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A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC).
- Source :
-
Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2019 Mar; Vol. 53 (2), pp. 243-248. Date of Electronic Publication: 2018 Mar 08. - Publication Year :
- 2019
-
Abstract
- 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.<br />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.<br />Results: A pilot was successfully run using CompAC to provide recommendations on compassionate use access to a Johnson & Johnson oncology investigational asset called daratumumab.<br />Conclusion: This innovative model provides a framework that can be emulated by the industry globally.
Details
- Language :
- English
- ISSN :
- 2168-4804
- Volume :
- 53
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Therapeutic innovation & regulatory science
- Publication Type :
- Academic Journal
- Accession number :
- 29714573
- Full Text :
- https://doi.org/10.1177/2168479018759659