Research & Development in the Pharmaceutical Industry

Content

• 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