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Roles, Resourcing and Management of
       Medical Science Liaisons




     Best Practices, LLC Benchmarking Report
Table of Contents
                                   INTRODUCTION                                                                      4
                                     Project Methodology and Study objective                                         5
                                   KEY FINDINGS                                                                      6
                                   UNIVERSE OF LEARNING                                                              13
                                     List of Participating Companies                                                 14
                                     Range of Career Levels Lend Insight                                             15
                                   SPECIALIST ROLES AND SERVICE SCOPE                                                20
                                     Pre-Launch Role and Activities for MSLs                                         22
                                     Post-Launch Roles and Activities for MSLs                                       23
                                     Pre-Launch Roles and Activities Related to Clinical Trials for MSLs             24
                                     Post-Launch Roles and Activities Related to Clinical Trials for MSLs            25
                                     Pre-Launch Roles and Activities for MSLs with Clinical Trials (2011 Data Only) 26
                                     Post-Launch Roles and Activities for MSLs with Clinical Trials (2011 Data Only) 27
                                     Pre-Launch Roles and Activities for MSLs with Thought Leaders                   28
                                     Post-Launch Roles and Activities for MSLs with Thought Leaders                  29
                                     Nearly All Educate KOLs and HCPs at Pre-Launch                                  30
                                     All Companies Seek to Educate KOLs and HCPs Post-Launch                         31
                                     Other Pre-Launch Roles and Activities for MSLs                                  32
                                     Other Post-Launch Roles and Activities for MSLs                                 33
                                     MSLs Active in Developing Scientific Collateral & Delivering Speeches Pre Launch
                                                                                                                     34
                                     All MSLs Deliver Speeches and Presentations Post-Launch                         35
                                     MSLs Deployed in Relations to Number of KOLs in a Therapeutic Area              36
                                     Many Do Not Deploy MSLs Based on Revenue Calculations                           37




Copyright © Best Practices®, LLC                         1
Table of Contents (Cont’d)
                                     Lifecycle Does Play Important Role in MSL Deployment                         38
                                     Geographic Concentration of KOLs & Medical Centers Key Drivers in MSL Field
                                   Allocation…..                                                                  39
                                      MSL Alignment Driven by Reach and Frequency of Meetings with KOLs           40
                                   RELATIONSHIP MANAGEMENT STANDARDS OF EXCELLENCE                                41
                                      Face-to-Face Meetings Most Widely Used Relationship Builder for MSLs with KOLs.
                                                                                                                  42
                                      MSLs Continue to Call on Regional KOLs, Though Frequency Is Falling         43
                                      MSLs Calling on National KOLs Less Regularly than in 2009                   44
                                      Companies Take More Moderate Approach to Growing New KOL Relationships 45
                                      Maintaining KOL Relationships Takes Fewer Touches                           46
                                   RESOURCE MANAGEMENT/SHIFTING AND FORECASTING                                   47
                                      MSL Work Kept In-House With Tight Managerial Oversight                      48
                                      Companies Engage MSLs Early For Success                                     49
                                      Drivers to Increase the Number of MSLs in the Field                         50
                                      More Reasons to Raise Number of MSLs Utilized                               51
                                      Not Standard Policy to Cut MSL Staff After Launch of Product                52
                                      Maturity of Product and Reimbursement Changes Can Influence MSL Reductions53
                                      Other Factors Declining In Importance for Cutting MSLs                      54
                                      Factors for Shifting MSLs - Voices from the Field                           55
                                   VALUE ASSOCIATED WITH MSL                                                      56
                                      Value of MSL Responsibilities -- Marketing and Sales                        57
                                      Value of MSL Responsibilities -- KOLs                                       58
                                      Value of Other MSL Responsibilities                                         59
                                      Perceived Value of Quantitative Measurements for MSLs                       60
                                      Perceived Value of Qualitative Measurements for MSLs                        61
                                      Time Spent by MSLs on Activities -- Actual vs. Expected                     62
Copyright © Best Practices®, LLC                               2
Table of Contents (Cont’d)
                                   BUDGET ALLOCATION TO MSL               65
                                     Allocation of MSL Budget             66
                                     Medical Affairs Funds MSL Function   67
                                     Factors That Affect the MSL Budget   68
                                   LESSONS LEARNED                        69
                                   ABOUT BEST PRACTICES, LLC              78




Copyright © Best Practices®, LLC                   3
Project Methodology and Study Objectives
Competition for the time and attention of physicians and Key Opinion Leaders (KOLs) is
intensifying. Thus, companies increasingly use Medical Science Liaisons (MSL) to build and
strengthen relationships with physicians and KOLs.


