9780470487532

Pharmaceutical Lifecycle Management : Making the Most of Each and Every Brand

by ;
  • ISBN13:

    9780470487532

  • ISBN10:

    0470487534

  • Edition: 1st
  • Format: Hardcover
  • Copyright: 2012-06-05
  • Publisher: Wiley

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Summary

This book systematically explains how LCM strategies can help the pharmaceutical industry maximize drug development programs and brand management. The author shares his 30-years of experience in the industry, citing recent examples and case histories, and demonstrating how different measures can be combined to create winning strategies. The text helps pharmaceutical professionals understand challenges facing the industry and the role LCM has in confronting them, and offers a look ahead to predict which LCM strategies will continue to be effective in the future. A must-read for pharmaceutical executives and managers.

Author Biography

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.

Table of Contents

Acknowledgmentsp. xvii
Introductionp. xix
Lifecycle Ma nagement Business Environmentp. 1
Challenges F acing the Branded D rug Industryp. 3
Depleted NME Pipelines/Lower R&D Efficiencyp. 4
Higher Development Costsp. 8
Safety Concernsp. 9
Tougher Environment for Pricing, Reimbursement, and Listingp. 12
Increased Competitionp. 16
Earlier Genericizationp. 17
Faster Sales Erosion Following Patent Expiryp. 18
Poor Image of Branded Drug Industryp. 20
Diversificationp. 26
The L ife C ycle of Industries, T echnologies, and Brandsp. 30
Diffusion of Innovationsp. 30
The Lifecycle Curvep. 32
Lifecycle Phasesp. 34
The L ife C ycle of a Pharmaceutical Brandp. 38
Lifecycle Curve of Pharmaceuticalsp. 41
Factors Affecting Rate of Conversion to Genericsp. 44
The Life Cycle of a Pharmaceutical Brandp. 46
Lifecycle Ma nagement R egulatory and L egal E nvironmentp. 55
The G eneric Approval Processp. 57
United Statesp. 57
Europep. 59
Japanp. 61
Hatch-Waxman L egislation and Its E ffects on LCMp. 62
Hatch-Waxman Act of 1984p. 62
Medicare Modernization Act of 2003p. 64
FDA Amendments Act of 2007p. 65
Q1 Program Supplemental Funding Act of 2008p. 66
Discussion of Hatch-Waxman Legislationp. 66
U.S. Health-Care R eform 2010p. 69
European S ector Inquiryp. 72
Patents a nd E xclusivitiesp. 77
Patents and O ther Intellectual Property R ightsp. 79
Nonpatent Intellectual Property Rightsp. 79
What Are Patents?p. 81
What Is Patentable?p. 83
How Long Does a Patent Last?p. 87
Patent Term Restoration in the United Statesp. 87
Supplementary Protection Certificates in Europep. 88
Patent Term Extension in Japanp. 89
How Are Patents Obtained?p. 89
Patent Enforcementp. 91
Types of Patentsp. 92
KSR versus Teleflex-Raising the Nonobviousness Barp. 94
Patent Strategyp. 96
Nonpatent E xclusivitiesp. 99
NCE Exclusivity (United States)p. 99
New Clinical Study Exclusivity (United States)p. 100
Data and Marketing Exclusivity (Europe)p. 100
Data Exclusivity (Japan)p. 101
Orphan Drug Exclusivityp. 101
Pediatric Exclusivityp. 103
180-Day Generic Product Exclusivityp. 105
Patent S ettlementsp. 107
Developmental LCMp. 113
Strategic Principles of D evelopmental LCMp. 115
Developmental LCM Goal 1: Provide a Meaningful Improvement in Clinical Profilep. 116
Developmental LCM Goal 2: Increase the Potential Real-World Patient Potential for the Brandp. 118
Developmental LCM Goal 3: The Ability to Generate an ROIp. 120
Developmental LCM Goal 4: The Ability to Enhance Market Exclusivity of the Brand Franchisep. 121
Indication E xpansion and S equencingp. 123
Categories of Indication Expansionp. 123
Patient S ubpopulations and Personalized M edicinep. 131
What Does a Good Patient Selection Strategy Look Like?p. 135
Patient Selection without Predictive Criteria: Post Hoc Approachesp. 138
What about the Patients Who Are Not Selected?p. 139
New D osage S trengths, N ew D osage R egimensp. 140
New Dosage Strengthsp. 140
New Dosage Regimensp. 141
Reformulation, N ew R outes of Administration, and D rug D eliveryp. 143
Reformulation and New Routes of Administrationp. 143
Drug Delivery Devicesp. 149
Fixed-Dose C ombinations (FDCs) and C o-Packagingp. 152
Second-Generation Products and M odified C hemistryp. 159
Isomerismp. 160
Polymorphismp. 161
Salts, Ethers, and Estersp. 162
Prodrugs and Metabolitesp. 163
Other D evelopment LCM S trategiesp. 165
Manufacturing Strategiesp. 165
White Papers and Citizen Petitionsp. 166
Commercial LCMp. 167
Strategic Principles of C ommercial LCMp. 169
Commercial LCM Goal 1: The Ability to Drive Widespread and Preferential Patient Access to the Brandp. 170
Commercial LCM Goal 2: The Ability to Defend Market Access and Formulary Positionp. 170
Commercial LCM Goal 3: The Ability to Optimize Profitability of the Brand Franchisep. 171
Geographical E xpansion and O ptimizationp. 172
