Outsourcing Preclinical Studies to China: Benefits and Challenges Overview

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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.

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Outsourcing Preclinical Studies to China: Benefits and Challenges Overview

  1. 1. Outsourcing Preclinical Studies to China: Benefits and Challenges OverviewReport SummaryWithin the past several years in China, a number of state-owned labs as well as private andjoint 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/orauditing at the most advanced labs, provides a detailed view of the current and evolvingpreclinical study capabilities in China, their structures and services as well as an analysis ofthe comparative costs between US and China-based CRO’s.Buy Now: Preclinical Studies to China MarketBrowse All: Newly Published Market Research ReportsThis report reviews the state of preclinical study services in China to identify the currentlevel and near term trends for compliance with Western GLP standards. Competition tosupply CRO services is beginning to cause consolidation and attrition within China. A smallnumber of key preclinical service providers, identified and profiled in this report, haveemerged as strong CRO providers. A detailed cost comparison between China and US-basedCRO’s and a detailed case study analysis shows that study savings of between 35−50% areachievable 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 impactthe approach one takes to evaluating and managing preclinical studies when using a China-based CRO. Western companies with and without operations in China have developedsuccessful approaches to conducting preclinical trials in China. The report describes severalapproaches companies have taken to address such issues.The cost savings associated with using CRO preclinical services in China are discussed inthis report in the context of organizational and operational differences between CRO’s basedin the West and in China. A number of factors are presented that study sponsors mustconsider before committing to a Chinese CRO. Small and medium companies can make theirpreclinical studies budget go further by using Chinabased CRO’s through appropriate due diligence and upfront project planning. FDA and EUregulators have accepted preclinical data generated by China-based CRO’s as described inthe 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 haveon what studies and how best to structure preclinical studies in China. Also evaluated arethe broad issues such as IP protection and CRO ownership as well as laboratory animalrights regulations. CRO’s in China have access to large NHP breeding facilities and offer a
  2. 2. clear advantage to those companies planning NHP studies. The report also discusses theseveral Western laboratory mice, rat and beagle dog vendors and well as lab animal feedproviders operating in China.The report presents an analysis of the current and near term state of preclinical servicesavailable in China beginning with a short introduction to the evolution of preclinical servicesas well as a background description of the three laboratory ownership categories. Chapter 2describes the differences in organizational and operational structures, business practices aswell as personnel storages and infrastructure issues that impact the choices available toWestern companies. Chapter 3 provides a cost comparison and a case study comparingpreclinical study cost between the US and China. Chapter 4 provides a discussion of possiblecaveats and due diligence factors to be considered when considering placing a preclinicalstudy in China. Chapter 5 provides profiles covering operations, facilities and servicesof the eleven most advanced CRO’s in China.Latest Market Research Reports: Direct-To-Consumer Genetic Testing: Business Prospects in the United States Strategic Management of Resources and Portfolios MVNO Business Plan Comprehensive MVNO/MVNE Package China Wind Turbine Gearbox Industry, (2011 Deep Research Report) China coal mining and washing industry, 2011 Markets for OLED MaterialsTable of contents:Chapter 1INTRODUCTION1.1. Why China: The Current High Level Perspective1.2 Why China: Motivation and Strategic Considerations for Assessing the ChinaOpportunity1.3. Why China: Emergence of the Preclinical CRO Sector1.4. Why China: Trends in Safety Science Services and China’s Role1.5. Report Background and ContentChapter 2THE STATE OF PRECLINICAL SAFETY SERVICES IN CHINA2.1. OverviewOrganizational HistoryHigh Profile LaboratoriesSFDA AccreditationSFDA vs. US/OECD GLP Standards2.2. Industry Structure and Competitive DynamicsSFDA LabsPrivate Labs
