Outsourcing in Drug Development: The Contract CRO Market, 3rd Edition

Outsourcing in Drug Development: The Contract CRO Market, 3rd Edition
TABLE OF CONTENTS

CHAPTER ONE: EXECUTIVE SUMMARY

  • The Drug Development Process
  • Government Regulation of Clinical Researc
  • Active Phase I, II & III Clinical Trial
  • Phase IV Studies: Post Approval
  • Recruiting for Clinical Trial
  • The Complexity and Costs Of Clinical Trials Are Increasing
  • Clinical Trials Worldwide
  • The Contract Drug Development Industry
  • R&D Outsourced to Contract Drug Development
  • Contract Drug Development Market
  • Trends Affecting Growth of Contract Drug Development Industry
    • Globalization of Drug Development
    • Rapid Technological Change Increasing Data
    • Biotechnology Industry Growth
    • Increased Regulatory Scrutiny
    • Need for Fast, Efficient, and Cost-Effective Drug Development
    • Drug Development Process

CHAPTER TWO: INTRODUCTION

  • Government Regulation of Clinical Research
  • Center for Biological Evaluation and Review
  • Center for Drug Evaluation and Research
  • Investigational Review Board
  • Preclinical Research
  • In Vitro and In Vivo Testing Process
  • Investigational New Drug Application
  • Clinical Trials
  • Preclinical Phase
  • Phase I
  • Phase IIa
  • Phase IIb
  • Phase III
  • Phase IIIa
  • Phase IIIb
  • Phase IV: Post Approval
  • New Drug Applications
  • New Molecular Entities and Approval Times
  • Accelerated Approval
  • Has FDA’s PDUFA ACT Weakened Safety Standards?
  • Government Initiatives to Improve Research and the Review Process
  • FDA’s Critical Path Report
  • Exploratory IND Studies—An Approach to Complying with CGMP
  • INDs—Approaches to Complying with CGMP During Phase 1
  • Biotechnology Industry Endorses FDA’s Critical Path
  • Globalization Trends in Drug Development
  • Clinical Trials Worldwide
  • China is Ranked First
  • India's Growing Market
  • Russia Dominates Eastern Europe

CHAPTER THREE: CLINICAL TRIAL OPERATIONS

  • Conducting Clinical Trails
  • Government Sponsored Clinical Trials
  • Organizations Contracted to Conduct Clinical Trials
  • Contract Research Organizations (CROs)
  • Managed Site Networks
  • Major Elements of Clinical Trials
  • Protocol
  • Eligibility Criteria
  • Endpoints
  • Randomization
  • Stratification
  • Blinding
  • Data Collection and Management Tools
  • Statistical Interpretation
  • Data Collection and Management Tools
  • Statistical Interpretation
  • Phase IV Studies Post Approval Studies
  • Sentinel Initiative
  • Recruiting for clinical Trials
  • Clinical Trials Recruitment Promotion
  • Internet-Enabled Recruitment
  • Recruiting Principal Investigators
  • Physician as Principal Investigator
  • Recruiting Patients
  • Use of Homecare Services
  • Patient Recruitment Outside the U.S.
  • Delays in Patient Recruiting Increases Project Costs
  • Factors Influencing Participation in Clinical Trials
  • Increasing Complexity of Clinical Trials
  • Informed Consent Process
  • Demographics and Clinical Trials
  • Ethnicity and Gender in Clinical Trials
  • Electronic Data Management
  • Traditional Paper-based Case Report Forms
  • Advantages of EDC
  • Current Assessment of EDC Adoption
  • Need for an EDC Standard
  • FDA Releases Guidance for Using Computerized Systems in
  • Clinical investigations
  • Electronic Patient Diaries

CHAPTER FOUR: TRENDS

  • Drug Development Costs
  • Outsourcing Drug Development
  • A Brief History of Contract Research Outsourcing
  • Focus Shifts in Outsourced Clinical Research Operations from Phase II-III to Phase I to IIIb/IV
  • Major Factors Driving Contract Research Outsourcing Strategy
  • Outsourcing as a Cost Reduction Strategy
  • Number of New Chemical Entities (NCEs) in Pipeline Increasing
  • Growing Complexity of Regulatory Requirements
  • Outsourcing to Gain Rapid Access to Patient Recruiting
  • Contract Research Competitors
  • Academic Medical Centers (AMCs)
    • Competing Factors
  • Contract Research Organizations (CROs)
    • CRO Contract
  • Competing Factors Managed Site Networks
  • Competing Factors
  • Clinical Trial Laboratories
    • Competing Factors
  • Clinical Trials as a Business Opportunity
  • Community Physicians
  • Electronic Technology Solutions
  • Internet Patient/Investigator Recruiting
  • Clinical Trials Packaging
  • Effective Packaging Promotes Patient Compliance

