This report examines the various models that are being adopted by players and uses case studies to highlight the risks and rewards of different approaches to partnerships. The challenges facing companies when entering into a collaboration and factors that should be taken into account when selecting a partner are reviewed and recommendations given as to best practices in partnering.
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Strategies for effective partnerships between pharmaceutical and diagnostic companies
1. Strategies for Effective Partnerships Between Pharmaceutical and Diagnostic
Companies
Published:October 2011
No.Of Pages:100
Price:US $ 3835
Introduction
This report examines the various models that are being adopted by players and uses case
studies to highlight the risks and rewards of different approaches to Pharmaceutical and
Diagnostic Companies Partnership Strategies. The challenges facing companies when
entering into a collaboration and factors that should be taken into account when selecting a
partner are reviewed and recommendations given as to best practices in partnering.
Features and benefits
* With the use of case studies understand the various approaches to pharma-diagnostic
collaboration and decide the best fit for your company.
* Evaluate the benefits and disadvantages of emerging business models and collaborative
agreements for drug diagnostic co-development.
* Evaluate alternative partnership models that can drive revenue growth for both diagnostic
and pharma players.
* Understand regulatory trends that will influence the reimbursement status of both the
drug and diagnostic in any combined offering.
* Learn how to get the most out of a deal from both the pharma and the diagnostic
company's perspective.
Highlights
* The need for tropism testing to select patients for Pfizer’s maraviroc, prompted a co-
development collaboration with Monogram Biosciences, that’s laboratory-developed test was
the only clinically validated tropism assay. The partnership underlines the need for
education of physicians and the role of guidelines to support use of the assay.
* Prometheus achieved a five-fold increase in sales in six years for AstraZeneca’s treatment
for Crohn’s disease, Entocort EC, by promoting its IBD serology test in conjunction with the
therapy. The sales and marketing model focused on both diagnosis and treatment of
irritable bowel disease, an area in which differential diagnosis is difficult.
* Entering into a partnership early will facilitate a coordinated approach to simultaneous
approval and availability of the Rx and companion Dx. Formal working processes and
dedicated project teams engender transparency and good communication channels between
both partners.
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2. Table Of Contents
About the author
Disclaimer
EXECUTIVE SUMMARY
The personalized medicine paradigm
Co-development partnerships
Retrospective development alliances
Alternative partnership models
Best practices in RxDx partnering
Future trends influencing RxDx partnerships
The personalized medicine paradigm
Summary
Introduction
Drivers of Rx/Dx partnerships
Regulatory drivers
EU regulatory initiatives
A convergence of different industry sectors
Partnership trends
Scope of report
Co-development partnerships
Summary
Introduction
Genentech/Dako: Herceptin/HercepTest
The partnership
The results
Observations
Pfizer/Monogram Biosciences: Selzentry/Trofile
The partnership
Results
Observations
Plexxikon/Roche: Zelboraf/BRAF test
The partnership
Results
Observations
Bayer Schering/Prometheus
The partnership
Observations
Novartis/Invivoscribe: midostaurin/FLT3
The partnership
Observations
3. Retrospective development alliances
Summary
Introduction
Vectibix/Erbitux:KRAS
The partnerships
Observations
Iressa (AstraZeneca)/Qiagen
The partnership
Observations
Alternative partnership models
Summary
Introduction
Prometheus/Entocort
The partnership
The results
Observations
Takeda/Zinfandel: pioglitazone/TOMM40 assay
Background
The partnership
Observations
GSK/Enigma Diagnostics
The partnership
Observations
Dako/Quintiles
Background
The partnership
Observations
Medco/MolecularMD
The partnership
Observations
Best practices in RxDx partnering
Summary
Introduction
What are pharma companies looking for?
What are Dx companies looking for?
Negotiating the deal
Ingredients of a successful relationship
Start early
Sharing a common goal
Mutual understanding of different business models
Understanding risks
Good working processes
Reimbursement
Commercialization
Future trends influencing RxDx partnerships
Summary
4. Introduction
Industry dynamics
Regulators take proactive role
Pricing and reimbursement environment
UK Stratified Medicine initiative
Appendix
Bibliography/References
Abbreviations
LIST OF TABLES
Table: Scope of Rx-Dx partnership deals in Jan-August 2011
LIST OF FIGURES
Figure: Therapeutic categories of drugs with pharmacogenomic biomarkers in US label
Figure: Ideal Rx-Dx co-development scenario
Figure: Rx-Dx partnership deals 2007-2011
Figure: Zelboraf & CDx – From discovery to approval
Figure: KRAS timeline
Figure: Percentage of mCRC patients tested for KRAS
Figure: Sales of Entocort EC, 2005-2010, $m
Figure: Key considerations when choosing a Dx partner
Figure: Key considerations when choosing a Rx partner
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