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Date published 
February 2005 

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2015: 
Strategic Considerations for the U.S. Pharmaceutical Industry

Ronald A. DiFelice, MBA, Ph.D., Clearview Limited
Contributing Editor: Sam C. Tetlow, MBA, Clearview Limited

New Page 1

Chapter 1. Methodology and Executive Summary
1.1. Methodology
-Data Sources
-Process for Conclusions and Report Content
1.2. Executive Summary

Chapter 2. Adapting to Change
2.1. Adapting to Change: Overview
2.2. Responding to Trends
-Increased Globalization
-Evolving Regulatory Enviro nment
-Industry Consolidation
-Innovation and Speed to Market
-Limitations of Blockbuster Model
-The Changing Consumer
2.3. Tracking Changes: Major Players
-Large Pharmaceutical Companies
-HMOs
-Contract Research Organizations
-Biotechnology Companies
-Service Providers
2.4. Importance of Preparing for the Future: Summary

Chapter 3. Factors Driving Change
3.1. Macro-Environment
-Population Demographics
-Economic Factors
-Globalization
-Bio-Terrorism Threat
-Public Policy
3.2. Micro-Environment
-Drug Discovery
-Drug Delivery
-Drug Manufacturing
-Drug Distribution
-FDA and CMS
-Generics
-Healthcare Services

Chapter 4. Current Industry Issues
4.1 . Competitive Landscape
4.2. New Product Introduction
-R&D
-Regulatory Process
-Managing Clinical Trials and Information
-Commercialization
-Distribution Strategies
4.3. Intellectual Property
4.4. Role of Pharmacies and PBMs
4.5. Partnerships
4.6. Mergers and Acquisitions

Chapter 5. Winning Strategies: Addressing Industry Issues
5.1. Overview: Winning in a Competitive Environment
5.2. Aligning Company, Products, Markets, and Customers
-Organizational Design
-Product Pipeline Management
-Product Offerings
-New Product Introduction
-Marketing
-Public Relations
5.3. Leveraging the New Roles of Pharmacies and PBMs
5.4. Effective IP Management
5.5. Stressing Innovation
5.6. Managing the Regulatory Environment
-Drug Approval Processes
-Manufacturing Practices
-Marketing
-Pricing
5.7. Managing Costs
5.8. Optimizing Alliances

Chapter 6. Pharmaceutical Indu stry 2015: Scenario Analysis
6.1. Scenario Analysis: Success in a Changing Environment
6.2. Scenario 1: Customized Therapeutics and Free Market Innovation Rewarded
-Socio-Economic Developments
-Technology Developments
-Market and Regulatory Developments
-Distribution Developments
6.3. Scenario 2: Blockbuster and Free Market
-A Broken Model
-Socio-Economic Developments
-Technology Developments
-Market and Regulatory Developments
-Distribution Developments
6.4. Scenario 3: Blockbuster and Price Control
-Volume is King
-Socio-Economic Developments
-Technology Developments
-Market and Regulatory Developments
-Distribution Developments
6.5. Scenario 4: Customized Therapeutics and Price Control
-Slow Improvements
-Socio-Economic Developments
-Technology Developments
-Market and Regulatory Developments
-Distribution Developments
6.6. Being Prepared for 2015

References

 


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