CHAPTER FIVE: MARKETS

  • R&D Spending Increasing
  • Leading Pharmaceutical Developers
  • Clinical Research Products in Development
  • Shift in Spending for Clinical Research
  • Spending for Phase I Trials Slows from Highs in 2004
  • Safety Issues Drive Phase IIIb/IV Trial Spending
  • Contract Drug Research Market
  • Contract Research Competitors
  • CROs Market Share
  • CROs Broaden Services through Acquisitions
  • CROs Expanding Laboratory Services
  • AMC Market Share
  • AMCs Reassess Role in Industry-funded Clinical Research
  • Academic Clinical Reseach Organizations Expanding
  • Niche Competitors’ Market Share
  • Clinical Trial Laboratory Services
  • EDC Services Gaining Market Share
  • Managed Site Networks
  • Trends Affecting Growth in Contract Drug Development Industry
  • Globalization of Drug Development
  • Rapid Technological Change Increasing Data
  • Biotechnology Industry Growth
  • Increased Regulatory Scrutiny
  • Need for Fast, Efficient, and Cost-Effective Drug Development

    CHAPTER SIX: COMPANY PROFILES

  • Charles River Laboratories International, Inc.
  • Covance, Inc.
  • Encorium Group, Inc.
  • Icon, Plc
  • Kendle International, Inc.
  • MDS Pharma Services
  • Omnicare Clinical Research
  • Paraxel International Corporation
  • Pharmanet Development Inc.
  • Pharmaceutical Product Development, Inc.
  • Radiant Development
  • Clinical Trial Laboratories
  • Bioanalytical Research Corporation
  • Calvert Laboratories, Inc.
  • Kronos Science Laboratories, Inc.
  • Medtox Scientific Inc.
  • Pacific Biometric, Inc.
  • PRL Central Laboratory Services
  • Quest Diagnostics, inc.
  • TGA Sciences, Inc.
  • CNS Clinical Trials
  • DaVita Clinical Research
  • -USA, Inc.
  • Synarc, Inc.
  • Advanced Clinical Software
  • eTrials Worldwide, Inc.
  • Interactive Clinical Technologies, Inc.
  • Medidata Solutions Worldwide
  • Pharsight Corporation

APPENDIX: COMPANY DIRECTORY

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

  • Exhibit 1-1: The U.S. Drug Discovery, Development, and Approval Process

  • Exhibit 1-2: Number of Active Clinical Drug Development Programs (May 11, 2007)

  • Exhibit 1-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007

  • Exhibit 1-4: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006

  • Exhibit 1-5: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008

  • Exhibit 1-6: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent

  • Exhibit 1-7: Contract Drug Development Market Share, Percent by Competitor Type (AMC, CRO’s Others), 2007

  • Exhibit 1-8: Contract Research Market, Revenue by Competitor, 2002-2012

CHAPTER TWO: INTRODUCTION

  • Exhibit 2-1: Investigational New Drug Submissions, 1992-2006

  • Exhibit 2-3: Number of Clinical Trials Initiated Annually for U.S. Submissions

  • Exhibit 2-4: Median Total Approval Time for Standard NDAs, 1993-2006

  • Exhibit 2-5: Median Total Approval Time for Priority NDAs, 1993-2004

  • Exhibit 2-6: Median Total Approval Time for Standard NMEs, 1995-2004

  • Exhibit 2-7: Median Total Approval time for Priority NMEs, 1995-2004

  • Exhibit 2-8: U.S. NMEs 2006 Approvals: Review Times by Drug

  • Exhibit 2-10: Median Approval times for Safety vs All Drugs, By Decade

  • Exhibit 2-11: Number and Location of Clinical Trial Sites Worldwide, as of 7/12/2008

  • Exhibit 2-12: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008

CHAPTER THREE: CLINICAL TRIAL OPERATIONS

  • Exhibit 3-1: Key Clinical Trial Enrollment Statistics for: NMEs Approved in 2000-2006

  • Exhibit 3-2: Number of Active Clinical Drug Development Programs (May 11, 2007)

  • Exhibit 3-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007

  • Exhibit 3-4: Summary Of Postmarketing Study Commitments (Numbers as of September 30, 2007)

  • Exhibit 3-5: Benefits and Risks of Participating in Clinical Trials

  • Exhibit 3-6: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006

  • Exhibit 3-7: Aggregate Enrollment Data for All Extramural and Intramural Research Protocols Funded in FY2005 and Reported in FY2006, by Percent and Gender

CHAPTER FOUR: TRENDS

  • Exhibit 4-1: New Paradigm for R&D

  • Exhibit 4-2: Improvements in the Drug Development Process Reduce Development Costs

  • Exhibit 4-3: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent

  • Exhibit 4-4: Percentage of Industry-Sponsored Clinical Trials Awarded to Academic Medical Centers Versus Private Sector Companies: 1991, 1996,2001 and 2006

CHAPTER FIVE: MARKETS

  • Table 5-2: Global Drug Development Spending, 2002-2012

  • Table 5-2: Global Drug Development Spending, 2002-2012

  • Exhibit 5-3: R&D Expenditures of Leading Pharmaceutical Developers, 2006 vs. 2005

