West Windsor, N.J. - Michael Falkow, director and principal consultant for Parexel International, a leading global bio/pharmaceutical services organization, will examine the intricate clinical drug trial process in his talk, "Drug Development and Approval in the U.S. - Not Just for Biochemists," on Wednesday, Oct. 12 at noon at Mercer County Community College. This free lecture will be presented in the Communication Building, CM 107, on the West Windsor campus, 1200 Old Trenton Road. The talk is part of Mercer's Distinguished Lecture Series for the fall 2011 semester.

A former Food and Drug Administration (FDA) investigator and drug specialist, Falkow will draw upon his vast expertise to explain the legislative history of the agency and the process it has established for pharmaceutical development and manufacturing, as well as approval and control.

Falkow's areas of specialization include pharmaceuticals, biotechnology, in-vitro diagnostics and medical devices, with a specific focus on regulatory and quality compliance, quality auditing, quality assurance, and analytical research and development. He is approved by the FDA as a Good Manufacturing Practice (GMP) certifying authority.