Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand
412
Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand
412Overview
A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands
The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands.
Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future.
While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.
Product Details
| ISBN-13: | 9781118265895 |
|---|---|
| Publisher: | Wiley |
| Publication date: | 04/16/2012 |
| Sold by: | JOHN WILEY & SONS |
| Format: | eBook |
| Pages: | 412 |
| File size: | 2 MB |
About the Author
TONY ELLERY is a consultant with Ellery Pharma Consulting. Until September 2008, he was the Head of Pharmaceutical Lifecycle Management in Portfolio Management at Novartis AG. Prior to this, he occupied positions of increasing seniority in research, development, and marketing at different companies, including Roche, Ciba Vision, and Novartis. Dr. Ellery has served as a member of the Ciba-Geigy Research Advisory Board and the Novartis Pharma Development Management Board. He is a popular speaker on lifecycle, project, and portfolio management.
NEAL HANSEN is the Managing Director of Healthcare Consulting within the Informa Group, encompassing Datamonitor Healthcare Consulting and Phasic Strategy. Previously, he was the European Head of Consulting within Wood Mackenzie's Life Sciences Practice. He works with many key players in the pharmaceutical industry to support effective decision making for brand and portfolio strategy and has chaired and spoken at numerous conferences in the field of lifecycle management and the changing nature of the generic drug industry.
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Table of Contents
Acknowledgments xviiIntroduction xix
PART A Lifecycle Ma nagement Business Environment 1
1. Challenges F acing the Branded D rug Industry 3
1.1 Depleted NME Pipelines/Lower R&D Efficiency 4
1.2 Higher Development Costs 8
1.3 Safety Concerns 9
1.4 Tougher Environment for Pricing, Reimbursement, and Listing 12
1.5 Increased Competition 16
1.6 Earlier Genericization 17
1.7 Faster Sales Erosion Following Patent Expiry 18
1.8 Poor Image of Branded Drug Industry 20
1.9 Diversification 26
2. The L ife C ycle of Industries, T echnologies, and Brands 30
2.1 Diffusion of Innovations 30
2.2 The Lifecycle Curve 32
2.3 Lifecycle Phases 34
3. The L ife C ycle of a Pharmaceutical Brand 38
3.1 Lifecycle Curve of Pharmaceuticals 41
3.2 Factors Affecting Rate of Conversion to Generics 44
3.3 The Life Cycle of a Pharmaceutical Brand 46
PART B Lifecycle Ma nagement R egulatory and L egal E nvironment 55
4. The G eneric Approval Process 57
4.1 United States 57
4.2 Europe 59
4.3 Japan 61
5. Hatch–Waxman L egislation and Its E ffects on LCM 62
5.1 Hatch–Waxman Act of 1984 62
5.2 Medicare Modernization Act of 2003 64
5.3 FDA Amendments Act of 2007 65
5.4 Q1 Program Supplemental Funding Act of 2008 66
5.5 Discussion of Hatch-Waxman Legislation 66
6. U.S. Health-Care R eform 2010 69
7. European S ector Inquiry 72
PART C Patents a nd E xclusivities 77
8. Patents and O ther Intellectual Property R ights 79
8.1 Nonpatent Intellectual Property Rights 79
8.2 What Are Patents? 81
8.3 What Is Patentable? 83
8.4 How Long Does a Patent Last? 87
8.5 Patent Term Restoration in the United States 87
8.6 Supplementary Protection Certificates in Europe 88
8.7 Patent Term Extension in Japan 89
8.8 How Are Patents Obtained? 89
8.9 Patent Enforcement 91
8.10 Types of Patents 92
8.11 KSR versus Teleflex—Raising the Nonobviousness Bar 94
