Outsourcing in Drug Discovery, 3rd Edition

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

• Overview
• Scope and Methodology
• Introduction
  • Pharmaceutical industry challenges
• The Drug Discovery Process and Outsourcing
  • Accelerating the Drug Discovery Process
  • Bottlenecks in the Drug Discovery Process
  • Outsourcing to Increase Efficiency
• The Outsourcing Decision
  • Developing an Outsourcing Plan
  • Contract Research Organization
  • Strategic Versus Tactical Outsourcing Model
  • Effective Communication Is Essentia
  • Mitigating the Challenges of Protecting IP Rights
• Offshoring Contract Drug Discovery
  • Factors to Consider in Offshore Outsourcing
  • Benefits of Global Outsourcing
  • Cost Advantage
  • Concerns about Global Outsourcing
  • Outsourcing to China
  • WuXi China' s Largest CRO
  • First Chinese CRO Alliance
  • FDA to Establish Office at US Embassay in China
  • China' s Handling of IP Rights and Laws
  • Outsourcing to India
  • India' s Handling of IP Rights and Laws
  • Outsourcing to Eastern Europe
• Drug Discovery Outsourcing Market
  • Current Market and Forecast Summary

CHAPTER TWO: INTRODUCTION

• Overview
  • Number of NME Filings in Decline While R&D Spending Rising
  • Ramping Up the Pipelines
• Outsourcing Drug Discovery
• The Outsourcing Decision
  • Decision Criteria
  • Factors to Consider in Offshore Outsourcing
  • Benefits of Global Outsourcing
    • Cost Advantage
    • Access to Talent and Technologies
    • Compressed Timelines
    • Increased Production
  • Concerns About Global Outsourcing
    • Intellectual Property Protection (IP)
    • Confidential Information and Trade Secrets
    • Fraud and Corruption
    • Meeting Regulatory Compliance Demands
    • Long Distance
• Selecting a Contract Research Organization
  • Choosing the Right CRO
    • Experience is Paramount
    • Facility Standards
    • Excellent Track Record
  • Global Outsourcing

CHAPTER THREE: THE DRUG DISCOVERY PROCESS

• Introduction-Discovery Stages
  • Target Identification
  • Target Validation
  • High Throughput Screening
  • Lead Optimization
• Accelerating the Drug Discovery Process
• Technologies Used in Drug Discovery
  • Combinatorial Chemistry
  • Bioinformatics/Pharmacogenomics
  • ADME/Tox Screening
  • High Throughput Screening
  • Computational Modeling and Bioinformatics
• Addressing Bottlenecks in the Drug Discovery Process
• Outsourcing to Increase Efficiency
  • Outsourcing to Access Novel Technologies
  • Bioinformatics
  • Lab-on-a-Chip: Microfluidics in Drug Discovery

CHAPTER FOUR: OUTSOURCING DRUG DISCOVERY

• Overview
• Contract Research Organizations
  • Introduction
  • Role of a CRO
  • Strategic Versus Tactical Outsourcing Model
  • The Tactical Model
  • The Strategic Model
  • Effective Communication is Essential for a Successful Partnership
  • Mitigating the Challenges of Protecting IP Rights
• Offshoring Contract Drug Discovery
  • Introduction
  • Center of Gravity for the Pharmaceutical Industry Shifting from West to East
  • Evolution of Contract Drug Discovery in Asia
• Outsourcing to China
  • Introduction
  • Multi-National Pharmaceutical Companies Establish Drug Discovery Facilities in China
  • Chinese Contract Research Organizations
    • WuXi China' s Largest CRO
    • First Chinese CRO Alliance
  • FDA to Establish Office at US Embassay in China
  • China' s Handling of IP Rights and Laws
  • IP Rights Enforcement System
• Outsourcing to India
  • Introduction
  • AstraZeneca Sets up Drug Discovery Facility in Bangalore
  • Drug Discovery Services in India
  • India' s Handling of IP Rights and Laws
    • Patent Filing Considerations
    • Limitations on Patentability
    • Compulsory Licenses
• Outsourcing to Eastern Europe
  • Introduction
  • Russian and Ukraine CROs

