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Ther Innov Regul Sci ; 53(2): 243-248, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-29714573

RESUMO

BACKGROUND: Janssen Research & Development, LLC, part of the Janssen pharmaceutical companies of Johnson & Johnson, and NYU School of Medicine partnered to establish the Compassionate Use Advisory Committee (CompAC) to evaluate the use of an independent, external, expert committee in ensuring transparent, fair, beneficent, evidence-based, and patient-focused compassionate access to investigational medicines, a public health challenge that has been an ongoing issue for over 3 decades. METHODS: To this end, NYU School of Medicine was responsible for the formation, member selection, and operation of CompAC, consisting of physicians, ethicists, and patient advocates, under Johnson & Johnson's sponsorship. RESULTS: A pilot was successfully run using CompAC to provide recommendations on compassionate use access to a Johnson & Johnson oncology investigational asset called daratumumab. CONCLUSION: This innovative model provides a framework that can be emulated by the industry globally.


Assuntos
Comitês Consultivos , Ensaios de Uso Compassivo , Drogas em Investigação , Adolescente , Adulto , Idoso , Anticorpos Monoclonais , Antineoplásicos , Criança , Pré-Escolar , Indústria Farmacêutica , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Universidades , Adulto Jovem
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