A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC).
daratumumab
expanded access
multiple myeloma
preapproval access
unapproved medications
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
03 2019
03 2019
Historique:
pubmed:
2
5
2018
medline:
18
4
2019
entrez:
2
5
2018
Statut:
ppublish
Résumé
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. 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. A pilot was successfully run using CompAC to provide recommendations on compassionate use access to a Johnson & Johnson oncology investigational asset called daratumumab. This innovative model provides a framework that can be emulated by the industry globally.
Sections du résumé
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.
Identifiants
pubmed: 29714573
doi: 10.1177/2168479018759659
doi:
Substances chimiques
Antibodies, Monoclonal
0
Antineoplastic Agents
0
Drugs, Investigational
0
daratumumab
4Z63YK6E0E
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM