Where do you see Medical Affairs fitting into the drug development pathway? Traditionally, teams were involved from Phase 2 onwards. But today, we’re seeing an increasing need for their expertise much earlier – even from the beginnings of drug discovery.
This shift isn’t just a tick-box exercise or a way to transfer workloads. By contributing to strategies in trial design, evidence generation, and long-term planning, and by acting as a critical liaison between the internal and external worlds, Medical Affairs can help organisations anticipate obstacles and shape therapies that are more likely to succeed at launch and beyond.
Read on to find out why early involvement matters, where Medical Affairs can add the most value, and how partnering with agencies like Word Monster can help maximise impact.
What’s driving the need for earlier Medical Affairs involvement?
Medical Affairs has long been established in later stages of development, but several external and internal pressures are accelerating the need for earlier integration.
Externally, regulators have raised the bar. They now expect robust real-world evidence (RWE) alongside clinical trial results, with both payors and clinicians demanding proof of comparative effectiveness, outcomes, and cost-benefit. At the same time, health equity has risen up the agenda, requiring therapies to be relevant to diverse populations. All of these are Medical Affairs’ specialties.
We’re also seeing greater integration of complex innovations, precision medicine and novel digital health tools in clinical trials and treatment plans, requiring Medical Affairs’ expertise and guidance.
Internal factors are just as compelling. Strategically, involving Medical Affairs earlier ensures that clinical, regulatory, and commercial teams work toward a common vision. Medical Affairs can provide invaluable knowledge transfer, keeping everyone up to speed on disease landscapes, evolving standards of care, and competitive threats.
Organisations are understanding that cross-functional collaboration is crucial for success, and Med Affairs acts as a hub of potential insights for other teams like R&D, HEOR and commercial strategy.
How Medical Affairs adds value across the product lifecycle
Medical Affairs sits at the intersection of science, healthcare, and business, bridging gaps between clinical research, patient needs, and market realities. Their abilities – and strategic value – should not be underestimated at any point.
Actually, there’s an evident need for Medical Affairs across the whole product lifecycle. In the early development phase, Medical Affairs can spark external expert interest and shape the target product profile (TPP). Pre-launch, they build awareness, ensure understanding of the therapy, and highlight evidence gaps that need addressing. During launch, they provide the scientific backbone for communications, prepare stakeholders, and support reimbursement efforts. Afterwards, their focus turns to continued education, real-world evidence generation, and lifecycle optimisation.
Let’s take a closer look.
Discovery and early development
Too often, this phase is seen as “too early” for Medical Affairs, with teams mainly providing a support role and limited input on strategy. In reality, it’s the optimal moment to set the foundation, and the more Medical Affairs teams can engage at this point, with their deep understanding of the product, patient and landscape, the more impact they have on the short- and long-term success of the product.
- Help shape the essential target product profile (TPP), which drives clinical research efforts
- Help develop strategies by mapping evolving standards of care, unmet needs, and competitive insights
- Validate endpoints, biomarkers, and patient-reported outcomes – required by regulators and payors
- Develop a publications plan – and then revisit it as appropriate pre-launch
- Start to build early relationships with investigators, KOLs, and patient advocates to inform trial design and recruitment
Pre-launch
Here, Medical Affairs can add valuable contributions to the medical launch strategy. They can collaborate with other teams to build upon strategies internally, all while transferring valuable knowledge and building relationships externally.
- Ensure a deep understanding of the treatment landscape
- Identify and address gaps in evidence and communications
- Build a strategic scientific platform grounded in clinical context
- Develop knowledge and relationships with key external stakeholders, coordinate advisory boards and gather external validation to refine the value story
- Deliver market-shaping communications, establish educational materials and create a lexicon that ensures consistent scientific communication
Peri-launch and launch
At this critical moment, Medical Affairs is still essential, though teams will start to focus more on execution.
- Deliver cohesive, evidence-based communications to HCPs, payors, and policymakers, focused on filling known knowledge gaps
- Support payor engagement and reimbursement planning
- Train field teams and ensure they’re fully equipped with data and consistent narratives
- Monitor feedback from early adopters and adjust communications in real-time
Post-launch
There is still plenty to be done, including some of the more ‘typical’ Medical Affairs responsibilities we’re familiar with.
