Winning R&D Productivity Strategies

Content

• Executive Summary
  • Introduction
  • New technologies in R&D
  • Project and portfolio management
  • Licensing and partnerships in R&D
  • Resource management
  • Monitoring performance of strategies implemented
• Chapter 1 Introduction
  • Summary
  • Introduction
  • R&D
  • Decrease in R&D productivity
  • Industry opinion of R&D productivity
  • Risk and the commercial market in drug discovery
  • Challenges and causes of decline
  • Cost of drug development
  • Innovation and attrition
  • Regulatory burden
  • Size and scale of operations
  • Clinical development times
  • The key issues affecting R&D today
  • Opportunities and how to increase productivity
  • Responses to the crisis
  • Short-term
  • Long-term
  • Big Pharma emerging from the R&D productivity crisis
• Chapter 2 New technologies in R&D
  • Summary
  • Introduction
  • The future of innovative technologies in R&D
  • Integration of technologies in the R&D process
  • Comparison of technologies in the R&D process
  • Technologies to increase the number of targets in drug discovery
  • Array technology
  • Biomarkers
  • Stem cells
  • Technologies for decreasing costs and development times
  • RNAi
  • Microfluidics
  • Toxicogenomics/ADMETox
  • High through-put screening
  • Technologies for decision making and optimization
  • Bioinformatics
  • Chemogenomics
  • Pharmacogenomics
  • The move towards targeted therapies
  • Conclusions and key points
• Chapter 3 Project and portfolio management
  • Summary
  • Introduction
  • Why use project and portfolio management in R&D?
  • Challenges to project and portfolio management
  • Portfolio management
  • The R&D portfolio
  • The portfolio management process
  • Reviews and evaluations
  • Decision making and strategic alignment
  • Resource management
  • Portfolio management in action
  • Sanofi-Aventis
  • Genentech
  • Lundbeck
  • Project management
  • The project management process
  • Value and risk profiles
  • Financial evaluation
  • R&D Project management in action
  • Schering AG
  • AstraZeneca
  • Dr Reddy's
  • Conclusions and key points
• Chapter 4 Licensing and partnerships in R&D
  • Summary
  • Introduction
  • Licensing and collaborations
  • The licensing process
  • Licensing trends
  • Multi product deals, and long term collaborations
  • Increased number and average value of licensing deals
  • Biotech as a licensing partner
  • Oncology is the dominant therapy area by number of deals
  • Licensing deals for later stage drugs
  • Out-licensing
  • In-licensing
  • Biogen Idec
  • Novartis
  • Collaborations
  • Curis
  • Roche
  • Future of licensing and collaborations
  • Outsourcing
  • Out-sourcing to increase R&D productivity
  • Impact of mega-mergers on productivity
  • Conclusions and key points
• Chapter 5 Resource management
  • Summary
  • Introduction
  • Management and integration of deals in drug discovery
  • Alliance management
  • Managing partnerships
  • M&A
  • Timelines and preventing overruns
  • Organizational and operational issues in drug discovery
  • Restructuring - traditional versus networked R&D model
  • Company size - reduce organizational size to increase R&D performance
  • R&D outsourcing
  • Decentralizing R&D operations
  • Outsourcing to China and India
  • Big Pharma conducting R&D in China and India
  • Conclusions and key points
• Chapter 6 Monitoring performance of business strategies
  • Summary
  • Introduction
  • What to monitor and how?
  • Who monitors R&D productivity?
  • CMR programmes
  • Cognos
  • Cognos 8 business intelligence
  • Quality versus quantity
  • Short-term and long-term outcomes
  • Conclusions and key points
• Chapter 7 Appendix
  • Primary research survey
  • Index
• List of Figures
  • Figure 1.1: R&D expenditure versus annual NME approvals, 1995-2005
  • Figure 1.2: Total number of drug launches in the US, 1945-2004
  • Figure 1.3: Industry opinion of R&D productivity over time
  • Figure 1.4: Industry opinion of current R&D productivity in the Biopharma market
  • Figure 1.5: Managing risk in drug development
  • Figure 1.6: Industry opinion of the significance of challenges to R&D productivity, 0 = No significance 3 = Very significant.
  • Figure 1.7: US drug pipeline is increasing novel
  • Figure 1.8: Attrition rates by novelty status, current status of INDs filed 1996-1998
  • Figure 1.9: Key reasons for attrition in drug discovery, 2003
  • Figure 1.10: "Effective" patent life
  • Figure 1.11: Increasing clinical development times
  • Figure 2.12: Potential cost savings per drug using genomics ($m)
  • Figure 2.13: Integration of technologies in the R&D process
  • Figure 2.14: Comparison of innovative technologies in R&D
  • Figure 2.15: Industry opinion of how innovative technologies will affect R&D productivity over the next 5-10 years
  • Figure 2.16: Microfluidics, features, benefits and applications
  • Figure 2.17: Integration of databases within the discovery process
  • Figure 3.18: The portfolio management process
  • Figure 3.19: Risk assessment in practice
  • Figure 3.20: An example of project management commissioning at Schering AG
  • Figure 4.21: The pharmaceutical licensing process
  • Figure 4.22: Number of top 10 pharmaceutical company licensing deals by deal type, 2001-2005
  • Figure 4.23: Number of top 10 biotech company licensing deals by deal type, 2001-2005
  • Figure 4.24: Industry opinion of change in the number of licensing/partnering deals in the last 5 years
  • Figure 4.25: Industry opinion of change in the number of licensing/partnering deals in the next 5 years
  • Figure 4.26: Average value of top 10 pharmaceutical company licensing deals, 2001-2005
  • Figure 4.27: Number of top 10 pharmaceutical and biotech company licensing deals by partner, 2001-2005
  • Figure 4.28: Proportion of product-based licensing deals by therapy area, 2001-2005
  • Figure 4.29: Number of biotech R&D licensing deals by development stage, 2001-2005
  • Figure 4.30: Licensing process at Novartis
  • Figure 4.31: No economies of scale in pharmaceutical R&D
  • Figure 5.32: Vision of networked pharma in 2016
  • Figure 5.33: Wyeth's R&D productivity model, 2001
  • Figure 5.34: Advantages and disadvantages of inhouse, outsourced and collaborative R&D
  • Figure 5.35: Industry opinion of the most productive method of conducting R&D
  • Figure 5.36: Industry opinion of attractiveness of countries/regions for R&D outsourcing. 1 = very unattractive, 5 = very attractive. Response average shown
  • Figure 6.37: Major reasons to implement monitoring of R&D processes
  • Figure 6.38: Markers of productivity
  • Figure 7.39: R&D productivity survey respondents by company focus
• List of Tables
  • Table 1.1: R&D by function, PhRMA member companies, 2004
  • Table 2.2: Companies involved in array technologies, A-L
  • Table 2.3: Companies involved in array technologies, M-Z
  • Table 2.4: siRNA-based drugs and therapies
  • Table 2.5: Biotech providers of commercial ADMETox software
  • Table 3.6: Risk factors in project management
  • Table 5.7: Reasons for time and budget overruns
  • Table 5.8: Mean clinical development times in months, based on 400 protocols, 2000
  • Table 5.9: US R&D scientific, professional and technical personnel by function, PhRMA companies: 2004
  • Table 5.10: US FDA new drug application data generated from India