Technical Success Requirements for Medical Affairs Excellence

CapSys Group’s latest global research, Re-thinking Medical Affairs, uncovered that Medical Affairs functions in many pharmaceutical (pharma) and life sciences companies are still struggling to assume a leading role in shaping their organization’s strategy definition and execution. Together with the industry leaders participating in the study, CapSys experts described the main shortcomings responsible for this situation and identified six success requirements to overcome them and achieve Medical Affairs excellence (see figure 1.). Four of these crucial success requirements are of a technical nature while two are organizational. This insight paper describes the four common technical deficiencies and the success factors associated with them.

Figure 1: The six success requirements for achieving Medical Affairs Excellence. Success Factors 1 to 4 are the focus of this paper

For the first success requirement, Medical Affairs leaders and experts at CapSys observed that Medical Affairs in winning pharmaceutical and life sciences organizations tends to go beyond the science and strives for a deeper understanding of the disease and stakeholder needs. The primary purpose of the Medical Affairs function is to serve as an interface between the external medical and scientific community and the enterprise. Much like a cell membrane, Medical Affairs actively identifies and promotes the passage of vital material (knowledge and insights) into and out of the organizational ‘cell’. Sourcing critical knowledge and insights from external stakeholders, articulating the implications for internal activities like evidence generation, and feeding new and relevant knowledge back to the external world is the core work of the Medical Affairs function.

Our research suggests this knowledge and insights loop is becoming increasingly critical. The speed, cost and complexity of innovation today are causing regulators, payers and healthcare providers to demand a more holistic, nuanced and objective knowledge package from pharma companies – not only about new treatments, but also about unmet patient needs and burden of illness, emerging end-to-end treatment journeys and their costs and effectiveness, and ancillary healthcare system requirements to meet the needs of patients. Amongst the many pharma functions that interact with stakeholders, Medical Affairs is best positioned to lead and manage this overall knowledge and insights loop. Further, our research suggests that companies are holding Medical Affairs increasingly responsible for doing so.

Are today’s Medical Affairs organizations prepared to deliver a robust knowledge and feedback loop? The short answer, based on what we’ve learned from our global panel, is “not really”. Specifically, our research points to four weak links in the loop. The main themes in these weaknesses are an insufficient understanding of the disease and stakeholder landscape, too little strategic foresight and a suboptimal use of the information that already is available.

So, how can these shortcomings be addressed? Insights from our Re-thinking Medical Affairs study show that successful industry leaders understand the disease and stakeholder landscape better than their less successful competitors by consistently employing four important levers for success.

Figure 2: Imperatives for a deeper understanding of disease and stakeholder needs

Regarding the second success requirement, Medical Affairs leaders and experts at CapSys observed that the Medical Affairs function is under mounting pressure to demonstrate value in an increasingly demanding ecosystem. For optimal value to be created, evidence generation must be planned and conducted with the end goal of developing new treatments to meet the needs of patients. Ensuring patient access to treatments requires that the right evidence is generated at the right time to meet the various needs and requirements of stakeholders involved throughout the clinical development process.

The Medical Affairs function is essential to any pharma or life sciences organization but is often underutilized. Through its scientific knowledge and stakeholder networks, the Medical Affairs function has the potential to evolve to a more central role within the organization to facilitate integrated evidence generation planning. Organizations that take advantage of this shift in the roles and responsibilities of Medical Affairs and reposition Medical Affairs to develop evidence generation strategies are on the path to Medical Affairs Excellence.

Creating winning evidence generation strategies inevitably involves making trade-off decisions between the various needs and requirements of external and internal stakeholders. Such trade-off discussions should take place early in the clinical development process and continue throughout the entire lifecycle of the asset. The development of scenarios with their corresponding migration strategies also needs to be considered in this manner, early and throughout clinical development. With its various stakeholder networks, Medical Affairs is well-positioned to play a role in facilitating internal communications and cross-functional

Based on these shortcomings and observed best practice in the industry, life sciences specialists and CapSys experts identified five key levers of success within the Medical Affairs Excellence Framework that Medical Affairs leaders should employ to better facilitate evidence generation.

