Lisa L. McChesney-Harris, Ph.D. is an entrepreneur and currently a small business owner since April of 2010. She founded two businesses; firstly, an independent consultancy that provides subject matter expertise in the area of pharmaceutical chemistry, manufacturing, and control (CMC) and secondly, a rapid analysis pharmaceutical testing laboratory integrating science and information technologies. She has also functioned in the capacity of a US Agent and liaison for all regulatory lifecycle aspects of a portfolio of approved drug products. She previously served as Vice President of Regulatory Affairs of APP Pharmaceuticals, LLC from February 2008 to March 2010; in her capacity, she worked closely with a staff of 42 employees and corresponded frequently with the Office of Generic Drugs regarding various technical and regulatory aspects of the pharmaceutical industry. She also served as Senior Director/Director of Protocol Link, Inc. from April 2004 to January 2008, during which time she provided expert technical, compliance, and regulatory services to clients throughout the pharma industry. She has over 26 years of industrial experience including 7 years in ethical drug development, 4 years in a start-up generic company, specializing in both the analytical and formulation development of injectable ANDA products. She is a co-inventor on one issued US patent. Dr. McChesney-Harris received her B.A. degree in Chemistry from the University of Missouri, St. Louis, and her doctorate degree in Pharmaceutical Chemistry from the University of Kansas.
As CEO/CSO, Dr. McChesney-Harris provides high level technical, subject matter expertise in completion of all project test protocols. Her extensive knowledge of chemistry, study design, drug regulations/boundaries and the US regulatory framework, facilitates the overall effectiveness and efficiency of PPL’s workflows and research and development outcomes.