Pharmaceutical Lifecycle Management

Making the Most of Each and Every Brand

Tony Ellery, Neal Hansen

• Publisher: Wiley
• Year: 2012
• Print ISBN: 9780470487532
• eBook ISBN: 9781118265895
• Edition: 1
• Topic: Medicine
• Subtopic: Pharmacology

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.

INDEX

Abbott

Abbreviated New Drug Applications

ACE-inhibitors. See also names of specific ACE-inhibitors

acetanilide

Acino

Aclasta®

acne treatments. See also names of specific acne drugs

ACS (acute coronary syndromes). See also names of specific ACS drugs

active ingredients, and generic drugs

active metabolites

active substance, as barrier to entry

Actonel®

Actoplus Met®

Actos®

acute coronary syndromes (ACS). See also names of specific ACS drugs

AD (Alzheimer’s disease). See also names of specific AD drugs

adalimumab

additive effects of fixed-dose combination therapies

Afinitor®

age-related macular degeneration (AMD). See also names of specific AMD drugs

AIA (America Invents Act)

AIDS

Alcon

alendronate

aliskiren

Alkermes

Allergan

allergic rhinitis. See also names of specific allergic rhinitis drugs

Altana

Alzheimer’s disease (AD). See also names of specific AD drugs

AMD (age-related macular degeneration). See also names of specific AMD drugs

America Invents Act

Amgen

amlodipine

ANDAs. See Abbreviated New Drug Applications

AndroGel®

anemia. See also names of specific anemia drugs

Angeliq®

angiotensin receptor blockers (ARBs). See also names of specific ARBs

annual fee for drug companies, and U.S. health-care reform

antacids. See also names of specific antacids

antibiotics. See also names of specific antibiotics

antihistamines. See also names of specific antihistamines

antihypertensives. See hypertension; specific categories and names of antihypertensives

antiplatelet agents. See also names of specific antiplatelet agents

antipsychotic drugs. See also names of specific antipsychotic drugs

antisepsis drugs. See also names of specific antisepsis drugs

antitrust lawsuit, drug retailers and BMS/Sanofi-Aventis

antivascular endothelial growth factor (VEGF) therapy. See also names of specific VEGF inhibitors

AOK

Apotex

approval of drugs

Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

Approved LCM Proposal

Aranesp®

ARBs (angiotensin receptor blockers). See also names of specific ARBs

Arcoxia®

Aricept®

aspirin

asthma. See also names of specific asthma drugs

AstraZeneca

and biosimilars development

and generics

and over-the-counter switching

and switch from Prilosec® to Nexium®

atorvastatin

“at-risk” launche...

Table of contents

• Cover
• Title page
• Copyright page
• DEDICATION
• ACKNOWLEDGMENTS
• INTRODUCTION
• PART A: LIFECYCLE MANAGEMENT BUSINESS ENVIRONMENT
• PART B: LIFECYCLE MANAGEMENT REGULATORY AND LEGAL ENVIRONMENT
• PART C: PATENTS AND EXCLUSIVITIES
• PART D: DEVELOPMENTAL LCM
• PART E: COMMERCIAL LCM
• PART F: BIOLOGICS AND BIOSIMILARS
• PART G: THE INTEGRATED BRAND LCM STRATEGY AND ITS IMPLEMENTATION
• PART H: INTEGRATING LCM WITH PORTFOLIO MANAGEMENT
• CONCLUSIONS
• APPENDIX: Case Histories
• Index