IND-Enabling Pre-Clinical Studies to Accelerate the Clinical Development of a Humanized Anti-Cocaine Monoclonal Antibody

U01 Scope of Work Chris Crutchfield My role as Co-Investigator on NIH grant U01DA050330 has been to support Dr. Andrew Norman in the validation and operation of the Shimadzu LCMS-8060, which was acquired with capital funds as part of the grant submission and is housed in the Vontz Center at the University of Cincinnati College of Medicine campus. To this end, I have been able to maintain effectiveness through a combination of video and phone consultation in addition to remote access software which allows for me to operate the instrument from Chicago. Some of the experiments I have helped to design and execute include evaluation of plasma and brain matrix effects on the LCMS-based quantification of cocaine and metabolites. Our next projects will include determination of cocaine and metabolites in a urine matrix as well as the development of a targeted LCMS-based assay for the quantification of the humanized anti-cocaine monoclonal antibody, h2E2, which is the focus of the grant. In addition to remote support, I will also provide periodic on-site visitation to Cincinnati to provide hands-on training and addressing other issues for which remote support may be difficult (such as those requiring physical manipulation of the instrument).