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

Buy this product or for assistance call +44 20 7060 7474

PDF £695.00$1156 | €778

FAX Order above formats by FAX

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