Abstract
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 China FDA' s
willingness to accept preclinical data from Chinese labs Advantages of
conducting non-human primate studies in China The importance of due diligence
and project monitoring Options 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
- & 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
