医務：戦略的価値

Abstract

Increase the effectiveness of your medical affairs efforts:

Medical affairs plays an instrumental role in providing medical and scientific perspectives for a company' s brands. While the function has long been considered vital, recent years have brought tremendous change. Pressure to remain compliant and increasing globalization have had a profound impact on companies' medical affairs structures, budgets and strategies. This transition is exciting-it creates a motivator for dynamic growth opportunities that underscore medical affairs' importance to pharma companies. At the same time, such growth spurs new challenges. Medical affairs teams often struggle to strike a balance- between serving both internal and external customers, as well as being faithful to clinical truths and contributing to commercial goals.

Cutting Edge Information' s report Medical Affairs: Delivering Strategic Value addresses the major trends of the medical affairs landscape. It benchmarks industry-leading medical affairs structures and explores best practices departments have implemented to remain compliant with regulatory guidelines. The report provides medical affairs departments with the tools to improve their functions by comparing their spending, staffing, global structures, and strategies to those of top pharmaceutical companies.

The report makes its case with metrics and techniques for managing medical affairs in these key areas:

• Structure, Communication and Globalization - Learn how and why pharmaceutical companies are restructuring their medical affairs departments. Explore department best practices in achieving optimal communication and coordination. Discover how medical affairs is growing globally.
• Budget, Staffing and Success Measurements - Examine top companies' 2008 medical affairs budgets and staffing by activity. Discover what measures medical affairs departments use to gauge success.
• Strategy, Activities and Compliance - Explore medical affairs' involvement in strategy-setting, as well as some of the major activities the function is responsible for. Understand how compliance has affected medical affairs today.

Table of Contents

Metrics Overview

Medical Affairs contains the following metrics:

• Medical Affairs Reporting Structures 2002 vs. 2008
• Companies' Medical Affairs Structures
• Medical Affairs Internal Alignment
• Medical Affairs Reporting Structure in 2002
• Medical Affairs Reporting Structure in 2008
• Company I' s US Medical Affairs Structure
• Company K' s Scientific Affairs Structure
• Medical Affairs Funding Source(s)
• Company Medical Affairs Funding Source(s)
• 2008 US Medical Affairs Budgets
• 2008 US Medical Affairs Budget Allocation
• Company Medical Affairs Budget Allocations by Function
• Average US Medical Affairs Budget by Activity
• 2008 Medical Affairs Budget Allocation ($10 Million or Less)
• 2008 Medical Affairs Budget Allocation (More Than $10 Million)
• 2008 US Thought Leader Spending
• 2008 US MSL Programs Spending
• 2008 US Medical Publications Spending
• 2008 US Medical Education Spending
• 2008 US Medical Information Spending
• 2008 US Investigator-Initiated Trials Spending
• 2008 US Medical Grants Spending
• 2008 US Other Spending
• 2008 US Medical Affairs Budgets and Staffing Resource Allocation
• 2008 Medical Affairs Staffing
• 2008 US Medical Affairs Staffing Allocation
• Company Medical Affairs Staffing Allocations by Function
• Average US Medical Affairs Staffing by Activity
• 2008 US Medical Affairs Staffing Allocation
• 2008 US Thought Leader Headcounts
• 2008 US MSL Program Headcounts
• 2008 US Medical Publications Headcounts
• 2008 US Medical Education Headcounts
• 2008 US Medical Information Headcounts
• 2008 US Investigator-Initiated Trials Headcounts
• 2008 US Medical Grants Headcounts
• 2008 US Other Headcounts
• Percentage of Average US Medical Affairs Budget Outsourced in 2008
• Percentage of 2008 US Medical Affairs Budget Outsourced by Company
• Outsourced US Medical Affairs Budget in 2008
• Weighing Outsourcing Advantages vs. Disadvantages
• Medical Affairs Strategy, Activities and Compliance
• Aligning Medical Affairs with Brand Strategy
• Thought Leaders: First Involvement During Drug Development
• Thought Leaders: Last Involvement With a Drug
• MSL Programs: First Involvement During Drug Development
• MSL Programs: Last Involvement With a Drug
• Medical Publications: First Involvement During Drug Development
• Medical Publications: Last Involvement With a Drug
• Medical Education: First Involvement During Drug Development
• Medical Education: Last Involvement With a Drug
• Medical Information: First Involvement During Drug Development
• Medical Information: Last Involvement With a Drug
• Investigator-Initiated Trials: First Involvement During Drug Development
• Investigator-Initiated Trials: Last Involvement With a Drug
• Medical Grants: First Involvement During Drug Development
• Medical Grants: Last Involvement With a Drug
• Medical Affairs Compliance
• Impact of OIG Guidelines
• Impact of Uniform Requirements from International Committee of Medical Journal Editors (ICMJE)
• Impact of Good Publication Practices (GPP)
• Impact of CONSORT Statement
• Impact of Food and Drug Administration Modernization Act (FDAMA)
• Impact of PhRMA code
• Impact of GCP Code