The Evolution of Medical Affairs: A Changing Landscape

This podcast, presented by Robert Groebel, VP of Medical Strategy at Veeva Systems, initiates a series focused on the evolving role of Medical Affairs (MA) within the life sciences industry. The core purpose is to analyze the external and internal shifts impacting MA and to outline how organizations can leverage these changes to create a competitive advantage. Groebel establishes that the healthcare landscape is fundamentally changing, driven by shifts in quality care, patient outcomes, cost reduction, and enhanced patient experience. These external pressures are fueled by the emergence of new stakeholders, novel data sources, and an increased demand for deep, specific scientific information.

Internally, the pharmaceutical pipeline is undergoing a massive transformation, moving away from chronic diseases toward highly targeted indications, particularly rare diseases. The video highlights that nearly 500 compounds currently under review are specific to the rare disease space, a significant shift from 10-15 years ago. This pipeline evolution places immense strategic demands on Medical Affairs, whose traditional function—disseminating data, building scientific relationships, and providing education—must now adapt to address complex information requests linked to highly targeted indications, all while considering patient access issues.

The analysis underscores the growing strategic importance of MA, evidenced by substantial organizational growth and budget increases. MSL organizations, for example, saw a 300% increase in size by 2020. This growth contrasts sharply with the challenges faced by commercial teams, where nearly 50% of physicians place restrictions on commercial access. The video segments the drivers of change within MA into three key buckets: stakeholders, data, and scientific information. MA functions must now use quantifiable data to identify and engage different stakeholders in account-based models, becoming almost solely responsible for building long-term scientific relationships. Furthermore, MA must provide a single, consistent source of truth to the medical community, demonstrate performance impact through metrics, and ensure accurate reporting for compliance, especially in the context of Corporate Integrity Agreements. Ultimately, the goal is for MA to evolve from a required operational function to a truly differentiated strategic asset throughout the product lifecycle, linking people, process, strategy, technology, and metrics effectively.

Key Takeaways: • Fundamental Pipeline Shift: The pharmaceutical industry is experiencing a fundamental shift in pipelines, moving heavily toward rare diseases and highly targeted indications, necessitating complex and specific scientific data dissemination by Medical Affairs. • MA as a Strategic Differentiator: Medical Affairs must evolve from being a required operational function to a strategic, differentiated asset that drives value throughout the product lifecycle, especially given the increasing restrictions placed on commercial access. • Growth of MSL Organizations: The size of MSL organizations saw a 300% increase by 2020, reflecting the growing reliance on scientific engagement channels, particularly as approximately 50% of physicians restrict commercial access. • Data-Driven Stakeholder Identification: MA teams must utilize quantifiable data sources to accurately identify and engage diverse stakeholders, moving toward account-based models and key account management partnerships. • Single Source of Truth Requirement: A critical responsibility for evolving MA functions is providing the medical community with a consistent, single source of scientific truth, requiring robust data integration and management systems. • Compliance and Reporting Mandates: Due to external pressures like Corporate Integrity Agreements (CIAs), MA functions require systems that enable accurate reporting on every external touchpoint, detailing who was engaged, why, and what information was shared. • Managing Information Complexity: The shift to rare diseases necessitates managing vast libraries of complex scientific information and delivering it accurately and aligned to the specific channel requested by the stakeholder (e.g., email, MSL direct contact, medical information call centers). • Performance Measurement Necessity: As MA budgets and responsibilities increase, organizations must implement performance measures and metrics to demonstrate the function's impact and value contribution to the larger business. • Holistic MA Evolution: Successful MA evolution requires integrating five core elements: people, process, strategy, technology, and metrics, ensuring they link together to provide accurate and strategic value. • Evolving Stakeholder Landscape: External changes are driven by an evolution of stakeholders, the emergence of new data sources, and an increased demand for better scientific information, all of which MA must address.

Tools/Resources Mentioned:

• Veeva Systems (Contextual platform of the speaker)
• Medical Information Call Centers (Channel for information delivery)

Key Concepts:

• Medical Affairs (MA): The function responsible for disseminating scientific data, building scientific relationships, and educating healthcare professionals and stakeholders.
• Corporate Integrity Agreements (CIAs): Agreements often mandated by government agencies (like the OIG) that require strict reporting and compliance measures, emphasizing the need for accurate tracking of external engagements.
• MSL (Medical Science Liaison): Field-based professionals within MA responsible for building scientific relationships with key opinion leaders and disseminating complex scientific information.
• Account-Based Models: Strategies where MA engages with entire healthcare accounts or systems rather than just individual physicians, requiring partnerships around key account management.