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Building Best-in-Class Capabilities for Medical Affairs

ID: POP-228


52 Info Graphics

42 Data Graphics

625+ Metrics

35 Narratives

7 Best Practices

Pages: 116

Published: Pre-2019

Delivery Format: Shipped


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Charged with building and maintaining physician relationships, pharmaceutical Medical Affairs organizations typically oversee several important functions -- including publications, KOL programs, grants and medical education (CME) -- that have been impacted in recent years by a call for increased transparency. As such, forward-looking biopharmaceutical executives are beginning to evaluate Medical Affairs operations to ensure that the vital organization is appropriately structured and resourced to operate effectively in the current environment.

This Best Practices, LLC study explores how U.S. and global biopharmaceutical companies are structuring and managing their Medical Affairs organizations today. The study also examines recent trends in budget and staffing resources, key challenges and top success factors for the function.

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Medical Device; Manufacturing; Biotech; Consumer Products; Chemical; Biopharmaceutical; Financial Services; Technology

Companies Profiled:
Abbott; Akron Molecules; Alkem Laboratories; Astellas; AstraZeneca; Baxter; Baxter Healthcare; Bayer; Becton Dickinson; Biogen Idec; BMS; Bracco Diagnostics; Covidien; Cubist Pharmaceuticals; Eisai; Endo Health Solutions; Esteve; Ethicon; Ferring Pharmaceuticals; Forest; Genentech; Gilead; GlaxoSmithKline; Grunenthal; Guerbet; Ipsen; LifeCell; Janssen; MAP Pharmaceuticals; MedImmune; Medtronic; Methapharm; MSD Pharma; Mylan; Novartis; Novo Nordisk; Onyx; Pfizer; Philips Healthcare; Ranbaxy; Roche; Sanofi Pasteur; Shire; Shire HGT; Teva; UCB; Upsher-Smith Labs; Valeant; ViroPharma; Xanodyne

Study Snapshot

The report is based on the insights of 68 Medical Affairs executives and managers at 50 leading global companies. The benchmark class in this study consists of a Mature Markets and Emerging Markets Segment. The Mature Market Segment includes 41 participants from pharma and 12 device respondents.  The Emerging Markets Segment consists of 15 participants working in India, China, Brazil, and Turkey.

Key research objects include:

  • Illustrate how leading Pharmaceutical and Medical Device companies structure and organize their Medical Affairs functions based on industry and market changes.
  • Identify trends expected to impact the allocation of resources across different Medical Affairs functions.
  • Analyze how regulatory requirements are internalized and managed by Medical Affairs.
  • Describe the success factors and top current challenges regarding Medical Affairs.
  • Identify what percentage of MA budget leading companies allocate for outsourcing spending.
  • Trace how successful Medical Affairs organizations work cross-functionally to enhance effectiveness.

Sample Key Findings

Centralization of Medical Affairs Unit: Nearly half of study participants favor a centralized approach for their Medical Affairs organization, both in 2009 and 2012. That approach is heavily utilized by the pharma segment whereas the device segment is much more likely to use a hybrid model. Some companies are decentralizing or shifting to a hybrid model because of the varying regulatory hurdles encountered within different regions or therapeutic areas.

Health Outcomes Importance on the Rise: As the industry becomes more sophisticated and data-driven, Medical Affairs needs to rely increasingly on health outcomes as a driver for both the success of the function as well as the company and its products. Healthcare payers in the mature markets want more value for their money and, as a result, the industry must show that their treatments reduce the overall use of resources and let patients remain as healthy as possible, for as long as possible.

Medical Affairs, especially Pharma, Budget Growing Moderately: Forty-five percent of respondents said budget increased from 2011 to 2012, but the benchmark class was more tempered in their expectations for 2013. In 2009, over one-third of the benchmark class was growing at a rate of greater than 10%. While 45% of pharma expect budget to grow in the next year, half of the device segment predicts budgets to stay the same next year. Some of medical device Medical Affairs groups are finding their budgets under pressure because of the 2.3% medical device tax set to start Jan. 1, 2013.

Table of Contents

Executive Summary    pp. 3-13 
    • Research Overview  pp. 3
    • Participating Companies  pp. 4-6
    • Key Recommendations  pp. 8
    • Maturity of Medical Affairs  pp. 9
    • Key Findings & Insights  pp. 10-13
    • Scope & Structure  pp. 14-24 
  • Leadership & Oversight  pp. 25-35
  • Regulatory Landscape & Challenges Facing Function  pp. 36-44
  • Spend Allocation      pp. 45-55
  • Staffing  pp. 56-77
  • Functional Responsibility      pp. 78-93
  • Budget Trends & Success Factors  pp. 94-104
  • Participant Demographic Data      pp. 105-112
  • Appendix    pp. 113-114
  • About Best Practices, LLC    pp. 115-116

List of Charts & Exhibits

Type of structure (centralization)
  • Medical Affairs group dedication
  • Departmental reporting relationships
  • Job level or Medical Affairs head
  • Geographic span of organization
  • Percentage of spending per Medical Affairs function
  • Directional trends in Medical Affairs funding levels
  • Directional trends in staffing levels
  • Reasons cited for budget/staff increases
  • Reasons cited for budget/staff decreases
  • Relative importance of seven different Medical Affairs functions
  • Reasons cited for increased importance
  • Reasons cited for decreased importance
  • Percentage of budget allocated for outsourcing
  • Percent of companies impacted by FDA Revitalization Act
  • Top three success factors for developing and maintaining effective Medical Affairs group
  • Top three challenges for developing and maintaining effective Medical Affairs group