Innovative Strategies and Models for R&D Success:
The evolving networked pharma company
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| Overview: | |
| Many pharma companies are currently engaged in wide-scale R&D restructuring, adopting a biotechnological approach to drug development by establishing disease-focused R&D units, R&D spin-offs, strategic partnerships and joint ventures. This trend has been reinforced by the emergence of public/private partnerships, co-operatives and open-source research initiatives that have encouraged companies to target previously neglected disease areas such as biotherapeutics and vaccines. Emerging markets are also driving change throughout R&D, with companies increasingly internationalizing their processes to take advantage of tax incentives, government investment, cheap labor and technology specialists. ‘Innovative Strategies and Models for R&D Success’ is a new report published by Business Insights that explores how the latest pharma R&D strategies are improving productivity and containing costs. The effectiveness of new and emerging approaches to drug discovery and development are assessed, with over 40 detailed case studies of partnerships, alliances, collaborations, outsourcing and in-licensing opportunities. This report also explores the potential benefits and disadvantages of key offshore markets including China, India and Russia and examines the recent internal restructurings of major companies such as AstraZeneca, GlaxoSmithKline, Pfizer and Roche. Use over 40 detailed case studies to assess new R&D approaches, and identify which strategies are most effective for different company sizes, therapeutic area focus, product portfolios and geographical locations. |
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| Keywords: CRO, cost-savings, CRADA, De-risk, In-licensing, Intellectual Property (IP), Increased productivity, Offshoring, Outsourcing, Private Federal Partnerships, Public-Private Partnerships (PPP), Repositi | |
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By Dr Cheryl L Barton / Publication Date: 29th August 2008
Contents:
Innovative Strategies and Models for R&D Success
Executive Summary 12
Evolution of R&D Strategies: A Moving Target 12
Private-Public Partnerships 13
Private-Federal Partnerships 14
Outsourcing: Home Territories 15
Offshoring: Emerging Markets 16
In-licensing: Virtual Pharma Models 17
R&D Spin Offs 18
Internal Reorganization, Market Trends & Conclusions 19
Chapter 1 Evolution of R&D Strategies: A
Moving Target 22
Summary 22
Introduction 23
Trends in R&D 24
The Evolving Network R&D Model 30
Chapter 2 Public-Private Partnerships 34
Summary 34
What is a PPP? 35
Open-source R&D 35
Applications to the pharma industry 37
Alliance Case Studies 42
Case Study: GlaxoSmithKline and the MMV, MVI and GATB 42
Case Study: Bayer and the TB Alliance 44
‘Crowd’ Sourcing Case Studies 45
Case Study: InnoCentive & Scienteur Corporation 45
Technology Transfer Case Studies 45
Case Study: Technology transfer PPPs with NIH 45
Conclusions 47
Chapter 3 Private-Federal Partnerships 50
Summary 50
Cooperative Research & Development agreements 51
Small Business Innovation Research Programs 52
Regulation enabling technology transfer 52
Technology alliances 54
The Cooperate Research (CORE) database (US alliances) 54
The Cooperate Research (CORE) database (International alliances) 55
Publicly funded medicines 56
Applications to the pharma industry 58
Technology transfer case studies 58
Case Study: Taxol technology transfer NIH to BMS 58
Case Study: Erythropoietin technology transfer to Amgen and Johnson &
Johnson 61
Case Study: FluMist technology transfer NIAID to Aviron 62
Case Study: Velcade technology transfer from NIH to Millennium
Pharmaceuticals 63
Conclusions 64
Chapter 4 Outsourcing: within mature
markets 68
Summary 68
