This action might not be possible to undo. Are you sure you want to continue?
Guide to Pharmaceutical Outsourcing in China
A Handbook for Pharmaceutical and Biotechnology Companies Planning to Outsource to China
By Jim J. Zhang, Ph.D. February, 2008
JZM Inc. ed,
Jim J. Zhang, Ph. D. Jim J. Zhang currently is president and managing director of JZMed, Inc., a US-based, full scale pharmaceutical service company specializing in outsourcing to China. Before founding the company, Jim worked for nine years with Albany Molecular Research, Inc. (AMRI), a US-based and currently one of the world largest CROs. During his tenure at AMRI Jim was responsible for managing and overseeing multiple drug R&D projects that involved the international cooperation of AMRI’s multiple sites (USA, Singapore and Hungary). He played key roles in helping numerous pharma and biotech companies discover and develop a series of drug candidates that later entered preclinical and clinical development including advanced clinical trials. He was also the key contributor to the development of chemical production process for several developmental drugs. Prior to pursuing his Ph.D. program in the US, Jim worked for six years in a China-based CMO as process engineer and developed production process for a number of pharma products. In the practice of more than fifteen years Jim developed his expertise in chemical process research and development and in the therapeutic areas of viral infection, cancer, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. Currently he holds 18 patents and is also the principal author of 11 peer-reviewed research articles. Jim received his master’s degree in Chemical Engineering from East China University of Science & Technology (Shanghai), and his Ph.D. degree in Synthetic Organic Chemistry from the University of Iowa. He also received additional trainings in Medicinal Chemistry through working at Research Triangle Institute (Research Triangle Park, North Carolina).
Description of the Guide
As China has become the hottest area 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 complex outsourcing process, to have a complete collection of information with regards to how to effectively conduct outsourcing in China. This Guide is thus designed to provide assistance to these companies. The Guide examined following issues concerned by all outsourcing companies and provided detailed answers to each of them: Why must I choose China as the destination of outsourcing? Whether is it the right time to go to China for outsourcing? What is the cost saving I can achieve? What other benefits can I achieve if I choose China for outsourcing? Whether is the IP protection in China still a concern? Who are those Chinese service providers? What can they do? How good is each of these individual Chinese service providers? Where are they located? How to approach them? What is the right approach to choose an ideal Chinese service provider? How to ensure my outsourcing effort in China will be successful?
The Guide differs from any of the market research reports already published in related fields. It is solely concentrated on description of the current service capabilities of Chinese CROs/CMOs and the step-by-step procedures of how to conduct and effectively manage 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 Guide is written by industry expert who possesses over ten years of experience in pharmaceutical outsourcing industry. It is also based on the direct results of a broad survey most recently conducted on Chinese pharmaceutical outsourcing industry.
Main Features of the Guide
The Guide conducted a complete and detailed examination on current service capability of Chinese outsourcing industry in each service area including their strengths and weakness. Based on the results, it provided to the outsourcing companies the right strategies and approaches of how to choose an ideal service provider whose service capability matches the requirements of their outsourcing projects. The Guide made an in-depth and objective evaluation of the potential risks of outsourcing to China at present. It also made detailed comparisons of apparent rewards versus the potential risks. The Guide provided a comprehensive list of suggestions of proper actions outsourcing companies should exercise in order to minimize risks and maximize rewards in their outsourcing effort in China. The Guide contains a complete collection of information of more than 60 Chinabased, currently the best service providers. The complete package of information for each of these service providers includes: Service scope and capability; Evaluation on their service strengths; Background, culture and service history/experience; Current number of technical employees including approximate percentage of senior level scientists; Complete contact information including street and e-mail addresses, phone and fax numbers as well as websites. In addition, the Guide also made detailed comparisons in outsourcing industry between India and China including strengths and weakness of each country in each service area. Based on the service features each country possesses, the Guide further provides suggestions to outsourcing companies of where to choose a suitable service provider for their specific outsourcing projects. The Guide provided valuable insights into the development trend of world pharmaceutical outsourcing industry. Based on the results of these analyses, the Guide made reasonable forecasts of the future development of the Chinese pharmaceutical outsourcing industry in following 5 to 10 years.
