Length 112 pages

Date published July 2009

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Outsourcing Preclinical Studies to China: Benefits and Challenges Table of Contents

 

Author: Eric Meyers, MBA

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

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