Current market trends and introduction to the six success factors for Medical Affairs Excellence

CapSys Group’s latest global research, Re-thinking Medical Affairs, found that Medical Affairs, as a function, often still struggles to take on and occupy the increasingly important strategic role within organizations as the function that helps to educate and shape the pharmaceutical (pharma) and life sciences industries. All too often, Medical Affairs is still seen as a mere supporting function for Commercial, underleveraging its potential and thereby leading to suboptimal results for the whole company. In addition, the Medical Affairs function also faces significant external challenges with the evolution of stakeholder engagement, the complexification of evidence generation and scarcity of Medical Affairs talent. This whitepaper provides an overview of the current trends, main challenges and the six success requirements to uniquely position Medical Affairs as a strategic pillar within organizations. The insights have been summarized in a Medical Affairs Canvas, a toolbox designed to help Medical Affairs executives assessing their organization and to serve as a framework for developing a world-class Medical Affairs function and enable Medical Affairs Excellence.

If we think of today’s pharma companies as a “family” of corporate functions, Medical Affairs is the problematic “middle child” – a beloved member of the nuclear family that often struggles to find its place. R&D and Sales & Marketing have clear, measurable roles: the former delivering new, innovative therapies to market, the latter generating demand for those same therapies to deliver the all-important topline. Regulatory Affairs delivers approvals and the target label. Market Access delivers targeted reimbursement and price, and so on through the organizational chart. But Medical Affairs is a grab-bag of activities that don’t have corresponding financial KPIs – and in fact cannot for compliance reasons. Ask a Chief Medical Officer to point to her function’s contribution on
a corporate P&L or balance sheet, and she will be hard pressed to do so. At CapSys, we’ve had the privilege of working closely with a number of leading Medical Affairs organizations, and we have been fascinated by how they, and their parent companies, have addressed this existential dilemma. Further, our research and experience has shown that we’re witnessing a marked intensification of corporate efforts to resolve this dilemma. In today’s cost-conscious post-pandemic environment, pharma companies are putting pressure on Medical Affairs to demonstrate its strategic role and business case more clearly.

Our latest white paper series, Re-thinking Medical Affairs, is the result of a global study which aims to illuminate the function’s current challenges and the external trends driving them. Our findings provide rich insights that have led us to identify six levers of success, strategic and operational, to guide Medical Affairs leaders endeavoring to transform their function. Further, we’ve derived from the findings a systematic approach that Medical Affairs leaders can apply to assess the current state of their function and chart a course to a more robust strategic role with greater impact.

The first important finding from our interviews with global and regional Medical Affairs leaders, experts and opinion leaders is that three well-documented external trends are driving the intensification of pressure on the function:

Let’s take a closer look at how these three trends combine to create a Sisyphean task for Medical Affairs leaders.

Figure 1: External challenges that impact Medical Affairs Excellence; CapSys Group

Accelerated digitalization due to the COVID-19 pandemic has ended the era of predominantly face-to-face interactions between Medical Affairs and HCPs. Today’s relationships are now largely a set of remote, digital interactions offering limited opportunities to build meaningful, trust-based ties. This trend hasn’t lessened in post-pandemic times, as healthcare systems continue to work in over-stretched, cost-constrained conditions, and will most likely worsen still. Even HCP-patient relationships have suffered as long wait-times for consultations and telemedicine become more the norm, limiting Medical Affairs’ patient-centric efforts.

Thus far, companies haven’t been able to execute omnichannel engagement well enough to recover the ground lost, in terms of amount and quality of HCP engagement, and it is not for lack of technology investment. Rather, the issue is unclear and/or indecisive organizational strategy to deploy the technology. Successful omnichannel engagement requires a choice between two options: option one includes specialized roles and talent (often in centralized teams) who are accountable for omnichannel segmentation and targeting, strategy and planning, and tracking, performance management and digital insights generation. Some teams also have content and digital execution responsibilities. The other option is a redesign of the role of the medical field force that includes accountabilities for the same activities above, and that asks MSLs to manage a portfolio of HCPs across most channels and activities.

Regulatory approval is necessary for marketing authorization, but clinical efficacy and safety alone are no longer sufficient to demonstrate the value of new medicines for pricing and reimbursement negotiations. The definition of value is being determined by an increasingly wide and varied stakeholder landscape with more stringent evidence requirements for its reviews and value assessments. For instance, real-world evidence (RWE) and comparative effectiveness are becoming essential supplements to randomized controlled trial (RCT) data. Further, outcome measures such as quality of life measured with patient-reported outcomes (PROs) become more critical for reimbursement and uptake. Therefore, relevant and timely evidence generation is essential to demonstrate a product’s value to key stakeholders for successful launch and commercialization.

