“Common Sense” Considerations Regarding Chief Medical Officer Talent

The Chief Medical Officer (CMO) is a core member of any biopharmaceutical company’s leadership team.  This executive is responsible for the design and execution of a clinical development strategy that is central to the company’s success.  As such, significant time and resources are committed to hiring a CMO whose specific expertise will facilitate achievement of program objectives.  While a background in a specific disease state is often believed to be the prioritized prerequisite, other considerations may be of equal, or possibly greater, importance especially to earlier-stage companies.  These include:
 

• Insightful Clinical Strategist – Cogent strategic guidance well in advance of initiation of clinical trials is of utmost importance to earlier-stage companies so that they can align their intended clinical development path with preclinical initiatives.  Lack of alignment often results in significant development delays and increased costs, issues which can be avoided by the early involvement of the CMO.

 

• Background in Clinical Development – The career paths of CMOs often lean towards clinical development or medical affairs.  CMOs with greater earlier-stage company experience tend to have more clinical development expertise while those from later-stage companies often have greater medical affairs exposure.

 

• Diversity of Corporate Experience – As a larger pharmaceutical or biopharmaceutical company will likely be the company’s development partner, the CMO’s appreciation of big pharma’s expectations and cultural biases is central to thoughtful clinical trial design and implement.  At the same time, the CMO must also intimately appreciate the financial and other constraints faced by smaller biotech companies, issues that their big pharma peers may not encounter.

 

• Regulatory Aptitude – Success in maneuvering through the FDA and other regulatory agencies often requires an ability to convert opaque agency guidance into a coherent plan of action, insight that only experience can provide.  Prior regulatory interactions best position the CMO to craft streamlined clinical programs intended to expedite regulatory approval.

 

• Skilled Communicator – The ability to communicate often complex issues in clear, concise and convincing terms to a disparate range of interested parties, including KOLs, investigators, regulators, and investors, among others, is a critical component of the CMO’s job and promotes confidence and commitment.

 
Despite the multiple benefits of involving a CMO early in a drug candidate’s development, companies frequently do not hire a CMO prior to filing an IND.  Often it is because of the expense or the less than a full-time need.  Instead, these companies often rely on KOL or SAB members as a substitute, advisors that may lack the relevant clinical experience or may not have sufficient time for thoughtful engagement.
 
Prior to committing to a full-time hire, an appropriate functional bridge may be the fractional CMO.  Accessing a senior-level CMO talent on a fractional level provides the company the multitude of benefits a CMO can offer it without many of the financial encumbrances of a permanent employee. Moreover, while indication-specific knowledge may be desired, the broad functional capabilities of an experienced CMO often outweigh an understanding of a particular disease state.  The backgrounds of seasoned CMO talents include experiences across many disease states, indicative of their ability to acquire requisite indication insights rapidly.