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Outsourcing

Outsourcing Chemistry Services Made Easy

A Guide for the Pharmaceutical and Biotech Industries

Publication Date   January 2007
Publisher   Biopharm Knowledge Publishing
Product Type  
Pages   120
ISBN Number   not applicable
Product Code   BKP004
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Price £695.00

approximately: $1,376 | €883

Summary


More pharmaceutical and biotech companies are outsourcing more of their work than ever before - it can save time and money. But to succeed you need to understand the processes involved and getting it wrong can be disastrous. This new report provides a clear, comprehensive guide to the processes involved in outsourcing chemical and biotech development and production. It also contains in-depth interviews with development service providers and outsourcers to give a real life understanding of the issues from both sides of the fence. It will help you to:
  • Understand the rationale for outsourcing
  • See how outsourcing fits into the R&D continuum
  • Select process development providers
  • Negotiate contracts
  • Manage the outsourcing process
  • Understand when to outsource - and when not to
  • Minimise outsourcing risk
And it has a full listing of service providers categorised by services offered and location. Contents include:
  • Rational for outsourcing
  • Research and development continuum
  • Selecting a process development provider
  • Contract negotiation
  • Managing outsourcing
  • Risk management
  • Outsourcing economics
  • Interviews with outsourcing companies
  • Interviews with outsourcers
  • Outsourcing directory

Content


  • 1.0 Introduction
    • 1.1 Historical Perspective
    • 1.2 Report Objectives and Structure
      • 1.2.1 Terminology
    • 1.3 Overview of Outsourcing Markets
  • 2.0 Rationale for Outsourcing
    • 2.1 Reducing Cost and Maximising Profit
    • 2.2 Technology
    • 2.3 Capacity
    • 2.4 Equipment
    • 2.5 Facilities and Infrastructure
    • 2.6 Skilled Personnel
    • 2.7 Speed
    • 2.8 Flexibility
    • 2.9 Reducing Risk
  • 3.0 Drug Research and Development Continuum
    • 3.1 Compound Libraries
    • 3.2 Competitor Standards
    • 3.3 Radiolabelled Compounds
    • 3.4 Custom Synthesis Options
    • 3.5 Research Chemicals
    • 3.6 Resynthesis Compounds
    • 3.7 Outsourcing Research Services
      • 3.7.1 Industry Academic Collaboration
      • 3.7.2 Contract Research by FTE
    • 3.8 Process Development Services
  • 4.0 How to Select a Process Development Provider
  • 5.0 Negotiating the Contract
  • 6.0 Managing Outsourcing Contracts
  • 7.0 Rationale Against Outsourcing
    • 7.1 Retention of Core Competencies
    • 7.2 Loss of IP
    • 7.3 Internal Versus External Cost
    • 7.4 Missing Deadlines
    • 7.5 Missing Quality Targets
    • 7.6 Lock-in Contracts
  • 8.0 Minimising Outsourcing Risk
    • 8.1 Ways For Limiting Probability
      • 8.1.1 Structured Contractor Selection
      • 8.1.2 Clearly Defined Deliverables
      • 8.1.3 Setting up a Solid Contract
      • 8.1.4 Monitoring and Diligence
      • 8.1.5 Protection of IPR
    • 8.2 Ways of Limiting Severity
      • 8.2.1 Establishing Clear Strategy
      • 8.2.2 Contingency Planning
      • 8.2.3 Insurance Provisions
  • 9.0 Outsourcing Economics
    • 9.1 Estimating the Volume of Work
    • 9.2 Estimating the Outsourcing Cost
    • 9.3 Getting the Right Number of Quotations
    • 9.4 Critical Comparison of Quotations
    • 9.5 Off Shoring Beyond the Home Base
    • 9.6 How to Pay for Outsourcing Services
      • 9.6.1 Fee For Service (Fixed Cost)
      • 9.6.2 Full Time Equivalent (FTE)
      • 9.6.3 Flexible or Shared Risk Contracts
      • 9.6.4 Best Efforts (Payment per Batch)
      • 9.6.5 Time and Material
      • 9.6.6 Success Fee Agreements
    • 9.7 Role of Consultants in Outsourcing
  • 10.0 Glossary and List of Abbreviations
  • 11.0 References
  • 12.0 Views and Opinions of CROs
    • 12.1 Derek Faries, Business Development Manager, Charnwood Molecular Ltd
    • 12.2 Dr Colin Piper, Business Development Manager, Key Organics Ltd.
    • 12.3 Denise Bowser, Commercial Director, Onyx Scientific
  • 13.0 Views and Opinions of Existing Outsourcers
    • 13.1 Dr John Milton, Senior Director, Chemistry, Solexa, Inc.
    • 13.2 Dr David Ager, Competence Manager for Homogenous Catalysis, DSM Pharma Chemicals
  • 14.0 CROs Categorised by Location and Services Offered
    • 14.1 Table I - United Kingdom
    • 14.2 Table II - USA & Canada
    • 14.3 Table III - Europe
    • 14.4 Table IV - India, China, Russia & Ukraine
  • 15.0 CRO Directory
    • 15.1 United Kingdom
    • 15.2 USA & Canada
    • 15.3 Europe 96
    • 15.4 India, China, Russia & Ukraine