Figure 3: Imperatives for generating relevant and timely evidence

For the third success requirement, CapSys experts and industry leaders contributing to the Re-thinking Medical Affairs study observed that Medical Affairs plays a vital role in helping organizations navigate stakeholder engagement and manage, or even deepen, quality stakeholder relationships. It does so by leveraging its therapeutic expertise and interactions with internal and external contacts and hence supports organizations deriving enhanced value from stakeholder engagement. The important role of the Medical Affairs function in stakeholder engagement becomes even more pronounced with the observable shift towards more complex and virtual stakeholder interactions.

Industry experts involved in the Re-thinking Medical Affairs study saw the need for Medical Affairs to assume even more responsibility and an even more active role in ensuring that patients receive the best possible care by providing relevant scientific or medical information and ensuring medicines are used according to their intended purpose. To do this effectively, Medical Affairs must engage with key stakeholders throughout the healthcare ecosystem, intimately understand their needs, and build strong and lasting relationships. Organizations that successfully leverage their Medical Affairs teams in stakeholder engagement are better positioned to ensure that clinical development meets disease or patient needs and improves patient outcomes.

However, for many organizations, communicating effectively with stakeholders and being responsive to all their needs remains challenging. Medical Affairs leaders and experts at CapSys recognized several frequent shortcomings in stakeholder engagement that limit the value derived from stakeholder interactions and prevent Medical Affairs from playing an active role in shaping their organization’s strategy.

Our study saw clear commonalities among those organizations who manage to address these challenges effectively. They all seem to attribute high value to four imperatives for effective and increasingly personalized stakeholder engagement. These include a broadened stakeholder scope, an adequate engagement infrastructure, and intensive cross-functional collaboration.

Figure 4: Imperatives for effective, personalized stakeholder engagement

This brings us to the fourth technical success factor the global study identified: being able to communicate scientific value in a consistently strong and convincing way. Pharmaceutical and life sciences organizations are constantly challenged by stakeholders to generate robust and demonstratable evidence for their products to enable market access, reimbursement or utilization. A key to success in demonstrating that generated evidence meets the needs of the key stakeholders is through strong scientific value communication. This requires organizations to clearly communicate the evidence, identify stakeholders’ unmet needs effectively, and demonstrate the true impact of the evidence on those needs.

Medical Affairs professionals are scientific experts in the disease area and treatments. They communicate directly with stakeholders such as regulators, prescribers, and patients. Medical Affairs is, therefore, well-placed to facilitate a two-way conversation between the organization and its stakeholders. Firstly, this ensures that relevant evidence can be communicated effectively to demonstrate the value to stakeholders and to improve clinical awareness. Secondly, effective stakeholder engagement by Medical Affairs can provide a valuable feedback loop to the organization, enabling evolving stakeholder needs and healthcare outcomes to be considered for further evidence generation and the potential value of the product within the treatment paradigm to be strengthened.

None of what has been described above is new. What is still relatively new and a challenge to many Medical Affairs professionals, however, is that both directions of this two-way communication witness increasing demand from stakeholders to be digitalized to a certain extent. Medical Affairs communication is on an irreversible path towards omnichannel, and no one is so far mastering effective omnichannel Medical Affairs communication to its full potential. Finding the right way for any individual organization will be a critical task involving both the risks of investing in unattractive offerings and the potential of differentiation as well as effectiveness and efficiency gains in delivering strong scientific value communication.

Regarding communication with stakeholders, Medical Affairs leaders and experts at CapSys recognized three frequent shortcomings that prevent the delivery of an impactful value narrative.

Considering these prevalent shortcomings and experiences provided by contributing industry experts, Capsys formulated five imperatives for strengthening scientific value communication. They are centered around understanding what value is for individual stakeholders, effective use of omnichannel communication approaches and the use of cooperations with strategic partners.

Figure 5: Imperatives for strong scientific value communication

This is part two 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. The first article of the series (part 1) gave an overview of the external trends influencing Medical Affairs and the main challenges arising from them. 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/.