Convening a Medical Advisory Board

The Ask

A therapeutic development company sought investment to enable further clinical development of a mid-stage candidate cell therapy, including funding for a licensure-enabling trial. In combination with the findings and recommendations identified and developed through DHC’s due diligence of the therapeutic candidate’s Chemistry, Manufacturing and Controls (CMC) and Regulatory position, the practice was appointed to recruit, convene and chair a Clinical Advisory Board to provide independent evaluation of existing clinical data to enable an informed view to be developed regarding the readiness and near-term potential for evaluation within a licensure-enabling trial.

The Impact

DHC’s leadership and expertise in executing a first rate Clinical Advisory Board afforded our client an unparalleled opportunity to optimally inform their investment decision, appropriately based on the development of an impartial, multi-factorial evidence-based position.

DHC’S Approach

The practice appreciates the complexities and sensitivities inherent to the relationship between a Clinical Advisory Board and a therapeutic development organization, particularly in the context of due diligence. It is critical to assemble an Ad Board capable of dispassionately assessing and opining on the clinical and commercial potential of a therapeutic asset, while remaining empowered to identify and highlight strengths, weaknesses, opportunities, and threats, in order to optimize the likelihood of Clinical, Technical, Regulatory, and Commercial success
DHC identified and prescreened a selection of top-tier potential Clinical KOLs based on project requirements. In doing this, the client benefited from leveraging and gaining immediate access to DHC’s network of top-tier resources
DHC analyzed and disseminated data for pre-read and initially conducted individual interviews and group sessions with Ad Board members to evaluate Clinical safety and efficacy data generated during the Phase II trial relative to the company’s selected endpoints. The strategies employed to facilitate evaluation of the data enabled KOL opinions to be both gathered on an individual basis and considered in a group setting, including critical consideration of the employed clinical end points relative to the disparities associated with those expected and considered most relevant by different Competent Authorities. DHC’s deep expertise in the strategic planning and execution of these evaluations enabled generation of dispassionate, informed positions and clear recommendations.
DHC assimilated the outcomes of the Clinical workstream together with key findings of the CMC-Regulatory workstream, to generate a comprehensive data package and key recommendations enabling our client to make an informed decision with actionable recommendations proposed where any strategic element was deemed insufficient or suboptimal.