Outsourcing Chemistry Services Made Easy

A Guide for the Pharmaceutical and Biotech Industries

Publication Date	January 2007
Publisher	Biopharm Knowledge
Product Type	Report
Pages	120
ISBN Number	not applicable
Product Code	BKP00008

Price

£695.00
approximately: $1,299 | €881

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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