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Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand
DAFTAR ISI
PART A LIFECYCLE MANAGEMENT BUSINESS ENVIRONMENT 1
1. Challenges facing the branded drug industry 3-26
2. The Life cycle of industries, technologies, and brands 30-36
3. The Life cycle of a pharmaceutical brand 38-46
PART B LIFECYCLE MANAGEMENT REGULATORY AND LEGAL ENVIRONMENT 55
4. The Generic approval process 57-61
5. Hatch-waxman legislation and its effects on LCM 62-66
6. U.S. Health-care reform 2010 69
7. European sector inquiry 72
PART C PATENTS AND EXCLUSIVITIES 77
8. Patents and other intellectual property rights 79-96
9. Nonpatent exclusivities 99-105
10. Patent settlements 107
PART D DEVELOPMENTAL LCM 113
11. Strategic principles of developmental LCm 115-121
12. Indication expansion and sequencing 123
13. Ptient subpopulations and personalized medicine 131-139
14. New dosage strengths, new dosage regimens 140-141
15. Reformulation, new routes of administration, and drug delivery 143-149
16. Fixed-dose combinations (FDCs) and co-packaging 152
17. Second-generation products and modified chemistry 159-163
18. Other development LCm strategies 165-166
PART E COMMERCIAL LCM 167
19. Strategic principles of commercial LCm 169-171
20. Geographical expansion and optimization 172-175
21. OTC switching 178-184
22. Barnd loyalty and service programs 186
23. Strategic pricing strategies 190-193
24. Generic strategic and tacties 198-202
25. Exit strategies 204-206
PART F BIOLOGICS AND BIOSIMILARS 207
26. Biologies and LCm 209-215
27. Biosimilars and their impact on biologic LCM 217-231
PART G THE INTEGRATED BRAND LCM STRATEGY AND ITS IMPLEMENTATION 233
28. Strategic goals of LCM brand plans 235-237
29. Ten keys to successful LCM 238-252
30. Organizational structures and systems for ensuring successful LCM 254-266
31. The LCM process: description, timing, and participants 268-271
PART H INTEGRATING LCM WITH PORTFOLIO MANAGEMENT 277
32. Principles of portfolio management 279
33. LCM projects in the development portfolio 284
34. Managing established brand portfolios 286-290
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