Research & Development in the Pharmaceutical Industry Options for Success

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