2005 ACPA Annual Dinner Meeting

The 2005 Annual Dinner Meeting took place from 6:30–10:00 PM on November 9, 2005 at the Gaylord Opryland Resort & Convention Center in Nashville, Tennessee. The meeting was held in conjunction with the 2005 Annual Conference and Exhibition of the American Association for Pharmaceutical Scientists. Eighty-one ACPA members attended the event.

The evening started with cocktails. This was followed by an American-style buffet and a brief message from ACPA’s president, Keith Chan, Ph.D. The keynote speaker for the meeting was Duu-Gong Wu, Ph.D. The title of Dr. Wu’s presentation was “A Regulatory Update on FDA’s Pre-approval Inspection.” The presentation provided a general introduction to the FDA’s organization, GMP regulations, and approaches related to pre-approval inspections for drugs as well as an update on the FDA’s recent initiatives pertaining to risk-based GMP inspections.

Dr. Wu is the Executive Director of the Consulting Division of PharmaNet, Inc., which is located in Washington DC. PharmaNet is an international drug development company based in Princeton, New Jersey. The firm has over 800 employees as well as more than 20 offices in North America, Europe, and Asia. PharmaNet specializes in the Phase III and Phase IV clinical development of oncology, cardiovascular, neurology, and anti-infective drugs.

Before joining PharmaNet in 2004, Dr. Wu was employed by the U.S. Food and Drug Administration for over 12 years. During this time, he worked as a reviewer, Chemistry Team Leader, and as Deputy Division Director of the Division of New Drug Chemistry II, Office of New Drug Chemistry (ONDC), which supports CMC reviews for six clinical divisions in the Center for Drug Evaluation and Research (CDER). Dr. Wu was Chairman of the Protein Drug Products Technical Committee under the CDER Complex Drug Substance Coordinating Committee. Most recently, he represented CDER as a member of the ICH Expert Working Group for both Q5E and Common Technical Document Quality for biotech products. In addition to his aforementioned roles, Dr. Wu served as chairman of the Follow-on Growth hormone and Insulin Working group, was a member of the FDA Follow-on Biologics Working Group, and served as an Ad Hoc Reviewer for the USP Biotechnology Committee.

Dr. Wu received his Ph.D. degree in Biochemistry and Molecular Biology from the University of Maryland Medical School and did his postdoctoral research at the Johns Hopkins University Medical School.

Overall, it was a very informative and useful presentation. Everyone appeared to enjoy a good evening with old and new friends.

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