CHAPTER FIVE: DRUG DISCOVERY OUTSOURCING MARKET

• Overview
• Current Market Size and Forecast
• Contract Drug Discovery Competitors
  • Acquisitions to Gain Market Share or Entrance to the Market
• Market Analysis by Segment
  • Chemistry Services Market and Forecast
  • Biology Services Market
  • High Throughput Screening Services Market
  • Lead Optimization Services Market
  • Current Market and Forecast
• Market Growth Expanding Global Reach of Drug Discovery Services

CHAPTER SIX: COMPETITOR PROFILES

• Albany Molecular Research, Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Financial Information
• Asinex Ltd.
  • History and Lines of Business
  • Drug Discovery Services
• BioDuro, Inc.
  • History and Lines of Business
  • Drug Discovery Services
    • Chemistry Services
    • Biology Services
  • Bridge Laboratories
    • History and Lines of Business
    • Drug Discovery Services
  • Services in U.S.
  • Services in China
  • Financial Information
• Caliper Life Sciences
  • History and Lines of Business
  • Drug Discovery Services
  • Financial Information
• Charles River Laboratories, Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Financial Information
• Chembiotek Research
  • History and Lines of Business
  • Drug Development Services
• ChemBridge Research Laboratories, Inc.
  • History and Lines of Business
  • Drug Discovery Services
• Chemical Diversity Inc.
  • History and Lines of Business
    • Drug Discovery Services
    • Lead Optimization Services
    • High Throughput Services
    • Biologically Annotated Libraries
    • Focused Diversity
• deCODE Chemistry and Biostructures
  • History and Lines of Business
  • Drug Discovery Services
    • Structural Biology Services
    • High Throughput Screening & Assay Services
    • Lead Optimization
    • Financial Information
• Enamine Ltd.
  • History and Lines of Business
  • Drug Discovery Services
    • Screening Compounds
    • Screening Compounds From REAL Database®
    • Lead Optimization
    • Discovery Chemistry and Custom Synthesis
    • Research
• Evotec OAI
  • History and Lines of Business
  • Drug Discovery Services
    • Assay Development Services
    • High throughput Screening
    • Medicinal Chemistry Services
    • Compound Library Services
  • Financial Information
• GVK Biosciences Private Limited
  • History and Lines of Business
  • Drug Discovery Services
    • Bioinformatics
    • Chemoinformatics
    • Structural Biology
    • Biology Services
• Hutchison MediPharma Ltd.
  • History and Lines of Business
  • Drug Discovery Services
    • Discovery Chemistry
    • Discovery Biology
    • Discovery Pharmacology
    • Drug Metabolism and Pharmacokinetics (DMPK)
• J-Star Research, Inc.
  • History and Lines of Business
  • Drug Discovery Services
• Jubilant Biosys Ltd.
  • History and Lines of Business
  • Drug Discovery Services
  • Discovery Informatics
  • Discovery Research
  • Drug Development
  • IT Services
• MDS Pharma Services
  • History and Lines of Business
  • Drug Discovery Services
  • Financial Information
• Medicilon Inc.
  • History and Lines of Business
  • Drug Discovery Services
    • Custom Chemical Synthesis
    • Pharmacokinetics
    • Metabolism Services
    • Bioanalytical Services
    • Structural Biology Services
    • Other Biological Services
• Pharmacopeia Drug Discovery, Inc.
  • History and Lines of Business
  • Drug Discovery Services
    • Lead Optimization
    • ADME and Toxicity Characteristics of New Molecules
    • In vivo Optimization
    • Early ADME/Tox Determination
  • Financial Information
• Ricerca Biosciences, LLC
  • History and Lines of Business
  • Drug Discovery Services
  • Financial Information
• Scynexis, Inc.
  • History and Lines Business
  • Drug Discovery Services
    • Medicinal Chemistry
    • Custom Synthesis
    • High Throughput Purification & Analysis
    • ADMET & Bioanalytical Services
    • Bioanalytical Capabilities
    • Data Management And Collaboration
• Shanghai ChemPartner Co.,Ltd.
  • History and Lines of Business
  • Drug Discovery Services
  • Discovery Chemistry
  • Library Generation
  • Analytical Chemistry
  • Medicinal Chemistry
  • ADME Studies
  • Natural Product Chemistry
  • Computational Chemistry and Drug Design
• WuXI PharmaTech Co. Ltd.
  • History and Lines of Buisness
  • Drug Discovery Services
  • Discovery Chemistry Services
  • Analytical Services
  • Biological Services
  • Financial Information

