Winning R&D Productivity Strategies: Exploiting Innovation, Licensing and Outsourcing Opportunities

Published by: Business Insights

Published: Oct. 1, 2006 - 136 Pages

Table of Contents

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

years

Figure 4.25: Industry opinion of change in the number of licensing/partnering deals in the next

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

Abstract

• India is forecast to be the most attractive country for outsourcing by 60% of industry executives.
• What is the current state of R&D in biopharma and what are the future challenges and opportunities for R&D?
• What are the most effective strategies to implement to address the rising costs of R&D and which companies have achieved this?
• How can innovative technologies, project and portfolio management and licensing and partnerships be implemented to reduce development times and improve the flow of drug candidates?
• What does the industry think of the future of R&D productivity and which strategies do they view as most attractive?

• The largest share of the R&D spend by PhRMA members is in Phase III and prehuman/preclinical trials, and over 20% of drug failures in drug development have been attributed to toxicity concerns.
• Target validation is predicted to be the main focus of licensing deals by pharma in the next 3 years.
• The application of genomic technologies, such as biomarkers, offers the opportunity to save up to 34% of R&D costs.
• 80% of industry executives believe that multi-product licensing deals are set to increase over the next 5 years.
• India is forecast to be the most attractive country for outsourcing by 60% of industry executives.

• Licensing deals are increasing in complexity and value.
• The average value of deals have also increased over the last few years as indicated by $194m increase in average value of the top
10 pharmaceutical company licensing deals from 2001 to 2005.
• The move towards the networked pharma model.
• Biopharma are looking to exploit the flexible networked pharma model, which allows companies to gain benefits of a global scale pharma while keeping resources at a minimum and sharing risk.
• Emergence of innovative technologies.
• The vast range of technologies acts an opportunity to improve development times, attrition rates and end product price. The use of pharmacogenomics and biomarkers is set to rapidly increase and have a huge long term potential in drug discovery.
• Increased clinical development times.
• Development times have increased over the last decade, which is largely due to drugs becoming more innovative and subsequently requiring more testing and developing compared to less novel drugs with familiar mechanisms of action.

• Identify strategies implemented by the biopharma industry to decrease R&D costs and increase productivity, and assess key trends and novel approaches to outsourcing and resource management which enable company re-structure and maximization of in-house resources.
• Assess key technology providers and establish which technologies should be implemented at various stages of the
R&D process, enabling you to enhance productivity levels and gain a competitive edge.
• Benchmark your performance monitoring process, enabling you to choose the most appropriate markers to measure your own company productivity and assess your position within the industry.
• Develop innovative future strategies by utilizing the report’s analysis of successful project and portfolio, licensing and partnership and resource management strategies by companies including Wyeth, GlaxoSmithKline and AstraZeneca.
• Anticipate future trends in the market, by using the report’s predictions for areas of growth and gain insights into the outlook for innovative technologies in the R&D process.

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 160,000 market research reports, company profiles and country profiles from over 600 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.