The Medical Affairs Leadership Catalyst: Unlocking Strategic Potential through Medical Planning
In today’s rapidly evolving healthcare landscape, the role of Medical Affairs (MA) is undergoing a profound transformation. Long relegated to a supporting role, MA is now poised to become a strategic leader within biopharma companies, standing shoulder to shoulder with Commercial and R&D teams. But while the drivers behind this shift – data expansion, digital engagement, and increased regulatory complexity – are clear, many organizations have yet to fully elevate MA to its rightful place at the strategic table.
So, how can MA step up and claim its spot? The answer lies in one often-overlooked tool: the medical plan.
The Future of Medical Affairs is Now, and It Has Been for Quite Some Time
“The time is now for Medical Affairs to take a seat at the table alongside Commercial and R&D and become a strategic leader within the organization.”
Calls for Medical Affairs to take a more prominent role in shaping strategy have been loud and clear for several years, but the time to act is now.
Indeed, looking at the dynamic healthcare landscape reveals several prominent trends, including:
- An expansion in the depth and breadth of healthcare data (e.g., RWE, insights)
- A paradigm shift towards digital HCP and patient engagement
- MA and MSLs becoming the primary ‘face’ of the company in external engagements, thus becoming the key interface between biopharma companies and HCPs as regulations and preferences evolve
- Ever-increasing complexity surrounding clinical decision making (i.e., more therapies acting on more targets, with more treatment-stratifying criteria)
- A growing need to effectively demonstrate clinical value to address mounting regulatory and life cycle expiry pressures (e.g., HTA, IRA)
These developments do emphasize the essential role of Medical Affairs in driving both external success and internal alignment, reinforcing the need for its strategic evolution; however, aside from a few uneven strides forward, the foretold transformation of Medical Affairs into a leadership role has yet to come to fruition at scale across the industry.
The Medical Plan: An Overlooked Springboard to the Medical Affairs Ambition
The medical plan is far more than a checklist of activities – it’s the center of the strategy. It is critical to both the success of an asset and the establishment of leadership within a therapeutic area. The medical plan lays the foundation for strategic success, ensuring that clinicians understand the clinical utility and value of new and innovative therapies and, ultimately, driving meaningful impact on patient care. Equally important is its internal value – providing wider organizational understanding of the role Medical Affairs has in supporting the overarching strategy. Consequently, developing an exemplary medical plan has a two-fold impact: positioning your asset(s) for success in the external landscape, while also establishing MA teams as credible strategic leaders within the organization.
Six Steps That Take Your Medical Plan to the Next Level
For all its impact, the process of developing a best-in-class medical plan can be challenging. Based on our extensive medical planning experience, we have identified these guiding principles to help you maintain your medical planning A-game:
- Start with strategy, not tactics: A top-down, strategy-first approach is essential to ensure that all activities in the field support the desired outcomes. Begin by taking time to define and solidify the strategy for the asset or disease state before outlining tactics. The benefits are three-fold: first, this forces teams to clearly articulate their ultimate strategic aims, which are often ill-defined if considered from a tactical mindset (i.e., too broad or too narrow). Second, a strategy-first approach affords teams the space to align on the big-picture priorities early, often across global and/or regional functions. Finally, a well-defined strategy begets well-suited activities, facilitating the development of tailored tactics whose whole is more than the sum of their parts in support of an overarching strategic pillar. Bookending this process should be purposeful medical impact assessments that measure progress toward strategic goals and provide inputs for downstream strategic and/or tactical adjustments.
- Remember the audience: The best plan is a usable one. The contents of a medical plan are inherently highly detailed (NCCN guidelines aren’t exactly renowned for their digestibility, after all); however, an exhaustive account of all information related to the asset and/or disease area is unwieldy and, ultimately, counter-productive for the reader. Conscientious consideration of the key ‘must-know’ information can go a long way in elevating the utility of your medical plan; non-essential information can be linked to the medical plan, but housed in adjacent documents (e.g., insights and CI reports). This is a practical way to strike a balance that provides access to comprehensive information on an ‘as-needed’ basis without overwhelming the medical plan user.
- Strive for Consistency…: All medical plans are similar, with each containing several key core components (e.g., situational analysis, gaps, strategic objectives). For midsize and large MA teams, this similarity should be encouraged even further, with an established organizational perspective on ‘must-have’ vs. modifiable components for all medical plans. Establishing a consistent medical plan structure and process for development will make planning easier, aligning expectations and avoiding wide variations in content and approach across teams. It also supports leadership by creating a standardized format for cross-asset comparison and synthesis of disease area and portfolio decisions.
