It’s Never Too Soon: How and When to Engage Medical Affairs

Are you involving Medical Affairs as early as you should?

The role of Medical Affairs has evolved more rapidly and dynamically over the past five years than almost any other role in biopharma. Instead of focusing on information support, regulatory reporting, and compliance, today’s Medical Affairs team is considered the third pillar of the strategy team, working along with R&D and Commercial to drive the business forward and improve patient outcomes. Engagement with Medical Affairs is critical at every juncture in the drug development process, with Medical Affairs acting as a key liaison between internal stakeholders, a new generation of physicians, and patient advocates.

The strategic role of Medical Affairs

In many companies, Medical Affairs comprises multidisciplinary teams of experts that proactively generate data, analyze information, and create relationships that deliver:

• A better understanding of unmet needs and the patient journey
• Stronger clinical trial designs with meaningful endpoints
• Identification of differences that help achieve competitive advantage and improved return on investment
• Insight-driven advocacy efforts to inform real-world evidence (RWE) generation
• Access and reimbursement strategies that matter to Medical Affairs and other medical professionals and payers
• Thought leader management
• The ability for physicians and patients to make informed decisions about a product

With all that Medical Affairs has to offer, why don’t more organizations take full advantage of their expertise earlier in the process? In short, it’s due to a lack of time, resources, and a provable value proposition. Many Medical Affairs teams find it challenging to provide measurable KPIs, as their successes cannot be managed and evaluated through a profit-and-loss model. Thus, it is challenging to prove value. However, this mindset is changing as it becomes more obvious that instead of concrete bottom-line measurements, Medical Affairs delivers value through insights and data generation, which is then communicated to the broader team to inform decisions throughout the drug development process.

Changing perceptions: insights and trends

KPIs: The consensus is that there’s no consensus on the best way to measure the value Medical Affairs delivers. Recent research focused on Medical Affairs professionals revealed that KPIs were polarizing. Some felt that organizations that recognized and embraced “soft” metrics like insights were more likely to succeed; others discussed the benefits of comprehensive dashboards with built-in KPIs more clearly articulated the value that Medical Affairs delivered.

Innovation and impact: From the judicious use of generative AI to increasing the impact of medical activities through thoughtful prioritization, Medical Affairs is becoming a key linchpin for strategies that improve patient outcomes while optimizing business objectives. Many Medical Affairs teams are re-orienting their focus to build purposeful models that address unmet needs, such as health equity. Data and analytics will also become an integrated and integral part of Medical Affairs, with many leading organizations building models designed to:

• Prioritize and refine existing analytics capabilities to account for existing needs, in addition to building a business case for additional investment in advanced analytics that provide more robust data sets to inform decisions.
• Integrate analytics into everyday decisions to better test hypotheses, inform processes and priorities, and monitor the impact of engagement efforts.
• Automate repetitive, mundane tasks, including the use of AI to scan and summarize sources and optimize reviews.

Collaboration strategies: While multidisciplinary integration is key on a functional level, it is also necessary for Medical Affairs to become more entrenched in guiding overall brand strategy. Developing and sharing medical insights across disciplines can result in stronger, more targeted, and cohesive strategies and tactics. It is imperative that these insights be updated regularly, requiring investment in the tools and technology that will allow Medical Affairs to deliver the information necessary for the brand and marketing teams to evolve their strategies to match the market and help them more readily achieve the organization’s vision.

Closing evidence gaps: Medical Affairs is uniquely positioned to identify and address evidence gaps due to its in-depth knowledge of the healthcare landscape. Some initiatives that can help drive innovation and change at the cross-functional team level are

1. Integrated evidence generation planning. Breaking down the silos between functional needs and wider organizational objectives will be key to optimizing drug lifecycle management. An integrated evidence-generation approach brings together appropriate resources who can collaborate to determine the correct datasets to inform evidence generation and dissemination. These insights will inform planning that takes patient, HCP, payer, regulatory, and other stakeholder needs into consideration and selects the best tools to bring that evidence forward.
2. Operationalizing rapid data generation. Data is changing rapidly, and Medical Affairs will need to keep up with the pace. It is estimated that by 2030, AI will be able to design clinical trials based on input from internal and external databases. Moreover, there will be new methodologies to generate evidence based on multiple sources ranging from claims data to registry and omics information. Establishing and refining an evidence-generation engine will require cross-disciplinary partnerships and alignments.
3. Custom evidence engagement. Evidence will be tailored to specific audience preferences, enabling real-time data interactions, more visual interfaces, and more personalized experiences that allow HCPs to realize the implications of their practices in relevant, actionable ways.

A vision for the future

The role of Medical Affairs has evolved dramatically from providing background scientific support to serving as a strategic brand driver. The rise of highly specialized and targeted treatments requires not only an understanding of the science but also in-depth knowledge of how markets are responding, what inroads have been made, what potential gaps are available to fill, and which audiences are the appropriate focus for engagement. The decision model has changed from KOL/HCP to a shared model that includes payers and patients, and technology has made it possible to generate RWE faster and more accurately than ever before. The focus on patient centricity has also impacted the role of Medical Affairs, who have moved beyond scientific exchanges to regularly incorporate patient perspectives and outcomes into their workflow. As a result, successful Medical Affairs initiatives will blend medical and business acumen that translates unmet needs into strategic solutions across the drug development lifecycle. This transition will require investment in personnel and technology. However, the result will be transformational, allowing fully integrated, multidisciplinary teams to collaborate more closely and more quickly to improve patient lives.