  • Exhibit 5-4: Number of Companies with Active Product Development Projects, 1997-2006

  • Exhibit 5-5: Total Average Number of Active Phase I-III Clinical Trials Worldwide, 2001-2007

  • Exhibit 5-6: Top Ten Therapeutic Categories in R&D Worldwide, March 2007

  • Exhibit 5-7: A Comparison of Spending Rates in Phase I and Phase II/III Trials, 2004-2008

  • Exhibit 5-8: Clinical Trials Phase IIIb/IV Market 2004-2008 (in U.S. billions)

  • Exhibit 5-9: Global R&D Spending and Portion Outsourced to Contract Research, 2002-2012 (in US Billions)

  • Exhibit 5-10: Contract Drug Development Market, 2002-2012 (Outsourced to CROs, Others)

  • Exhibit 5-11: Contract Research Market (CRO, AMC, Other) 127

  • Exhibit 5-12: CRO Market Share, 2007

  • Exhibit 5-13: Selected Acquisitions of Leading CROs, 2006 to present

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

  • Table 1-1: The U.S. Drug Discovery, Development, and Approval Process

  • Exhibit 1-2: Number of Active Clinical Drug Development Programs (May 11, 2007)

  • Exhibit 1-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007

  • Exhibit 1-4: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006

  • Exhibit 1-5: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008

  • Exhibit 1-6: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent

  • Exhibit 1-7: Contract Drug Development Market Share, Percent by Competitor Type (AMC, CRO’s Others), 2007

  • Exhibit 1-8: Contract Research Market, Revenue by Competitor, 2002-2012

CHAPTER TWO: INTRODUCTION

  • Exhibit 2-1: Investigational New Drug Submissions, 1992-2006

  • Exhibit 2-3: Number of Clinical Trials Initiated Annually for U.S. Submissions

  • Exhibit 2-4: Median Total Approval Time for Standard NDAs, 1993-2006

  • Exhibit 2-5: Median Total Approval Time for Priority NDAs, 1993-2004

  • Exhibit 2-6: Median Total Approval Time for Standard NMEs, 1995-2004

  • Exhibit 2-7: Median Total Approval time for Priority NMEs, 1995-2004

  • Exhibit 2-8: U.S. NMEs 2006 Approvals: Review Times by Drug

  • Exhibit 2-10: Median Approval times for Safety vs All Drugs, By Decade

  • Exhibit 2-11: Number and Location of Clinical Trial Sites Worldwide, as of 7/12/2008

  • Exhibit 2-12: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008

CHAPTER THREE: CLINICAL TRIAL OPERATIONS

  • Exhibit 3-1: Key Clinical Trial Enrollment Statistics for: NMEs Approved in 2000-2006

  • Exhibit 3-2: Number of Active Clinical Drug Development Programs (May 11, 2007)

  • Exhibit 3-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007

  • Exhibit 3-4: Summary Of Postmarketing Study Commitments (Numbers as of September 30, 2007)

  • Exhibit 3-5: Benefits and Risks of Participating in Clinical Trials

  • Exhibit 3-6: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006

  • Exhibit 3-7: Aggregate Enrollment Data for All Extramural and Intramural Research Protocols Funded in FY2005 and Reported in FY2006, by Percent and Gender

CHAPTER FOUR: TRENDS

  • Exhibit 4-1: New Paradigm for R&D

  • Exhibit 4-2: Improvements in the Drug Development Process Reduce Development Costs

  • Exhibit 4-3: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent

  • Exhibit 4-4: Percentage of Industry-Sponsored Clinical Trials Awarded to Academic Medical Centers Versus Private Sector Companies: 1991, 1996,2001 and 2006

CHAPTER FIVE: MARKETS

  • Table 5-2: Global Drug Development Spending, 2002-2012

  • Table 5-2: Global Drug Development Spending, 2002-2012

  • Exhibit 5-3: R&D Expenditures of Leading Pharmaceutical Developers, 2006 vs. 2005

  • Exhibit 5-4: Number of Companies with Active Product Development Projects, 1997-2006

  • Exhibit 5-5: Total Average Number of Active Phase I-III Clinical Trials Worldwide, 2001-2007

  • Exhibit 5-6: Top Ten Therapeutic Categories in R&D Worldwide, March 2007

  • Exhibit 5-7: A Comparison of Spending Rates in Phase I and Phase II/III Trials, 2004-2008

  • Exhibit 5-8: Clinical Trials Phase IIIb/IV Market 2004-2008 (in U.S. billions)

  • Exhibit 5-9: Global R&D Spending and Portion Outsourced to Contract Research, 2002-2012 (in US Billions)

  • Exhibit 5-10: Contract Drug Development Market, 2002-2012 (Outsourced to CROs, Others)

  • Exhibit 5-11: Contract Research Market (CRO, AMC, Other)

  • Exhibit 5-12: CRO Market Share, 2007

  • Exhibit 5-13: Selected Acquisitions of Leading CROs, 2006 to present