Van Ly

Background

About Van Ly

Involved in the development of anti-viral and anti-cancer drugs. Two drugs that I worked on, Reyataz and Ixempra, were approved for the treatment of AIDS and cancer, respectively. Conducted in vitro drug metabolism studies with microsomes, Supersomes, S9, hepatocytes and liver slices and in vivo drug metabolism studies in human, animals and plants. Conducted tissue distribution and mass balance studies using 14C- and/or 13C labeled test compounds. Used LC/MSn or collaborated with experts in other analytical groups (NMR, AR & D, formulations …) to elucidate the structures of unknown metabolites. Performed GLP HPLC/UV analysis to generate pharmacokinetic data to support preclinical toxicokinetic studies. Organized and processed clinical data from the sites. Responsibilities also included detailed report writing for the preclinical, biotransformation and sections of clinical studies. Prepared IND and NDA documents for United States and Europe submissions. Collaborated with LEAP Technologies to create and develop Collect PAL, a fully automated fraction collector. Involved in developing the templates in BioBook (IDBS electronic notebook) to be used for record keeping of the routine analyses of Biotransformation experiments. Currently conducting method development of sandwich culture for use with low turn-over compounds. Also leading the effort in the preparation of hepatocyte spheroids for use in metabolism of low turn-over compounds, compounds with unusual metabolic pathway, for investigation of hepatotoxicity, induction of CYPs.