As innovation transforms the healthcare landscape, science and data are becoming the foundation for pharma to meet its obligations to patients and customers—and realize commercial opportunities. This imperative is accelerating the evolution of medical affairs as the third strategic pillar of the organization alongside R&D and commercial.
Innovation in both digital technology and the bio sciences is advancing at a furious pace, while the quantity of data generated is skyrocketing. Business models are starting to evolve both around and beyond the “product” to encompass the wider therapeutic context, while organizations seek to explain and contextualize the ever-more-complex medical science to a diverse range of stakeholders (physicians, patients, payers). Advanced analytics of patient data have become central to supporting decision making on product use and to demonstrating patient value.
The winners will be those who succeed in positioning their science—especially their ability to combine, analyze, and interpret disparate data sets—to inform their interactions with stakeholders and ultimately improve patient outcomes. This will involve real-world evidence (RWE), electronic medical records (EMR), and novel sources of data, such as genomics in combination with innovative ways of mining and interpreting that data.
With this in mind, McKinsey has been working closely with industry executives to create a bold vision for the medical-affairs function in 2025: one that embraces these profound changes and consequently seeks to drive positive impact for patients, caregivers, and healthcare professionals by enhancing medical affairs’ strategic focus and optimizing the impact of its activities. This offers medical affairs the opportunity to forge a new role as a primary strategic pillar of the organization alongside research and development, as well as commercial and market-access functions.
A bolder vision for medical affairs
Today we see an even clearer case for medical affairs taking on a more strategic leadership role in the face of current technology, economic, and regulatory trends. Significant aspects of medical affairs activity need to be updated: for instance, to rethink medical performance management to maximize the impact of medical activities. There is an overwhelming need to embrace the power of data and analytics, as well as digital-engagement techniques. A far larger and more ambitious vision for medical affairs is defined by the following:
1. Innovate evidence generation: Leading rapid-cycle integrated and comprehensive evidence generation
How we gather, integrate, and interpret data will define the future. Rapid-cycle, integrated evidence generation across health economics and outcomes research (HEOR), RWE, Phase IIIb/IV studies, and so on will be supported by microanalysis that tailors the vast amount of available information to the needs of individual patients. Medical-affairs teams, through their deep understanding of science, data capabilities, and their dialogue with stakeholders, will be well positioned to understand how to seek the evidence required to support the entire life cycle of the offering to optimize patient outcomes.
2. Accelerating access to treatments: Articulating clinical and economic value to make our products an option for patients who need them
We expect to see a clear articulation of clinical and economic value to providers, corporatized providers, and patients. This will be supported by robust, customer-centric data models and medically led outcomes-based contracting that provide the required data to ensure the right patient gets the right drug at the right time.
3. Transform and personalize medical engagement: Upgrading physician and patient decision making around our product
The future will see a broad expansion of medical engagement across providers, patients, and others—across a range of touchpoints that will be increasingly digital—designed to provide tailored information, support tools, and innovative approaches to education focused on improving outcomes.
4. Step up internal medical leadership: Delivering strategic medical direction to the organization
A radical transformation of medical leadership will see medical affairs leading from the C-suite, transforming public opinion of the industry, putting the patient front and center, and rethinking how company performance is measured to prioritize improved patient outcomes. We see this transformation happening across three dimensions: a) elevation of medical strategic planning across all critical processes within and outside of medical affairs, b) an imperative to acquire and nurture strategic medical talent, and c) a focus on performance management and resource allocation to elevate performance.
Organizations seeking to develop a best-in-class medical-affairs function should note the following:
Embrace the power of technology to transform medical—especially digital, including artificial intelligence and other new tools, advanced analytics, and new data sets—by defining a prioritized set of use cases, building a technology capability stack, and developing a strategic plan for one, three, and five years ahead.
Measure how the organization performs in terms of maximizing patient outcomes both by understanding the real-world consequences of specific medical-affairs activities and then also having the performance-management capability to make better use of such insights to drive the excellence of the right activity.
Directly address patient medical needs, for example, through a seamless combination of engagement on social platforms and new tools that support patients on their medical journey.
Modernize ways of working to embrace new value-creation opportunities and build strategic leadership know-how with enhanced skills and capabilities to cement strong partnerships with R&D and commercial.
Seek out cross-industry collaboration to advance the function and build talent—examples include PhactMI, the Medical Affairs Leadership Academy (MALA), and the Medical Affairs Professional Society (MAPS).
Download the full paper from which this article is adapted, A vision for medical affairs in 2025 (PDF-2.4MB).