Kathleen has been with FDA for 20 years as a Chemist in the Southeast Regional Laboratory, an Investigator in Atlanta District and an Investigator and Drug Preapproval Manager in Cincinnati District.
March 15 - 18, 2016 --PharmaLink is held at the Award Winning Cintas Center at Xavier University
Featured PharmaLink Speakers 2016
Michael Davison has over 27 years of experience in the Pharmaceutical Industry, he is an analytical chemist by training and joined Pfizer in 1986.
Assistant Commissioner for Operations, Office of Regulatory Affairs
Vice President Corporate Quality Systems & Compliance
Dr. Lawrence X. Yu is the Deputy Director for Science and Director of Chemistry at the Office of Generic Drugs, Food and Drug Administration, overseeing CMC review operation, policy development, and regulatory research with over 140 staff scientists. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan. 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 past section Chair of the American Association of Pharmaceutical Scientists and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 200 papers, book chapters, and abstracts, and given over 150 invited presentations. He is a co-editor of the book entitled “Biopharmaceutics Applications in Drug Development”. Dr. Yu is 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 M. S. in Chemical Engineering from Zhejiang University, his M. S. in Pharmaceutics from the University of Cincinnati, and his Ph.D. in Pharmaceutics from the University of Michigan.
Vice President for Commercial Technology N.A.
The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of the Food & Drug Administration. We help participants create links to drive new thinking. The solutions might not be evident within our industry, so we explore beyond industry, beyond borders, and beyond comfort zones. Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization and our industry. PharmaLink actively fosters engagement among all participants and regulators, so true opportunity for change can be identified.Learn More
Xavier University offers a new Master’s program that will fill jobs desperately needed in the health care industry. The U.S. Bureau of Labor Statistics expects the demand for analysts to grow by 14% over the next 10 years, an increase of more than 2,300 jobs. The demand for health analysts in particular will likely outpace […]
Marla Phillips took to the road once again to share the information from the Xavier Health Integrity of Supply Initiative, however, this time outside the continental United States.