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Reportlinker Adds Advances in Drug-Diagnostic Co-Development

NEW YORK, May 26, 2011 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Advances in Drug-Diagnostic Co-Development


This report provides in depth analysis of the current and evolving regulatory framework for drugs and diagnostics in the US and EU and specific guidance for their co-development. Advances in biomarker development and validation are assessed and case studies given of regulatory approvals of drugs and companion tests. Strategies for drug-diagnostic co-development are evaluated.

Features and benefits

* Understand the current regulatory environment for both diagnostics and drugs within the EU and the US and how these relate to their co-development.

* Understand the biomarker discovery and validation process.

* Using case studies discover how drugs and their companion diagnostics have already received approval in the US and EU.

* Discover the various types of collaborations used by pharma and diagnostic companies.

* Assess the impact of drug-diagnostic co-development on key stakeholders including the industry, regulators, physicians, and pharmacy benefit managers.


The regulatory landscape for drug-diagnostic co-development projects is evolving. The FDA and EMA both have similar biomarker qualification processes in place that enable companies to obtain advice or qualification of the biomarker in question and the agenices have published their current thinking in relation to drug-diagnostic co-development.

Changes to diagnostics regulation in the EU and US are under discussion and are viewed as critical given the pivotal and game changing role of diagnostics in the future of healthcare. Both the FDA and lawmakers in the US are taking steps to address the problems with the current system and a public consulation recently completed in the EU.

The lack of clarity around regulations for drug-diagnostic co-development is only one of the hurdles facing the commercialisation of companion diagnostics. Market acess issues provide another major hurdle as clear pathways to gaining value-based reimbursement for high value molecular diagnostic tests are not available.

Your Key questions answered

* How is the regulatory landscape for drug-diagnostic co-development evolving in the US and Europe?

* How do the FDA and EMA qualify biomarkers prior to their inclusion in a diagnostic procedure?

* How can pharma and diagnostic companies make collaborations between them work for both parties?

* How has the type of deal between pharma and diagnostic companies changed over the last six years?

* How can key stakeholders including industry, regulators, and physicians benefit from the introduction of drug-diagnostic developments

Executive Summary


Drug-diagnostic co-development: from concept to reality

New pathways and regulatory change

Strategies for drug-diagnostic co-development in pharma R&D

Stakeholder perspectives on regulatory change: outlook for pharma and diagnostics

About the Authors

Sara Sleigh

Cheryl L Barton





Regulatory framework for drugs and diagnostics in the US

Biomarker guidance

Drug-diagnostic co-development guidance

FDA organization

Drug and biologics regulation by the FDA

Diagnostics regulation by the FDA

Regulatory framework for drugs and diagnostics in the EU

EMA guidance for personalized medicine

Drug and biologics regulation by the EMA

Diagnostics regulation in the EU

Comparing and contrasting regulation in the EU and US: drivers for change

Report outline

Drug-diagnostic co-development: from concept to reality


Biomarkers and companion diagnostics in drug development

Stages of drug-diagnostic co-development

Biomarker discovery

Analytical validation

Clinical validation and clinical utility

Regulatory approvals of drugs and companion diagnostic tests

Drug-diagnostic co-development: Selzentry

Introducing companion diagnostic tests for efficacy post-approval

Omapro (Chemgenex): a case study

Introducing companion diagnostics for safety reasons

Labeling considerations


New pathways and regulatory change



Biomarker qualification

Biomarker qualification: FDA

Biomarker qualification: EMA

FDA guidance on drug-diagnostic co-development

FDA-industry discussion of the drug-diagnostic co-development concept paper

New FDA guidance documents relating to co-development

Changes to device regulations in the US

Changes at the FDA

Proposed legislative changes

EMA guidance on drug-diagnostic co-development

Changes to device regulations in the EU


Strategies for drug-diagnostic co-development in pharma R&D



Partnership for a specific drug-diagnostic co-development programs

Broad partnership: the preferred provider route


In-house diagnostics development

The widening role of CROs


Stakeholder perspectives on regulatory change: outlook for pharma and diagnostics




Pharma industry

Diagnostics industry




Emerging stakeholders

Pharmacy benefit managers

Next generation sequencing companies

Health IT companies

Conclusions and outlook


Research methodology





To order this report:

Drug and Medication Industry: Advances in Drug-Diagnostic Co-Development

Drug and Medication Business News

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

Nicolas Bombourg
US: (805)652-2626
Intl: +1 805-652-2626

SOURCE Reportlinker
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All rights reserved

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