Ellery / Hansen Pharmaceutical Lifecycle Management

Making the Most of Each and Every Brand
1. Auflage 2012
ISBN: 978-1-118-26679-3
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 412 Seiten, E-Book

A comprehensive guide to optimizing the lifecycle managementof pharmaceutical brands
The mounting challenges posed by cost containment policies andthe prevalence of generic alternatives make optimizing thelifecycle management (LCM) of brand drugs essential forpharmaceutical companies looking to maximize the value of theirproducts. Demonstrating how different measures can be combined tocreate winning strategies, Pharmaceutical Lifecycle Management:Making the Most of Each and Every Brand explores thisincreasingly important field to help readers understand what theycan--and must--do to get the most out of theirbrands.
Offering a truly immersive introduction to LCM options forpharmaceuticals, the book incorporates numerous real-life casestudies that demonstrate successful and failed lifecycle managementinitiatives, explaining the key takeaway of each example. Filledwith practical information on the process of actually writing andpresenting an LCM plan, as well as how to link corporate,portfolio, and individual brand strategies, the book also offers alook ahead to predict which LCM strategies will continue to beeffective in the future.
While the development of new drugs designed to address unmetpatient needs remains the single most important goal of anypharmaceutical company, effective LCM is invaluable for getting thegreatest possible value from existing brands. PharmaceuticalLifecycle Management walks you through the process step bystep, making it indispensable reading for pharmaceutical executivesand managers, as well as anyone working in the fields of drugresearch, development, and regulation.

Autoren/Hrsg.

Ellery, Tony

Hansen, Neal

Inhaltsverzeichnis

Introduction 15
Section A. Lifecycle Management Business Environment 17
Chapter 1. Challenges facing the branded pharmaceutical industry 17
Chapter 2. The lifecycle of industries, technologies and brands 32
Chapter 3. The lifecycle of a pharmaceutical brand 36
Section B. Lifecycle Management Regulatory and Legal Environment 45
Chapter 4. The generic approval process 45
Chapter 5. Hatch-Waxman Legislation and its effects on LCM 48
Section C. Patents and Exclusivities 56
Chapter 8. Patents and other property rights 56
Chapter 9. Non-patent exclusivities 67
Chapter 10. Developmental settlements 72
Section D. Developmental LCM 75
Chapter 11. Strategic principles of developmental LCM 75
Chapter 12. Indication expansion and sequencing 79
Chapter 13. Patient subpopulations and personalized medicine 83
Chapter 14. New dosage strengths, new dosage regimens 89
Chapter 15. Reformulation, new routes of administration and drug delivery 91
Chapter 16. Fixed-dose combinations (FDCs) and Co-packaging 96
Chapter 17. Second Generation Products and Modified Chemistry 99
Chapter 18. Other development LCM strategies 102
Section E. Commercial LCM 104
Chapter 19. Strategic principles of commercial LCM 104
Chapter 20. Geographical expansion and optimization 106
Chapter 21. OTC switching 109
Chapter 22. Brand loyalty and service programmes 113
Chapter 23. Strategic pricing strategies 115
Section F. Biologics and Biosimilars 124
Chapter 26. Biologics and LCM 124
Chapter 27. Biosimilars and their impact on biologic LCM 129
Section F. The Integrated Brand LCM Strategy and Its Implementation 137
Chapter 28. Strategic goals on LCM brand plans 138
Chapter 29. Ten Keys to Successful LCM 141
Chapter 30. Organizational structures and systems for ensuring successful LCM 150
Chapter 31. The LCM process - description, timing and participants 158
Section G. Integrating LCM with Portfolio Management 163
Chapter 32. Principles of Portfolio Management 164
Chapter 33. LCM projects in the development portfolio 166
Chapter 34. Managing Established Brand Portfolios 167
Conclusions 170
Appendix - Case Histories 173

Über Autor(innen)

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.