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Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand [Kietas viršelis]

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  • Formatas: Hardback, 412 pages, aukštis x plotis x storis: 245x163x28 mm, weight: 739 g
  • Išleidimo metai: 15-Jun-2012
  • Leidėjas: John Wiley & Sons Inc
  • ISBN-10: 0470487534
  • ISBN-13: 9780470487532
Kitos knygos pagal šią temą:
Pharmaceutical Lifecycle Management: Making the Most of Each and Every BrandDidesnis paveikslėlis
  • Formatas: Hardback, 412 pages, aukštis x plotis x storis: 245x163x28 mm, weight: 739 g
  • Išleidimo metai: 15-Jun-2012
  • Leidėjas: John Wiley & Sons Inc
  • ISBN-10: 0470487534
  • ISBN-13: 9780470487532
Kitos knygos pagal šią temą:
Pastovi nuoroda: https://www.kriso.lt/db/9780470487532.html
Raktažodžiai:

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.

Recenzijos

In conclusion, it should be stated that the authors reached their goals in providing a reference manual for potential measures that should be applied in case the life and profit of a brand are to be maximized. (Green Processing and Synthesis, 1 March 2014)

 

 

Acknowledgments xvii
Introduction xix
PART A LIFECYCLE MANAGEMENT BUSINESS ENVIRONMENT
1(54)
1 Challenges Facing the Branded Drug Industry
3(27)
1.1 Depleted NME Pipelines/Lower R&D Efficiency
4(4)
1.2 Higher Development Costs
8(1)
1.3 Safety Concerns
9(3)
1.4 Tougher Environment for Pricing, Reimbursement, and Listing
12(4)
1.5 Increased Competition
16(1)
1.6 Earlier Genericization
17(1)
1.7 Faster Sales Erosion Following Patent Expiry
18(2)
1.8 Poor Image of Branded Drug Industry
20(6)
1.8.1 Prosperity of the Branded Drug Industry
21(1)
1.8.2 Lack of Innovation
22(1)
1.8.3 Marketing Spend and Tactics
22(1)
1.8.4 Safety Issues
23(1)
1.8.5 Keeping Generics Off the Market
24(2)
1.9 Diversification
26(4)
2 The Life Cycle of Industries, Technologies, and Brands
30(8)
2.1 Diffusion of Innovations
30(2)
2.2 The Lifecycle Curve
32(2)
2.3 Lifecycle Phases
34(4)
2.3.1 Development Phase
34(1)
2.3.2 Introduction Phase
35(1)
2.3.3 Growth Phase
35(1)
2.3.4 Maturity Phase
36(1)
2.3.5 Decline Phase
36(2)
3 The Life Cycle of a Pharmaceutical Brand
38(17)
3.1 Lifecycle Curve of Pharmaceuticals
41(3)
3.1.1 Slow Rate of Growth during the Growth Phase
42(1)
3.1.2 Lack of a True Maturity Phase
43(1)
3.1.3 Precipitous Decline Phase
43(1)
3.2 Factors Affecting Rate of Conversion to Generics
44(2)
3.2.1 Government Policy
44(1)
3.2.2 Disease
44(1)
3.2.3 Size of Brand
45(1)
3.2.4 Hospital versus Nonhospital Drug Usage
45(1)
3.2.5 Active Substance and Other Barriers to Entry
46(1)
3.3 The Life Cycle of a Pharmaceutical Brand
46(9)
PART B LIFECYCLE MANAGEMENT REGULATORY AND LEGAL ENVIRONMENT
55(22)
4 The Generic Approval Process
57(5)
4.1 United States
57(2)
4.2 Europe
59(2)
4.3 Japan
61(1)
5 Hatch-Waxman Legislation and Its Effects on LCM
62(7)
5.1 Hatch-Waxman Act of 1984
62(2)
5.2 Medicare Modernization Act of 2003
64(1)
5.3 FDA Amendments Act of 2007
65(1)
5.4 Q1 Program Supplemental Funding Act of 2008
66(1)
5.5 Discussion of Hatch-Waxman Legislation
66(3)
6 U.S. Health-Care Reform 2010
69(3)
7 European Sector Inquiry
72(5)
PART C PATENTS AND EXCLUSIVITIES
77(36)
8 Patents and Other Intellectual Property Rights
79(20)
8.1 Nonpatent Intellectual Property Rights
79(2)
8.2 What Are Patents?
81(2)
8.3 What Is Patentable?
83(4)
