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Morning Plenary Session

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Contributors

  • Enaksha Wickremsinhe, Ph.D., Eli Lilly and Company

    Enaksha is a Research Advisor at Eli Lilly and Company. He currently serves as the Subject Matter Expert and technical leader for all small molecule LC/MS/MS bioanalytical needs supporting both preclinical and clinical development. He received his B.Sc. from the University of Peradeniya (Sri Lanka) and his Ph.D. from the Pennsylvania State University. Prior to joining Eli Lilly, he worked at Centre Analytical Labs Inc., where he developed over 30 GLP compliant LC/MS/MS methods to support registration studies for the EPA and the FDA. He has over 15 years of bioanalytical experience in quantitative LC/MS/MS supporting all phases of drug development (discovery through clinical development). He is also experienced as an ADME project leader and has been responsible for both preclinical and clinical development of several oncology assets. Currently he also has responsibility over regulatory and innovation aspects related to quantitative LCMS analysis of small molecules across the Lilly portfolio and advises project teams. He has been the recipient of several Eli Lilly awards (President’s award, Global 3Rs award, Innovator award, Pediatric Excellence award). He is the co-chair of the AAPS Bioanalytical Community Microsampling subgroup and a member of the CPSA USA organizing committee.

  • Qin Ji, Ph.D., Bristol-Myers Squibb

    Qin Ji, Ph.D., currently is a Research Fellow at Bristol-Mayes Squibb. Prior to joining BMS, Dr. Qin Ji held scientific and management positions including Senior Director of Bioanalytical Chemistry at Covance Laboratories and Associate Research Fellow in the prestigious Volwiler Scientific Society at Abbott Laboratories. Dr. Qin Ji obtained his Ph.D. from Michigan State University and had postdoctoral training at Mayo Clinic. He has authored/co-authored more than 70 peer reviewed scientific publications, 5 book chapters, and co-edited 2 books. Dr. Qin Ji obtained two President Awards while he was at Abbott Laboratories. He was also a recipient of a BMS Chemistry Leadership Award and the prestigious James B.D. Palmer Award for Excellence in Drug Development.

  • Carol R. Gleason, MS, Bristol-Myers Squibb

    Carol Gleason has more than 35 years’ experience supporting bioanalytical method development and validation of pharmacokinetic, immunogenicity, biomarker, and genetic toxicology assays. A Bristol-Myers Squibb (BMS) employee for 20 years, and contractor for BMS as well as Sanofi, Amgen, Pfizer and other major pharmaceutical companies for an additional 15 years, Carol has extensive knowledge about application of appropriate statistical methods for bioanalytical methods for large and small molecules for clinical and non-clinical studies. In addition to supporting the bioanalytical group at BMS, Carol also supports regulated and non-regulated drug safety evaluation in-life studies, as well as genetic toxicology and immunotoxicology, and supports the discovery groups in the development and validation of multiplex cytokine profile assays. In recent years Carol has given presentations at the AAPS National Biotechnology meeting, Land O’Lakes Bioanalytical meeting, the American College of Toxicology, PEGS Summit 2016, and the 9th and 13th Annual WRIB.

July 7, 2020
Tue 11:00 AM EDT

Duration 1H 30M

This live web event has ended.