          This research seeks to uncover the optimal number of liaisons, mix of
          responsibilities, number of interactions and span of control.
          Key study objectives
                Benchmark Pre and Post-Launch Service Activities
                Identify Drivers of Group Size & Focus
                Gain insight into Structuring & Aligning Medical With Sales Organizations
                Identify Optimal Call Frequencies and Service Levels with Thought
                Leaders
                Identify Relationship Management Standards of Excellence
                Value Associated with MSL
                Budget Allocation to MSLs


Copyright © Best Practices®, LLC                4
Key Opinion Leaders Segment Definitions
KOLs have different spheres of influence. This provides how Best Practices, LLC defines
the different roles of national and regional leaders. Field researchers used the following
definitions to evaluate service levels for each segment.




     National Thought Leader: Have a national
 following, are well-published, affect therapeutic
      practice, and are often found at major
                academic centers.


 Regional Thought Leader: Are less well known
 but influence policy, practice and local primary
 care or specialist views within a multi-state or
                  small region.




Copyright © Best Practices®, LLC            5
Summary of Key Insights


           Key Findings Focus on the Following:
             •Monitoring Markets and Interactions
             •Tracking Value, Determining Group Size
             •Frequency of Interactions and Span of Control
             •Managing KOL Relationships and Field Deployment
             •Resource Allocation and Value



Copyright © Best Practices®, LLC           6
List of Participating Companies
Best Practices®, LLC distilled observations and insights from interviews and benchmark
performance data from a total of 27 leaders from 24 pharmaceutical and biotechnology
companies.

           2011                                                            2009
        Abbott Labs
        Amgen                                                            Abbott Labs
        Astellas                                                         AstrazZeneca
        AstraZeneca                                                      Axcan Pharma Inc.
        Baxter Healthcare                                                Boehringer Ingelheim
        Boehringer Ingelheim                                             Eli Lilly and Company
        Celgene                                                          Focus Technologies
        Cubist Pharmaceuticals                                           Genentech
        Eisai                                                            Innovex
        Genentech                                                        Janssen cilag
        GlaxoSmithKline                                                  Mylan Bertek
        Ipsen                                                            Pharmaceuticals
        Laboratories Esteve                                              Novartis
        Merz Pharma                                                      Novo Nordisk
                                                                         Pharmaceuticals
        Mitsubishi Tanabe Pharma
        America                                                          Organon Netherlands
        Merck Sharp & Dohme                                              Organon U.S.
        Novartis                                                         Sanofi-Aventis
        Shire                                                            Schering Plough
        Takeda                                                           TTY Biopharm
        Teva (branded)                                                   UCP
        ViroPharma Inc                                                   Vertex
        ViiV Healthcare

Copyright © Best Practices®, LLC          7
Range of Career Levels Lend Insight

Research participants’ roles ranged from senior leaders to managers of medical affairs
to medical science liaisons.


       Associate Director, Medical Affairs             Medical Manager
       Associate Director, Medical Science             Medical Director, Biosurgery
       Liaisons                                        Medical Director
       Clinical Communication Leader                   Medical Science Liaison
       Director, Medical Affairs (Oncology)            Regional Director, MSL Medical Affairs
       Director, Regional Medical Liaisons             Senior Regional Medical Scientist,
       Director, Global Medical Affairs Strategy       Managed Care and Therapeutic Lead
       Executive Director, Medical Affairs             Specialist III, Medical Affairs Operations
       Medical Affairs                                 Sr. Scientific Liaison
       Executive Director, Medical and                 Sr. Vice President, Medical Affairs and
       Scientific Affairs                              Drug Development
       Lead Clinical Development & CRO                 Sr. Director, Medical Science Liaisons
       Liaison
                                                       Vice President, Medical Affairs &
       Medical Manager, Medical Science                Regulatory Affairs
       Liaison
                                                       Vice President, Medical Services
       Marketing Manager                               Medical Affairs
       Medical Manager in Medical Affairs              Vice President and Head North
       Medical Director                                American Medical Affairs


Copyright © Best Practices®, LLC                   8
48% of Respondents Directors or Above
Nearly half of the respondents were director and above. Others respondents include Clinical
Communication Manager, Marketing Manager and Clinical Liaison.


