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Reportlinker Adds Outsourcing Preclinical Studies to China
Date:10/26/2009

NEW YORK, Oct. 26 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue.

Reportlinker Adds Outsourcing Preclinical Studies to China

http://www.reportlinker.com/p0156558/Reportlinker-Adds-Outsourcing-Preclinical-Studies-to-China.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire

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.

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

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

Shanghai

Shenyang

5.2. Laboratory Profiles

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

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

To order this report:

Reportlinker Adds Outsourcing Preclinical Studies to China

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    Contact Nicolas Bombourg
    Reportlinker
    Email: nbo@reportlinker.com
    US: (805)652-2626
    Intl: +1 805-652-2626

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