Integrated Evidence Generation Planning: Optimizing Strategy Through Medical Insights

The Evolving Role and Dynamic Capabilities of the Medical Science Liaison (MSL)

The role of the MSL has evolved significantly within the modern pharmaceutical and MedTech industries. Once seen as a predominantly reactive support function, Medical Affairs is now widely recognized as a strategic business partner that translates scientific insights into actionable go-to-market strategies.1 As field-based clinical experts, MSLs are uniquely positioned to develop peer-to-peer relationships with healthcare professionals (HCPs) and key opinion leaders (KOLs). These engagements support high-quality, bidirectional scientific exchange2 – ranging from disease-state- and product-specific education to the systematic collection and interpretation of medical insights and voice-of-customer (VOC) feedback. In this capacity, MSLs serve as a critical conduit between industry and the medical community, ensuring that scientific information is communicated accurately and that therapeutic and diagnostic advancements are shaped by real-world medical needs.3

The modern MSL role has matured and now encompasses a wide range of responsibilities. These include handling complex medical inquiries; creating and sharing omnichannel educational content; leading the development of medical narratives and scientific publications; conducting literature reviews; guiding congress strategies and analyzing competitive intelligence; and identifying, profiling, and engaging scientific experts within the healthcare ecosystem. Increasingly, MSLs are also involved in digital transformation efforts, such as integrating artificial intelligence, implementing data-driven engagement strategies, and supporting cross-functional strategic education.4 Overall, these skills establish the MSL as a vital stakeholder in the evidence-to-impact process throughout product lifecycles.

Cross-Functional Integrated Evidence Generation Planning (IEGP)

A burgeoning value-add contribution from Medical Affairs is shaping evidence generation strategies that support clinical differentiation, product innovation, and effective lifecycle management. This development reflects escalating demands in the biotechnology and pharmaceutical sectors for robust, data-driven evidence to inform regulatory decisions, payer evaluations, and clinical practice. Central to this mission is the IEGP – a unified, cross-functional roadmap that aligns the evidence needs of diverse internal and external stakeholders, including clinicians, patients, regulators, policymakers, and health technology assessment (HTA) bodies.5

Contemporary evidence generation has advanced far beyond traditional interventional clinical trials. Modern strategies now include real-world evidence (RWE), data gap analyses for specific populations (such as pediatrics, geriatrics, rare diseases, and historically marginalized or disenfranchised groups), post-marketing safety and effectiveness evaluations, label expansion considerations, and comparative effectiveness research (CER). These approaches focus on real-world relevance, improved decision-making, patient-reported outcomes, cost efficiency, and sophisticated analytical techniques. An IEGP functions as a comprehensive guide that covers peri- and post-approval evidence optimization, highlights evidence gaps, prioritizes claims-matrix outputs, and presents a clear, multimodal approach to meeting unmet medical needs.6,7

A fully developed IEGP involves coordinated efforts across Phase IIIb/IV studies, investigator-initiated or investigator-sponsored research collaborations, real-world data (RWD) collection frameworks, registry capabilities, and health economic outcomes research (HEOR). As a living document, updated every 6-18 months to remain aligned with changing disease landscapes, an IEGP scores proposed research initiatives using evidence-impact rubrics, evaluations of design feasibility and timelines, risk mitigation strategies, and return on investment (ROI).8

When implemented effectively as a cohesive, cross-functional strategy, the IEGP translates broad evidence-generation principles into tailored, actionable workstreams designed to meet specific clinical, patient, regulatory, and payor needs. Interconnected research frameworks show the potential to reduce duplications of research efforts, guide temporal and financial prioritization, enhance regulatory readiness, accelerate payer coverage and reimbursement, and promote clinical adoption. Additionally, operational efficiencies built into the IEGP framework enable systematic monitoring of study performance milestones, scrutiny of research expenses, evaluation of evidence investments, and ongoing assessment of the ROI.

Strategic Shaping of the IEGP through MSL Field Insight Initiatives

As an enterprise-wide strategic tool, the IEGP is designed to align holistic research priorities at the portfolio level, break down functional silos, and optimize the allocation of scientific and financial resources. Its effectiveness, however, depends on meaningful, real-world, pressure-tested clinical insights that reflect the needs and perspectives of patients, HCPs, KOLs, regulators, and payors. Herein lies the unique opportunity for MSLs – as field-based scientific partners – to both directly and indirectly influence IEGP development and evolution. Operating at the intersection of industry and clinical practice, MSLs gather high-value insights through trusted, peer-to-peer scientific exchanges; these interactions enable MSLs to unearth subtle and nuanced clinician sentiments, emerging diagnostic and therapeutic trends, sources of clinical inertia, aspects of the patient journey, feedback on product performance, and the perceived value of new evidence.