Who Should Buy This Guide
The Guide is a must-have book for: Pharma/biotech companies in particular those small to medium-sized ones 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. Pharma/biotech companies who have never conducted outsourcing activities in China before but wish to do so now and need a general guide to help them navigate the process. Pharma/biotech companies large or small who have had outsourcing activities in China before or presently but would like to update their knowledge about the development of this Chinese industry. Executives in the industries of pharmaceutical, biotechnology and financial investment as well as those in government agencies who wish to have a complete understanding of what is really going on in China pharmaceutical industry and how this industry would likely develop in near future. Worldwide pharmaceutical outsourcing service companies who wish to better understand current situation including service capabilities of their Chinese competitors Pharmaceutical companies and outsourcing service companies in China who wish to better understand the current situation of world pharmaceutical outsourcing industry as well as the service capabilities of their peer competitors in order to improve their own service capability.
Table of Contents
Executive Summary Chapter 1. Global Pharmaceutical Industry Experiencing Extraordinary Pressures Chapter 2. Necessity of Pharmaceutical Outsourcing and Emerging of Asian Countries as Favored Places 2.1 A brief description of drug discovery, development and manufacturing process 2.2 Driving forces for outsourcing: to reduce cost and gain access to alternative resources 2.3 Emerging of Asian countries as favored places for pharmaceutical outsourcing 2.4 Summary of necessity, benefits and current development trend of pharmaceutical outsourcing Chapter 3. Comparisons between China and India in Pharmaceutical Outsourcing 3.1 Strengths of Indian pharmaceutical industry 3.2 Comparisons between Indian pharmaceutical industry and Chinese pharmaceutical industry: why is China becoming more and more favored for pharmaceutical outsourcing? 3.3 Where to choose a service provider: India or China? Chapter 4. Emerging of China as a New, Favored Place for Pharmaceutical Outsourcing: Current Development Situation and Service Capability 4.1 Changes in the structure of Chinese pharmaceutical industry 4.2 Overall environment of pharmaceutical outsourcing in China 4.3 Current service capabilities of Chinese pharmaceutical outsourcing industry 4.3.1 Chinese pharmaceutical outsourcing industry is backed by a strong higher education system 4.3.2 Current service capability 1. Service capability in early stage drug R&D 2. Service capability in preclinical research 3. Service capability in clinical research 4. Service capability in contract manufacturing 4.4 Benefits of outsourcing to China Chapter 5. IP Issue in China − An Objective Evaluation of Risks and Rewards for Outsourcing to China
5.1 IP protection in China: the real situation 5.1.1 Actions taken by Government to correct this issue 5.1.2 Chinese people have become more self-conscious about IP protection 5.1.3 Positive reactions of Western companies to current situation of IP protection in China 5.2 Evaluation of potential risks for outsourcing to China 5.3 Comparisons of risks versus rewards for outsourcing to China 5.4 How to maximize rewards 5.4.1 Do a self-assessment first 5.4.2 Choose a CRO/CMO carefully 5.4.3 Check availability of internal resources 5.4.4 Bring Western standard at the very beginning 5.4.5 Manage your outsourced projects effectively 5.4.6 Pay attention to relationship 5.5 Dismiss fears of outsourcing drug R&D to China Chapter 6. Right Procedures for Outsourcing to China 6.1 Step 1. Classifying the projects to be outsourced to China and assessing their risk tolerance level 6.2 Step 2. Identifying a qualified Chinese service provider whose capabilities match the requirements of your projects 6.2.1 Classification of Chinese service providers according to their service capabilities 6.2.2 Geographic distributions of Chinese service providers 6.2.3 Factors affecting the decision of choosing a right outsourcing service provider 1. Service quality 2. IP protection and confidentiality commitment 3. Cost 4. Geographic location 5. Business model 6. Management 6.2.4 Advices for selection of a right CRO/CMO 6.3 Step 3. Right approaches to a Chinese service provider 6.3.1 Starting contact with potential partners 6.3.2 Signing Confidential Disclosure Agreement (CDA) 6.3.3 Requesting bid proposals 6.3.4 Pay on-site visit to potential service providers: Facility audit 6.3.5 Singing contract 6.4 Step 4. Effectively managing your outsourced projects 6.4.1 Facilities and how an outsourced project is managed in a Chinese CRO/CMO 6.4.2 How to effectively manage your outsourced projects in China 6.4.3 Pay attention to establishing a good relationship
