The Evolution of Medical Affairs: Stakeholder Engagement

This presentation, led by Robert Groebel, Vice President for Global Medical Strategy at Veeva Systems, focuses on the critical evolution of stakeholder engagement within the Medical Affairs function. The central thesis is that understanding the external landscape and the shifting influence of various groups is essential for creating a competitive advantage. Groebel emphasizes that Medical Affairs must move beyond traditional identification methods to accurately align its engagement strategies with the specific needs dictated by a product's life cycle and the current market dynamics.

The discussion highlights a dramatic historical shift in influence within the pharmaceutical ecosystem. In the 1990s, the stakeholder landscape was relatively simple, centered on a triangle of influence: Healthcare Professionals (HCPs), Key Opinion Leaders (KOLs), and Regulators. Resources were primarily deployed to these three groups to ensure they were informed about drug development and that their viewpoints were understood. However, by the year 2000, the landscape expanded significantly with the advent of policy makers, payers, and patients. This shift was driven by the proliferation of direct-to-consumer advertising, the rise of the internet informing patients, and the growing influence of payer organizations demanding data on cost of care and health economics.

Looking at the current and future landscape, the presentation stresses that these "new" stakeholders—payers, patient advocacy groups, and government bodies—have become even more influential and must be central to Medical Affairs strategy. As the primary delivery mechanism for scientific data and information, Medical Affairs teams must be prepared to address this highly evolved and diverse group of influencers. The core challenge is accurately identifying and building out this expanded stakeholder pool in a way that ensures a thorough understanding of the data and the disease state requirements.

To meet this challenge, the methodology for stakeholder identification must fundamentally change. Historically, organizations relied on traditional methods such as clinical data, publications, academic affiliation, and internal word-of-mouth, which produced a homogeneous group of stakeholders relevant primarily to the 1990s model. Today, Medical Affairs must couple these traditional sources with advanced data streams. Groebel specifically calls for incorporating insights derived from social media, network connection analysis, and claims and referral data. This comprehensive approach is critical for building a complete understanding of all voices within the healthcare landscape, ensuring that Medical Affairs can address varying needs at different stages of the product life cycle.

Key Takeaways: • Stakeholder Alignment is Life Cycle Dependent: Medical Affairs must align its engagement strategies with the specific stage of drug development. The types of advice needed and the corresponding stakeholders required for engagement change drastically as a product moves through its life cycle.

• The 1990s Influence Model is Obsolete: The traditional focus on HCPs, KOLs, and Regulators as the primary influencers is no longer sufficient. This model resulted in a homogeneous stakeholder group that fails to capture the complexity of modern healthcare decision-making.

• The Rise of the Payer and Patient: Since 2000, payers and patients have become critical influencers. Payers require data addressing cost of care and health economics, while informed patients, driven by consumer advertising and the internet, actively seek specific therapies.

• Government and Policy Influence is Growing: Government bodies are increasingly demanding greater oversight and accountability regarding how pharmaceutical organizations bring drugs to market, necessitating proactive engagement from Medical Affairs.

• Medical Affairs Must Evolve as Data Deliverers: Medical Affairs teams must be prepared to address a highly evolved group of stakeholders by acting as the primary, authoritative delivery mechanism for scientific and clinical data.

• Shift from Traditional to Data-Driven Identification: Relying solely on publications, academic affiliations, and internal knowledge is insufficient. Modern stakeholder identification requires supplementing these sources with quantifiable, external data.

• Leverage Advanced Data Sources for Competitive Advantage: To accurately build out the necessary stakeholder pool, organizations must integrate data from social media analysis, network connection mapping, and claims and referral data, moving beyond simple academic metrics.

• The Need for Comprehensive Landscape Understanding: Utilizing advanced data integration allows Medical Affairs to gain a holistic understanding of all influential voices within the healthcare ecosystem, enabling targeted and timely engagement throughout the product life cycle.

• Optimizing Resource Deployment: By accurately identifying the most influential stakeholders at any given time, Medical Affairs can strategically deploy resources to maximize impact and ensure that compounds and development plans are understood by those who matter most.

Key Concepts:

• Stakeholder Evolution: The shift in influential groups from a narrow focus (HCPs, KOLs, Regulators) to a broad ecosystem including policy makers, payers, and patients.
• Life Cycle Alignment: The strategic necessity of tailoring stakeholder engagement based on the current stage of the drug's development (e.g., early development requires different advice than post-launch commercialization).
• Advanced Identification Methods: The integration of non-traditional data sources (social media, network data, claims/referral data) with traditional sources (publications, clinical data) to create a comprehensive stakeholder map.