2025
Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence
Olaghere J, Williams D, Farrar J, Büning H, Calhoun C, Ho T, Inamdar M, Liu D, Makani J, Nyarko K, Ruiz S, Tisdale J, McCune J, Boadi E, for the FDA R. Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence. Biomedicines 2025, 13: 758. PMID: 40149734, PMCID: PMC11940732, DOI: 10.3390/biomedicines13030758.Peer-Reviewed Original ResearchFood and Drug AdministrationGene therapySickle cell diseaseFDA-approved therapiesCost of therapyRegulatory convergenceGates FoundationCell diseaseTherapyDrug AdministrationMiddle-income countriesGlobal health advocatesModel disorderRegulatory gapsInternational regulatory bodiesReagan-Udall FoundationRegulated industriesGenesRegulatory bodies
2021
COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients
Stewart M, Rodriguez-Watson C, Albayrak A, Asubonteng J, Belli A, Brown T, Cho K, Das R, Eldridge E, Gatto N, Gelman A, Gerlovin H, Goldberg SL, Hansen E, Hirsch J, Ho YL, Ip A, Izano M, Jones J, Justice AC, Klesh R, Kuranz S, Lam C, Mao Q, Mataraso S, Mera R, Posner DC, Rassen JA, Siefkas A, Schrag A, Tourassi G, Weckstein A, Wolf F, Bhat A, Winckler S, Sigal EV, Allen J. COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients. PLOS ONE 2021, 16: e0248128. PMID: 33730088, PMCID: PMC7968637, DOI: 10.1371/journal.pone.0248128.Peer-Reviewed Original ResearchConceptsHospitalized COVID-19 patientsCOVID-19 patientsUse of hydroxychloroquineElectronic health recordsAdverse eventsTreatment groupsCOVID-19Administration of hydroxychloroquineReagan-Udall FoundationProportional hazards modelHealth systems researchHospitalized patientsElevated riskPropensity score methodsHazards modelHydroxychloroquinePatientsSignificant global threatPharmaceutical interventionsAzithromycinHealth recordsMortalityCOVID-19 pandemicCancer researchTreatment
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