This study was designed to provide metrics and executive insights on the structure and function of early-stage commercialization organizations within pharmaceutical and biotechnology companies.

1. Medical Affairs
Resources, Structures & Trends
Best Practices, LLC
Strategic Benchmarking Research
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2. Research Objective
Study Objective Key Topic Areas
Organizational Structure
Objective: This survey was developed
Reporting Relationship
to identify benchmarks for resources, Job Level of Group Leader
structures and activities of Medical Geographic Span
Budget and Staff Resource Levels
Affairs organizations within leading
Budget Allocation by Medical Affairs
pharmaceutical, medical device and Function
biotech companies. Percent of Budget Allocated for
Outsourcing
Metrics and insights developed from Recent and Anticipated Changes in
Resource Levels
survey data may be used to evaluate and Impact of Medical Affairs Functions on
Company Success
improve Medical Affairs organizations
Key Success Factors for Medical Affairs
throughout the industry.
Key Challenges for Medical Affairs
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3. Definitions Used in This Report
The following definitions are used in this study.
Medical Affairs: Functions dedicated to building and maintaining relationships with
physicians and the medical community, including, but not limited to, the following:
Medical Education: Responsible for CME & educational grants
Medical Communications & Publications: Develops or reviews scientific/medical content--
including medical journal articles--for communications to health care professionals, patients,
consumers and payers. Develops/ manages publication plan. Includes Medical Info Call Center.
Medical/Clinical Research Operations: Creates and guides strategy for clinical development
programs. Develops and executes investigator and company-initiated clinical studies, including
cost-marketing/ Phase IV studies. Includes Medical Directors.
Medical/Scientific Liaisons (MSLs): Non-sales field force responsible for medical relations &
training.
Outcomes Research: Collection and analysis of Health Outcomes/ Economics data.
Phamacovigilance/Safety: The collection and analysis of information on adverse drug reactions.
Thought Leader Management: The identification, recruitment and development of physicians
who can influence the medical perspective and practice of their peers.
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4. Selected Key Findings
The following key findings and insights are among those that emerged from the field
surveys and executive interviews.
Structure:
The Medical Affairs organization is most often a centralized, dedicated group
with a global geographic span that includes the U.S.
Typically, Medical Affairs organizations report to the Executive Team (42
percent) rather than to Marketing or R&D.
The head of Medical Affairs holds the job level of vice president or above at a
majority of companies (54 percent.)
Spending:
On average, 37 percent of Medical Affairs spending is allocated for
medical/clinical research operations, with the top quartile spending more than
60% for the clinical function.
Medical Educations takes up about 18% of Medical Affairs allocations.
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5. Research Participants
Twenty-six Medical Affairs leaders at 25 pharmaceutical companies participated in
this benchmarking study.
Participants in Survey
Werrick
Pharmaceuticals
Participating Companies: Amgen, ApoPharma, Astellas, AstraZeneca, Auxilium, Bayer Healthcare, Bayer Schering
Pharma, Becton Dickinson, Bristol-Myers Squibb, Cubist, Esteve, Genentech, Johnson & Johnson, Myriad, Novartis, Novo
Nordisk, OctoPlus, Pfizer, ProCaps, Savient, Schering-Plough, SK&F, Solvay, Vertex, Werrick Pharmaceuticals.
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6. Medical Affairs Departments Have High-Level Leadership
Executives at the vice president level or above lead Medical Affairs departments at
54% of the participating companies.
Q. What is the job level of the person who currently heads Medical Affairs?
Job Level of Medical Affairs Head
* Other, 8%
Director, 19%
23% Chief Medical Officer
4% Senior/Executive VP
27% Vice President
Senior/Executive
Director, 19%
* Other= Head of Medical Affairs;
Manager of Medical Affairs
n=26
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7. Half the Medical Affairs Organizations Have Global Span
Survey respondents most often represented groups with span covering the globe,
including responsibility for the United States.
Q. What is the geographic span of responsibility of Medical Affairs at your company?
Geographic Span of Medical Affairs Head
50%
% Responses
31%
* Other=Global (excluding
19% US), North America,
Hybrid, No reporting line
between Global Medical
Affairs & Regional/local
Medical Affairs; Country
Global U.S. Only * Other Only (4 responses)
n=26 (including
U.S.)
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8. Few Companies Decreasing Medical Affairs Resources Cite
Varied Reasons
Fewer than 20% of companies experienced or projected any decreases in Medical Affairs
Staff or budget resources. Key reasons given were the state of the economy, loss of
patents, acquisitions, shift of clinical operations, and corporate cost-saving initiatives.
Q. Please describe the key reasons for an decreases in spending or headcount that you indicated
occurred in the past year or that you anticipate next year.
Representative Quotes:
“Economy.”
“Products are going off patent.”
$ $
“Acquisition of another company.” Medical Medical
Affairs Affairs
“The company has initiatives
to do more with less.”
18% of companies either expect or have experienced
decreases in budget resources for Medical Affairs.
“Laboratory operations functions
are being moved out of Medical About 20% have seen or expect staff reductions.
Affairs next year.”
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9. About Best Practices, LLC
Best Practices, LLC is a research and consulting firm that conducts work based
on the simple yet profound principle that organizations can chart a course to
superior economic performance by studying the best business practices,
operating tactics and winning strategies of world-class companies.
Best Practices, LLC
6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
919-403-0251
best@best-in-class.com
www3.best-in-class.com
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