NEW YORK, May 26, 2011 /PRNewswire/ — Reportlinker.com
announces that a new market research report is available in its
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 qual