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Guide to Pharmaceutical Outsourcing in China: A Handbook for Pharmaceutical and Biotechnology Companies Planning to Outsource to China
JZMed Inc., March 2008, Pages: 180
Executive Summary
Chapter 1. Introduction: Global pharmaceutical industry experiencing extraordinary pressures
Chapter 2. Necessity of pharmaceutical outsourcing and emerging of Asian countries as favored places
I. A brief description of drug discovery, development and manufacturing process
II. Driving forces for outsourcing: to reduce cost and gain access to alternative resources
III. Emerging of Asian countries as favored places for pharmaceutical outsourcing
IV. Summary of necessity, benefits and current development trend of pharmaceutical outsourcing
Chapter 3. Comparisons between Chinese CROs and Indian CROs
I. Strengths of Indian pharmaceutical industry
II. Comparisons between the Indian pharmaceutical industry and the Chinese pharmaceutical industry: why is China becoming more and more favored for pharmaceutical outsourcing?
III. Where to choose a CRO: India or China
Chapter 4. Emerging of China as a new, favored place for pharmaceutical outsourcing: its current development situation and service capabilities
I. Changes in the structure of the Chinese pharmaceutical industry
II. Overall environment of pharmaceutical outsourcing in China
III. Current service capabilities of the Chinese pharmaceutical service industry
1. Chinese pharmaceutical service industry is backed by a strong higher education system
2. Current service capabilities of Chinese CROs
A. Service capabilities for early stage drug R&D
B. Service capabilities for preclinical research
C. Service capabilities for clinical research
D. Service capabilities for contract manufacturing
IV. Benefits of outsourcing to China
Chapter 5. IP Issue in China: an objective evaluation of risks and rewards for outsourcing to China
I. IP protection in China: the real situation
1. Actions taken by the Government to correct this issue
2. Chinese people have become more self-conscious about IP protection
3. Positive reactions of the Western companies to the current situation of
IP protection in China
II. Evaluation of potential risks for outsourcing to China
III. Comparisons of risks versus rewards for outsourcing to China
IV. How to maximize the rewards
1. Do a self-assessment first
2. Choose a CRO carefully
3. Check availability of internal resources
4. Bring the Western standard at the very beginning
5. Manage your outsourced projects effectively
6. Pay attention to the relationship
V. Dismissal of fears of outsourcing drug R&D to China
Chapter 6. Procedures for outsourcing to China
Step 1. Classifying the projects to be outsourced to China and assessing their risk tolerance level
Step 2. Identifying a qualified Chinese CRO whose service capabilities match the requirements of your projects to be outsourced
I. Classification of Chinese CROs according to their service capabilities
II. Geographic distributions of the Chinese CROs
III. Factors affecting the decision of choosing an outsourcing service provider in China
1. Service quality
2. IP protection and confidentiality commitment
3. Cost
4. Geographic location
5.Business mode
6. Management
IV. Advices for selection of a right CRO
Step 3. Approaching a Chinese CRO
I. Starting contact with potential partners
II. Signing Confidential Disclosure Agreement (CDA)
III. Requesting bid proposals
IV. Pay on-site visit to the potential service providers: Facility audit
V. Singing contract
Step 4. Effectively managing your outsourced projects
I. Facilities and how an outsourced project is managed in a Chinese CRO
II. How to effectively manage your outsourced projects in China
III. Pay attention to establishing a good relationship
Chapter 7. Evaluation of the possibility of small biotech companies to outsource to China
I. Necessity of small-sized biotech companies to outsource to China
II. Advices for small-sized biotech companies planning to outsource to China
III. Steps to effectively protect your IP rights
Chapter 8. Prediction of the future development of the Chinese pharmaceutical service industry
I. Development of the Western pharmaceutical service industry
II. Development of the Indian Pharmaceutical service industry
III. Future prediction of the development of the Chinese pharmaceutical service industry
Chapter 9. Company profiles of China-based CROs (A total of 61 Chinese CROs that are able to conduct contract research)
Appendixes
Appendix I. About JZMed, Inc
Appendix II. Author’s Biography
Appendix III. Sample CDA
Indexes
Index: Company profiles of China-based CROs
List of tables
Table 1. Layoffs recently announced by world major pharma and biotech companies
Table 2. Pressures and requirements for the pharmaceutical industry
Table 3. Some representative Chinese pharmaceutical companies that provide contract manufacturing services to the Western pharmaceutical companies
Table 4. List of CROs capable of conducting custom synthesis on small to medium scale (grams to kilograms)
Table 5. List of CROs capable of conducting chemical process research, development and optimization
Table 6. List of CROs capable of conducting medicinal chemistry research
Table 7. List of CROs capable of conducting pharmacological property study
Table 8. List of CROs capable of conducting preclinical trials
Table 9. List of CROs capable of conducting cGMP production on various scales (kilograms to metric tons)
Table 10. List of CROs capable of conducting clinical trials
Table 11. List of Chinese CMOs (contract manufacturing companies)
Table 12. List of CROs located in the Great Shanghai Area
Table 13. List of CROs located in Beijing
Table 14. List of CROs located in other cities than Great Shanghai Area and Beijing
List of figures
Figure 1. Description of entire drug discovery, development and manufacturing Process
Figure 2. Service capabilities for early stage drug R&D
Figure 3. Service capabilities for preclinical research
Figure 4. Service capabilities for clinical research
Figure 5. Service capabilities for contract manufacturing
** Hard copy versions available on request **
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