8.12 Patent Strategy 96
9. Nonpatent E xclusivities 99
9.1 NCE Exclusivity (United States) 99
9.2 New Clinical Study Exclusivity (United States) 100
9.3 Data and Marketing Exclusivity (Europe) 100
9.4 Data Exclusivity (Japan) 101
9.5 Orphan Drug Exclusivity 101
9.6 Pediatric Exclusivity 103
9.7 180-Day Generic Product Exclusivity 105
10. Patent S ettlements 107
PART D Developmental LCM 113
11. Strategic Principles of D evelopmental LCM 115
11.1 Developmental LCM Goal 1: Provide a Meaningful Improvement in Clinical Profile 116
11.2 Developmental LCM Goal 2: Increase the Potential Real-World Patient Potential for the Brand 118
11.3 Developmental LCM Goal 3: The Ability to Generate an ROI 120
11.4 Developmental LCM Goal 4: The Ability to Enhance Market Exclusivity of the Brand Franchise 121
12. Indication E xpansion and S equencing 123
12.1 Categories of Indication Expansion 123
13. Patient S ubpopulations and Personalized M edicine 131
13.1 What Does a Good Patient Selection Strategy Look Like? 135
13.2 Patient Selection without Predictive Criteria: Post Hoc Approaches 138
13.3 What about the Patients Who Are Not Selected? 139
14. New D osage S trengths, N ew D osage R egimens 140
14.1 New Dosage Strengths 140
14.2 New Dosage Regimens 141
15. Reformulation, N ew R outes of Administration, and D rug D elivery 143
15.1 Reformulation and New Routes of Administration 143
15.2 Drug Delivery Devices 149
16. Fixed-Dose C ombinations (FDCs) and C o-Packaging 152
17. Second-Generation Products and M odified C hemistry 159
17.1 Isomerism 160
17.2 Polymorphism 161
17.3 Salts, Ethers, and Esters 162
17.4 Prodrugs and Metabolites 163
18. Other D evelopment LCM S trategies 165
18.1 Manufacturing Strategies 165
18.2 White Papers and Citizen Petitions 166
PART E Commercial LCM 167
19. Strategic Principles of C ommercial LCM 169
19.1 Commercial LCM Goal 1: The Ability to Drive Widespread and Preferential Patient Access to the Brand 170
19.2 Commercial LCM Goal 2: The Ability to Defend Market Access and Formulary Position 170
19.3 Commercial LCM Goal 3: The Ability to Optimize Profitability of the Brand Franchise 171
20. Geographical E xpansion and O ptimization 172
20.1 Geographic Expansion 174
20.2 Harmonization and Rationalization 175
21. OTC S witching 178
21.1 What to Switch: Choosing the Best Approach 179
21.2 Where to Switch: Dealing with Intermarket Variability 181
21.3 When to Switch: Balancing the Product Life Cycle? 183
21.4 How to Make the Switch Successful: What Corporate Support Is Required? 184
22. Brand L oyalty and S ervice Programs 186
23. Strategic Pricing S trategies 190
23.1 Pricing Strategy and Tactics in the Launch and Growth Phases 190
23.2 Pricing Strategy and Tactics Following Patent Expiry 193
24. Generic S trategies and T actics 198
25. Exit S trategies 204
PART F Biologics a nd Biosimilars 207
26. Biologics and LCM 209
26.1 Emergence of Biotech 209
26.2 Some Definitions 210
26.2.1 Biologics 210
26.3 Uptake and Value of Biologics 211
26.4 LCM of Biologics 213
27. Biosimilars and T heir Impact on Biologic LCM 217
27.1 Changing Terminology: Biogenerics, Biosimilars, and FOBs 217
27.2 Why Are Biosimilars a Big Deal? 219
27.3 How Are Biosimilars Different? 220
27.4 Biosimilar Approval Pathways 220
27.5 Substitution of Biosimilars 223
27.6 Innovator Responses to Biosimilar Threats 225
27.7 The Future for Biologics LCM 226
27.8 The Emergence of the "Innovasimilar" Biopharma Company 229
27.9 Final Words 231
PART G The Integrated Brand LCM S trategy and Its Implementation 233
