Medical Affairs
Resources, Structures & Trends




              Best Practices, LLC
       Strategic Benchmarking Research


             Copyright © Best Practices®, LLC   BEST PRACTICES,   ®
                                                                      LLC
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

2                                     Copyright © Best Practices®, LLC                            BEST PRACTICES,   ®
                                                                                                                        LLC
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.


3                                   Copyright © Best Practices®, LLC                  BEST PRACTICES,     ®
                                                                                                              LLC
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.



4                                 Copyright © Best Practices®, LLC             BEST PRACTICES,   ®
                                                                                                     LLC
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.
5                                           Copyright © Best Practices®, LLC                          BEST PRACTICES,      ®
                                                                                                                               LLC
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

6                                      Copyright © Best Practices®, LLC                         BEST PRACTICES,   ®
                                                                                                                      LLC
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.)

7                                         Copyright © Best Practices®, LLC              BEST PRACTICES,    ®
                                                                                                               LLC
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.”

8                                     Copyright © Best Practices®, LLC                  BEST PRACTICES,   ®
                                                                                                              LLC
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




9                            Copyright © Best Practices®, LLC        BEST PRACTICES,   ®
                                                                                           LLC

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Medical Affairs Resources, Structures & Trends Report Summary

  • 1. Medical Affairs Resources, Structures & Trends Best Practices, LLC Strategic Benchmarking Research Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 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 2 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 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. 3 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 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. 4 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 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. 5 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 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 6 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 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.) 7 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 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.” 8 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 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 9 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC