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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).


Buy This Report Now (Publication date: April 4, 2011)

Pricing: $3,500 (single-user license), $8500 (enterprise-wide license)

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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 the pharmaceutical 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, Eli Lilly


Expert Commentary
Interviews with top officials from the leading pharmaceutical and diagnostic companies about the changes they anticipate from new discoveries in personalized medicine, including genomic science, biomarker advances, and information technology, as well as on the challenges and opportunities they see ahead in PM.


Displays
Over 50 data-rich tables and figures reflecting PM-specific analyses.

Key reasons to purchase this report:

  • Evaluation of the top ten pharmaceutical companies activities in PM
  • A review of the current trends in PM
  • A special treatment of IP in opening and unlocking markets
  • Analysis of the Ideal PM organization and how it operates
  • PM competitiveness ranking of the top ten pharmaceutical companies
  • Future outlook of the PM industry
  • Market performance of PM drugs

 

TABLE OF CONTENTS


ABOUT THE AUTHOR

METHODS EMPLOYED

1.0 INTRODUCTION

2.0 THE INDUSTRY OUTLOOK FOR PERSONALIZED MEDICINE

2.1 TRENDS IN PERSONALIZED MEDICINE

2.1.1 PERSONALIZED MEDICINE COUNTRY MIX

2.1.2 NEW AREAS FOR PERSONALIZED MEDICINE

2.1.3 THE PHARMACEUTICAL INDUSTRY

3.0 THE “IDEAL” PERSONALIZED MEDICINE COMPANY

3.1 MODEL MAINTENANCE VS. MODEL MIGRATION

3.1.1 SOURCES OF INNOVATION

3.1.2 DESIGN AND DEVELOPMENT

3.1.3 OPTIMIZING ACCESS

3.1.4 MANAGING CHANNELS

3.1.5 MAINTAIN THE MODEL—OR MIGRATE IT?

3.2 THE VALUE OF MODEL MIGRATION

3.3 NICHE OR DISRUPTIVE INNOVATION? PHARMACEUTICAL COMPANIES PLACE BETS

4.0 PHARMA READINESS FOR PERSONALIZED MEDICINE

4.1 INTERNAL READINESS

4.1.1 THE OPTIONS FOR TEST INDEX (OFTI™)

  • CALCULATING THE OFTI™

4.1.2 PIPELINE ANALYSIS

  • PROPORTION OF PHASE 3 PIPELINES ASSOCIATED WITH PERSONALIZED MEDICINE
  • MISSED OPPORTUNITIES?

4.2.1 ASSESSMENT OF EXTERNAL READINESS

  • PACE AND EXPERIENCE IN BRINGING NEW PERSONALIZED THERAPIES TO MARKET
  • MARKET PERFORMANCE OF PERSONALIZED THERAPIES ALREADY IN THE MARKET
  • DEAL FLOW RELATED TO PERSONALIZED MEDICINE
  • PERSONALIZED MEDICINE RELATED PRESS ACTIVITY
  • CONCLUSIONS ABOUT EXTERNAL READINESS

4.2.2 COMPETITIVE RANKING OF PHARMACEUTICAL COMPANIES

  • MEASURING COMPETITIVENESS
  • RANKING OF OVERALL READINESS
  • CONCLUSIONS FOR COMPETITIVE RANKING OF THE PHARMACEUTICAL COMPANIES

4.2.3 CASE STUDY: THE ROLE OF INTELLECTUAL PROPERTY IN LOCKING AND UNLOCKING MARKETS

  • INTELLECTUAL PROPERTY
  • THE ROLE OF EGFR MUTATIONS IN CANCER TREATMENT
  • THE IP PROTECTION CASCADE IN EGFR MUTATION TESTING: AN OVERVIEW
  • IMPACT OF EGFR MUTATION IP ON CLINICAL LABORATORIES
  • BEYOND EGFR: IMPLICATIONS OF IP FOR THE EVOLUTION OF PERSONALIZED MEDICINE

5.0 PHARMACEUTICAL/DIAGNOSTIC OPERATING MODELS: FUTURE OUTLOOK

5.1 PHARMACEUTICAL AND DIAGNOSTIC TARGETED THERAPY MODELS

5.1.1 TRADITIONAL RX VS. DX

5.1.2 STRATEGIC TARGETED THERAPY PARTNERSHIP

5.1.3 RX/DX HOLDING

5.1.4 INTEGRATED TARGETED THERAPY

5.2 COMPARISON OF THE FOUR MODELS

5.2.1 RX CONTROL OVER DX COMMERCIALIZATION

5.2.2 FLEXIBILITY OF RX-INTERNAL DX RESOURCES

5.2.3 DILUTION OF CORPORATE OPERATING MARGINS

5.2.4 BASIS FOR LONG-TERM TARGETED THERAPY STRATEGY

5.2.5 EXTERNAL VISIBILITY OF TARGETED THERAPY COMMITMENT

5.3 GROWING INTO FUTURE RX/DX MODELS

5.3.1 CONCLUSIONS FOR FUTURE RX/DX MODELS

  • IS ROCHE ON TRACK TO BECOME AN INTEGRATED COMPANY?

6.0 COMPANY PROFILES

6.1 AMGEN

6.1.1 INTERNAL READINESS

6.1.2 EXTERNAL READINESS

6.2 ASTRAZENECA

6.2.1 INTERNAL READINESS

6.2.2 EXTERNAL READINESS

6.3 BRISTOL-MYERS SQUIBB

6.3.1 INTERNAL READINESS

6.3.2 EXTERNAL READINESS

6.4 GLAXOSMITHKLINE

6.4.1 INTERNAL READINESS

6.4.2 EXTERNAL READINESS

6.5 ELI LILLY AND COMPANY

6.5.1 INTERNAL READINESS

6.5.2 EXTERNAL READINESS

6.6 MERCK & CO.

6.6.1 INTERNAL READINESS

6.6.2 EXTERNAL READINESS

6.7 NOVARTIS

6.7.1 INTERNAL READINESS

6.7.2 EXTERNAL READINESS

6.8 PFIZER

6.8.1 INTERNAL READINESS

6.8.2 EXTERNAL READINESS

6.9 ROCHE HOLDING AG

6.9.1 INTERNAL READINESS

6.9.2 EXTERNAL READINESS

6.10 SANOFI-AVENTIS

6.10.1 INTERNAL READINESS

6.10.2 EXTERNAL READINESS

CONCLUSIONS

BIBLIOGRAPHY

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