Medical Affairs is well connected with internal and external stakeholders and has the scientific and medical knowledge to coordinate relevant evidence generation within the organization and advocate value demonstration to stakeholders. However, our research shows that this potential too often remains underleveraged. Moving towards this central role requires Medical Affairs to be involved early and throughout the product lifecycle and to be aligned with other organizational functions.

Medical Affairs is increasingly required to build and leverage new skills and capabilities to expand from the traditional role of supporting Commercial operations into the central role of shaping the organizational strategy. Medical Affairs are under pressure to display the scientific acumen to engage with R&D, the strategic mindset to work hand-in-hand with brand and marketing teams, the regulatory background to understand legal and compliance matters, and the stakeholder engagement competencies to co-operate well with their Commercial counterparts. However, these broadening Medical Affairs responsibilities and more comprehensive expectations demand hard-to-find agility and skillsets from talent in the marketplace.

Further, the pressure and urgency to rapidly adopt and incorporate digital solutions due to digitalization and COVID-19 have exposed deficits both in the infrastructure required for digital engagement and in the respective capabilities, skills, and talent in Medical Affairs. Organizations must therefore invest into building the right blend of Medical Affairs workforce to enable the function to take on a central role in building organizational strategy. The organization can support Medical Affairs to transition from a technical to a leadership role by upskilling or outsourcing strategic and digital capabilities, developing commercial acumen, and facilitating cross-functional collaboration. Over time, the investment in Medical Affairs will translate into a competitive advantage for the organization.

Medical Affairs has the potential to be a pivotal pillar in the organization when it comes to strategy building. This, however, requires a set of technical and organizational pre-requisites to be in place within the function. CapSys identified six requirements for success to enable Medical Affairs functions to respond to external challenges and achieve Medical Affairs Excellence.

Figure 2: Six success requirements for achieving Medical Affairs Excellence; CapSys Group

Four of these crucial success requirements are of a technical nature. They encompass the necessary activities that a Medical Affairs function needs to master to ensure sustainable success and achieve Medical Affairs Excellence:

1. Gain a deep understanding of the disease and stakeholder (HCP and patients) needs
2. Generate relevant and timely evidence
3. Engage effectively with stakeholders
4. Effectively demonstrate strong scientific value communication

Furthermore, two organizational success requirements form the fundamental basis to ensure the effective execution of the technical success requirements:

5. Establish, invest in, and improve the relevant organizational skills and Medical Affairs capabilities
6. Develop a clear and effective organizational setup to support Medical Affairs

Performing well on all six success requirements will enable pharmaceutical and life sciences organizations to address the identified market trends and challenges and achieve Medical Affairs Excellence. The six success factors will be described and analyzed in more depth in parts 2 and 3 of the Re-thinking Medical Affairs series.

Based on these insights, CapSys Group has developed an actionable Medical Affairs Excellence Canvas toolbox designed to help Medical Affairs executives to assess their organization’s maturity level along the six success requirements and to identify potential gaps to close on the journey to develop and achieve world class Medical Affairs Excellence.

Figure 3: Illustration of (self-)assessment component of the CapSys Medical Affairs Excellence Canvas; CapSys Group

The pack contains three components that are built on each other.

1. Medical Affairs Excellence (Self-) Assessment Canvas
2. Medical Affairs Excellence Planning Canvas
3. Medical Affairs Excellence Action Canvas

The three components of the Medical Affairs Excellence Canvas pack and our recommendation of how to proceed on the path towards Medical Affairs Excellence will be described in more detail in part 4 of the Re-thinking Medical Affairs series.

This is the first in a series of four insight articles based on CapSys’ global Re-thinking Medical Affairs study and focused on Medical Affairs Excellence in pharma and life sciences. Parts 2 and 3 provide key content and insights on the six success requirements for Medical Affairs Excellence. Part 4 provides a framework for a continuous improvement and (self-) assessment, the Medical Affairs Excellence Canvas.

For these Re-thinking Medical Affairs series of articles and other upcoming industry insights please visit the Capsys group website under https://capsysgroup.com/insights/.