Dr. Layloff is currently Technical Advisor, FHI 360 Product Quality and Compliance Division (fhi360.org); Senior Environmental Advisor, Partnership for Supply Chain Management (PFSCM, pfscm.org); and Principal Technical Advisor, Pharmaceutical Health Technologies Division, Management Sciences for Health (MSH, msh.org).
Prior to serving in those capacities he was employed by MSH as Principal Program Associate in the Center for Pharmaceutical Management on the Bill and Melinda Gates funded SEAM project (https://www.msh.org/news-events/stories/getting-medicines-to-the-people-of-tanzania). Prior to joining MSH served in the United States Pharmacopeia (USP) as Vice-President and Director of the Pharmaceutical Division (Rockville, MD). He also previously served in US FDA Center for Drug Evaluation and Research (CDER) as Associate Director for Standards Development (Rockville, MD) and for over 20 years as the Director of FDA’s leading pharmaceutical testing laboratory (National Center for Drug Analysis) in St. Louis, MO. He also served as a Special Government Employee to CDER as a member of the Manufacturing Advisory Sub-Committee and Past-Chair of the Pharmaceutical Analytical Technology (PAT) Sub-Committee. These committees were advisory to CDER in the development of a guidance documents which address the incorporation of new technologies into the approval and inspection processes.
He is Past-President and elected Fellow of AOAC International, and elected Fellow of the American Association of Pharmaceutical Scientists. He is a member of Sigma Xi and Phi Lambda Upsilon honor societies. He received BA/BS degrees in Chemistry and MS degree in Organic Chemistry from Washington University (St. Louis, MO), and a Ph.D. in Analytical Chemistry from the University of Kansas (Lawrence).
|Food and Drug Administration
(FDA) St. Louis pharmaceutical laboratory, 1967-1994
Compendium of Thin Layer Chromatography Methods
|This page was established to share materials of interest. Some documents, such as the Executive Summaries of the St. Louis FDA laboratory, are public domain; they were distributed to visitors and other individuals interested in the laboratorys activities. All other materials were submitted for publication or presented in public meetings and forums.|
Tim Grady’s Corner
My good friend and former USP colleague Tim Grady and I frequently challenged each other and wrote articles addressing positions as the USP evolved new standards. Some of these articles were never published and the web now
These articles present Tim’s views which may not be those of the USP or me but getting them out there may stir some thoughts and that is good.
I hope you enjoy his articles and I’m sure there will be others.
2017 Sept 13 - New Minilab methods added.
Last updated 2017 August. Questions or comments concerning this web site should be sent to email@example.com.