                                    What is your current role in regards to MSL?


                                               37%




                                                                              19%   19%
                                                               15%


                                   7%
                4%



        Chief Medical              VP        Director       Regional          MSL   Other
           Officer                                          Associate
                                                        Director/Manager
    N=27
Copyright © Best Practices®, LLC                        9
Specialist Roles and
Service Scope
Two-thirds of MSL Groups Led by Director or
Higher Level
More than 60 percent of the supervisory responsibility to oversee the MSL function is with
Directors and Vice Presidents. Other executives overseeing the MSLs include Executive
Directors, Strategy and Planning or Clinical Liaison groups.

                   Who has oversight responsibility for your Medical Science Liaison function?


           Assistant                 Manager,
          Director, 4%                 21%




                                              Other, 8%

 Director,
   38%



                                            Vice
                                         President,
                                            29%
    N=24
Copyright © Best Practices®, LLC                      11
Lifecycle Does Play Important Role in MSL
Deployment
Companies continue to consider product lifecycle in MSL deployment as well as the
company commitment to a franchise

   Assess the effectiveness of the following factors by which you determine how many liaisons to put
                                              into the field.
                                        Very Important   Important   Not Important   Do Not Use

                                   4%                6%                     9%                    11%
                                                     6%                     4%                    6%
                               35%
                                                     35%
                                                                           57%                    44%



                               61%
                                                     53%
                                                                                                  39%
                                                                           30%


                               2011                 2009                   2011                   2009
                                                                        Corporate commitment to an
                               Product lifecycle plan
                                                                          over-arching franchise
N 2011=23 N 2009=19
Copyright © Best Practices®, LLC                              12
Factors for Shifting MSLs - Voices from the
Field
The shift or relocation of MSLs in the field is in response to the decreasing relevance of
traditional sales and marketing activities as they relate to building relationships with
KOLs and promoting comparative evidence and efficacy of products.




  “Note that decreasing does not have to mean
  eliminating the resources, but transitioning
  them to other therapeutic areas.” -- Specialist
  III, Medical Affairs Operations



   “The reach/frequency pharmaceutical business model is increasingly ineffective as
   traditional sales and marketing activities lose acceptance. This will inevitably shift the
   focus to the Medical organizations to:
        • Drive development of (comparative) evidence
        • And leverage aligned communication channels to optimize the safe and
           effective use of our products.” -- Executive Director, Medical Affairs


Copyright © Best Practices®, LLC              13
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
                                    www.best-in-class.com

