Optimizing Partnerships with Contract Organizations: Effective management, key issues and the development of virtual pharmacos : Market Research Report

Optimizing Partnerships with Contract Organizations: Effective management, key issues and the development of virtual pharmacos

Published: Nov. 1, 2007 - 167 Pages

Optimizing Partnerships with Contract Organizations
Executive Summary: Pharmaceutical outsourcing today; Contract research partnerships; Contract manufacturing partnerships; Offshore outsourcing partnerships; Future trends in partnerships with contract organizations
Chapter 1 Pharmaceutical outsourcing today: Summary; The concept of outsourcing; Pharmaceutical vs. biotech outsourcing; Approaches to outsourcing; Outsourcing research and development; Services offered by CROs; The role of CROs in clinical trials; The role of CROs in pre-clinical trials; Outsourcing manufacturing; Services offered by CMOs; Degree of outsourcing; Level of utilization; How outsourcing decisions are made; Usage of preferred vendors; Virtual drug development companies; Non-profit virtual drug development groups; Big pharma virtual drug development groups; Case study: GlaxoSmithKline; Strategic management of outsourcing; Selecting outsourcing partners; Managing partnerships; Timelines and preventing overruns; Continuous improvement; Conclusion
Chapter 2 Contract research partnerships: Summary; Introduction; Drivers of outsourced R&D; Advantages and disadvantages of using CROs; Level of R&D outsourcing; Reasons for R&D outsourcing; Contract R&D partnerships; Types of relationships; Preferred vendors; Functional service providers; Risk sharing; Case study: Pharmaceutical Product Development, Inc. (PPDI); Case study: Wyeth; Technology partnerships; Drug licensing; Pharmaceutical contract research alliances; Optimizing relationships with CROs; Risks and mitigation; Confidentiality and intellectual property risks; Personnel risks; Company volatility risks; Contract research agreements; Case study: Novartis; Pricing; Conclusion
Chapter 3 Contract manufacturing partnerships: Summary; Introduction; Outsourcing biotech manufacturing; Drivers of outsourcing manufacturing; Cost savings; Risk reduction; Shifting manufacturing requirements; Increased supply of contract manufacturing services; Biotech product approvals; Advantages and disadvantages of using CMOs; Fixed cost savings vs. high variable expenses; Lead time savings vs. relationship management time losses; Access to expertise vs. quality control; Escalating level of manufacturing outsourcing; Reasons for manufacturing outsourcing; Contract manufacturing partnerships; Types of relationships; Pilot plant production; Risk sharing; Capacity sharing; Optimizing relationships with CMOs; Risks and mitigation; Confidentiality and intellectual property risks; Production risks; CMO size; Contract manufacturing agreements; Site visits; Pricing; Selecting outsourcing partners; Conclusion
Chapter 4 Offshore outsourcing partnerships: Summary; Introduction; Offshore outsourcing of contract research; Offshore outsourcing of contract manufacturing; Biopharmaceutical outsourcing; Eastern Europe; Contract research in Eastern Europe; CRO developments in Eastern Europe; Contract manufacturing in Eastern Europe; CMO developments in Eastern Europe; India; Contract research in India; Patent issues; CRO developments in India; Contract manufacturing in India; CMO developments in India; China; Contract research in China; Patent Issues in China; CRO developments in China; Contract manufacturing in China; CMO developments in China; Latin America; Contract research in Latin America; CRO developments in Latin America; Contract manufacturing in Latin America; CMO developments in Latin America; Offshore outsourcing partnerships; Types of relationships; Early stage collaborations; Global networks; Optimizing offshore contracting relationships; Country selection; Contractor communications; Global regulatory reach; Conclusion; Summary; Introduction; Trends in contract research partnering; Preferred vendors; Functional service providers; Risk sharing; Technology partnerships; Drug licensing; CRO alliances; Trends in contract manufacturing partnering; Pilot plant production; Risk sharing; Capacity sharing; Trends in offshore outsourcing partnerships; Early stage collaborations; Global networks; Conclusion
Chapter 6 Appendix: Methodology; Index
List of Figures: Figure 1.1: Tactical vs. strategic outsourcing by type of drug developer, 2007; Figure 1.2: Outsourcing plans by pharmaceutical companies in 2005 and 2006 for the coming year; Figure 1.3: Outsourcing plans by drug developers in 2006 by company size; Figure 1.4: Importance of contract organization characteristics to pharmaceutical outsourcers, 2007; Figure 1.5: Utilization of preferred outsourcing vendors by type of drug developer, 2007; Figure 1.6: Percentage of outsourcing dollars spent on preferred vendors by type of drug developer, 2007; Figure 1.7: View of outsourcing relationship as a partnership by type of drug developer, 2007; Figure 2.8: Potential advantages and disadvantages of using a CRO; Figure 4.9: Relative pharmaceutical research and manufacturing capabilities in Eastern Europe, India, China and Latin America, 2007; Figure 5.10: Relative growth of different types of contract research partnering; Figure 5.11: Relative growth of different types of contract manufacturing partnering; Figure 5.12: Relative growth of different types of offshore outsourcing partnerships
List of Tables: Table 1.1: Summary of drug testing objectives by phase; Table 1.2: Relationships between virtual pharma sponsor and contractors; Table 1.3: Selected virtual drug development organizations; Table 1.4: Reasons for time and budget overruns; Table 2.5: Key characteristics of CRO partnering relationships; Table 3.6: Key characteristics of CMO partnering relationships; Table 3.7: Selected pharmaceutical manufacturing violations, 2002 - 2007; Table 4.8: Advantages and disadvantages of international outsourcing; Table 4.9: Eastern European operations of leading CROs; Table 4.10: Key characteristics of offshore partnering relationships

