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Winning Pharmaceutical R&D Strategies: Boosting Profitability Through Improvements In Portfolio Management, Licensing And Clinical Trials
Business Insights, March 2004, Pages: 90
Table of Contents
Winning Pharmaceutical R&D Strategies: Boosting
Profitability through improvements in portfolio
management, licensing and clinical trials
Executive Summary 8
Pharma’s R&D challenge 8
Portfolio management to optimize resource allocation 9
Filling portfolio gaps as the licensing partner of choice 10
Improving trial design to reduce time to market 11
Chapter 1 Pharma’s R&D challenge 14
Summary 14
Introduction 14
Threats to R&D productivity 16
A risky business 16
Innovation versus patent defense 19
Consolidation is not the answer: analysis of historical data 22
Process improvements: an overview 24
Chapter 2 Portfolio management to
optimize resource allocation 27
Summary 27
Introduction to portfolio management 28
Drivers of portfolio management 29
Shortfalls in portfolio management practices 30
Insufficient buy-in throughout organization 32
Solution: proactively involve senior managers and project
management teams 32
Lack of team structure and cross-functional participation 34
Solution: resist working in silos by involving all business units in
value chain 37
Inadequate external support 40
Solution: seek an independent perspective 41
Chapter 3 Filling portfolio gaps as the
licensing partner of choice 45
Summary 45
Licensing trends 46
Increasing reliance on licensing 46
Attraction of late-stage deals 48
Competition for licensed drugs is increasing the value of deals 50
Oncology compounds are the most desirable 51
Attrition rates remain high 55
Reducing deal attrition rates 55
Effective resource allocation 56
Identify and deal with cultural differences 56
Actively manage alliance 57
Hand-over to project team 58
Clear definition of roles and responsibilities 58
Monitor alliance progress 59
Becoming licensing partner of choice 60
Chapter 4 Improving trial design to reduce
time to market 64
Summary 64
The importance of clinical trial design 66
Impact of trial design on quality and cost 66
Clinical trial failures 67
Merck & Co. – GABA-A a2/a3 agonist 67
Abbott – atrasentan 68
Sanofi – dronedarone 69
Objectives of clinical trial design 69
Short-term 70
Mid-term 71
Long-term 72
Elements of trial design 73
Meeting regulatory requirements 74
High-profile drug rejections by the FDA 74
Increasingly rigorous FDA approval requirements 79
t
FDA moves to speed drug approval process 80
Communicating with regulatory agencies 81
Marketing to physicians 82
Pre-approval comparator studies: AstraZeneca’s Exanta and
GlaxoSmithKline’s Lexiva 83
Post-approval comparator study: Merck & Co.’s Vasotec 85
Market intelligence 85
Biogen’s Amevive 86
Pharmacoeconomic considerations 87
Phase III pharmacoeconomic studies – design considerations 88
Advantages of earlier pharmacoeconomic assessments 90
List of Figures
Figure 1.1: Increasing costs of drug development 17
Figure 1.2: Major forthcoming patent expiries 21
Figure 1.3: The commercial value of leading companies’ late stage pipelines is directly
proportional to their R&D spend 22
Figure 1.4: R&D budget allocation 25
Figure 2.5: Barriers to successful portfolio management 31
Figure 2.6: Typical portfolio management team structures 35
Figure 2.7: Personnel involved in portfolio management 36
Figure 2.8: Contribution of pharmacoeconomics executives to R&D decision-making 39
Figure 2.9: Use of external organizations in portfolio management 41
Figure 3.10: Reliance on in-licensing, 2001 versus 2007 47
Figure 3.11: Top 20 pharmas’ licensing deals segmented by development stage, 2000-02 49
Figure 3.12: Oncology was the target for most in-licensing deals by the top 20 pharmas in 2000-02
52
Figure 4.13: The new drug development process 81
Figure 4.14: Benefits of early integration of pharmacoeconomics into R&D 92
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