Copyright © Best Practices®, LLC                14

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MSL Update Summary

  • 1. Roles, Resourcing and Management of Medical Science Liaisons Best Practices, LLC Benchmarking Report
  • 2. Table of Contents INTRODUCTION 4 Project Methodology and Study objective 5 KEY FINDINGS 6 UNIVERSE OF LEARNING 13 List of Participating Companies 14 Range of Career Levels Lend Insight 15 SPECIALIST ROLES AND SERVICE SCOPE 20 Pre-Launch Role and Activities for MSLs 22 Post-Launch Roles and Activities for MSLs 23 Pre-Launch Roles and Activities Related to Clinical Trials for MSLs 24 Post-Launch Roles and Activities Related to Clinical Trials for MSLs 25 Pre-Launch Roles and Activities for MSLs with Clinical Trials (2011 Data Only) 26 Post-Launch Roles and Activities for MSLs with Clinical Trials (2011 Data Only) 27 Pre-Launch Roles and Activities for MSLs with Thought Leaders 28 Post-Launch Roles and Activities for MSLs with Thought Leaders 29 Nearly All Educate KOLs and HCPs at Pre-Launch 30 All Companies Seek to Educate KOLs and HCPs Post-Launch 31 Other Pre-Launch Roles and Activities for MSLs 32 Other Post-Launch Roles and Activities for MSLs 33 MSLs Active in Developing Scientific Collateral & Delivering Speeches Pre Launch 34 All MSLs Deliver Speeches and Presentations Post-Launch 35 MSLs Deployed in Relations to Number of KOLs in a Therapeutic Area 36 Many Do Not Deploy MSLs Based on Revenue Calculations 37 Copyright © Best Practices®, LLC 1
  • 3. Table of Contents (Cont’d) Lifecycle Does Play Important Role in MSL Deployment 38 Geographic Concentration of KOLs & Medical Centers Key Drivers in MSL Field Allocation….. 39 MSL Alignment Driven by Reach and Frequency of Meetings with KOLs 40 RELATIONSHIP MANAGEMENT STANDARDS OF EXCELLENCE 41 Face-to-Face Meetings Most Widely Used Relationship Builder for MSLs with KOLs. 42 MSLs Continue to Call on Regional KOLs, Though Frequency Is Falling 43 MSLs Calling on National KOLs Less Regularly than in 2009 44 Companies Take More Moderate Approach to Growing New KOL Relationships 45 Maintaining KOL Relationships Takes Fewer Touches 46 RESOURCE MANAGEMENT/SHIFTING AND FORECASTING 47 MSL Work Kept In-House With Tight Managerial Oversight 48 Companies Engage MSLs Early For Success 49 Drivers to Increase the Number of MSLs in the Field 50 More Reasons to Raise Number of MSLs Utilized 51 Not Standard Policy to Cut MSL Staff After Launch of Product 52 Maturity of Product and Reimbursement Changes Can Influence MSL Reductions53 Other Factors Declining In Importance for Cutting MSLs 54 Factors for Shifting MSLs - Voices from the Field 55 VALUE ASSOCIATED WITH MSL 56 Value of MSL Responsibilities -- Marketing and Sales 57 Value of MSL Responsibilities -- KOLs 58 Value of Other MSL Responsibilities 59 Perceived Value of Quantitative Measurements for MSLs 60 Perceived Value of Qualitative Measurements for MSLs 61 Time Spent by MSLs on Activities -- Actual vs. Expected 62 Copyright © Best Practices®, LLC 2
  • 4. Table of Contents (Cont’d) BUDGET ALLOCATION TO MSL 65 Allocation of MSL Budget 66 Medical Affairs Funds MSL Function 67 Factors That Affect the MSL Budget 68 LESSONS LEARNED 69 ABOUT BEST PRACTICES, LLC 78 Copyright © Best Practices®, LLC 3
  • 5. Project Methodology and Study Objectives Competition for the time and attention of physicians and Key Opinion Leaders (KOLs) is intensifying. Thus, companies increasingly use Medical Science Liaisons (MSL) to build and strengthen relationships with physicians and KOLs. This research seeks to uncover the optimal number of liaisons, mix of responsibilities, number of interactions and span of control. Key study objectives Benchmark Pre and Post-Launch Service Activities Identify Drivers of Group Size & Focus Gain insight into Structuring & Aligning Medical With Sales Organizations Identify Optimal Call Frequencies and Service Levels with Thought Leaders Identify Relationship Management Standards of Excellence Value Associated with MSL Budget Allocation to MSLs Copyright © Best Practices®, LLC 4
  • 6. Key Opinion Leaders Segment Definitions KOLs have different spheres of influence. This provides how Best Practices, LLC defines the different roles of national and regional leaders. Field researchers used the following definitions to evaluate service levels for each segment. National Thought Leader: Have a national following, are well-published, affect therapeutic practice, and are often found at major academic centers. Regional Thought Leader: Are less well known but influence policy, practice and local primary care or specialist views within a multi-state or small region. Copyright © Best Practices®, LLC 5
