endocrinol."},{"issue":"9","key":"2023061607430845100_CIT0033","doi-asserted-by":"crossref","first-page":"e79","DOI":"10.1056\/NEJMe2028547","article-title":"Audio interview: operation warp speed and Covid-19","volume":"383","author":"Rubin","year":"2020","journal-title":"N Engl J Med."},{"issue":"2","key":"2023061607430845100_CIT0034","doi-asserted-by":"crossref","first-page":"273","DOI":"10.1093\/biostatistics\/kxx069","article-title":"Estimation of clinical trial success rates and related parameters","volume":"20","author":"Wong","year":"2019","journal-title":"Biostatistics"}],"container-title":["The Journals of Gerontology: Series A"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/biomedgerontology\/article-pdf\/78\/Supplement_1\/94\/50625723\/glad028.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/biomedgerontology\/article-pdf\/78\/Supplement_1\/94\/50625723\/glad028.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,6,16]],"date-time":"2023-06-16T07:44:29Z","timestamp":1686901469000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/biomedgerontology\/article\/78\/Supplement_1\/94\/7199281"}},"subtitle":[],"editor":[{"given":"David","family":"Le Couteur","sequence":"additional","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2023,6,1]]},"references-count":34,"journal-issue":{"issue":"Supplement_1","published-online":{"date-parts":[[2023,6,16]]},"published-print":{"date-parts":[[2023,6,16]]}},"URL":"https:\/\/doi.org\/10.1093\/gerona\/glad028","relation":{},"ISSN":["1079-5006","1758-535X"],"issn-type":[{"type":"print","value":"1079-5006"},{"type":"electronic","value":"1758-535X"}],"subject":[],"published-other":{"date-parts":[[2023,6,1]]},"published":{"date-parts":[[2023,6,1]]}}}