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July Biomed/Biotech SIG Meeting #2
Kelly's Deli Conference Center
Next to the entrance to 7519 Standish Drive
Rockville, Maryland 20855
Jul 30, 2009 6:00 pm - 8:45 pm
�Generic Drugs: Myths and Facts�
Lawrence X. Yu, MS, PhD
Director for Science
Office of Generic Drugs (OGD)
Center for Drugs Evaluation and Review (CDER), FDA
Thursday, July 30, 2009
The Kelly�s Deli Conference Room
7519 Standish Place, Rockville, MD 20855
6:00 - 6:20 pm: Networking and Pizza/Soda
6:20 - 8:20 pm: Program
8:20 - 8:40 pm: Door prize drawing and networking
Cost: Free to the general public with a door prize drawing
Registration: Event is full. ASQ Section 509 regrets that it had to close the registration for this event due to the meeting room capacity.
Event Contact: Dr. George Chang at or 240-793-8425.
Dr. Lawrence X. Yu is the Director for Science at the Office of Generic Drugs (OGD), Food and Drug Administration. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan and adjunct associate Professor of Pharmaceutical Sciences at the University of Maryland. Prior to joining the FDA, Dr. Yu had worked at Pfizer (Upjohn) and GlaxoWellcome for 8 years. Dr. Yu joined the FDA in 1999 and has served as Team Leader, Deputy Division Director, and Division Director.
Dr. Yu�s research interests have centered on the prediction of oral drug delivery and the development of pharmaceutical Quality by Design. His compartmental absorption and transit (CAT) model has laid the foundation for the commercial software, GastroPLUSTM and Simcyp�, which are being widely used in the pharmaceutical industry. Dr. Yu is a fellow and the Section Chair of the American Association of Pharmaceutical Scientists (AAPS) and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 150 papers, book chapters, and abstracts, and given over 120 invited presentations. He is a co-editor of the book entitled �Biopharmaceutics Applications in Drug Development�. Dr. Yu is also the winner of numerous awards including the American Foundation for Pharmaceutical Education Fellowship, AAPS Excellent Graduate Research, Department of Health and Human Service Outstanding Leadership Award, FDA Commissioner�s Special Citation, Outstanding Achievement, Group Recognition, Regulatory Science, and Team Excellence awards, Upjohn special recognition award, and Naigai Foundation Japan Tokyo Distinguished Lectureship.
Dr. Yu received his B.S. in Chemical Engineering from Zhejiang Institute of Technology, his 1st M.S. in Chemical Engineering from Zhejiang University and 2nd M.S. in Pharmaceutics from the University of Cincinnati, and his Ph.D. in Pharmaceutics from the University of Michigan.
For directions to the meeting, see the July 30, 2009 Biomed/Biotech SIG Meeting Announcement. https://asq509.org/ht/a/GetDocumentAction/i/40119