Guide to Pharmaceutical Outsourcing in China: A Handbook for Pharmaceutical and Biotechnology Companies Planning to Outsource to China
JZMed Inc, March 2008, Pages: 180
As China has become one of the hottest areas for pharmaceutical and biopharmaceutical outsourcing, there is an urgent need for the Western pharma and biotech companies, in particular those small-sized ones who do not have sufficient internal resources to manage all steps of the outsourcing process, to have a complete collection of the information with regards to the current situation and service capabilities of the Chinese pharmaceutical outsourcing service providers. This guide is thus prepared to address these issues.
It provides answers to such questions as:
- Whether is it the right time to go to China for outsourcing?
- 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?
- How to ensure my outsourcing effort in China will be successful?
Besides, it also provides a step-by-step procedure for conducting pharmaceutical outsourcing in China. The Guide could also serve as a useful reference book for those executives in the pharmaceutical and biotechnology industries as well as in the financial investment industry who wish to have a complete understanding of what is really going on in the Chinese pharmaceutical industry and how this industry will develop in the near future.
Guide to Pharmaceutical Outsourcing in China - A Handbook for Pharmaceutical and Biotechnology Companies Planning to Outsource to China is concentrated on description of the current service capabilities of Chinese CROs and the step-by-step procedures of how to conduct and effectively manage the outsourcing activities in China, the two urgent issues that at present need to be addressed for pharmaceutical and biotech companies that either have potential interests or are in planning to outsource to China.
The main features of the Guide include:
- 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 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.
The Guide intends to target the vast pool of readers in pharmaceutical and biotech industry, in particular those executives in the small to medium-sized companies who have urgent needs to outsource their R&D and/or manufacturing tasks but have limited information resources to understand the Chinese outsourcing service industry (its providers and service capabilities). To better serve these readers, the Guide has also sorted the Chinese CROs according to their service capabilities as well as geographic locations in China. The Guide is well defined in nine chapters and more than 180 pages (including close to 20 tables and figures).
This Guide differs from any of the market research reports and/or books already published in this field. It does not intend to provide the complete information about the current development situation of the Chinese pharmaceutical industry. Instead, it focuses on the specific topics in the entire, complicated process of pharmaceutical outsourcing in China. The Guide is written based on the ten years experience of mine in the pharmaceutical outsourcing industry and a broad survey on the Chinese CROs conducted most recently as well as my knowledge about the Chinese pharmaceutical industry accumulated over last two decades.
Based on the current hot situation of the pharmaceutical outsourcing in China, I believe it is the perfect time to publish such a guide. It will certainly provide enormous help in a timely fashion to many pharma and biotech companies that wish to outsource their costly drug research, development and manufacturing work to China.
** Hard copy versions available on request **
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 **
- AbMax Biotechnology Co. Ltd
- AcceleDev Chemical, Co. LLC
- AllyChem, Ltd
- Alputon, Inc
- AstaTech, Inc
- Asymchem Laboratories, Inc
- Beijing Honghui Meditech
- Beijing Joinn Pharmaceutical Center
- Beijing Pharma Sciences
- Beijing WisdomChem Co. Ltd
- BioDuro
- Bridge Pharmaceuticals
- Charles River Laboratories
- ChemExplorer
- ChemiK Co. Ltd
- Chemizon
- ChemPacific Corporation
- ChemPartner
- ChengYi Pharmaceuticals Co
- Chimica Laboratories
- China Gateway Pharma Products, Ltd
- Chiral Quest, Inc
- CrimsonPharma
- Crown Biosciences, Inc
- Daxian Chemical Institute, Ltd
- Ennova MedChem Group, Inc
- Excel Pharma Studies
- Fountain Medical Development, Ltd
- FuXin Hengton Fluorine Chemicals Co. Ltd
- HD Biosciences Co. Ltd
- Huaxipharm Co. Ltd
- Jiangsu Zhongdan Drug Research Co. Ltd
- Laviana Corporation
- Medicilon
- Nanjing Chemzam Pharmtech Co. Ltd
- ONICHEM
- Paramax International, Inc
- Pharmabridge, Inc
- Pharmaron
- Porton Corporation
- Radiant Pharma & Tech Co., Ltd
- ScinoPharm Kunshan
- Shanghai LeadChem Co. Ltd
- Shanghai SINCH Pharmaceuticals Tech. Co. Ltd
- Shanghai SynCores Technologies, Inc
- Sinova, Inc
- StarVax, Inc
- Sundia Meditech Co. Ltd
- SynChem, Inc
- Synergetica, Inc
- Synergy PharmaTech Co. Ltd
- Tyger Scientific, Inc
- United PharmaTech
- Vivo Development, Ltd
- WatsonChem
- Wilmington PharmaTech
- WuXi PharmaTech
- 2Y-CHEM, Ltd
- Yield Pharma
- Zannan Pharma
- Zhejiang Qiming Pharmaceuticals Co. Ltd
** Hard copy versions available on request **
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