Roundtable: Transitioning Medical Affairs to strategically co-lead clinical development and commercialization efforts

September 21, 2023
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This article was published by Medical Affairs Professional Society (MAPS).

In May 2023, CRA’s Life Sciences Practice held a roundtable discussion with Medical Affairs leaders in Lisbon on best practices in transitioning from a function that provides scientific communications and engagement and that partners with development and commercial teams on activities from product development to launch into a function that is co-leading strategically the clinical development and commercialization efforts.

The group touched on how a Medical Affairs function could be structured and supported to be able to create value, how it needs to be integrated with commercial and R&D, and how the added value should be measured and communicated. Finally, we discussed the merits of a stepwise evolution in a company’s Medical Affairs function.

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.

2. Full integration of Medical Affairs across the business
Integration of Medical Affairs in relevant business processes throughout the product lifecycle and across functions is crucial to its ability to add strategic input and deliver value. The main recommendations coming from the panel discussion are:

Early integration into the product lifecycle
that will enable early and continuous trusted engagement with relevant stakeholders. This will ensure that patient insight and experience are integrated into clinical trial design, including endpoint identification, trial site selection with key opinion leaders (KOLs), and holistic clinical protocols. Medical Affairs should also become the center of excellence for identifying evidence gaps, real-world evidence generation, assessing significance and developing tactics to address gaps.

Shared objectives with other functions
which are pursued by each line function within their own purview and with the required firewalls. Unified goals as well as shared KPIs will support cross-functional alignment, collaboration, and accountability so that all work towards the same goals. This will push functions to communicate their contributions and make joint decisions (where appropriate) on what initiatives to invest in.

Increased business acumen
will be an essential skill to ensure an understanding of how Medical Affairs goals align with the goals of the organization.

3. Measure the added value and become champions
External stakeholders spend considerably more time with Medical Affairs compared to other functions, demonstrating the value of these interactions. Although Medical Affairs metrics have been established to “keep up” with the dashboards of other functions, measuring success within Medical Affairs needs to move beyond quantitative metrics to demonstrate the qualitative value Medical Affairs brings to the organization. The panel discussion recommended that Medical Affairs:

Shape the narrative
on what are the targeted outcomes. While other functions focus on quantitative metrics that may be achieved over short timeframes, or traditionally “claim” certain success metrics for themselves, Medical Affairs needs to educate internally on the relevance of their goals and manage expectations on what is achievable within a given timeframe, including the value of identifying unmet medical needs to inform the portfolio strategy.

Select suitable outcome measures
that align with the function’s strategy and objectives, could demonstrate progress towards goals, and would help demonstrate value to metric-driven organizations. Suitable metrics should measure the holistic impact that Medical Affairs has on patients and healthcare teams as well as access, equity, and sustainability. Focusing on medical insights and their significance as business insights could be a useful starting point.

Champion and communicate successes
including the business value of those successes. Medical Affairs can improve on how vocal they are about both their short- and long-term wins. These updates should be communicated across the organization, including leadership levels. From successful pilot programs in certain regions to large-scale changes in physician behavior that better help patients, sharing wins will improve the internal understanding of what Medical Affairs can provide.

When considering foundational business areas such as team leadership values, organizational/reporting structure, budgeting, talent development, and processes, pharma/biotech needs to recognize and support Medical Affairs as a strategic pillar. Once the aforementioned areas are shaped to recognize appropriately the value of Medical Affairs, the function can more easily integrate across teams and more accurately measure and champion its value. One key to fostering these changes is taking small steps—creating pilots rather than aiming to immediately transition to a perfect state is more likely to lead to a longer lasting transformation.