Pharmaceutical Lifecycle Management Making the Most of Each and Every Brand
by Ellery, Tony; Hansen, NealEdition: 1st
Format: Hardcover
Pub. Date: 2012-06-05
Publisher(s): 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
| Acknowledgments | p. xvii |
| Introduction | p. xix |
| Lifecycle Ma nagement Business Environment | p. 1 |
| Challenges F acing the Branded D rug Industry | p. 3 |
| Depleted NME Pipelines/Lower R&D Efficiency | p. 4 |
| Higher Development Costs | p. 8 |
| Safety Concerns | p. 9 |
| Tougher Environment for Pricing, Reimbursement, and Listing | p. 12 |
| Increased Competition | p. 16 |
| Earlier Genericization | p. 17 |
| Faster Sales Erosion Following Patent Expiry | p. 18 |
| Poor Image of Branded Drug Industry | p. 20 |
| Diversification | p. 26 |
| The L ife C ycle of Industries, T echnologies, and Brands | p. 30 |
| Diffusion of Innovations | p. 30 |
| The Lifecycle Curve | p. 32 |
| Lifecycle Phases | p. 34 |
| The L ife C ycle of a Pharmaceutical Brand | p. 38 |
| Lifecycle Curve of Pharmaceuticals | p. 41 |
| Factors Affecting Rate of Conversion to Generics | p. 44 |
| The Life Cycle of a Pharmaceutical Brand | p. 46 |
| Lifecycle Ma nagement R egulatory and L egal E nvironment | p. 55 |
| The G eneric Approval Process | p. 57 |
| United States | p. 57 |
| Europe | p. 59 |
| Japan | p. 61 |
| Hatch-Waxman L egislation and Its E ffects on LCM | p. 62 |
| Hatch-Waxman Act of 1984 | p. 62 |
| Medicare Modernization Act of 2003 | p. 64 |
| FDA Amendments Act of 2007 | p. 65 |
| Q1 Program Supplemental Funding Act of 2008 | p. 66 |
| Discussion of Hatch-Waxman Legislation | p. 66 |
| U.S. Health-Care R eform 2010 | p. 69 |
| European S ector Inquiry | p. 72 |
| Patents a nd E xclusivities | p. 77 |
| Patents and O ther Intellectual Property R ights | p. 79 |
| Nonpatent Intellectual Property Rights | p. 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 States | p. 87 |
| Supplementary Protection Certificates in Europe | p. 88 |
| Patent Term Extension in Japan | p. 89 |
| How Are Patents Obtained? | p. 89 |
| Patent Enforcement | p. 91 |
| Types of Patents | p. 92 |
| KSR versus Teleflex-Raising the Nonobviousness Bar | p. 94 |
| Patent Strategy | p. 96 |
| Nonpatent E xclusivities | p. 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 Exclusivity | p. 101 |
| Pediatric Exclusivity | p. 103 |
| 180-Day Generic Product Exclusivity | p. 105 |
| Patent S ettlements | p. 107 |
| Developmental LCM | p. 113 |
| Strategic Principles of D evelopmental LCM | p. 115 |
| Developmental LCM Goal 1: Provide a Meaningful Improvement in Clinical Profile | p. 116 |
| Developmental LCM Goal 2: Increase the Potential Real-World Patient Potential for the Brand | p. 118 |
| Developmental LCM Goal 3: The Ability to Generate an ROI | p. 120 |
| Developmental LCM Goal 4: The Ability to Enhance Market Exclusivity of the Brand Franchise | p. 121 |
| Indication E xpansion and S equencing | p. 123 |
| Categories of Indication Expansion | p. 123 |
| Patient S ubpopulations and Personalized M edicine | p. 131 |
| What Does a Good Patient Selection Strategy Look Like? | p. 135 |
| Patient Selection without Predictive Criteria: Post Hoc Approaches | p. 138 |
| What about the Patients Who Are Not Selected? | p. 139 |
| New D osage S trengths, N ew D osage R egimens | p. 140 |
| New Dosage Strengths | p. 140 |
| New Dosage Regimens | p. 141 |
| Reformulation, N ew R outes of Administration, and D rug D elivery | p. 143 |
| Reformulation and New Routes of Administration | p. 143 |
| Drug Delivery Devices | p. 149 |
| Fixed-Dose C ombinations (FDCs) and C o-Packaging | p. 152 |
| Second-Generation Products and M odified C hemistry | p. 159 |
| Isomerism | p. 160 |
| Polymorphism | p. 161 |
| Salts, Ethers, and Esters | p. 162 |
| Prodrugs and Metabolites | p. 163 |
| Other D evelopment LCM S trategies | p. 165 |
| Manufacturing Strategies | p. 165 |
| White Papers and Citizen Petitions | p. 166 |
| Commercial LCM | p. 167 |
| Strategic Principles of C ommercial LCM | p. 169 |
| Commercial LCM Goal 1: The Ability to Drive Widespread and Preferential Patient Access to the Brand | p. 170 |
| Commercial LCM Goal 2: The Ability to Defend Market Access and Formulary Position | p. 170 |
| Commercial LCM Goal 3: The Ability to Optimize Profitability of the Brand Franchise | p. 171 |
| Geographical E xpansion and O ptimization | p. 172 |
| Geographic Expansion | p. 174 |
| Harmonization and Rationalization | p. 175 |
| OTC S witching | p. 178 |
| What to Switch: Choosing the Best Approach | p. 179 |
| Where to Switch: Dealing with Intermarket Variability | p. 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 Programs | p. 186 |
| Strategic Pricing S trategies | p. 190 |
| Pricing Strategy and Tactics in the Launch and Growth Phases | p. 190 |
| Pricing Strategy and Tactics Following Patent Expiry | p. 193 |
