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Medical Affairs: Delivering Strategic Value
Cutting Edge Information, March 2008, Pages: 119
Executive Summary 9
Profiled Companies 14
Study Methodology 15
Study Definitions 16
Medical Affairs: Five Principles for Success 17
Structuring Efficient Medical Affairs Departments 25
Structure Medical Affairs for Success 28
Medical Affairs Communication and Coordination 39
The Globalization of Medical Affairs 45
Resourcing and Staffing 51
Obtaining and Allocating Resources 53
Staffing and Outsourcing 69
Success Measurements 85
Medical Affairs Strategy, Activities and Compliance 91
Aligning Medical Affairs with Brand Strategy 92
Medical Affairs Compliance 107
List of Charts and Graphics
Executive Summary
Figure Ex.1: Medical Affairs Reporting Structures 2002 vs. 2008 18
Structuring Efficient Medical Affairs Departments
Figure 1.1: Medical Affairs Reporting Structures 2002 vs. 2008 26
Figure 1.2: Companies’ Medical Affairs Structures 28
Structure Medical Affairs for Success
Figure 1.3: Medical Affairs Internal Alignment 30
Figure 1.4: Medical Affairs Reporting Structure in 2002 31
Figure 1.5: Medical Affairs Reporting Structure in 2008 32
Figure 1.6: Company I’s US Medical Affairs Structure 34
Figure 1.7: Company K’s Scientific Affairs Structure 37
Resourcing and Staffing
Obtaining and Allocating Resources
Figure 2.1: Medical Affairs Funding Source(s) 54
Figure 2.2: Company Medical Affairs Funding Source(s) 55
Figure 2.3: 2008 US Medical Affairs Budgets 56
Figure 2.4: 2008 US Medical Affairs Budget Allocation 60
Figure 2.5: Company Medical Affairs Budget Allocations by Function 61
Figure 2.6: Average US Medical Affairs Budget by Activity 62
Figure 2.7: 2008 Medical Affairs Budget Allocation ($10 Million or Less) 62
Figure 2.8: 2008 Medical Affairs Budget Allocation (More Than $10 Million) 63
Figure 2.9: 2008 US Thought Leader Spending 64
Figure 2.10: 2008 US MSL Programs Spending 65
Figure 2.11: 2008 US Medical Publications Spending 65
Figure 2.12: 2008 US Medical Education Spending 66
Figure 2.13: 2008 US Medical Information Spending 66
Figure 2.14: 2008 US Investigator-Initiated Trials Spending 67
Figure 2.15: 2008 US Medical Grants Spending 67
Figure 2.16: 2008 US Other Spending 68
Staffing and Outsourcing
Figure 2.17: 2008 US Medical Affairs Budgets and Staffing Resource Allocation 69
Figure 2.18: 2008 Medical Affairs Staffing 70
Figure 2.19: 2008 US Medical Affairs Staffing Allocation 71
Figure 2.20: Company Medical Affairs Staffing Allocations by Function 72
Figure 2.21: Average US Medical Affairs Staffing by Activity 73
Figure 2.22: 2008 US Medical Affairs Staffing Allocation 74
Figure 2.23: 2008 US Thought Leader Headcounts 75
Figure 2.24: 2008 US MSL Program Headcounts 75
Figure 2.25: 2008 US Medical Publications Headcounts 76
Figure 2.26: 2008 US Medical Education Headcounts 76
Figure 2.27: 2008 US Medical Information Headcounts 77
Figure 2.28: 2008 US Investigator-Initiated Trials Headcounts 77
Figure 2.29: 2008 US Medical Grants Headcounts 78
Figure 2.30: 2008 US Other Headcounts 78
Figure 2.31: Percentage of Average US Medical Affairs Budget Outsourced in 2008 79
Figure 2.32: Percentage of 2008 US Medical Affairs Budget Outsourced by Company 80
Figure 2.33: Outsourced US Medical Affairs Budget in 2008 81
Figure 2.34: Weighing Outsourcing Advantages vs. Disadvantages 82
Medical Affairs Strategy, Activities and Compliance
Aligning Medical Affairs with Brand Strategy
Figure 3.1: Thought Leaders: First Involvement During Drug Development 97
Figure 3.2: Thought Leaders: Last Involvement With a Drug 97
Figure 3.3: MSL Programs: First Involvement During Drug Development 98
Figure 3.4: MSL Programs: Last Involvement With a Drug 99
Figure 3.5: Medical Publications: First Involvement During Drug Development 100
Figure 3.6: Medical Publications: Last Involvement With a Drug 100
Figure 3.7: Medical Education: First Involvement During Drug Development 101
Figure 3.8: Medical Education: Last Involvement With a Drug 101
Figure 3.9: Medical Information: First Involvement During Drug Development 102
Figure 3.10: Medical Information: Last Involvement With a Drug 102
Figure 3.11: Investigator-Initiated Trials: First Involvement During Drug Development 103
Figure 3.12: Investigator-Initiated Trials: Last Involvement With a Drug 104
Figure 3.13: Medical Grants: First Involvement During Drug Development 104
Figure 3.14: Medical Grants: Last Involvement With a Drug 105
Medical Affairs Compliance
Figure 3.15: Impact of OIG Guidelines 113
Figure 3.16: Impact of Uniform Requirements from International Committee 114
of Medical Journal Editors (ICMJE)
Figure 3.17: Impact of Good Publication Practices (GPP) 115
Figure 3.18: Impact of CONSORT Statement 116
Figure 3.19: Impact of Food and Drug Administration Modernization Act (FDAMA) 117
Figure 3.20: Impact of PhRMA code 118
Figure 3.20: Impact of GCP Code 118
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