A phrase often recited within the pharmaceutical and biotechnology industries in recent years is that medical affairs is the third strategic pillar of success, along with R&D and commercial. Ongoing advancements in the cell and gene therapy sector have further highlighted the critical role of the medical affairs function. The science that supports cell and gene therapies is highly complex to execute and communicate. The sector also has been the subject of safety and tolerability concerns from several healthcare stakeholders, and medical affairs teams have the often-difficult task of communicating long-term outcomes based on surrogate or novel endpoints, due to a lack of long-term efficacy data. All challenges are understandable considering that these therapeutic modalities are still relatively novel. Cell and gene therapy manufacturers must nonetheless navigate these hurdles, often under accelerated clinical and corporate timelines imposed by investors and board members.
Historically, medical affairs has been seen as more of a resource – it is the group that answers complex scientific questions. However, given a recent evolution to a more strategic role and the opportunity to help navigate the increasingly complex cell and gene therapy sector, the remit of medical affairs needs to be redefined.
The Medical Affairs Professional Society (MAPS) declares the medical affairs mission as “being a strategic leader at the center of clinical development and commercialization efforts, addressing unmet patient, payer, policymaker, and provider needs that advance clinical practice and improve patient outcomes.”1 This evolved role and responsibility, accompanied by the increased demands to communicate more complex efficacy, safety and tolerability data for cell and gene therapies, presents the overall challenge of proving the value of medical affairs. To demonstrate strategic value, it is critical that medical affairs teams take the following steps:
- Define the team’s desired outcomes and purpose.
- Create clear metrics based on the desired outcomes.
- Track the team’s impact with data.