APPENDIX: COMPANY DIRECTORY

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Exhibit 1-1: Drug Discovery Timeline: Research to Viable Product to Commercialization
• Exhibit 1-2: NMEs and New BLAs Filed, 1996-2007
• Exhibit 1-3: Global R&D Spending, 1996-2007
• Exhibit 1-4: Global Drug Discovery Outsourcing Market 2005-2013
• Exhibit 1-5: Share of Outsourced Drug Discovery Market by Segment (Biology Services, Chemistry Services, Lead Optimization, High Throughput Screening) 2007

CHAPTER TWO: INTRODUCTION

• Exhibit 2-1: Number of NMEs and New BLAs Filed 1996-2007
• Exhibit 2-2: Global R&D Spending 1996-2007
• Exhibit 2-3: Factors Involved in Making Outsourcing Decisions

CHAPTER THREE: THE DRUG DISCOVERY PROCESS

• Exhibit 3-1: The Drug Discovery Process
• Exhibit 3-2: Drug Discovery Timeline: Research to Viable Product to Commercialization
• Exhibit 3-3: Bioinformatics/Pharmacogenomics: The Role of the "-Omics"
• Exhibit 3-4: Causes of New Drug Attrition
• Exhibit 3-5: Drug Discovery Processes Frequently Outsourced
• Exhibit 3-6: Bioinformatics as a Central Hub A Schematic of Discovery Disciplines and Methods

CHAPTER FOUR: OUTSOURCING DRUG DISCOVERY

• Exhibit 4-1: Major Chinese Drug Discovery CROs (Company, Location, Services)
• Exhibit 4-2: Major Indian Drug Discovery CROs (Company, Location, Services)
• Exhibit 4-3: Major CROs Operating in Russia and the Ukraine

CHAPTER FIVE: DRUG DISCOVERY OUTSOURCING MARKET

• Exhibit 5-1: Global Drug Discovery Outsourcing Market 2005-2013
• Exhibit 5-2: Contract Drug Discovery Services by Market Segment (Chemistry, Biology, High-Throughput Screening, Lead Optimization) 2005-2013
• Exhibit 5-3: Leading Contractors by Market Segment
• Exhibit 5-4: Major Acquisitions in Drug Discovery Outsourcing
• Exhibit 5-5: Market Share of the Segments within the Drug Discovery Market 2007
• Exhibit 5-6: Chemistry Services Market: Revenues, Annual Growth, and Share of the Outsourced Drug Discovery Market 2005-2013
• Exhibit 5-7: Chemistry Market Revenue by Service Type (Building Blocks Compound Synthesis, Libraries, Process Research, Other Services) 2007
• Exhibit 5-8: Biology Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market 2005-2013
• Exhibit 5-9: Biology Market Revenue by Service Type (Protein Expression, Structural Analysis, Target Validation, Pathways Analysis, Other Service) 2007
• Exhibit 5-10: Screening Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market 2005-2013
• Exhibit 5-11: Screening Services Market Revenue by Service Type (Assay Development, Primary Screening, Secondary Screening) 2007
• Exhibit 5-12: Lead Optimization Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market 2005-2013
• Exhibit 5-13: Lead Optimization Services Market by Service Type (Early ADME/Tox, Create Analogues,Computational Support, and Other Services) 2007
• Exhibit 5-14: Global Expansion of Drug Discovery Services: A Selection of Companies Expanding East and West