Introduction 69
Contract Research Organizations 70
Outsourcing services 71
Investment in contract research 73
Balancing Outsourcing Portfolio: Home & Abroad 74
Shift from North America & Western European Contract Services 75
Shift in customer base 78
Shift in partnerships 79
Strategic Partnerships & Risk Sharing 79
Strategic partnerships case studies 81
Case Study: Accenture & Wyeth 81
Case Study: Functional service providers & Pfizer 81
Risk sharing case studies 82
Case Study: NovaQuest & Eli Lilly & ProStrakan 82
Case Study: PPD & Ranbaxy/Takeda/ALZA/Accentia Biopharmaceuticals 83
Conclusions 84
Chapter 5 Offshoring: emerging markets 88
Summary 88
Introduction 89
Offshore outsourcing 90
Investment in offshore contract research. 91
Outsourcing services in China 93
Contract R&D in China 94
Contract clinical research in China 95
Leading R&D players in China 96
R&D Contract Services case study 99
Case Study: WuXi & AstraZeneca 99
Risk Sharing Agreement case studies 100
Case Study: Hutchison MediPharma & Eli Lilly, Merck KGaA and Procter &
Gamble 100
Research Collaboration case studies 101
Case Study: Chemizon & Takeda 101
Case Study: Sunway Biotech & Genzyme 101
Case Study: Sanofi-Aventis & the Chinese Academy of Medical Sciences. 102
Joint venture case studies 102
Case Study: Charles River Laboratories & Shanghai BioExplorer 102
Case Study: Eli-Lilly’s Asian Ventures 103
Key Issues in China 103
Outsourcing services in India 104
Contract R&D in India 105
Contract clinical research in India 106
Leading R&D players in India 107
Risk sharing agreements case studies 109
Case Study: Advinus & Merck & Co. 109
Case Study: Aurigene & Merck Serono 109
Case Study: Dr Reddy Laboratories & ClinTec International 109
Case Study: Ranbaxy & GlaxoSmithKline/Merck & Co. 110
Case Study: Nicholas Piramil India Ltd / Eli Lilly and Merck & Co. 110
Research partnership case studies 111
Case Study: Jubilant Biosys & Amgen 111
Case Study: Syngene & Bristol-Myers Squibb 112
Case Study: GVK Bio & Wyeth 112
Case Study: Dr Reddy & RheoSciences 112
Case Study: Bristol Myers Squibb & Accenture 113
Product in-licensing case studies 113
Case Study: Glenmark Pharma & Eli Lilly 113
Case Study: Glenmark Pharma & Forest Labs 114
Key issues in India 114
Outsourcing services in Russia 114
Contract R&D in Russia 115
Contract clinical research in Russia 115
Leading R&D players in Russia 117
Research collaboration case studies 120
Case Study: Chembridge & Pfizer 120
Case Study: ChemDiv & Schering-Plough 120
Key issues in Russia 121
Conclusions 122
Chapter 6 In-licensing: Virtual Pharma &
Technology Aggregators 126
Summary 126
Introduction 127
Virtual pharma companies and technology aggregators 128
Virtual pharma models 131
Virtual pharma models evolved from the pharma industry 132
Case Study: Fulcrum Pharma plc 132
Case Study: Chorus 133
Case Study: TAP Pharmaceuticals 135
Developing novel compounds case studies 135
Case Study: Concordia Pharmaceuticals 135
Case Study: Celtic Pharma LCC 136
Case Study: VDDI Pharmaceuticals 137
Repositioning old compounds case studies 139
Case Study: AGI Therapeutics 139
Case Study: Arachnova Ltd 140
Conclusions 141
Chapter 7 R&D spin offs 144
Summary 144
The motivation behind R&D spin offs 145
Pharma R&D spin offs 147
Case Study: AstraZeneca & Albireo 147
Case Study: Pfizer & Esperion 148
Case Study: Sanofi-Aventis & Novexel 150
Case Study: Roche & Basilea 151
CRO R&D spin offs 152
Case Study: Ranbaxy Life Science Research Ltd & Daiichi 152
Case Study: Sun Pharma Advance Research Company Ltd 153
Case Study: NPIL pharma R&D de-merger 154
Conclusions 155
Chapter 8 Internal reorganization, market
trends and conclusions 158
Summary 158
Introduction 159
Internal Reorganization 160
Large pharma R&D models 161
AstraZeneca 161
GlaxoSmithKline 164
Pfizer 168
Roche 171
Emerging Market Trends 174
