Chapter 1: A Background to Pharmaceutical R&D
Global pharmaceutical R&D investment
Productivity of the global industry
Case study: productivity of the Japanese pharmaceutical industry
Drug development innovation
Intellectual property
Protecting intellectual property
Case study: patent protection in developing countries
Consumer views on intellectual property
Declining new drug output
Drug development times
Reducing development times
Success rates
The cost of drug development
The in silico approach to drug development
Case study: Nippon Kayaku and NEC collaboration in cancer research
Case study: Pharsight
R&D commitment and risk assessment
Case study: Bioglan Pharma
Case study: Scotia Holdings
Clinical trials
Chapter 2: Strategies and Planning for Pharmaceutical R&D
Long-term planning
Therapeutic area focus
Diseases of the elderly
Osteoporosis
CNS disorders
Orphan drug development
Pharmacoeconomics
The economic costs of disease
The global emphasis of the pharmaceutical industry
Models of R&D
Organisational structure
An industry under pressure
A growing trend
The advantages of merging
The disadvantages of merging
Alternatives to mergers?
The Pfizer-Pharmacia merger
The Amgen-Immunex merger
Company culture and staff opinions
Chapter 3: Improving the Environment for Drug Development
Regulatory review
Regulatory strategy
The Georgetown conference on drug development issues
The FDA's aim to reduce the time and costs involved in drug development
The ICH E5 guideline
Chapter 4: Pharmaceutical R&D and the Generics Industry
R&D in the Pharmaceutical Industry
The generics industry
The growth of the market for pharmaceutical generics
Protection of the brand in the face of generic competition
Generic competition and R&D innovation
Lilly's year X strategy
Generics manufacturers and mainstream R&D
Teva
The Indian pharmaceutical industry
Mainstream pharmaceutical companies and generics
The opportunity for biogenerics
Obstacles to biogenerics
Impending biogeneric patent battles
Case study: biogeneric competition to Epogen
Outlook for biogenerics
Pharmaceutical R&D and public perceptions
Chapter 5: Using External Parties for Drug Development - Biotechnology,Drug Delivery Technologies and Outsourcing
R&D partnerships
Alliance management
Licensing and joint research
The potential of biotech
The growing impact of biotechnology
Companies involved in biotech research
Biotech company corporate culture
Biotech R&D
Financing biotech R&D
Case study: Genentech
Biotechnology in the US
Biotechnology at a European level
Financing biotech start-ups in France
Consolidation in the Swedish biotech industry
Biotechnology in Japan
The future of biotechnology
Drug delivery systems
The future of the drug delivery industry
Outsourcing
Case study: virtual pharmaceutical companies
Chapter 6: Pharmaceutical R&D Location and Staffing
Locations for R&D investment
Europe and North America as locations for R&D
Japan as a location for R&D
Other locations for pharmaceutical R&D
The importance of staff
Employment in the US pharmaceutical industry
Employment in the European pharmaceutical industry
Employment in the UK pharmaceutical industry
Employment in the German pharmaceutical industry
Employment in the French pharmaceutical industry
Employment in the Swiss pharmaceutical industry
Employment in the Japanese pharmaceutical industry
Indirect employment by the pharmaceutical industry
Recruiting staff
Retaining staff
The impact of staff losses
Looking outside the pharmaceutical and biotech industries for staff
Government incentives for the pharmaceutical industry
Incentives for the UK's pharmaceutical industry
References
List of Figures
Figure 1.1 Global split of pharmaceutical R&D
Figure 1.2 New drug substances by country of origin
Figure 1.3 R&D of the Japanese pharmaceutical industry
Figure 1.4 Number of NMEs launched globally, 1992-2002
Figure 1.5 Analysis of active drug clinical trials by therapeutic category: active INDs (commercial) for year-end 2001
Figure 2.1 US Pharma R&D investment by therapeutic area
Figure 2.2 Population projections for 2000 and 2020 - percentage of the population aged 65 years or over
Figure 2.3 The impact of osteoporosis in Europe: hospital costs for osteoporosis-related hip fracture
Figure 4.1 Average approval time for generic drugs, according to the FDA
Figure 4.2 Estimated European generics market by volume, 2000
Figure 4.3 Sales for major Lilly drugs, 2002
Figure 4.4 Top-selling biotech products, 2001/02
Figure 5.1 New US biotech drug and vaccine approvals/new indication approvals by year
Figure 5.2 Global biotech R&D, 1990-2000
Figure 5.3 Global split of biotech R&D
Figure 5.4 Worldwide spending on CRO services
Figure 6.1 R&D expenditure by pharmaceutical companies in the US and Europe
Figure 6.2 Japanese pharmaceutical company sales, 2001
Figure 6.3 Employment in the US pharmaceutical industry
Figure 6.4 Employment in the European pharmaceutical industry
Figure 6.5 Pharmaceutical output in Europe, Japan and the US
Figure 6.6 Pharmaceutical R&D in the UK
List of Tables
Table 2.1 Major Amgen products following the 2002 merger
Table 3.1 Ethnic factors as defined by the ICH E5 guideline
Table 6.1 Approaches to recruiting and retaining staff