| Generic S trategies and T actics | p. 198 |
| Exit S trategies | p. 204 |
| Biologics a nd Biosimilars | p. 207 |
| Biologics and LCM | p. 209 |
| Emergence of Biotech | p. 209 |
| Some Definitions | p. 210 |
| Biologics | p. 210 |
| Uptake and Value of Biologics | p. 211 |
| LCM of Biologics | p. 213 |
| Biosimilars and T heir Impact on Biologic LCM | p. 217 |
| Changing Terminology: Biogenerics, Biosimilars, and FOBs | p. 217 |
| Why Are Biosimilars a Big Deal? | p. 219 |
| How Are Biosimilars Different? | p. 220 |
| Biosimilar Approval Pathways | p. 220 |
| Substitution of Biosimilars | p. 223 |
| Innovator Responses to Biosimilar Threats | p. 225 |
| The Future for Biologics LCM | p. 226 |
| The Emergence of the "Innovasimilar" Biopharma Company | p. 229 |
| Final Words | p. 231 |
| The Integrated Brand LCM S trategy and Its Implementation | p. 233 |
| Strategic G oals of LCM Brand Plans | p. 235 |
| Position to Market | p. 235 |
| Comparative Clinical Profile versus Gold Standard | p. 237 |
| Level of Market Unmet Need | p. 237 |
| Ten K eys to S uccessful LCM | p. 238 |
| Excellent Functional Expertise | p. 238 |
| Visible Management Support | p. 244 |
| Unambiguous Ownership | p. 245 |
| An Early Start | p. 246 |
| A Robust "Broad to Bespoke" Process | p. 248 |
| Focus on "High LCM Value Brands" | p. 249 |
| Adequate Resources | p. 250 |
| Measurements and Rewards | p. 250 |
| Training and Support | p. 252 |
| Realism | p. 252 |
| Organizational S tructures and S ystems for E nsuring Successful LCM | p. 254 |
| Organization of Project and Brand Management | p. 254 |
| Project and Brand LCM Structures | p. 259 |
| LCM Center of Excellence | p. 263 |
| Composition of the LCM CoE | p. 266 |
| The LCM Process: D escription, T iming, and Participants | p. 268 |
| Purpose of the LCM Process | p. 268 |
| Timing of theLCM Process | p. 269 |
| Description of the LCM Process | p. 271 |
| Integrating LCM with Portfolio Management | p. 277 |
| Principles of Portfolio M anagement | p. 279 |
| LCM Projects in the D evelopment Portfolio | p. 284 |
| Managing E stablished Brand Portfolios | p. 286 |
| What Do You Do with a Priority Established Brand? | p. 288 |
| What about the Nonpriority Brands? | p. 289 |
| Building the Ideal Established Brands Portfolio | p. 290 |
| Conclusions | p. 291 |
| Appendix: Ca se Histories | p. 294 |
| Case History: Market and Product-Shaping Dynamics in Action | p. 294 |
| Case History: Optimizing Clinical Profile versus Gold Standards | p. 298 |
| Case History: Partnering to Ensure Reimbursement and Collect Cost-Effectiveness Data | p. 299 |
| Case History: Active Metabolites and Late-Listed Patents | p. 301 |
| Case History: A Fixed-Dose Combination (FDC) that Could Not Fail, or Could It? | p. 303 |
| Case History: Indication Expansion | p. 305 |
| Case History: Killing a Franchise through Over-the-Counter (OTC) Switching | p. 307 |
| Case History: Moving FDCs to the Fore in Diabetes | p. 308 |
| Case History: FDCs and Multiple Dosage Strengths | p. 310 |
| Case History: Building Compliance Support Program | p. 312 |
| Case History: Targeting Responders with High-Price Cancer Agents | p. 314 |
| Case History: Failure of a "No-Brainer" LCM Strategy | p. 315 |
| Case History: At-Risk Launches and Prodrug Patents | p. 320 |
| Case History: New Dosages, FDC, and Patent Litigation | p. 322 |
| Case History: High Regulatory Hurdles for Lifestyle Drugs | p. 325 |
| Case History: Big Money from Orphan Indications | p. 327 |
| Case History: Not Giving Up on a Controversial Brand | p. 330 |
| Case History: Expanding a Medical Aesthetics Franchise with an Ophthalmic Drug | p. 332 |
| Case History: Patent Expiry of the Biggest Drug Brand Ever | p. 335 |
| Case History: Early Out-Licensing by Biotech: Take the Money and Run | p. 336 |
| Case History: Codevelopment and Comarketing Deals End in a Megamerger | p. 338 |
| Case History: A Hugely Successful LLCM Switch Strategy: Business Needs and Reputational Issues Collide | p. 344 |
| Case History: Combining Production Outsourcing with Settlement with a Generic Competitor | p. 349 |
| Case History: Reformulating for Success in Osteoporosis | p. 351 |
| Case History: Isomerism, Polymorphism, and Settlements | p. 354 |
| Case History: Payers versus Brand for Patient Selection | p. 356 |
| Case History: Litigation Can Delay Generic Entry in the OTC Field Too | p. 358 |
| Case History: Inconsistent Court Decisions Can Hurt Both Brand and Generic Companies | p. 360 |
| Case History: Holding on to an Antipsychotic Franchise | p. 362 |
| Case History: LCM Creates an Almost Immortal Brand | p. 364 |
| Case History: LCM of a Women's Health Franchise | p. 366 |
| Case History: Indication Expansion/New Dosage Strength | p. 369 |
| Index | p. 371 |
| Table of Contents provided by Publisher. All Rights Reserved. |
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