A complex R&D process 174
A shift in R&D focus & attrition rates 177
A shift in therapeutic focus 179
Fragmentation of the industry 183
Geographical alignment of the industry 183
Conclusions 184
Index 187
Glossary 188
Bibliography & Endnotes 191
List of Tables:
List of Tables
Table 2.1: PPPs – public and industry partners 38
Table 2.2: R&D costs of PPP projects 39
Table 3.3: Approved medicines developed through CRADA research 57
Table 3.4: Recent CRADA projects under development 59
Table 3.5: Recent CRADA projects under development (continued) 60
Table 4.6: Advantages & disadvantages of CROs based on geography 75
Table 4.7: Leading International CROs 77
Table 5.8: Leading R&D Players in China 98
Table 5.9: Leading R&D Players in India 108
Table 5.10: Leading R&D Players in Russia 119
Table 6.11: Virtual Pharma & Technology Aggregators 129
Table 6.12: Examples of Therapeutic Switching 140
Table 7.13: Recent pharma R&D spin offs 147
Table 7.14: Recent CRO R&D Spin offs 152
Table 8.15: AstraZeneca Recent R&D Activities 163
Table 8.16: GlaxoSmithKline’s recent R&D acquisitions 166
Table 8.17: GlaxoSmithKline’s recent strategic research collaborations 167
Table 8.18: Simplified R&D Organization at Pfizer 168
Table 8.19: Pfizer’s Recent R&D Activities 170
Table 8.20: Roche’s Recent R&D Activities 173
List of Figures
Figure 1.1: Pharma R&D spend and trial costs, 2004-2009e 24
Figure 1.2: Global R&D spending by development phase ($bn), 2007 25
Figure 1.3: Biotech R&D spend and funding ($bn), 2004-2009e 26
Figure 1.4: Biotech R&D spend and funding ($bn), 2001-2007 26
Figure 1.5: Cost to develop a new biopharmaceutical (2005 $m) 27
Figure 1.6: Origin of New US drug approvals, 2000-2006 30
Figure 1.7: Migration from traditional to an externally driven R&D platform 31
Figure 2.8: R&D models A) Traditional approach and B) PPP approach 36
Figure 2.9: PPPs - neglected disease projects 40
Figure 2.10: PPP Developmental timelines 42
Figure 2.11: Portfolio of the MMV 43
Figure 3.12: CORE - technology alliances (number of alliances), 1985-2003 54
Figure 3.13: Global and US-based technology alliances (number of alliances), 1985-2003 55
Figure 3.14: Global technology alliances by region (number of alliances), 1985-2003 56
Figure 3.15: FluMist developmental timelines 63
Figure 4.16: Outsourcing Services 71
Figure 4.17: Global Expenditure on R&D and Contract Research 73
Figure 4.18: Pharma R&D Expenditure and spend on contract services by Phase, 2007 74
Figure 4.19: Three Stages of CRO Evolution 79
Figure 4.20: Strategic Outsourcing 80
Figure 5.21: Areas for offshore contracting 90
Figure 5.22: Average global clinical trial cost by region ($ per patient), 2006 92
Figure 5.23: Indexed clinical trial costs by country compared to the US per patient by region, 2006
93
Figure 5.24: Therapeutic areas for Russian CRO trials (2006) 117
Figure 6.25: Virtual Pharma R&D Model 131
Figure 6.26: Virtual Pharma Inter-relationships 132
Figure 6.27: Chorus Time & Cost Savings to Proof-of-Concept 134
Figure 6.28: VDDI Pharmaceutical R&D Model 138
Figure 7.29: Benefits of R&D spin offs 145
Figure 7.30: Esperion’s rebirth 149
Figure 8.31: AstraZeneca’s R&D Timeline 161
Figure 8.32: AstraZeneca’s Productivity gains 162
Figure 8.33: The Evolution of GSK's R&D Model 164
Figure 8.34: Complexity of the R&D process 166
Figure 8.35: Pfizer’s R&D Timeline 169
Figure 8.36: Roche’s Decision Making R&D process 171
Figure 8.37: Roche’s R&D Timeline 172
Figure 8.38: Complexity of the R&D process 175
Figure 8.39: Increased collaboration within the industry 177
Figure 8.40: Shift in R&D focus and attrition rates 178
Figure 8.41: Shift in therapeutic focus 180
Figure 8.42: Recent biopharma deals 181
Figure 8.43: Fragmentation of the industry 183
Figure 8.44: The Future of R&D – Fully-Integrated Networked Pharmaceutical Companies 186