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What is CompAC?

What is CompAC?

Advisory Committee

In May 2015, Johnson & Johnson announced a first-of-its-kind pilot partnership between Janssen and the Division of Medical Ethics at the New York University (NYU) School of Medicine to form the Compassionate Use Advisory Committee (CompAC). Comprised of external bioethical experts, physicians and patient representatives convened by NYU, the purpose of CompAC, a pilot program, is to ensure a fair, objective and ethical evaluation of single patient requests for investigational medicines.

CompAC Model

CompAC recommendations are based on available scientific evidence around risk and benefit and examined all requests in a fair and just manner, considering both individual patient need and public health benefit in its decisions.

Our physicians will conduct an initial review of all requests to identify those that may be immediately eligible for a clinical trial or an expanded access program and will direct those requests accordingly. If a patient has exhausted all available treatment options, does not have acceptable medical risk, and, does not qualify for any established pre-approval access program, the request is forwarded to CompAC. Forwarding to CompAC is automatic for all appropriate applications, and no further request needs to be made from requesting physicians. CompAC evaluates these requests and provides a recommendation to the Janssen Pharmaceutical Companies of Johnson & Johnson. Our physicians make a final decision on patient access, taking the CompAC’s recommendation into account.

Evaluation

CompAC has led to key learnings on how to objectively, fairly and ethically approach compassionate use requests. The company continues its commitment to share its experience from CompAC with a view to supporting this as a way to advance public health, and with the belief that CompAC is a model that has the potential for wider application within the industry.

Results

Watch this video to learn more about this important initiative.

Compassionate Use & Pre-Approval Access

Compassionate Use & Pre-Approval Access

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