• Chemicals
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M&A in pharma

Explores the merits of mega-deal in contrast to a more measured portfolio growth strategy

Mega-mergers and the blockbuster model have not delivered the benefits that were claimed for them. Growth in the pharmaceutical market has slowed to no more than five per cent and the world's biggest companies are growing slowly, if at all. Against that background pharmaceutical companies, large and small, are looking for new ways to do business - ways that will bring success in a difficult market. For ways to discover and deliver new drugs, to manufacture them more cost-effectively and to sell and market them more successfully.

There is a solution, a radical new approach, the virtual company: the company that retains key skills but outsources everything else, including:
- discovery research
- drug development
- manufacturing
- sales and marketing

This detailed and comprehensive report will help you to:

• understand the virtual pharma business model
• see what can be outsourced
• focus on the advantages
• avoid the pitfalls
• manage the outsourcing process
• understand what to keep in house

This report is essential reading for anyone in the biotech, pharmaceutical and clinical outsourcing industries from corporate management through development and research to marketing and sales. It gives an authoritative, detailed and clear explanation of the issues surrounding the virtual pharma business model and its implications for the market and for the biotech and pharmaceutical industries.

1.0 Introduction
1.1 Review of the challenges facing the pharma industry
1.1.1 Globalisation and emerging markets
1.1.2 Declining R&D productivity and innovation
1.1.3 Personalised medicine and the growth of the speciality sector
1.1.4 The need to reduce sales and marketing expense
1.1.5 Increasing generic competition
1.1.6 Cost containment and the increased use of cost benefit analysis
1.1.7 Changes in the manufacture of drugs
1.2 The Virtual Pharma business model
1.3 Potential pitfalls of a virtual pharma model
1.4 Implementation of a virtual pharma model

2.0 Virtual Discovery Research
2.1 The drug discovery process
2.2 Key advantages of a virtual drug discovery model
2.2.1 Access to a wide range of drug discovery expertise and technologies
2.2.2 Reduced capital expenditure
2.2.3 Greater operational and financial flexibility
2.2.4 A more efficient R&D process
2.2.5 Reduced organisational complexity and bureaucracy
2.3 Key disadvantages and risks of a virtual drug discovery model
2.3.1 Potential for loss of control
2.3.2 Over-dependence on the service provider
2.3.3 Potential for decline in quality
2.3.4 Higher transactional costs
2.3.5 Reduced opportunity to develop internal expertise
2.3.6 Potential for breaches of confidentiality
2.4 Implementation challenges of a virtual drug discovery model
2.4.1 Choosing the right service provider
2.4.2 Getting the right agreement in place
2.4.3 Managing relationships
2.4.4 Keeping control
2.4.5 Monitoring quality

3.0 Virtual Drug Development
3.1 Advantages of a virtual drug development model
3.1.1 Accelerate the development process
3.1.2 Benefit from greater depth and breadth of development expertise
3.1.3 Conduct clinical research in lower cost countries
3.2 Key disadvantages and risks of a virtual drug development model
3.3 Implementation challenges of a virtual drug development model
3.3.1 Choosing the right service provider
3.3.2 Getting the right agreement in place
3.3.3 Determine clear study specifications and endpoints ? and future plans
3.3.4 Managing relationships
3.3.5 Assessing the cost-benefit trade-off
3.3.6 Working with CROs in emerging markets

4.0 Virtual Manufacturing
4.1 Advantages of a virtual drug manufacturing model
4.1.1 Gain access to capacity with low upfront investment
4.1.2 Reduce the operational and financial risk of manufacturing
4.1.3 Gain access to cutting-edge manufacturing expertise and technology
4.1.4 Benefit from financial and operational flexibility
4.1.5 Benefit from low-cost manufacturing in emerging countries
4.2 Disadvantages and risks of a virtual drug manufacturing model
4.2.1 Loss of control
4.2.2 Potential for breaches of confidentiality
4.2.3 Risks of outsourcing manufacturing to emerging markets
4.2.4 Potential shortfalls in biologics manufacturing capacity
4.3 Implementation challenges of a virtual drug manufacturing model
4.3.1 Choosing the right service provider
4.3.2 Getting the right agreement in place
4.3.3 Invest resources in managing relationships
4.3.4 Internal manufacturing expertise is desirable

5.0 Virtual Sales and Marketing
5.1 Advantages of a virtual sales model
5.1.1 Cost and efficiency savings
5.1.2 Increase flexibility to adapt to changing market conditions
5.1.3 Retain control and maximise returns
5.2 Disadvantages of a virtual sales model
5.2.1 Potential for loss of control of product message and branding
5.2.2 Risk of breaches of confidentiality of proprietary information
5.3 Implementation challenges of a virtual sales model
5.3.1 Choosing the right service provider
5.3.2 Getting the right agreement in place
5.3.3 Handing over to the CSO
5.3.4 Managing relationships

6.0 References
Case Studies
J&J's Deal with NICE
Virtual Pharma Companies
GSK's Centres of Excellence for Drug Discovery
The Drug Development Process
Eli Lilly
VDDI Pharmaceuticals
Protodigm / Fulcrum
The Medicines Company
CROs in Emerging Markets
AstraZeneca
Pfizer
Overview of Drug Manufacturing
Lonza in Singapore
The Contract Sales Industry
ProStrakan and NovaQuest

Dr John MacDonald is a company analyst for IMS Health and a pharma industry analyst for PricewaterhouseCoopers.