Pharmaceutical Lifecycle Management

Tony Ellery 지음

Wiley 2012년 04월 16일 출간

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책소개

A comprehensive guide to optimizing the lifecycle management of pharmaceutical brandsThe 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 canm-and mustm-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.

목차

Acknowledgments xviiIntroduction xixPART A Lifecycle Management Business Environment 11. Challenges Facing the Branded Drug Industry 31.1 Depleted NME Pipelines/Lower RD Efficiency 41.2 Higher Development Costs 81.3 Safety Concerns 91.4 Tougher Environment for Pricing, Reimbursement, and Listing 121.5 Increased Competition 161.6 Earlier Genericization 171.7 Faster Sales Erosion Following Patent Expiry 181.8 Poor Image of Branded Drug Industry 201.9 Diversification 262. The Life Cycle of Industries, Technologies, and Brands 302.1 Diffusion of Innovations 302.2 The Lifecycle Curve 322.3 Lifecycle Phases 343. The Life Cycle of a Pharmaceutical Brand 383.1 Lifecycle Curve of Pharmaceuticals 413.2 Factors Affecting Rate of Conversion to Generics 443.3 The Life Cycle of a Pharmaceutical Brand 46PART B Lifecycle Management Regulatory and Legal Environment 554. The Generic Approval Process 574.1 United States 574.2 Europe 594.3 Japan 615. Hatch&n-Waxman Legislation and Its Effects on LCM 625.1 Hatch&n-Waxman Act of 1984 625.2 Medicare Modernization Act of 2003 645.3 FDA Amendments Act of 2007 655.4 Q1 Program Supplemental Funding Act of 2008 665.5 Discussion of Hatch-Waxman Legislation 666. U.S. Health-Care Reform 2010 697. European Sector Inquiry 72PART C Patents and Exclusivities 778. Patents and Other Intellectual Property Rights 798.1 Nonpatent Intellectual Property Rights 798.2 What Are Patents? 818.3 What Is Patentable? 838.4 How Long Does a Patent Last? 878.5 Patent Term Restoration in the United States 878.6 Supplementary Protection Certificates in Europe 888.7 Pate

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저자(글) Tony Ellery

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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.