About Us | Press Releases | 2008 | January 9

Speeding New Product Time to Market with FDA's Quality by Design

At a special luncheon of the BIO IT Coalition to be held on Wednesday, January 23rd, in Arlington, Virginia, Cerulean Associates' Managing Director, John Avellanet, will speak on the FDA's Quality by Design initiative.

Mr. Avellanet will discuss:

• Current industry facts on new drug, biologic and device development
• Recent arguments by FDA officials about Quality by Design
• Case study lessons from previous clients
• Five Quality by Design-based recommendations to speed time to market

To attend the luncheon and speech, contact Judi Giannini at 202-220-1242 or visit the "Events" page.

John Avellanet is the author of more than 20 internationally published articles and several leading industry reports.  In 2006, Mr. Avellanet co-founded his independent consultancy, Cerulean Associates LLC, after a career in and around research and development organizations and as CIO for a Fortune 50 medical device and biotechnology subsidiary.

Through his consultancy, Cerulean Associates LLC, Mr. Avellanet advises executives on cost-effective regulatory compliance, flexible quality systems, preventing intellectual property theft, and achieving faster time to market.  On the web at www.ceruleanllc.com.

The BIO IT Coalition is a non-profit organization which bridges the life sciences and information technology industries through interactive, content driven events that highlight innovation, investment, collaboration and partnership to build the bio IT industry.  For more information about the Coalition and its monthly programs and more, visit http://www.bioitcoalition.org.