Abstract

Business Intelligence for the Pharmaceutical Industry
Business Insights' portfolio of pharmaceutical outsourcing management reports are designed to help you make well informed and timely business decisions. We understand the problems facing today's pharmaceutical and healthcare executives when trying to drive your business forward, and appreciate the importance of accurate, up-to-date, incisive product, market and company analysis. We help you to crystallize your business decisions. The strength of our research and analysis is derived from access to unparalleled databases and libraries of information and the use of proprietary analytic techniques. Business Insights reports are authored by independent experts and contain findings garnered from dedicated primary research. Our authors' leading positions secure them access to interview key executives and to establish which issues will be of greatest strategic significance for the industry. Our healthcare portfolio of reports can be used across a wide range of business functions to assess market conditions and devise future strategy. Our reports cover key areas including strategy, industry analysis, market outlook, new business opportunities and strategic insight.

Some key findings from this report...

R&D and manufacturing outsourcing continues to increase, with CRO revenues forecast to grow by 11.5% through 2011 after reaching $16 billion in 2006. CMO revenues are expected to grow by 13.0% annually through 2011, having totalled $35 billion in 2006.
Establishing cross-cultural and distance-management capabilities is crucial for companies outsourcing to India, China and Eastern Europe, as contract research and manufacturing in these regions continues to experience rapid growth.
Quality has overtaken cost as the most desirable characteristic for contract organizations, having been cited as the single highest priority for respondents in a recent survey of outsourcing executives.
Preferred vendors have become the most popular form of CRO partnership due to significant time-savings and repeat business potential. A rise in R&D risk-sharing is also expected, as large CRO’s seek to participate in growth opportunities.

Optimizing Partnerships with Contract Organizations
As financial pressures continue to rise, cost containment efficiencies and time-to-market improvements have made outsourcing an attractive option for pharmaceutical companies. An increasing number of companies have becoming engaged in outsourced research and manufacturing, experiences highlight that the effective management of business relationships between a company and their contract organization is crucial to project success. Partnerships can help to develop closer relationships between sponsors and contractors, facilitating a mutual understanding of organizational structure, culture and priority that can ultimately lead to improved project outcomes. However, the ever changing nature of the pharma industry means that such partnerships are not always easy to establish and require careful management. Optimizing Partnerships with Contract Organizations is a new report published by Business Insights that provides a comprehensive review of pharmaceutical outsourcing partnerships and identifies expected changes in relationship dynamics over the next five years. This report uses case studies of successful and unsuccessful partnering strategies to highlight the most effective methods of reducing risk, in addition to evaluating the emerging trends and offshore outsourcing opportunities of markets such as Eastern Europe, China, India and Latin America. Evaluate the applicability of different partnering strategies, identify outsourcing trends in global regions and understand how to minimize risks in your CRO/CMO relationships with this new report...

Top five reasons to order your copy today

Assess the potential impact of partnering strategies on your drug development programs with this report’s detailed evaluation of preferred vendor relationships, functional service contracts, risk sharing, technology partnerships, drug licensing and CRO alliances.
Discover the offshore outsourcing potential of key global regions including Eastern Europe, India, China and Latin America with this report’s examination of patent protection issues and legislative changes affecting CRO’s and CMO’s in these areas.
Identify the synergistic capabilities of emerging partnering approaches from this report’s analysis of pilot plant production, risk-sharing and capacity-sharing.
Use case studies to understand the factors behind successful and unsuccessful partnering strategy implementations and enhance your relationships with R&D contractors to optimize research productivity.
Avoid costly project overruns and delays with this report’s risk minimization recommendations for intellectual property, personnel churn and industry volatility in CRO and CMO relationships.

Key issues examined in this report...

The partnership approach. Shifting away from contract-vendor styles of relationship is crucial for biopharma companies engaged in projects with CRO’s and CMO’s. The partnership-centric approach is emerging as a successful alternative that consistently meets expectations.
Relationship management. As pressures in the biopharma sector continue to prompt contract organization partnerships, there is a growing need for careful relationship management to diminish the risk of premature project terminations and unfulfilled objectives.
Industrial instability. Contract service providers are experiencing increased industrial consolidation, lay-offs, job switching and M&A activity. Long term partnerships are growing in importance as a means to survive such developments and reduce potential losses in relationship capital.
Emerging markets. The rise of CRO’s and CMO’s in emerging markets such as India, China and Latin America will offer potential cost-savings far greater than those of U.S. and European contractors. However, a host of cultural and other challenges must be addressed in order to develop and maintain successful relationships.

Your questions answered...

Why are partnerships becoming increasingly desirable for drug developers?
Which types of CRO and CMO partnering relationships will expand the most over the next five years?
How can partnering relationships help to reduse risks in research and manufacturing?
What are the obstacles to establishing successful relationships with offshore contractors?
Which emerging partnership trends are crucial to organizational agility and competitiveness?
What strategies are being employed by smaller CRO’s to compete with full-service groups?

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Optimizing Partnerships with Contract Organizations: Effective management, key issues and the development of virtual pharmacos

Table of Contents

Abstract