Can A KOL or SAB Member Replace a Chief Medical Officer?

In a recent sampling of biopharmaceutical companies we conducted, a stark contrast emerged between companies who had not yet filed an IND and those that had.  We were astonished to discover that roughly 80% of companies without a drug in the clinic did not list a Chief Medical Officer among their executive leadership, while the reverse is true of clinical stage companies.  Based on discussions with senior executives to understand this bifurcation in greater depth, it became apparent that many recognize the merits of aligning their intended clinical trial pathway with preclinical initiatives.  These same companies, however, rely on key opinion leaders or their scientific advisory board members as a substitute for the expertise of a Chief Medical Officer.
 
This reliance is likely misguided and can contribute to protracted development timelines and escalating financial costs.  KOLs and SAB members do play critical roles in guiding the advance of development programs, but their role is distinct from that of a Chief Medical Officer and the two roles are not interchangeable.   KOLs and SAB members possess an extensive understanding of a specific disease state but not necessarily an intimate appreciation of the strategic and operational aspects of drug development.  These capabilities fall squarely within the domain of the Chief Medical Officer.  Particularly for earlier-stage private companies who do not need a full-time executive, accessing a Chief Medical Officer on a fractional or interim basis enables these companies to gain the significant benefit of this expertise without incurring the burden of a full-time hire.