Situation:

As a NASDAQ traded oncology biotechnology company was preparing to expand globally, they requested Kineticos conduct a gap assessment of their Medical Affairs function. Specifically, the sponsor asked Kineticos to perform an in-depth review of their procedures, organizational structure, and staffing needs to determine where gaps existed as they prepared for global readiness.

Process:

Kineticos first spent time to review internal documentation provided by the sponsor. This review included SOPs, organizational charts, roles/responsibility matrices, and other relevant information. Subsequent to the documentation review, Kineticos developed a discussion guide that was utilized in interviewing 20 key stakeholders across Medical Affairs and adjacent functions. After gaining a comprehensive understanding of how the Medical Affairs team was actually operating compared to the written documentation, Kineticos leveraged its functional expertise to identify gaps that needed to be addressed prior to building out the global Medical Affairs function.

Outcome:

Throughout the evaluation, Kineticos was able to identify several opportunities for improvements across MSLs, medical communications/writing, medical information, medical education, and scientific alliances functions. Kineticos paired the observations with fact-based recommendations intended to address each gap. The sponsor leveraged the final report in building out a strategic global medical affairs function.