Abstract
STUDY OVERVIEW
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.
Pharmaceutical, biotech and medical device managers and executives will be
able to use this research to determine how their Medical Affairs organizations
compare with industry benchmarks.
KEY TOPICS
- Organizational Structure
- Reporting Relationship
- Job Level of Group Leader
- Geographic Span
- Budget Allocation by Medical Affairs Function
- Percent of Budget Allocated for Outsourcing
- Recent and Anticipated changes in Resource Levels
- Impact of Medical Affairs Functions on Company Success
- Key Success Factors for Medical Affairs
- Key Challenges for Medical Affairs
KEY METRICS
- 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 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
METHODOLOGY
The research involved an online survey of 26 Medical Affairs at 25 leading
pharmaceutical, biotechnology and medical device companies
INDUSTRIES PROFILED
Biotech; Pharmaceutical; Consumer Products; Diagnostic; Manufacturing; Health
Care
COMPANIES PROFILED
Amgen; Astellas; AstraZeneca Pharmaceuticals; Bayer Schering AG; Bayer;
Auxillium; Becton Dickinson; Bristol-Myers Squibb; Cubist Pharmaceuticals;
Esteve; Genentech; Johnson & Johnson; Myriad; Novartis; Novo Nordisk; Pfizer;
Schering-Plough; Solvay Pharmaceuticals; Vertex Pharmaceuticals; ApoPharma;
OctoPlus; Procaps; Savient; SK&F; Werrick
Table of Contents
- RESEARCH OVERVIEW
- Research Objective
- Definitions
- KEY FINDINGS
- RESEARCH PARTICIPANTS
- MEDICAL AFFAIRS STRUCTURE & ORGANIZATION
- Medical Affairs Structure
- Medical Affairs Organization
- Medical Affairs Reporting
- Medical Affairs Leadership
- Medical Affairs Global Span
- MEDICAL AFFAIRS RESOURCES
- Medical Affairs Spending
- Medical Affairs Spending Increases
- Medical Affairs Staff Increases
- Increasing Medical Affairs Resources
- Decreasing Medical Affairs Resources
- MEDICAL AFFAIRS TRENDS
- Importance of Medical Affairs Functions
- Median Outsourcing Expenses
- Impact of FDA Revitalization Act on Medical Affairs
- SUCCESS FACTORS & TOP CHALLENGES
- Success Factors
- Medical Affairs Challenges
- APPENDIX: PARTICIPANT DEMOGRAPHICS AND COMPLETE
- SURVEY RESPONSES
- List of Participating Companies
- Job Titles of Participants
- Number of Therapeutic Areas Supported
- Number of Compounds/Products Supported
- Annual Sales Revenue for Participating Companies
- Success Factors
- Key Challenges
- Reasons for Increasing Medical Affairs Resources
- Reasons for Decreasing Medical Affairs Resources
- Reasons for Increasing Importance of Medical Affairs
- Reasons for Declining Importance of Medical Affairs
- About Best Practices, LLC
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