We assisted a biotechnology company with clinical hypothesis testing and endpoint identification and prioritization

Client challenge

To determine and rank the most important clinical endpoints for an infectious disease treatment approach for which there is no existing precedent regarding clinical guidelines or regulatory approval

To develop a White Paper for the first meeting with regulatory authorities on the therapeutic concept


InterPhase Consult solution

Organisation and delivery of advisory board meeting, with pre-work designed to provide additional hard quantitative outputs to support expert opinion on the endpoints, and enable the subsequent development of the White Paper

Participants comprised prominent research leaders in the field, with particular expertise in clinical study design


Result

Detailed feedback provided on each relevant endpoint, and consensus reached on the most suitable endpoint to proceed with going forwards in the clinical development programme. Advisor recommendations supported by quantitative data obtained from pre-work

White Paper document developed, and subsequently reviewed by advisors prior to submission to regulatory authorities

Successful delivery of advisory board encouraged future input and interest from advisors regarding ongoing development of product