Roundtable: Transitioning Medical Affairs to Strategically Co-lead Clinical Development and Commercialization Efforts

Key Topics:

1. Foundational Elements for Medical Affairs’ Success

From the group’s perspective, the most significant challenges to value creation for Medical Affairs are structural: senior leadership and decision-makers may find it difficult to understand how resourcing and staffing decisions have limited Medical Affairs’ ability to support overall corporate strategies and other functions; that budgets need to be expanded, how talent needs to be upskilled, and what processes need to be redesigned for efficiency and effectiveness. These challenges often impede Medical Affairs’ ability to demonstrate its value internally, to the organization, and externally, to patients and healthcare professionals (HCPs). The group emphasized the following foundational organizational aspects:

• Strong thought leadership

  that believes in the potential and capabilities of Medical Affairs and advocates for it from the top of the organization, without shying away from healthy tension that is required to drive change. It is encouraging to see that senior leadership positions which inspire the sense of purpose of the company are being filled increasingly with people coming from Medical Affairs.

• Organizational structure

  that represents Medical Affairs as an autonomous pillar next to Commercial and R&D, reflected already at the top from the executive committee composition. The position and strategy of Medical Affairs should be clear and known throughout the organization.

• Optimum budget

  both on a short and mid-term time horizon enabling Medical Affairs initiatives and understanding that the return provided by Medical Affairs will be different from purely quantitative metrics that Commercial might provide, and will be achieved more in the long term.

• Talent evolution

  that considers new capabilities that will be needed to engage with a broader set of stakeholders, including an increased emphasis on patients and patient organizations as well as the adoption of digital channels and opportunities. There is a greater need for information that is personalized and shared via the right channel, efficient insights collection, communication using technology appropriately to enhance engagement, and storytelling skills. Medical Affairs teams need to build confidence in being a valued thought partner.

• Efficient processes and focus

  that enable Medical Affairs to add value. Processes should be able to handle the increasing amount of information that is communicated and a clear understanding of compliance limitations and how to work with them effectively. Moreover, while new initiatives are started, old initiatives should be periodically evaluated and pressure tested against their effectiveness and alignment with the strategy to keep the team focused.