Browsing by Author "Durbin A"

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    Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023.
    (2024-Feb) Cavaleri M; Kaslow D; Boateng E; Chen WH; Chiu C; Choy RKM; Correa-Oliveira R; Durbin A; Egesa M; Gibani M; Kapulu M; Katindi M; Olotu A; Pongsuwan P; Simuyandi M; Speder B; Talaat KR; Weller C; Wills B; Baay M; Balasingam S; Olesen OF; Neels P; Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA. Electronic address: rchoy@path.org.; European Vaccine Initiative, Heidelberg, Germany. Electronic address: ole.olesen@euvaccine.eu.; Imperial College London, UK. Electronic address: c.chiu@imperial.ac.uk.; Centre for Infectious Disease Research, Zambia. Electronic address: Michelo.Simuyandi@cidrz.org.; Center for Vaccine Development, University of Maryland School of Medicine, USA. Electronic address: wilbur.chen@som.umaryland.edu.; IABS-EU, Lyon, France. Electronic address: pieter.neels@vaccine-advice.be.; Imperial College London, UK. Electronic address: m.gibani@imperial.ac.uk.; Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: ktalaat@jhu.edu.; KEMRI-Wellcome Trust Research Programme, Kenya. Electronic address: mkapulu@kemri-wellcome.org.; HVIVO plc, UK. Electronic address: b.speder@hvivo.com.; Wellcome Trust, London, UK. Electronic address: shobana.balasingam@wellcome.org.; Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: adurbin1@jhu.edu.; US Food & Drugs Administration, USA. Electronic address: david.kaslow@fda.hhs.gov.; P95 Epidemiology & Pharmacovigilance, Leuven, Belgium. Electronic address: marc.baay@p-95.com.; Food and Drugs Authority, Ghana. Electronic address: gus4tee@gmail.com.; European Medicines Agency, Netherlands. Electronic address: marco.cavaleri@ema.europa.eu.; Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam. Electronic address: bwills@oucru.org.; Wellcome Trust, London, UK. Electronic address: C.Weller@wellcome.org.; Ifakara Health Institute, Tanzania. Electronic address: aolotu@ihi.or.tz.; Fundação Oswaldo Cruz (Fiocruz), Brazil.; Katindi & Company, Kenya. Electronic address: mkatindi@katindilawyers.co.ke.; MRC/UVRI and LSHTM Uganda Research Unit, Uganda; London School of Hygiene and Tropical Medicine, UK. Electronic address: Moses.Egesa@mrcuganda.org.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    Many aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on regulation of CHIM studies, bringing together scientists and regulators from high-, middle-, and low-income countries, to discuss barriers and hurdles in CHIM regulation. Valuable initiatives for regulation of CHIMs have already been undertaken but further capacity building remains essential. The Wellcome Considerations document is a good starting point for further discussions.