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