Christoph Bug: As therapies become more complex, key opinion leaders (KOLs) and healthcare professionals (HCPs) demand more comprehensive scientific exchange with the industry. As Veeva Pulse data shows, investment in scientific activities increases treatment adoption by 40% and pre-launch field medical education improves it by 50%. This presents a significant opportunity for medical affairs teams to play a more strategic role within the organisation. 

Technology advancements enable easy data capture and fast analysis. But with tight budgets and a lack of capabilities, medical affairs hasn’t traditionally been able to leverage data-driven decision-making. With an evolving stakeholder landscape and the right technology investments, medical affairs can solidify its role as a strategic function and increase operational effectiveness. 

Pascal Vande Gucht: Treatments are becoming more specific to certain patient (sub)populations. Delivering the right treatment at the right time to the right patient in an affordable way is the ambition of medical affairs teams. A combination of innovative and agile evidence-generation approaches, tailored scientific communications, appealing medical education programmes, and valuable field medical teams to address unmet patient and HCP needs is crucial. This requires a focus of the medical affairs function to invest additionally in data, digital, and analytics capabilities.

Christoph: Historically, medical teams have lacked strategic priority, and technological capabilities needed for informed decision-making. Measuring impact can help medical affairs teams gather data to assess whether their efforts are delivering the impact they should have, and if anything should be done differently. The impact of scientific exchanges often takes longer to materialise, making it hard to compare with sales-based metrics. With incomplete data sets and no industry-standard approach, consistently measuring impact across organisations isn’t easy.

Overcoming these challenges begins with a gap analysis of what capabilities are needed to be data-driven and what is available. With standardised quantitative and qualitative metrics, a consensus on key outcomes, and advanced data analytics, medical affairs teams can link activities directly to patient outcomes and use this data for informed decision-making. 

Pascal: Progress in truly transforming medical affairs has been hindered historically by organisational misalignment and budgetary constraints; prioritising commercial first and foremost. In the last two or three years, we have detected the case for medical affairs to play a leading role within the industry with increased attention and investments. Currently, profile and capability gaps in addition to competing priorities are still at the forefront to catalyse this change. Medical leadership, which embraces collective leadership practices that raise organisational performance and impact is an ingredient for transformation success. These leaders bring the best of medical affairs expertise to the company to improve patient outcomes.

Christoph: A single, industry-specific solution that unifies medical, marketing, sales, and service teams can help to break down silos and enable vital information to be shared across the organisation. For example, the progress of a clinical trial is vital information when medical science liaisons (MSLs) are interacting with KOLs and medical insights captured in the field can help shape development strategy. Using the same software increases efficiency and ensures each stakeholder interaction builds off the last. Cumbersome data uploads and downloads, and the need to internally align through multiple channels are inefficient, often frustrating processes that can go away.

Pascal: Medical affairs has a privileged position to connect R&D with commercialisation around the asset and contribute to the success of market access, marketing, and sales. By its deep understanding of the science and its close proximity to healthcare stakeholders such as patients, scientific experts, HCPs, and payers, medical affairs can drive scientific and clinically relevant engagements while bringing back stakeholder perceptions and insights to the organisation. It all starts with organisational alignment on how to improve patient outcomes and which role medical affairs will play at enterprise level to achieve this.

Christoph: To demonstrate the impact of medical teams across the industry, leaders are placing greater importance on standardising metrics that reflect their overarching goal: changing clinical practices to advance patient outcomes. We recently partnered with industry leaders to create a practical, modular approach to measuring medical impact. This modular approach provides flexibility and allows organisations to start where it makes the most sense and continue to move to more advanced modules.

Pascal: As the impact and value of medical affairs is difficult to measure short term or within one year, a combination of impact and activity/performance indicators can be a way to demonstrate how your activities will increase the probability of success and impact. It’s important to have functional alignment on how your aspiration is connected with the medical activities across the asset/patient population and a robust medical affairs data and analytics capability.

Christoph: In principle, all functions have the same objective: to help develop new medicines and get them to the patients who need them. For medical affairs, this means engaging in evidence-based scientific exchange with KOLs, gleaning high-quality medical insights, and supporting HCP education while maintaining a patient-centric focus. Ensuring that insights gathered from KOL interactions are communicated and used to inform strategies helps medical teams maintain trust while aligning with commercial objectives.

Pascal: Medical affairs plays a critical role in defining successful launch strategies. Delivering ambitious strategies and focusing on the following capabilities are hence ingredients for success:

1. Increasing scientific alignment on the new, innovative solution with scientific experts and clinical practice leaders
2. Collecting and sharing medical insights to elevate cross-functional strategy
3. Anticipating and planning integrated evidence-generation activities to meet stakeholders’ needs
4. Agile reviewing and approving of external engagement materials

Christoph: There is no simple answer to the ideal structure of a medical affairs team: it very much depends on its connection to the rest of the organisation and the market in which it operates. The key, however, is to structure medical affairs teams to ensure they operate with high efficiency and in collaboration with other functions like clinical and commercial. Information flow should be fast, effective, and customer-centric. A unified operational system to share information is a critical component of this. A structure for people, processes, and metrics should be set up to foster effective collaboration and alignment in objectives.

Pascal: Organisational alignment on what is expected from medical affairs is the first foundational step. From there, medical affairs leaders can drive strategies to focus resources on areas with greater impact or differentiated value with supporting data-driven decisions while deprioritising or automating other activities. Monitoring progress toward your ambition and adapting to external changes are essential elements.

Christoph: Many medical teams are considering the Medical Impact Model to demonstrate and communicate their success across the organisation. The model serves as a foundation for operational effectiveness, and those getting started are taking ownership of the process, people, and data to tell their impact story. While many medical affairs teams are already measuring impact to some extent, improving data input, analytics, and reporting with proactive benchmarking, are crucial in ensuring leadership understands the team’s value.

Pascal: Start with making clear choices and setting priorities. Articulating a compelling vision and narrative on how medical affairs will improve patient outcomes at scale. What is needed for the transformation (resources, skills, budget, etc.), and what impact this will have on improved outcomes and reductions in suboptimal care. Experimenting with innovative initiatives within medical affairs is a no-brainer for this. Frequent updates to key internal stakeholders to share progress, successes, and failures are required to secure sponsorship and buy-in. Driving internal education campaigns such as ‘medical affairs for non-medics’ are also helpful.

Christoph: As therapies become more complex, KOLs and HCPs require more scientific exchange with the industry. At the same time, scientific data has a big impact on launch success. Both trends are significant opportunities for medical affairs to take on a more strategic role within their organisations. As the cornerstone of R&D and commercial functions, translating the evidence for clinical practice, owning the scientific narrative, and engaging in scientific exchange with key stakeholders can drive trusted relationships and clinical practice change. This important role of advising, educating, and shaping the dialogue on new therapies has a direct effect on improving patient outcomes.

Pascal: I couldn’t agree more with Christoph. Acting on the vision of becoming the third strategic pillar within a pharma company can become a reality. Embracing the vision to identify and address the unmet needs from patients, healthcare professionals, policymakers, and payers with ambitious and innovative medical strategies will increase the importance of the department.