  3. 3. Additional Observations2.3. Industry InfrastructureLanguage and CommunicationProtection of Intellectual Property Rights and ConfidentialInformationFacilitiesLab SpaceLab Automation SystemsInstrumentation2.4. GLP Compliance2.5. FDA Acceptance of Data, Laboratory Inspections2.6. Human Resources, Key Job Categories, and Workforce StabilityExamples of Personnel LimitationsPathologyLaboratory Animal Health2.7. Animal Husbandry and SupplyLaboratory Animal WelfareAnimal SupplyNon-Human Primate (NHP) StudiesChapter 3COST COMPARISONS FOR PRECLINICAL SERVICES BETWEEN U.S. AND CHINA3.1. Comparison Cost Examples3.2. Management Oversight3.3. Study PricingPricing Case StudyPrice SustainabilityChapter 4KEY PLANNING ISSUES TO ADDRESS WHEN PLACING STUDIES IN CHINA4.1. Important Factors for ConsiderationTotal Cost ElementsTimingRange of ServicesHistopathologyStudy Management and OversightThird Party Option.Laboratory OwnershipBusiness AttitudeManaging Regulatory RiskClosing CommentChapter 5PRECLINICAL CROs IN CHINA5.1. IntroductionBeijingShanghaiShenyangChengdu5.2. Laboratory ProfilesBEIJINGBridge Laboratories—BeijingSummary and Background InformationFacilities
  4. 4. OperationsBeijing Join—BeijingSummary and Background InformationBioDuro—National Center for Safety Evaluation ofDrugs National Institute for the Control of Pharmaceutical& Biological Products (NCSED)Summary and Background InformationFacilitiesOperationsNational Beijing Center for Drug Safety Evaluation andResearch/IPT (NBCDSER)—MicroConstants ChinaSummary and Background InformationFacilitiesOperationsSHENYANGShenyang Chemical Industry Research Institute, SafetyEvaluation Center (aka National Shenyang Center for SafetyEvaluation of New Drug—NCDSE & PSEC)Summary and Background InformationFacilitiesCHENGDUNational Chengdu Center for Safety Evaluation of Drugs(NCCSED)—Frontier BioSciences (NCCSED is also knownas the West China-Frontier Pharmatech Co. Ltd.)Summary and Background InformationFacilitiesOperationsSHANGHAICharles River Labs—China (formed as part of the CharlesRiver Labs JV with Shanghai BioExplorer Co., Ltd.)Summary and Background InformationFacilitiesOperationsNational Shanghai Center for New Drug Safety Evaluation& Research (NCDSER), Zhangjiang Hi-Tech ParkSummary and Background InformationFacilitiesOperationsMedicilon-MPI, Zhangjiang Hi-Tech ParkSummary and Background InformationFacilitiesOperationsWuXi AppTec, Wuzhong District, Suzhou, Jiangsu Province(1–1.5 hours from Shanghai)Summary and Background InformationFacilitiesOperationsShangPharma, Zhangjiang Hi-Tech ParkSummary and Background InformationFacilities/OperationsSNBL China
  5. 5. Summary and Background InformationReferences and NotesLIST OF TABLESTable 3.1. Provides Cost Comparison for Sub-chronic Rat Studies andChronic Monkey StudiesTable 3.2. Cost Elements for System-to-Model Toxicology CostsTable 3.3. Cost Comparison for Preclinical Safety Testing—US vs.. ChinaTable 3.4. Comparison of Cost Elements for Preclinical Studies—China vs.. US.LIST OF FIGURESFigure 1.1. Timeline of Major Developments in the Preclinical Safety SectorFigure 2.1. Western GLP Compliance Distribution in China and USFigure 3.1. Cost Comparisons—6 Month NHP GLP StudiesFigure 3.2. Cost Comparisons—1-Month Rat GLP StudiesFigure 4.1. Relative risk points associated with a typical IND submissionAbout Us:ReportsnReports is an online library of over 75,000 market research reports and in-depthmarket research studies & analysis of over 5000 micro markets. We provide 24/7 online andoffline support to our customers. Get in touch with us for your needs of market researchreports.Contact:Mr.Priyank7557 Rambler road,Suite727,Dallas,TX75231Tel: +1-888-989-8004E-mail: sales@reportsnreports.comhttp://www.reportsnreports.com

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