8.3.1 Patentable Subject Matter
83(1)
8.3.2 Novelty
84(1)
8.3.3 Inventive Step
85(1)
8.3.4 Utility
86(1)
8.3.5 Disclosure
86(1)
8.4 How Long Does a Patent Last?
87(1)
8.5 Patent Term Restoration in the United States
87(1)
8.6 Supplementary Protection Certificates in Europe
88(1)
8.7 Patent Term Extension in Japan
89(1)
8.8 How Are Patents Obtained?
89(2)
8.9 Patent Enforcement
91(1)
8.10 Types of Patents
92(2)
8.10.1 Composition of Matter Patent
93(1)
8.10.2 Medical Use Patent
93(1)
8.10.3 Formulation Patent
94(1)
8.11 KSR versus Teleflex---Raising the Nonobviousness Bar
94(2)
8.12 Patent Strategy
96(3)
9 Nonpatent Exclusivities
99(8)
9.1 NCE Exclusivity (United States)
99(1)
9.2 New Clinical Study Exclusivity (United States)
100(1)
9.3 Data and Marketing Exclusivity (Europe)
100(1)
9.4 Data Exclusivity (Japan)
101(1)
9.5 Orphan Drug Exclusivity
101(2)
9.6 Pediatric Exclusivity
103(2)
9.7 180-Day Generic Product Exclusivity
105(2)
10 Patent Settlements
107(6)
PART D DEVELOPMENTAL LCM
113(54)
11 Strategic Principles of Developmental LCM
115(8)
11.1 Developmental LCM Goal 1: Provide a Meaningful Improvement in Clinical Profile
116(2)
11.2 Developmental LCM Goal 2: Increase the Potential Real-World Patient Potential for the Brand
118(2)
11.3 Developmental LCM Goal 3: The Ability to Generate an ROI
120(1)
11.4 Developmental LCM Goal 4: The Ability to Enhance Market Exclusivity of the Brand Franchise
121(2)
12 Indication Expansion and Sequencing
123(8)
12.1 Categories of Indication Expansion
123(8)
13 Patient Subpopulations and Personalized Medicine
131(9)
13.1 What Does a Good Patient Selection Strategy Look Like?
135(3)
13.2 Patient Selection without Predictive Criteria: Post Hoc Approaches
138(1)
13.3 What about the Patients Who Are Not Selected?
139(1)
14 New Dosage Strengths, New Dosage Regimens
140(3)
14.1 New Dosage Strengths
140(1)
14.2 New Dosage Regimens
141(2)
15 Reformulation, New Routes of Administration, and Drug Delivery
143(9)
15.1 Reformulation and New Routes of Administration
143(6)
15.1.1 Switch and Grow Strategy
143(2)
15.1.2 Expand and Grow Strategy
145(1)
15.1.3 Generic Defense
145(4)
15.2 Drug Delivery Devices
149(3)
16 Fixed-Dose Combinations (FDCs) and Co-Packaging
152(7)
17 Second-Generation Products and Modified Chemistry
159(6)
17.1 Isomerism
160(1)
17.2 Polymorphism
161(1)
17.3 Salts, Ethers, and Esters
162(1)
17.4 Prodrugs and Metabolites
163(2)
18 Other Developmental LCM Strategies
165(2)
18.1 Manufacturing Strategies
165(1)
18.2 White Papers and Citizen Petitions
166(1)
PART E COMMERCIAL LCM
167(40)
19 Strategic Principles of Commercial LCM
169(3)
19.1 Commercial LCM Goal 1: The Ability to Drive Widespread and Preferential Patient Access to the Brand
170(1)
19.2 Commercial LCM Goal 2: The Ability to Defend Market Access and Formulary Position
170(1)
19.3 Commercial LCM Goal 3: The Ability to Optimize Profitability of the Brand Franchise
171(1)
20 Geographical Expansion and Optimization
172(6)
20.1 Geographic Expansion
174(1)
20.2 Harmonization and Rationalization
175(3)
21 OTC Switching
178(8)
21.1 What to Switch: Choosing the Best Approach
179(2)
21.2 Where to Switch: Dealing with Intermarket Variability
181(2)
21.3 When to Switch: Balancing the Product Life Cycle?
183(1)
21.4 How to Make the Switch Successful: What Corporate Support Is Required?
184(2)
22 Brand Loyalty and Service Programs
186(4)
23 Strategic Pricing Strategies
190(8)