  • 7. Summary of Key Insights Key Findings Focus on the Following: •Monitoring Markets and Interactions •Tracking Value, Determining Group Size •Frequency of Interactions and Span of Control •Managing KOL Relationships and Field Deployment •Resource Allocation and Value Copyright © Best Practices®, LLC 6
  • 8. List of Participating Companies Best Practices®, LLC distilled observations and insights from interviews and benchmark performance data from a total of 27 leaders from 24 pharmaceutical and biotechnology companies. 2011 2009 Abbott Labs Amgen Abbott Labs Astellas AstrazZeneca AstraZeneca Axcan Pharma Inc. Baxter Healthcare Boehringer Ingelheim Boehringer Ingelheim Eli Lilly and Company Celgene Focus Technologies Cubist Pharmaceuticals Genentech Eisai Innovex Genentech Janssen cilag GlaxoSmithKline Mylan Bertek Ipsen Pharmaceuticals Laboratories Esteve Novartis Merz Pharma Novo Nordisk Pharmaceuticals Mitsubishi Tanabe Pharma America Organon Netherlands Merck Sharp & Dohme Organon U.S. Novartis Sanofi-Aventis Shire Schering Plough Takeda TTY Biopharm Teva (branded) UCP ViroPharma Inc Vertex ViiV Healthcare Copyright © Best Practices®, LLC 7
  • 9. Range of Career Levels Lend Insight Research participants’ roles ranged from senior leaders to managers of medical affairs to medical science liaisons. Associate Director, Medical Affairs Medical Manager Associate Director, Medical Science Medical Director, Biosurgery Liaisons Medical Director Clinical Communication Leader Medical Science Liaison Director, Medical Affairs (Oncology) Regional Director, MSL Medical Affairs Director, Regional Medical Liaisons Senior Regional Medical Scientist, Director, Global Medical Affairs Strategy Managed Care and Therapeutic Lead Executive Director, Medical Affairs Specialist III, Medical Affairs Operations Medical Affairs Sr. Scientific Liaison Executive Director, Medical and Sr. Vice President, Medical Affairs and Scientific Affairs Drug Development Lead Clinical Development & CRO Sr. Director, Medical Science Liaisons Liaison Vice President, Medical Affairs & Medical Manager, Medical Science Regulatory Affairs Liaison Vice President, Medical Services Marketing Manager Medical Affairs Medical Manager in Medical Affairs Vice President and Head North Medical Director American Medical Affairs Copyright © Best Practices®, LLC 8
  • 10. 48% of Respondents Directors or Above Nearly half of the respondents were director and above. Others respondents include Clinical Communication Manager, Marketing Manager and Clinical Liaison. What is your current role in regards to MSL? 37% 19% 19% 15% 7% 4% Chief Medical VP Director Regional MSL Other Officer Associate Director/Manager N=27 Copyright © Best Practices®, LLC 9
  • 12. Two-thirds of MSL Groups Led by Director or Higher Level More than 60 percent of the supervisory responsibility to oversee the MSL function is with Directors and Vice Presidents. Other executives overseeing the MSLs include Executive Directors, Strategy and Planning or Clinical Liaison groups. Who has oversight responsibility for your Medical Science Liaison function? Assistant Manager, Director, 4% 21% Other, 8% Director, 38% Vice President, 29% N=24 Copyright © Best Practices®, LLC 11
  • 13. Lifecycle Does Play Important Role in MSL Deployment Companies continue to consider product lifecycle in MSL deployment as well as the company commitment to a franchise Assess the effectiveness of the following factors by which you determine how many liaisons to put into the field. Very Important Important Not Important Do Not Use 4% 6% 9% 11% 6% 4% 6% 35% 35% 57% 44% 61% 53% 39% 30% 2011 2009 2011 2009 Corporate commitment to an Product lifecycle plan over-arching franchise N 2011=23 N 2009=19 Copyright © Best Practices®, LLC 12
  • 14. Factors for Shifting MSLs - Voices from the Field The shift or relocation of MSLs in the field is in response to the decreasing relevance of traditional sales and marketing activities as they relate to building relationships with KOLs and promoting comparative evidence and efficacy of products. “Note that decreasing does not have to mean eliminating the resources, but transitioning them to other therapeutic areas.” -- Specialist III, Medical Affairs Operations “The reach/frequency pharmaceutical business model is increasingly ineffective as traditional sales and marketing activities lose acceptance. This will inevitably shift the focus to the Medical organizations to: • Drive development of (comparative) evidence • And leverage aligned communication channels to optimize the safe and effective use of our products.” -- Executive Director, Medical Affairs Copyright © Best Practices®, LLC 13
  • 15. 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 www.best-in-class.com Copyright © Best Practices®, LLC 14