Guide to Pharmaceutical Outsourcing in China: A Handbook for Pharmaceutical and Biotechnology Companies Planning to Outsource to China

Published by: JZMed, Inc.

Published: Feb. 1, 2008 - 180 Pages

Table of Contents

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 model

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

Abstract

• Why must I choose China as the destination for my outsourcing activities?
• Whether is it the right time to go to China for outsourcing?
• Whether is the IP protection still a serious issue in China?
• Who are those Chinese service providers?
• What can they do?
• How good is each of these individual Chinese CROs?
• Where are they located?
• How to approach them?
• What is the right approach to choose an ideal service provider?
• How to ensure my outsourcing effort in China will be successful?

• A complete and detailed analysis of the current service capabilities of Chinese CROs in each outsourcing area and the strategies of how to choose an ideal CRO that meets outsourcing requirements.
• An in-depth and objective evaluation of the potential risks for outsourcing in China at present time and detailed comparisons of the potential risks against apparent rewards.
• A comprehensive list of suggestions of proper actions the outsourcing companies, in particular the small-sized biotech companies, should take in order to minimize the risks and maximize the benefits from their outsourcing effort in China.
• A complete collection of information of more than 60 Chinese CROs that have capabilities to conduct contract research in drug discovery and development. This information includes: the service scope/capability of each Chinese CRO, the author’s comments on the strengths of their service capability, the CRO company founder's background and the year the CRO was founded, the current number of technical employees (including the approximate percentage of senior (Ph.D. level) scientists) in each CRO company, as well as the complete contact information including street and e-mail addresses, phone and fax numbers as well as websites, etc.
• Detailed comparisons between the Indian pharmaceutical outsourcing service industry and the Chinese pharmaceutical outsourcing service industry, including the strengths and weakness of each country in each service area. Based on the detailed analysis of the service features of each country, the Guide further provides the suggestions to Western companies of where to choose a suitable CRO for their outsourcing projects.
• Valuable insights into the development trend of the world pharmaceutical outsourcing industry, and, based on this trend, a brave but reasonable prediction of the future development trend of the Chinese pharmaceutical outsourcing service industry in the next 5 to 10 years.

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