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Medical Affairs Excellence: Structuring, Aligning and Funding for Global Success

ID: OP-97


Features:

17 Info Graphics

21 Data Graphics

21 Metrics


Pages: 56


Published: Pre-2013


Delivery Format: Shipped


 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
In today's challenging healthcare environment, medical affairs' role has become even more crucial to pharmaceutical companies' success. Confronted with declining R&D productivity, escalating development costs, increasing competition, growing price pressures and intensified regulatory and public scrutiny, pharmaceutical companies seek to maintain double-digit revenue and earnings growth demanded by investors. In addition, companies are reallocating resources in response to Office of Inspector General (OIG) guidelines. This study uncovers how leading companies are working to align, staff and fund medical affairs capabilities to respond to these challenges.

Industries Profiled:
Biotech; Pharmaceutical; Chemical; Manufacturing; Health Care; Diagnostic; Medical Device


Companies Profiled:
Amgen; Sanofi-aventis; Eli Lilly; AstraZeneca; Solvay America; Schering-Plough; Biogen; Janssen; Abbott; Roche; Merck; GlaxoSmithKline















Study Snapshot


Medical Affairs Excellence: Structuring, Aligning & Funding for Global Success (OP-97) examines how the most successful pharmaceutical companies structure, align, staff and fund medical affairs capabilities. By benchmarking against these companies’ staffing and spend levels, your company will gain the necessary information to conduct a performance gap analysis, identify potential areas for improvement and then close performance gaps in structuring an efficient and effective medical affairs function.

After reading this report, you will gain insight into how to fulfill the growing strategic roles demanded of
medical affairs executives and how to continuously improve the medical affairs function by optimizing overall medical affairs capabilities. This study also includes the perspectives of interviewed and surveyed medical affairs staff on the services they value, how they select studies and how they gauge the credibility of a company.

Key Findings

1. Improve hiring, training and development to ensure that the right people are doing the right jobs. Interviewed executives at benchmark companies all accent the importance of putting the right people in the right positions. At the majority of the benchmark companies (73%), the head of medical affairs department reports directly into the head of country, regional or global pharmaceutical business. The other 27% report either into the head of research and development or to the head of commercial operations.

2. Evaluate appropriate levels of outsourcing, staffing and spending to ensure the quality and timely delivery of medical affairs objectives and action plans. All benchmark companies currently outsource, at varying degrees, part of their medical affairs activities and capabilities. For example, some of the companies outsource 70% to 90% of their medical operations, while others only outsource 10% to 20%. Which areas to outsource, when to outsource and to whom to outsource are the key issues that medical affairs executives and managers frequently examine in the context of their changing business goals and strategies, existing functional skills and competencies, potential cost-efficiencies and strategic risks.


Table of Contents

MEDICAL AFFAIRS EXCELLENCE: STRUCTURING, ALIGNING & FUNDING FOR GLOBAL SUCCESS 3
Project Background 3
Study Methodology and Benchmark Class 5
Key Lessons Learned 6
Align organizational structures with business objectives, strategies and change. 6
Improve processes to enhance operational efficiency and effectiveness. 7
Improve hiring, training and development to ensure that the right people are doing the right jobs. 7
Evaluate appropriate levels of outsourcing, staffing and spending to ensure the quality and timely delivery of medical affairs objectives and action plans. 8
Measure performance to drive continuous improvement. 9
Path Forward 9
ORGANIZATIONAL STRUCTURES AND PROCESSES 11
Mission: A Balancing Act 16
Reporting Relationships for Medical Affairs Function and Capabilities 17
Geographic span of responsibility 20
Multinational Model 22
Global Model 23
Transnational Model 24
Product Lifecycle Span of Responsibility 25
Functional Components and structure 27
Cross-functional interfaces through teams and processes 27
MEDICAL AFFAIRS STAFFING AND SPENDING: MAXIMIZING VALUE, DECREASING COSTS 30
Overall Medical Affairs Staffing Levels 32
Segmentation of Medical Affairs Staffing by Capabilities 33
Imputed FTEs per Dedicated MA Capability 34
Staffing Ratios: FTEs to Number of Compounds 35
Staffing Ratios: FTEs To Number of Therapy Areas 36
Staffing Ratios: FTEs to US Sales 37
Planned Staffing Change and Drivers 38
Levels of Outsourcing: By Company 39
LEVELS OF OUTSOURCING: BY CAPABILITY 40
External Spend: Average and Range 42
External Spend: Amount per Compound 45
Source and Distribution of Medical Affairs External Spend 46
Factors Driving High Resource Consumption 47
PERFORMANCE MEASUREMENT: BEYOND ROI 48
Sample medical affairs performance measures 50
CAPABILITIES DEFINITIONS 53

    List of Tables and Figures

    Figure 1: Benchmark Class 6
    Figure 1.1: MA Capabilities 13
    Figure 1.2: Influences on structure 14
    Figure 1.3: Idealized Skills Profile: Global Medical Affairs Leadership 15
    Figure 1.4: Advantages of Dedicated MA Function 16
    Figure 1.5: Distribution of US MA Capabilities 17
    Figure 1.6: MA Reporting Relationships 18
    Figure 1.7: Capabilities Movement 19
    Figure 1.8: Capabilities Most Frequently Residing in R&D 20
    Figure 1.9: Capabilities Most Frequently Residing in Sales and Marketing 21
    Figure 1.10: Multinational Model 23
    Figure 1.11: Global Model 24
    Figure 1.12: Transnational Model 25
    Figure 1.13: Responsibility by Clinical Trial Phase 27
    Figure 1.14: Organizational Structure of US MA Department 29
    Figure 1.15: Medical-Commercial Alignment 29
    Figure 1.16: Regional Strategic Operations Team Process 30
    Figure 2.1: Oversight of Compounds and Therapy 32
    Figure 2.2: Total FTEs 33
    Figure 2.3: FTEs by Capability 34
    Figure 2.4: Imputed FTEs Per Dedicated MA Capability 35
    Figure 2.5: FTEs per Compound 36
    Figure 2.6: FTEs Per Therapy Area 37
    Figure 2.7: FTEs per $100 Million in US Sales 38
    Planned Staffing Change and Drivers 39
    Figure 2.8: Planned Staffing Trend 39
    Figure 2.9: Total Outsourcing by Company 40
    Figure 2.10: Outsourcing by Capability 41
    Figure 2.11: External Spend 43
    Figure 2.12: External Spend by Capability 45
    Figure 2.13: External Spend per Compound 46
    Figure 2.14: Funding Source by Capability 47
    Figure 2.15: Factors Driving High Resource Consumption 48
    Figure 3.1: Effectiveness Rating 52