Pharmaceutical Lifecycle Management (eBook)

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.

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

"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)