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Introduction
The global pharmaceutical industry is undergoing significant transformation, from a previous focus on sales to become truly customer- and patient-centric. In parallel, both the availability of big data and the technologies needed to create meaning from these data are newly available to Medical Affairs teams. The result is the ability of the Medical Affairs function to help industry understand external healthcare challenges and opportunities via strategic insights capture and management – identifying areas of strategic importance for patient identification, diagnosis, treatment, management, and follow-up.
Through insights capture, analysis and communication, Medical Affairs professionals act as the adaptive mechanism within pharmaceutical and MedTech companies, bringing key data, facts and observations from the healthcare environment back to the organization to create or adjust strategic directions. This paper provides a foundational understanding of insights management, including the definition and value of insights, processes and technologies for insights management, and key challenges in implementation.
THE VALUE OF MEDICAL AFFAIRS INSIGHTS
Ultimately, the goal of the biopharmaceutical and MedTech industries is to support the evolution of clinical practice by introducing effective and tolerated therapies that address unmet needs, while ensuring these therapies reach the right patients at the right time. This requires behavior change from stakeholders in the healthcare ecosystem: An existing therapy is replaced with or augmented by a therapy with an improved risk/benefit profile or offers other benefits such as superior value, convenience, etc., often requiring new systems of diagnosis, treatment, and monitoring.
Medical Affairs insights can help identify the current state and pinpoint areas of knowledge, opinion or behavior change necessary for the successful launch and use of an emerging drug, diagnostic or device, accelerating the delivery of the right therapy to the right patient. For example, in the pre-launch period, insights may underlie strategic planning for evidence generation or external education, or may identify patient-centric endpoints to guide the design of registrational clinical trials. Post-launch, insights may signal change in knowledge, opinion, behavior, or action longitudinally in the disease community and healthcare ecosystem, confirming successful strategies or identifying gaps that indicate new or different strategies may be needed. Insights that identify unmet medical needs may point the direction for future life-cycle management opportunities.
As such, the value of Medical Affairs insights is not limited to Medical Affairs and rather can inform the execution of strategies by other industry pillars such as Research & Development and Commercial. Until an organization tests its strategies with members of the disease community, strategies are only hypotheses, requiring the validation of insights to know if the organization’s innovation is relevant. Without Medical Affairs insights, the potential exists to not only miss targets, but to be unaware of having missed them.
Operational excellence in the insight management process – including collection, validation, analysis and internal communication of insights – demonstrates the need for Medical Affairs collaboration as a driver of company strategy. This is especially true because Medical Affairs is usually uniquely equipped within the organization with the scientific and clinical expertise required to contextualize the value of insights. Just as Epigenetics allows cells to adapt to their surroundings, Medical Affairs insights allow biopharmaceutical and MedTech companies to reach a higher level of understanding and thus adapt to their surroundings. Organizations in which Medical Affairs drives the collection, analysis, and communication of actionable insights will efficiently recognize threats and opportunities in the external healthcare ecosystem, optimizing the ability to respond and adapt appropriately.