- … But Recognize Bespoke Plan Needs: While consistency is important, every medical plan is also unique! Although different plans contain the same types of information (ideally organized in a consistent structure), organizational and landscape context can vary greatly across teams and should be accounted for to optimize the impact of the medical plan. Some key indicators that could influence medical plan development include:
a) Content Novelty or Familiarity
Resident internal expertise and external complexity can vary substantially across assets and disease areas. Label expansions can bring the team into an unfamiliar therapeutic area, or into contact with a new type of stakeholder (e.g., medical oncologists vs. gynecological oncologists; dermatologists vs. gastroenterologists). In these instances, more time and resources should be dedicated to the development of a robust situational analysis, and to building and sharing scientific expertise throughout the organization. Conversely, teams working with established assets or mechanisms of action can look to leverage synergies stemming from internal and external familiarity, redirecting resources to other areas.
b) Team Maturity
When it comes to medical planning, practice certainly makes progress. Teams that have developed their fair share of medical plans have established ways of working and are familiar with what ‘good’ looks like, so they require less support compared to more junior teams; however, it’s important not to let this experience lead to complacency. By bringing everyone together for in-person brainstorming sessions or intentional, structured exercises, teams can avoid falling into ‘business as usual’ activities and instead go further, thinking more creatively and innovatively throughout the asset life cycle.
c) Internal and External Strengths and Weaknesses
Much like people, biopharma organizations have their strengths and weaknesses. Some Medical Affairs teams might benefit from well-established and robust collaboration with their Commercial colleagues, while other teams might enjoy having access to pre-eminent diagnostic capabilities in-house. Identifying organizational strengths and weaknesses, and recognizing how these might have evolved from the previous year, should be a key consideration in the medical planning process. Of course, identification and recognition are incomplete without thoughtful planning that allows for the implications of your unique organizational situation. For example, a Medical Affairs organization that works seamlessly with Commercial but struggles to collaborate with R&D might allocate additional time during the planning cycle to secure stronger alignment with their R&D colleagues.
Due consideration of any potential outward-facing strengths and weaknesses is also vital. Medical Affairs teams should be intimately aware of prevailing external stakeholder perceptions and how these might be relevant to the medical plan. For example, an established therapeutic area leader might look to leverage well-established relationships by prioritizing IISs or ESRs to address evidence gaps, while newer entrants might need to focus their activities on building relationships from the ground up before they can partner and collaborate at the same scale. - Prioritize Productivity, Not Perfection: By nature, MA professionals are detail-oriented and strive for perfection. Many might hesitate to share medical plan materials with their colleagues before they have been exhaustively deliberated, aligned upon, and finalized. While this is well-intentioned and often the result of professionals’ strenuous research backgrounds, there are many instances where work-in-progress medical plan materials can be sensibly shared with regional and cross-functional partners. Compliant sharing of early perspectives helps to clarify the direction of medical thinking. Inviting cross-functional and regional colleagues to participate in strategic and tactical workshops, even as passive participants, helps avoid the “silo effect” and drives synchronized activity planning throughout the organization. Ongoing medical plan visibility is an equally beneficial practice for leadership stakeholders, who should be reviewing the plan at select time points to pressure test and ensure alignment with organizational priorities.
- Plan Proactively, Not Reactively: Owing to lengthy time horizons, high pipeline activity volume and unpredictable regulatory and policy shifts, medical plans always grapple with an element of uncertainty. Medical Affairs leaders often address uncertainties by waiting for additional information, such as data releases or competitor events, to guide their strategic decision making; however, they also need to make a conscientious shift toward a more proactive approach. Proactive planning involves making informed assumptions, evaluating their likelihood of occurrence and assessing the potential impact of key events. Highly probable assumptions should provide the foundation for the medical plan, ensuring sufficient runway for time-consuming evidence generation and other market-shaping tactics, while less probable assumptions can be accounted for within the medical plan through contingency planning that sketches high-level strategies and tactics addressing a wider range of external possibilities. This two-pronged approach to proactive medical planning prevents unneeded paralysis while fostering additional readiness and agility to react to high-impact trigger events.
Medical Planning: A Launchpad for Strategic Leadership
Although the long-standing discourse on elevating Medical Affairs’ strategic standing has yet to be reflected throughout the industry, the drivers that demand this evolution will only increase in relevance moving forward. Organizations that invest in and empower MA’s strategic capabilities will be better positioned to synchronize strategies across functions, franchises and geographies from the early stages of the asset life cycle, providing material internal advantages and boosting external impact. The medical plan presents the perfect opportunity for Medical Affairs to showcase its value within the organization and catalyze a transformation in strategic leadership. We hope this article will inspire you to take the next step in elevating your approach as you develop your roadmap and processes for medical planning next year.
This article precedes a series of more comprehensive discussions on optimizing Medical Affairs capabilities and delivering on current and future-looking opportunities. Prescient looks forward to sharing these with you and your colleagues. Please fill out the form here if you would like to further explore how Prescient can support you and your Medical Affairs team.
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