Outsourcing Preclinical Studies to China

  • July 2009
  • -
  • CHI Insight Pharma Reports


Within the past several years, a number of government 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 and facility visits to 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.

Strategies being used by small, medium, and large pharmas in ChinaFDA’s willingness to accept preclinical data from Chinese labsAdvantages of conducting non-human primate studies in ChinaThe importance of due diligence and project monitoringOptions for managing China programs without an in-country presence

Outsourcing Preclinical Studies to China: Benefits and Challenges 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. Background material for this report was obtained through discussions with executives and facility visits in China. A detailed cost comparison between China and US-based CRO’s shows that study savings of between 35-50% are achievable and that these savings are likely to continue through 2012.

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-sized 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 that language skills and the shortages of key disciplines have on 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 non-human primate breeding facilities and offer a clear advantage to those companies planning non-human primate studies. The report discusses the several Western laboratory mice, rat, and beagle dog vendors and well as feed providers operating in China.

Outsourcing Preclinical Studies to China: Benefits and Challenges presents an analysis of the current and near-term state of preclinical services available in China. The report begins with a short introduction to the evolution of preclinical services as well as a description of the three laboratory ownership categories. Chapter 2 presents the differences in organizational and operational structures, business practices, as well as personnel shortages and infrastructure issues. Chapter 3 provides a cost 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.

About the Author: Eric A. Meyers, MBA, is a consultant to the drug development and medical device industries. His 20 years in the healthcare industry includes senior management positions with Fortune 50 companies and successful startups. Mr. Meyers is a recognized expert in drug development sectors in China and India, leading projects to assist both small and large pharmaceutical companies with their Asia drug development strategies. Mr. Meyers received both an MBA and a B.A. from Harvard University. 
 

Table Of Contents

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
and 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 and 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
and 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

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.

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

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