23.1 Pricing Strategy and Tactics in the Launch and Growth Phases
190(3)
23.2 Pricing Strategy and Tactics Following Patent Expiry
193(5)
24 Generic Strategies and Tactics
198(6)
Building a Generic Portfolio: Old versus New Thinking
202(2)
25 Exit Strategies
204(3)
Executing the Exit Strategy
206(1)
PART F BIOLOGICS AND BIOSIMILARS
207(26)
26 Biologies and LCM
209(8)
26.1 Emergence of Biotech
209(1)
26.2 Some Definitions
210(1)
26.2.1 Biologics
210(1)
26.3 Uptake and Value of Biologics
211(2)
26.4 LCM of Biologics
213(4)
26.4.1 Next-Generation Biologics
213(1)
26.4.2 Reformulation
214(1)
26.4.3 Indication Expansion
215(1)
26.4.4 Self-Injection Devices
215(2)
27 Biosimilars and Their Impact on Biologic LCM
217(16)
27.1 Changing Terminology: Biogenerics, Biosimilars, and FOBs
217(2)
27.2 Why Are Biosimilars a Big Deal?
219(1)
27.3 How Are Biosimilars Different?
220(1)
27.4 Biosimilar Approval Pathways
220(3)
27.4.1 Biosimilars in Europe
220(1)
27.4.2 Biosimilars in the United States
221(1)
27.4.3 Biosimilars around the World
222(1)
27.5 Substitution of Biosimilars
223(2)
27.5.1 Automatic Substitution
223(1)
27.5.2 Therapeutic Substitution
224(1)
27.6 Innovator Responses to Biosimilar Threats
225(1)
27.7 The Future for Biologics LCM
226(3)
27.7.1 Legal Strategies in the United States
227(1)
27.7.2 Indication Expansion in Europe
228(1)
27.7.3 Brand Loyalty Programs and Services
229(1)
27.8 The Emergence of the "Innovasimilar" Biopharma Company
229(2)
27.9 Final Words
231(2)
PART G THE INTEGRATED BRAND LCM STRATEGY AND ITS IMPLEMENTATION
233(44)
28 Strategic Goals of LCM Brand Plans
235(3)
28.1 Position to Market
235(2)
28.2 Comparative Clinical Profile versus Gold Standard
237(1)
28.3 Level of Market Unmet Need
237(1)
29 Ten Keys to Successful LCM
238(16)
29.1 Excellent Functional Expertise
238(6)
29.1.1 Patent Attorneys
239(1)
29.1.2 Regulatory Affairs
240(1)
29.1.3 Clinical Development
240(1)
29.1.4 Formulation Scientists
241(1)
29.1.5 Marketing and Sales
242(1)
29.1.6 Manufacturing
243(1)
29.2 Visible Management Support
244(1)
29.3 Unambiguous Ownership
245(1)
29.4 An Early Start
246(2)
29.5 A Robust "Broad to Bespoke" Process
248(1)
29.6 Focus on "High LCM Value Brands"
249(1)
29.7 Adequate Resources
250(1)
29.8 Measurements and Rewards
250(2)
29.9 Training and Support
252(1)
29.10 Realism
252(2)
30 Organizational Structures and Systems for Ensuring Successful LCM
254(14)
30.1 Organization of Project and Brand Management
254(5)
30.1.1 Functional Structure
255(1)
30.1.2 Project Structure
255(2)
30.1.3 Matrix Structure
257(2)
30.2 Project and Brand LCM Structures
259(4)
30.3 LCM Center of Excellence
263(3)
30.4 Composition of the LCM CoE
266(2)
31 The LCM Process: Description, Timing, and Participants
268(9)
31.1 Purpose of the LCM Process
268(1)
31.2 Timing of the LCM Process
269(2)
31.3 Description of the LCM Process
271(6)
PART H INTEGRATING LCM WITH PORTFOLIO MANAGEMENT
277(14)
32 Principles of Portfolio Management
279(5)
33 LCM Projects in the Development Portfolio
284(2)
34 Managing Established Brand Portfolios
286(5)
34.1 What Do You Do with a Priority Established Brand?
288(1)
34.2 What about the Nonpriority Brands?
289(1)
34.3 Building the Ideal Established Brands Portfolio
290(1)
CONCLUSIONS
291(3)
APPENDIX: CASE HISTORIES
294(77)
A.1 Market and Product-Shaping Dynamics in Action
294(4)
Alzheimer's Disease Therapies: Aricept®, Exelon®, and Reminyl®/Razadyne®
