Best Practices In Aligning the Medical Affairs Function to Meet Its Role in a Changing Healthcare Environment

Best Practices, LLC undertook this research to identify shifts in Medical Affairs structure, staffing and investment in Mature and Emerging Markets. Leaders in Medical Affairs can use this study to explore critical strategies and tactics in communicating the value of their function and mitigating the negative effects of changing regulatory landscape.

Study Snapshot

This study engaged executives from 30 leading health care companies. Segmentation analysis was key to examining trends and effective practices. 22 participants make up the Mature Markets Segment, while the Emerging Markets Segment consists of 6 participants from Brazil, India and other Asia markets. The Medical Device Segment consists of 9 participants.

Key Findings

Current Structure of Medical Affairs Unit:  While 45% of the Mature Markets participants favor a centralized approach for their Medical Affairs organization, only 17% of the Emerging Markets participants have a centralized Medical Affairs structure. In addition, within the Mature Markets segment we observed a 37% increase in the Hybrid structure from 29% in 2009¹ to 40% in 2013. Companies in Emerging Markets generally favor a decentralized structure by region, most likely because these groups are affiliates of global Medical Affairs groups. Trends towards Hybrid and decentralized structures reflect the varying regulatory hurdles encountered within different regions or therapeutic areas.

• Reporting Relationship Different in Mature Markets and Emerging Markets: 45% of the Mature Market benchmark class reports to R&D/Clinical. In the Emerging Markets segment, the reporting relationship is distributed among Commercial/Marketing, Hybrid (Commercial and R&D), and Executive Committees. Mature Markets Medical Affairs groups are more aligned with R&D, reflecting a common drive to differentiate themselves from the commercial side of the organization. On the other hand, two-thirds of the Emerging Markets group still reports to Commercial/Marketing or via a Hybrid structure. 

• Research Overview pp. 4
• Participating Companies pp. 5-6
• Descriptions pp. 7-8
• Key Recommendations pp. 9-10
• Key Findings & Insights pp. 11-26
• Participant Demographic Data pp. 27-33
• Medical Affairs pp. 34-61
• Scope & Structure pp. 34-37
• Leadership & Oversight pp. 38-40
• Spend Allocation & Staffing pp. 41-48
• Budget Trends & Outsourcing pp. 49-51
• Performance Metrics pp. 52-61
• Medical Liaisons pp. 62-86
• Leadership and Value pp. 62-71
• Resources and Budget pp. 72-76
• Size Of Medical Science Liaison Teams pp. 77-82
• Effective Operations Of Medical Science Liaison Teams pp. 83-86
• Thought Leader Management pp. 87-120
• Scope, Leadership & Oversight pp. 87-92
• Managing Relationships pp. 93-97
• New Technologies pp. 98-103
• Interaction Frequency pp. 104-107
• Interaction Channel pp. 108-112
• TL Access Challenges pp. 113-116
• Challenges in Interactions pp. 117-120
• About Best Practices, LLC pp. 121-122

• Current structure of Medical Affairs
• Medical Affairs Reporting Relationship
• Medical Affairs Leadership
• Medical Affairs Spend Breakout
• Trends Of Important Budget Allocation Areas
• Medical Affairs FTE Breakout
• Reasons for Change in Spend & FTEs
• Resource Level Changes
• Outsourcing Expense
• Performance Metrics & Its Evaluation Frequency
• Value of MSLs
• Factors To Determine Team Size
• Internal Stakeholder Needs
• Deploying Medical Liaisons Into The Field
• Developing & maintaining Thought Leader Relationships
• New Technologies To Serve Thought Leaders
• Thought Leader Interaction Channels
• Thought Leader Access Challenges