Chapter 7. Small Biotech Companies Outsourcing to China 7.1 Necessity of small-sized biotech companies to outsource to China 7.2 Advices to small-sized biotech companies planning to outsource to China 7.3 Steps of effectively protecting your IP rights Chapter 8. Prediction of Future Development of Chinese Pharmaceutical Outsourcing Industry 8.1 Development of Western pharmaceutical outsourcing industry 8.2 Development of Indian Pharmaceutical outsourcing industry 8.3 Future development of Chinese pharmaceutical outsourcing industry Chapter 9. Company Profile of 61 China-based, Best Outsourcing Service Providers Appendixes Appendix I. About JZMed, Inc. Appendix II. About Author Appendix III. Sample CDA Indexes List of profiled CROs/CMOs List of Tables Table 1. Layoffs recently announced by world major pharma and biotech companies Table 2. Pressures and requirements global pharmaceutical industry is facing Table 3. Representative Chinese pharmaceutical companies that provide contract manufacturing services Table 4. CROs/CMOs capable of conducting custom synthesis on small to medium scale (grams to kilograms) Table 5. CROs/CMOs capable of conducting chemical process research, development and optimization Table 6. CROs capable of conducting medicinal chemistry research Table 7. CROs capable of conducting pharmacological property study Table 8. CROs capable of conducting preclinical research Table 9. CROs/CMOs capable of conducting cGMP production on various scales (kilograms to metric tons) Table 10. CROs capable of conducting clinical research Table 11. List of China-based CMOs Table 12. CROs/CMOs located in Great Shanghai Area Table 13. CROs/CMOs located in Beijing Table 14. CROs/CMOs 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 in early stage drug R&D Figure 3. Service capabilities in preclinical research Figure 4. Service capabilities in clinical research Figure 5. Service capabilities in contract manufacturing
About JZMed, Inc.
JZMed, Inc. is a leading pharmaceutical outsourcing service provider that specializes in services for pharmaceutical and biotechnology industry. The company’s primary focus is to help Western pharmaceutical and biotech companies explore the opportunities in China, including tapping the Chinese pharmaceutical market and the resources in the Chinese pharmaceutical industry. Meanwhile, it also provides intelligence and market research services to these companies to facilitate their entrance into the Chinese pharmaceutical market or collaborations with any Chinese companies. The company has had opportunities to provide services to and collaborate with a variety of pharmaceutical and biotech companies worldwide that focus on drug discovery, development and/or manufacturing. It also has a network of preferred contract pharmaceutical research and manufacturing companies in China.
Information about the report: Report title: Guide to Pharmaceutical Outsourcing in China − A Handbook for Pharmaceutical and Biotechnology Companies Planning to Outsource to China Author: Jim J. Zhang, Ph.D. Publisher: JZMed, Inc. Total number of pages: 180 Date published: February, 2008
Price Information: For single user: $2,999/PDF copy; $3,099/hard copy For department licensing: $4,699 (PDF copy only) For enterprise-wide licensing: $7,699 (PDF copy only)
Easy payment: Report ordering can be processed through Paypal, secured online payment, at the website of JZMed, Inc. (www.jzmedi.com). All major credit cards are accepted. Or pay via electronic bank wire. Please contact JZMed, Inc. for bank information.
Report delivery: Upon the confirmation of order payment, electronic copy (PDF version) will be delivered via e-mail within 24 hours. Hardcopy will be mailed out within 2 business days.
Return policy Please read the Return Policy at the website of JZMed, Inc. www.jzmedi.com.
Your contact Information:
Your name: First Name________________ Last Name ___________________ Job Title ________________________________________________________ Company Name __________________________________________________ Type of Business __________________________________________________ Address _________________________________________________________ _________________________________________________________ Phone___________________________________________________________ Fax_____________________________________________________________ E-mail __________________________________________________________ Web ___________________________________________________________
Electronic copy (PDF version. For single user only): Price: $2,999 Hardcopy: Price: $3,099 per copy. Number of copies:_______ Total price: ____________ Department licensing: $4,699 Enterprisewide licensing: $7,699
Please forward your order form to JZMed, Inc. through E-mail: firstname.lastname@example.org or Fax: 1-518-477-4831.
This action might not be possible to undo. Are you sure you want to continue?
We've moved you to where you read on your other device.
Get the full title to continue listening from where you left off, or restart the preview.