28. Strategic G oals of LCM Brand Plans 235
28.1 Position to Market 235
28.2 Comparative Clinical Profile versus Gold Standard 237
28.3 Level of Market Unmet Need 237
29. Ten K eys to S uccessful LCM 238
29.1 Excellent Functional Expertise 238
29.2 Visible Management Support 244
29.3 Unambiguous Ownership 245
29.4 An Early Start 246
29.5 A Robust “Broad to Bespoke” Process 248
29.6 Focus on “High LCM Value Brands” 249
29.7 Adequate Resources 250
29.8 Measurements and Rewards 250
29.9 Training and Support 252
29.10 Realism 252
30. Organizational S tructures and S ystems for E nsuring Successful LCM 254
30.1 Organization of Project and Brand Management 254
30.2 Project and Brand LCM Structures 259
30.3 LCM Center of Excellence 263
30.4 Composition of the LCM CoE 266
31. The LCM Process: D escription, T iming, and Participants 268
31.1 Purpose of the LCM Process 268
31.2 Timing of theLCM Process 269
31.3 Description of the LCM Process 271
PART H Integrating LCM with Portfolio Management 277
32. Principles of Portfolio M anagement 279
33. LCM Projects in the D evelopment Portfolio 284
34. Managing E stablished Brand Portfolios 286
34.1 What Do You Do with a Priority Established Brand? 288
34.2 What about the Nonpriority Brands? 289
34.3 Building the Ideal Established Brands Portfolio 290
Conclusions 291
APPENDIX: Ca se Histories 294
1 Case History: Market and Product-Shaping Dynamics in Action 294
2 Case History: Optimizing Clinical Profile versus Gold Standards 298
3 Case History: Partnering to Ensure Reimbursement and Collect Cost-Effectiveness Data 299
4 Case History: Active Metabolites and Late-Listed Patents 301
5 Case History: A Fixed-Dose Combination (FDC) that Could Not Fail, or Could It? 303
6 Case History: Indication Expansion 305
7 Case History: Killing a Franchise through Over-the-Counter (OTC) Switching 307
8 Case History: Moving FDCs to the Fore in Diabetes 308
9 Case History: FDCs and Multiple Dosage Strengths 310
10 Case History: Building Compliance Support Program 312
11 Case History: Targeting Responders with High-Price Cancer Agents 314
12 Case History: Failure of a "No-Brainer" LCM Strategy 315
13 Case History: At-Risk Launches and Prodrug Patents 320
14 Case History: New Dosages, FDC, and Patent Litigation 322
15 Case History: High Regulatory Hurdles for Lifestyle Drugs 325
16 Case History: Big Money from Orphan Indications 327
17 Case History: Not Giving Up on a Controversial Brand 330
18 Case History: Expanding a Medical Aesthetics Franchise with an Ophthalmic Drug 332
19 Case History: Patent Expiry of the Biggest Drug Brand Ever 335
20 Case History: Early Out-Licensing by Biotech: Take the Money and Run 336
21 Case History: Codevelopment and Comarketing Deals End in a Megamerger 338
22 Case History: A Hugely Successful LLCM Switch Strategy: Business Needs and Reputational Issues Collide 344
23 Case History: Combining Production Outsourcing with Settlement with a Generic Competitor 349
24 Case History: Reformulating for Success in Osteoporosis 351
25 Case History: Isomerism, Polymorphism, and Settlements 354
26 Case History: Payers versus Brand for Patient Selection 356
27 Case History: Litigation Can Delay Generic Entry in the OTC Field Too 358
28 Case History: Inconsistent Court Decisions Can Hurt Both Brand and Generic Companies 360
29 Case History: Holding on to an Antipsychotic Franchise 362
30 Case History: LCM Creates an Almost Immortal Brand 364
31 Case History: LCM of a Women’s Health Franchise 366
32 Case History: Indication Expansion/New Dosage Strength 369
INDEX 371