MSLs glean insights from a wide range of platforms. Traditional one-on-one KOL engagements remain foundational, while group-based scientific forums – such as advisory boards, focus groups, clinical roundtables, user group meetings, and expert consensus panels – allow for broader perception collection. Scientific congresses also serve as high-yield environments for analyzing presentations and posters, spotting emerging literature, monitoring clinical trial results, tracking guideline updates, and gathering competitive intelligence. More novel mediums – including digital opinion leader (DOL) interactions, online platform analytics, and omnichannel engagement tools – offer additional ways to gather real-time voice of the customer data. Internally, Medical Affairs works with Pharmacovigilance, Medical Information, Market Access, and other cross-functional segments to combine insights and maintain a finger on the pulse of the ever-evolving clinical community.9

Recent experiences in launching novel diagnostic radiopharmaceuticals have reaffirmed the criticality of field medical insights. Both the oncology and cardiovascular imaging sectors have observed the introduction of innovative tracers that have reshaped the diagnostic landscape for metastatic breast cancer and coronary artery disease, respectively. New Fluorine-18 (F-18) radiotracers have transformed positron emission tomography (PET) by enabling highly specific molecular imaging, shifting diagnostic approaches from general metabolic activity to precise, targeted biological characterization. Despite robust phase I-III clinical data and successful regulatory approvals, clinical adoption of such agents can be slow due to ingrained habits and clinical inertia, systemic or organizational friction, guideline fatigue, and reimbursement and insurance hurdles. Peri-launch field insights garnered by MSLs have been pivotal for identifying evidence gaps that serve as hurdles to clinical adoption as HCPs, payors, and other stakeholders require data beyond traditional phase-III safety and efficacy information. Insights support the notion of implementation science as a systematic study of methods for driving appropriate uptake and integration of evidence-based practices into real-world and clinical settings, bridging the “know-do gap.”10

These diverse inputs require a structured, compliant, and technological framework for collecting, synthesizing, and translating insights into strategic intelligence that guides go-to-market strategies and IEGPs. Insight frameworks help identify high-impact learnings from everyday observations, leading to real-time insights that influence medical strategy, affect market access, and support evidence generation. An effective framework must also be compliant, adaptable to the size and scope of a field MSL team, technologically capable, and focused on prioritizing actionable insights that can shape market entry, product launches, and/or lifecycle management strategies. Equally important are regularly scheduled feedback loops—often quarterly or biannually—that ensure insights are shared across functions, incorporated into IEGP updates, and evaluated for clear business strategic impact.

Through this structured, data-driven approach, MSLs become key contributors to evidence planning and go-to-market strategies. Their insights guide the prioritization of research questions, identify unmet clinical needs, refine protocol designs, and shape HEOR/RWE strategies tailored to reimbursement and access factors.9 Feedback from MSLs can spark investigator-initiated research concepts, validate or modify clinical value propositions, anticipate external stakeholder concerns, and highlight evidence gaps that might hinder adoption or patient access. In doing so, MSLs serve not only as scientific communicators but also as vital architects of an adaptive IEGP—ensuring that evidence plans stay clinically relevant, aligned with business priorities, and adaptable to the changing healthcare environment.

Disclosure – Limited artificial intelligence tools were used in the development of this article for searching source material and in language refinement.

References:

1. Farrington AD, et al. The value and deliverables of medical affairs: Affiliate perspectives and future expectations. Pharmaceut Med. 2023.
2. Dyer SJ, et al. Measuring the impact of medical science liaisons: A global cross-sectional survey. Cureus. 2026.
3. Medical Science Liaison Society. MSL guidelines. 2025. [themsls.org]
4. Fröling E et al. Artificial intelligence in medical affairs: A new paradigm with novel opportunities. Pharmaceut Med. 2024.
5. Prescient Healthcare Group. Developing a best-in-class integrated evidence plan. 2024.
6. Capkun G, Olson MS. Integrated evidence planning for enhancing patient care: Harnessing the power of real-world evidence. Clin Pharmacol Ther. 2025.
7. Lee WC et al. The evolution and future of integrated evidence planning. Expert Rev Pharmacoecon Outcomes Res. 2025.
8. Lumanity. Integrated evidence generation planning: From strategy to execution. 2026.
9. ACMA. Harnessing the power of real-world evidence in medical affairs. 2025.
10. Rubin R. It takes an average of 17 years for evidence to change practice – The burgeoning field of implementation science seeks to speed things up. JAMA. 2023.

About the authors:

Dustin M. Dunham, DMSc, DC, MBA, FRSM, FRSPH, FACHDM

Dustin is a board-certified clinician and scientist, an executive MBA, and a Medical Affairs strategist with 20+ years of combined pharmaceutical, medical device, and clinical experience. Dustin serves as Head of Global Medical Science for GE HealthCare’s Pharmaceutical Diagnostics organization, serving as the strategic bridge between mid- and late-stage development and commercialization, ensuring that scientific evidence drives business strategy and patient outcomes. Dustin is a Board-Certified Medical Science Liaison, Board-Certified Medical Affairs Specialist, Board-Certified Biologics & Biosimilars Specialist, Board-Certified Patient Advocate, Fellow of the Royal Society of Medicine, Fellow of the Royal Society for Public Health, and Fellow of the American College of Health Data Management.

Nicholas A. DiGregorio, DO, MBA

Nicholas holds a Doctorate in Osteopathic Medicine from Philadelphia College of Osteopathic Medicine (PCOM) and a Master of Business Administration from La Salle University. He serves as Medical Director, Care Area Lead – Oncology for GE HealthCare’s Pharmaceutical Diagnostics organization, providing strategic guidance and leadership to the broader oncology molecular imaging portfolio. Nicholas is a Board-Certified Medical Affairs Specialist and serves on the Alumni Association Board of Directors at La Salle University and as a voting member of the Admissions Committee at PCOM.