294(3)
Learnings
297(1)
A.2 Optimizing Clinical Profile versus Gold Standards
298(1)
Angiotensin II Receptor Blockers (ARBs): Cozaar®, Micardis®, and Benicar®
298(1)
Learnings
299(1)
A.3 Partnering to Ensure Reimbursement and Collection of Cost-Effectiveness Data
299(2)
Aricept
299(2)
Learnings
301(1)
A.4 Active Metabolites and Late-Listed Patents
301(2)
Buspar®
301(2)
Learnings
303(1)
A.5 A Fixed-Dose Combination (FDC) That Could Not Fail, or Could It?
303(2)
Caduet®
303(1)
Learnings
304(1)
A.6 Indication Expansion
305(2)
Certican®/Zortress® and Afinitor®
305(1)
Learnings
306(1)
A.7 Killing a Franchise through Over-the-Counter (OTC) Switching
307(1)
Claritin®
307(1)
Learnings
308(1)
A.8 Moving FDCs to the Fore in Diabetes
308(2)
Diabetes Therapies: Glucophage®, Avandia®, Actos®, and Januvia®
308(2)
Learnings
310(1)
A.9 FDCs and Multiple Dosage Strengths
310(2)
Diovan® and Tekturna®/Rasilez®
310(2)
Learnings
312(1)
A.10 Building a Compliance Support Program
312(2)
Enbrel®
312(2)
Learnings
314(1)
A.11 Targeting Responders with High-Price Cancer Agents
314(1)
Erbitux®
314(1)
Learnings
315(1)
A.12 Failure of a "No-Brainer" LCM Strategy
315(5)
Exubera®
315(4)
Learnings
319(1)
A.13 At-Risk Launches and Prodrug Patents
320(2)
Famvir®
320(1)
Learnings
321(1)
A.14 New Dosages, FDC, and Patent Litigation
322(3)
Fosamax®
322(2)
Learnings
324(1)
A.15 High Regulatory Hurdles for Lifestyle Drugs
325(2)
Girosa®
325(2)
Learnings
327(1)
A.16 Big Money from Orphan Indications
327(3)
Gleevec®
327(2)
Learnings
329(1)
A.17 Not Giving Up on a Controversial Brand
330(2)
Iressa®
330(2)
Learnings
332(1)
A.18 Expanding a Medical Aesthetics Franchise with an Ophthalmic Drug
332(3)
Latisse®
332(2)
Learnings
334(1)
A.19 Patent Expiry of the Biggest Drug Brand Ever
335(1)
Lipitor®
335(1)
Learnings
336(1)
A.20 Early Out-Licensing by Biotech: Take the Money and Run
336(2)
Macugen®
336(2)
Learnings
338(1)
A.21 Codevelopment and Comarketing Deals End in a Megamerger
338(6)
Merck and Schering-Plough: Zetia®/Vytorin® and Claritin/Singulair®
338(1)
Zetia/Vytorin
339(3)
Claritin/Singulair
342(1)
Learnings
343(1)
A.22 A Hugely Successful LLCM Switch Strategy: Business Needs and Reputational Issues Collide
344(5)
Prilosec® and Nexium
344(1)
The Facts
344(1)
The Public Reaction
345(2)
Learnings
347(2)
A.23 Combining Production Outsourcing with Settlement with a Generic Competitor
349(2)
Nexium
349(2)
Learnings
351(1)
A.24 Reformulating for Success in Osteoporosis
351(3)
Osteoporosis Drugs: Fosamax, Actonel®, Boniva®, and Aclasta®
351(2)
Learnings
353(1)
A.25 Isomerism, Polymorphism, and Settlements
354(2)
Plavix®
354(1)
Learnings
355(1)
A.26 Payers versus Brand for Patient Selection
356(2)
Plavix and Brilinta
356(1)
Learnings
357(1)
A.27 Litigation Can Delay Generic Entry in the OTC Field Too
358(2)
Prilosec OTC
358(1)
Learnings
359(1)
A.28 Inconsistent Court Decisions Can Hurt Both Brand and Generic Companies
360(2)
Protonix®
360(1)
Learnings
361(1)
A.29 Holding on to an Antipsychotic Franchise
362(2)
Risperdal®/Invega®
362(1)
Learnings
363(1)
A.30 LCM Creates an Almost Immortal Brand
364(2)
Voltaren®
364(1)
Learnings
365(1)
A.31 LCM of a Women's Health Franchise
366(3)
The Yasmin® Family
366(2)
Learnings
368(1)
A.32 Indication Expansion/New Dosage Strength
369(2)
Zometa/Reclast® (Aclasta)
369(1)
Learnings
370(1)
Index 371
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.