Monday, October 24, 2011

Pharma Readiness for Personalized Medicine

This new report from Diaceutics for the first time analyzes which pharmaceutical companies are best prepared to capitalize on new discoveries in genetic biomarkers and translate them into personalized medicine (PM).
“Pharma Readiness for Personalized Medicine” looks at how traditional drug development approach has changed since the advent of PM, as well as the ways that leading pharmaceutical companies have adapted.
Over the past decade, several significant advances in biomarker development and diagnostic modalities have allowed for the development of targeted therapies that improve the ability to treat certain diseases and lead to a reduction in the use of ineffective therapies. Although the pharmaceutical industry’s investment in PM is beginning to show valuable results, that investment is unevenly distributed, with some companies demonstrating greater commitment and more structure in their approach than others.
The groundwork for the future competitive landscape in PM for the entire pharmaceutical industry is currently being laid by select pharmaceutical companies pursuing a range of approaches. Success in this space will be determined by how each company embraces PM, as measured both by how they restructure their internal R&D and external commercialization and launch behaviours.
Questions Answered in This Report:
• At many of the leading pharmaceutical companies, their internal and external behavior in PM is bringing them closer to becoming an “ideal PM organization.”. What does an ideal PM organization look like and how does it operate?
• Personalized medicine strategies have typically only been implemented in scenarios where identification of a specific biomarker association is proved out during Phase II/III clinical studies to justify development of a companion diagnostic along with a therapy in anticipation of launch. This practice may miss other scenarios that could ultimately lead to a successful personalized strategy.
What are these other scenarios and which drugs in the pipelines of the top ten pharmaceutical companies might benefit from a personalized (i.e. test based) strategy?
• Although the number of PM drug launches is increasing, the pharmaceutical industry is still holding tight to the blockbuster model.What is the shift in the number of PM versus non-­PM launches?
• Commercialized PM drugs have performed with varying success on the market.What is the market performance of PM drugs currently in the market?
• In the past few years there have been a number of interesting deals made between the companies. What is the overall activity of the leading pharmaceutical companies of PM-­related deals and partnerships?
• The PM environment is a highly competitive landscape. How do the leading pharmaceutical companies rank against each other in terms of their competition?
• The current pharmaceutical and diagnostic targeted therapy models have varying levels of organizational integration and operational alignment. What change is needed in these models to optimize this integration and alignment and where are thepharmaceutical companies in this regard? What is the future outlook for pharmaceutical/diagnostic targeted therapy models?
• There is a complex web of intellectual property (IP) issues surrounding PM in terms of tests, instruments and drugs. What is the role of IP in locking and unlocking PM markets?
Companies covered:Roche, Merck, Novartis, Amgen, Bristol-­‐Myers Squibb, Sanofi-­‐Aventis, GlaxoSmithKline, AstraZeneca, Pfizer, Lilly

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