Geographic Expansionp. 174
Harmonization and Rationalizationp. 175
OTC S witchingp. 178
What to Switch: Choosing the Best Approachp. 179
Where to Switch: Dealing with Intermarket Variabilityp. 181
When to Switch: Balancing the Product Life Cycle?p. 183
How to Make the Switch Successful: What Corporate Support Is Required?p. 184
Brand L oyalty and S ervice Programsp. 186
Strategic Pricing S trategiesp. 190
Pricing Strategy and Tactics in the Launch and Growth Phasesp. 190
Pricing Strategy and Tactics Following Patent Expiryp. 193
Generic S trategies and T acticsp. 198
Exit S trategiesp. 204
Biologics a nd Biosimilarsp. 207
Biologics and LCMp. 209
Emergence of Biotechp. 209
Some Definitionsp. 210
Biologicsp. 210
Uptake and Value of Biologicsp. 211
LCM of Biologicsp. 213
Biosimilars and T heir Impact on Biologic LCMp. 217
Changing Terminology: Biogenerics, Biosimilars, and FOBsp. 217
Why Are Biosimilars a Big Deal?p. 219
How Are Biosimilars Different?p. 220
Biosimilar Approval Pathwaysp. 220
Substitution of Biosimilarsp. 223
Innovator Responses to Biosimilar Threatsp. 225
The Future for Biologics LCMp. 226
The Emergence of the "Innovasimilar" Biopharma Companyp. 229
Final Wordsp. 231
The Integrated Brand LCM S trategy and Its Implementationp. 233
Strategic G oals of LCM Brand Plansp. 235
Position to Marketp. 235
Comparative Clinical Profile versus Gold Standardp. 237
Level of Market Unmet Needp. 237
Ten K eys to S uccessful LCMp. 238
Excellent Functional Expertisep. 238
Visible Management Supportp. 244
Unambiguous Ownershipp. 245
An Early Startp. 246
A Robust "Broad to Bespoke" Processp. 248
Focus on "High LCM Value Brands"p. 249
Adequate Resourcesp. 250
Measurements and Rewardsp. 250
Training and Supportp. 252
Realismp. 252
Organizational S tructures and S ystems for E nsuring Successful LCMp. 254
Organization of Project and Brand Managementp. 254
Project and Brand LCM Structuresp. 259
LCM Center of Excellencep. 263
Composition of the LCM CoEp. 266
The LCM Process: D escription, T iming, and Participantsp. 268
Purpose of the LCM Processp. 268
Timing of theLCM Processp. 269
Description of the LCM Processp. 271
Integrating LCM with Portfolio Managementp. 277
Principles of Portfolio M anagementp. 279
LCM Projects in the D evelopment Portfoliop. 284
Managing E stablished Brand Portfoliosp. 286
What Do You Do with a Priority Established Brand?p. 288
What about the Nonpriority Brands?p. 289
Building the Ideal Established Brands Portfoliop. 290
Conclusionsp. 291
Appendix: Ca se Historiesp. 294
Case History: Market and Product-Shaping Dynamics in Actionp. 294
Case History: Optimizing Clinical Profile versus Gold Standardsp. 298
Case History: Partnering to Ensure Reimbursement and Collect Cost-Effectiveness Datap. 299
Case History: Active Metabolites and Late-Listed Patentsp. 301
Case History: A Fixed-Dose Combination (FDC) that Could Not Fail, or Could It?p. 303
Case History: Indication Expansionp. 305
Case History: Killing a Franchise through Over-the-Counter (OTC) Switchingp. 307
Case History: Moving FDCs to the Fore in Diabetesp. 308
Case History: FDCs and Multiple Dosage Strengthsp. 310
Case History: Building Compliance Support Programp. 312
Case History: Targeting Responders with High-Price Cancer Agentsp. 314
Case History: Failure of a "No-Brainer" LCM Strategyp. 315
Case History: At-Risk Launches and Prodrug Patentsp. 320
Case History: New Dosages, FDC, and Patent Litigationp. 322
Case History: High Regulatory Hurdles for Lifestyle Drugsp. 325
Case History: Big Money from Orphan Indicationsp. 327
Case History: Not Giving Up on a Controversial Brandp. 330
Case History: Expanding a Medical Aesthetics Franchise with an Ophthalmic Drugp. 332
Case History: Patent Expiry of the Biggest Drug Brand Everp. 335
Case History: Early Out-Licensing by Biotech: Take the Money and Runp. 336
Case History: Codevelopment and Comarketing Deals End in a Megamergerp. 338
Case History: A Hugely Successful LLCM Switch Strategy: Business Needs and Reputational Issues Collidep. 344
Case History: Combining Production Outsourcing with Settlement with a Generic Competitorp. 349
Case History: Reformulating for Success in Osteoporosisp. 351
Case History: Isomerism, Polymorphism, and Settlementsp. 354
Case History: Payers versus Brand for Patient Selectionp. 356
Case History: Litigation Can Delay Generic Entry in the OTC Field Toop. 358
Case History: Inconsistent Court Decisions Can Hurt Both Brand and Generic Companiesp. 360
Case History: Holding on to an Antipsychotic Franchisep. 362
Case History: LCM Creates an Almost Immortal Brandp. 364
Case History: LCM of a Women's Health Franchisep. 366
Case History: Indication Expansion/New Dosage Strengthp. 369
Indexp. 371
Table of Contents provided by Publisher. All Rights Reserved.

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