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PAREXEL Consulting Quantifies Speed to Market: First-Cycle Approval for NME Produces $640 Million in Incremental Revenue on Average
Date:10/16/2008

tial new drug application submissions," said Gadi Saarony, Corporate Vice President and Worldwide Head, PAREXEL Consulting. "More than ever, biopharmaceutical companies should focus on reaping the greatest return on their R&D investments, maximizing product value at every stage of the lifecycle, and gaining the most efficiency from the development process. Crucial decisions must be made early in development planning, including which regulatory approaches to apply to achieve first-cycle approval."

"With continuing focus on first-cycle approvals for new drugs, especially under FDA Good Review Management Practices, our goal was to provide biopharmaceutical companies with a real-world metric on the value of first-cycle approvals," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting. "Our data show that priority designations are now closely linked to first-cycle approvals for both NMEs and NDAs. As a result, this metric can help biopharmaceutical companies assess the value of the new priority review vouchers available under the FDA Amendments Act."

The Getting to Approval white paper is part of PAREXEL Consulting's Intelligent Development Series, which provides data and insights in support of successful biopharmaceutical and medical device product development. The white paper is available at http://www.PAREXELConsulting.com/firstcycleapproval.

About PAREXEL Consulting

PAREXEL Consulting is a leading life sciences consultancy that helps companies design and execute their biopharmaceutical and medical device product strategies through our unique fusion of scientific, regulatory, and business expertise. Our approach helps clients manage risk, and drives superior quality and performance for clients worldwide. The firm has more than 270 experts, and serves clients on a global basis. For further information visit:

SOURCE PAREXEL International
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