Free Webcast on Pharmaceutical Quality by Design: The Road Ahead

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This October 14 event will feature FDA's Moheb Nasr and Helen Winkle, Wyeth's Michael Kowolenko, and Cerulean Associates' John Avellanet, plus an opportunity to ask speakers questions directly.

For several years now, Quality by Design (QbD) has been a buzzword within the pharmaceutical industry. As more companies and professionals from different functional areas within the industry embrace the concept, there's growing evidence of potential savings and return on investment.

A free webcast, "Pharmaceutical Quality by Design: The Road Ahead," will look at the progress, challenges that remain, and how the industry can take a more strategic approach to drug development and the knowledge management it requires.

The 75-minute webcast will take place on October 14 at 11:00 a.m. EDT in the U.S. (10:00 a.m. Central, 8:00 a.m. Pacific). Speakers will include FDA's Moheb Nasr and Helen Winkle, two of the chief architects of the QbD initiative in the pharmaceutical industry, as well as Wyeth Biotech Sr. VP Michael Kowolenko, and prominent consultant John Avellanet of Cerulean Associates. The event will be moderated by Agnes Shanley, editor in chief of Pharmaceutical Manufacturing magazine. Sponsors include Ahura Scientific, Celsis, ESA Biosciences, Malvern Instruments, SAP, and Tunnell Consulting.

"By focusing, rather than eliminating, scientific inquiry and experiment, QbD has the potential to transform the entire industry," says Shanley. "This focus can only help the patient and improve the bottom line, at a time when it takes over 10 years and a billion dollars to bring a new drug to market."

The webcast coincides with the same-day launch of, a new website devoted to advancing Quality by Design within the drug industry.

The program will be as follows:

Helen Winkle, Director, Office of Pharmaceuticals, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)
"The Desired State: Challenges and Speed Bumps"

Dr. Moheb Nasr Director. Office of Pharmaceuticals, New Drug Safety, FDA
"How Far We've Come and Where We Need to Go : A QbD Progress Report"

John Avellanet, Managing Director, Cerulean Associates, LLP
"Turning Data into Knowledge"

Dr. Michael Kowolenko, Wyeth Pharmaceuticals
"Special Issues for Applying QbD Concepts to Biopharma R&D"

To register, please visit:


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