- Monitor landscape and competition trends and address as appropriate
- Lead Phase IV and real-world evidence programmes
- Grow and maintain stakeholder relationships and sustain disease education
- Capture insights from HCPs and patients, and feed them back into lifecycle management strategies
We’ve seen what they can do – but why so early?
The case for early involvement rests on four clear benefits.
Firstly, Medical Affairs brings strategic alignment, ensuring the organisation is unified around unmet needs, patient priorities, and a well-defined target product profile. Their unique insights into standards of care, product attributes, and competitor activity make them invaluable in guiding both short- and long-term planning.
Secondly, for future-proofing. By anticipating shifts in reimbursement pathways, treatment guidelines, and the competitive landscape, Medical Affairs helps to shape trial designs and evidence plans that stand strong at the time of launch. They can also identify patient populations, expert perspectives, and potential barriers to care.
Thirdly, relationship building. By engaging investigators, advisors, and advocacy groups early, Medical Affairs lays the groundwork for long-term trust and collaboration. And, by managing these relationships from the very beginning, they can also gain invaluable insights, raise disease awareness and create educational materials from the get-go.
Last but not least – external validation. By gathering and sharing real-world perspectives that strengthen internal decision-making, Medical Affairs can ensure strategies are rooted in the needs of healthcare professionals, patients, and payors.
As we’ve seen, in today’s healthcare landscape, waiting until Phase 2 to bring Medical Affairs to the table is a missed opportunity. Early involvement – ideally years before launch – enables teams to shape strategy, anticipate barriers, and build relationships that underpin long-term success.
Barriers to early involvement
Despite the clear benefits, embedding Medical Affairs early can be challenging. Too often their value is under-recognised, with leadership prioritising the late-stage pipeline.
Lack of clear roles, responsibilities and processes in the early stages, as well as lack of alignment and limited resources can also lead to friction and difficulties, and demonstrating impact in early phases is difficult without clear KPIs.
Sounds like too much? How agencies can help
For organisations with limited infrastructure or those entering new therapeutic areas, external partners can make a critical difference. An agency adds executional muscle, but more importantly, it provides a structured, insight-driven strategy to help Medical Affairs teams demonstrate their value early and often.
This support is particularly valuable when disease awareness is low, when no reimbursement pathway yet exists, when research is limited or the mechanism of action is novel, or when patient communities are disengaged. It also helps where KOL networks are underdeveloped or internal Medical Affairs infrastructure is still maturing. By stepping in at these moments, agencies can help Medical Affairs demonstrate their value early and consistently.
Final thoughts
Organisations that invest in early Medical Affairs engagement gain stronger evidence plans, more credible communications, and smoother pathways to adoption. Those that delay risk misalignment, evidence gaps, and missed opportunities.
Where Medical Affairs was once seen as a scientific support function, today it is a strategic driver, positioned at the nexus of Regulatory, Clinical, Market Access, and Commercial functions. With early and ongoing involvement, Medical Affairs becomes the fulcrum of information, managing the flow of insights into and out of the company and using them to shape strategy and engagement.
At Word Monster, we help Medical Affairs teams unlock their full potential across the product lifecycle. From insight-driven strategy to clear, compelling communications, we support you in turning complexity into clarity and strategy into impact. Whether you’re entering a new therapeutic area, preparing for launch, or shaping your evidence plan, we’re here to help you succeed – starting at the very beginning.
Don’t wait to bring Medical Affairs – and your communications partner – into the room. Let’s talk about how we can support your next pitch, launch, or clinical milestone.
References
MAPS. Medical Affairs Launch Excellence: Best Practices for Medical Affairs. Available at: https://medicalaffairs.org/wp-content/uploads/2021/05/Launch-Excellence-Standards-Guidance.pdf
MAPS. Optimizing Early-Stage Product Development: Is It Ever “Too Early” for Medical Affairs Involvement in Strategic Planning?. Available at: https://cdn.ymaws.com/medicalaffairs.site-ym.com/resource/resmgr/elevate_articles/optimizing_early-stage_produ.pdf