Outsourcing Preclinical Studies to China: Benefits and Challenges Overview

Report Summary

Within the past several years in China, a number of state-owned labs as well as private and joint venture CRO’s have or will soon offer preclinical GLP study services to Western clients. This report, built on discussions, facility visits, and in many cases study monitoring and/or auditing at the most advanced labs, provides a detailed view of the current and evolving preclinical study capabilities in China, their structures and services as well as an analysis of the comparative costs between US and China-based CRO’s.

This report reviews the state of preclinical study services in China to identify the current level and near term trends for compliance with Western GLP standards. Competition to supply CRO services is beginning to cause consolidation and attrition within China. A small number of key preclinical service providers, identified and profiled in this report, have emerged as strong CRO providers. A detailed cost comparison between China and US-based CRO’s and a detailed case study analysis shows that study savings of between 35−50% are achievable and that these saving are likely to continue through 2012 and beyond. However, as the report details, a series of cultural, language, training and operational issues impact the approach one takes to evaluating and managing preclinical studies when using a China-based CRO. Western companies with and without operations in China have developed successful approaches to conducting preclinical trials in China. The report describes several approaches companies have taken to address such issues.

The cost savings associated with using CRO preclinical services in China are discussed in this report in the context of organizational and operational differences between CRO’s based in the West and in China. A number of factors are presented that study sponsors must consider before committing to a Chinese CRO. Small and medium companies can make their preclinical studies budget go further by using China

based CRO’s through appropriate due diligence and upfront project planning. FDA and EU regulators have accepted preclinical data generated by China-based CRO’s as described in the report and the FDA has begun to build a resident inspector network in China.

This report describes the impact of language skills and the shortages of key disciplines have on what studies and how best to structure preclinical studies in China. Also evaluated are the broad issues such as IP protection and CRO ownership as well as laboratory animal rights regulations. CRO’s in China have access to large NHP breeding facilities and offer a clear advantage to those companies planning NHP studies. The report also discusses the several Western laboratory mice, rat and beagle dog vendors and well as lab animal feed providers operating in China.

The report presents an analysis of the current and near term state of preclinical services available in China beginning with a short introduction to the evolution of preclinical services as well as a background description of the three laboratory ownership categories. Chapter 2 describes the differences in organizational and operational structures, business practices as well as personnel storages and infrastructure issues that impact the choices available to Western companies. Chapter 3 provides a cost comparison and a case study comparing preclinical study cost between the US and China. Chapter 4 provides a discussion of possible caveats and due diligence factors to be considered when considering placing a preclinical study in China. Chapter 5 provides profiles covering operations, facilities and services
of the eleven most advanced CRO’s in China.

Chapter 1
INTRODUCTION
1.1. Why China: The Current High Level Perspective
1.2 Why China: Motivation and Strategic Considerations for Assessing the China Opportunity
1.3. Why China: Emergence of the Preclinical CRO Sector
1.4. Why China: Trends in Safety Science Services and China’s Role
1.5. Report Background and Content

Chapter 2
THE STATE OF PRECLINICAL SAFETY SERVICES IN CHINA
2.1. Overview
Organizational History
High Profile Laboratories
SFDA Accreditation
SFDA vs. US/OECD GLP Standards
2.2. Industry Structure and Competitive Dynamics
SFDA Labs
Private Labs
Additional Observations
2.3. Industry Infrastructure
Language and Communication
Protection of Intellectual Property Rights and Confidential
Information
Facilities
Lab Space
Lab Automation Systems
Instrumentation
2.4. GLP Compliance
2.5. FDA Acceptance of Data, Laboratory Inspections
2.6. Human Resources, Key Job Categories, and Workforce Stability
Examples of Personnel Limitations
Pathology
Laboratory Animal Health
2.7. Animal Husbandry and Supply
Laboratory Animal Welfare
Animal Supply
Non-Human Primate (NHP) Studies

Chapter 3
COST COMPARISONS FOR PRECLINICAL SERVICES BETWEEN U.S. AND CHINA
3.1. Comparison Cost Examples
3.2. Management Oversight
3.3. Study Pricing
Pricing Case Study
Price Sustainability

Chapter 4
KEY PLANNING ISSUES TO ADDRESS WHEN PLACING STUDIES IN CHINA
4.1. Important Factors for Consideration
Total Cost Elements
Timing
Range of Services
Histopathology
Study Management and Oversight
Third Party Option.
Laboratory Ownership
Business Attitude
Managing Regulatory Risk
Closing Comment

Chapter 5
PRECLINICAL CROs IN CHINA
5.1. Introduction 
Beijing
Shanghai
Shenyang
Chengdu
5.2. Laboratory Profiles
BEIJING
Bridge Laboratories—Beijing
Summary and Background Information
Facilities
Operations
Beijing Join—Beijing
Summary and Background Information
BioDuro—National Center for Safety Evaluation of
Drugs National Institute for the Control of Pharmaceutical
& Biological Products (NCSED)
Summary and Background Information
Facilities
Operations
National Beijing Center for Drug Safety Evaluation and
Research/IPT (NBCDSER)—MicroConstants China
Summary and Background Information
Facilities
Operations
SHENYANG
Shenyang Chemical Industry Research Institute, Safety
Evaluation Center (aka National Shenyang Center for Safety
Evaluation of New Drug—NCDSE & PSEC)
Summary and Background Information
Facilities
CHENGDU
National Chengdu Center for Safety Evaluation of Drugs
(NCCSED)—Frontier BioSciences (NCCSED is also known
as the West China-Frontier Pharmatech Co. Ltd.)
Summary and Background Information
Facilities
Operations
SHANGHAI
Charles River Labs—China (formed as part of the Charles
River Labs JV with Shanghai BioExplorer Co., Ltd.)
Summary and Background Information
Facilities
Operations
National Shanghai Center for New Drug Safety Evaluation
& Research (NCDSER), Zhangjiang Hi-Tech Park
Summary and Background Information
Facilities
Operations
Medicilon-MPI, Zhangjiang Hi-Tech Park
Summary and Background Information
Facilities
Operations
WuXi AppTec, Wuzhong District, Suzhou, Jiangsu Province
(1–1.5 hours from Shanghai)
Summary and Background Information
Facilities
Operations
ShangPharma, Zhangjiang Hi-Tech Park
Summary and Background Information
Facilities/Operations
SNBL China

Summary and Background Information
References and Notes

LIST OF TABLES

Table 3.1. Provides Cost Comparison for Sub-chronic Rat Studies and
Chronic Monkey Studies
Table 3.2. Cost Elements for System-to-Model Toxicology Costs
Table 3.3. Cost Comparison for Preclinical Safety Testing—US vs.. China
Table 3.4. Comparison of Cost Elements for Preclinical Studies—
China vs.. US.

LIST OF FIGURES

Figure 1.1. Timeline of Major Developments in the Preclinical Safety Sector
Figure 2.1. Western GLP Compliance Distribution in China and US
Figure 3.1. Cost Comparisons—6 Month NHP GLP Studies
Figure 3.2. Cost Comparisons—1-Month Rat GLP Studies
Figure 4.1. Relative risk points associated with a typical IND submission