It is our mission to share key learnings on how to objectively, fairly and ethically approach compassionate use requests and advance public health. CompAC is a model that has the potential for wider application within the industry.
We believe the CompAC model offers insights that can serve as an industry best practice for fair evaluation of compassionate use requests, and we are proud to be leading this discussion.
- This study in Therapeutic Innovation & Regulatory Science features results from the 19-month pilot of CompAC for daratumumab, a drug since approved for use in multiple myeloma. This infographic also includes key results.
- This web page hosted by New York University (NYU) Langone Health focuses on current issues that both pre-approval access (PAA) to investigational medicines and compassionate use are currently facing.
- This article co-authored by Janssen and NYU Langone Health from the Journal of the American Medical Association (JAMA) details some of the ethical challenges that compassionate use faces.
- This site includes several videos, a meeting report, and a podcast regarding pre-approval access and compassionate use from a 2015 colloquium hosted by NYU Langone Health and the New York Academy of Sciences (NYAS) and sponsored by Johnson & Johnson.