Bioanalysis for Ocular Indications (Open Scientific Discussion Forum)
Wed, Sep 30, 2020 12:00 PM - 1:00 PM (EDT)
Dr. Eric Wakshull - Eric has been a scientist in the BioPharm industry since 1986 as a drug discovery scientist at Pfizer and AlphaBeta Technology and for over 20 years as a bioanalytical scientist at Biogen and Genentech. As a bioanalytical scientist Eric led groups that specialized in the development, validation, and implementation of pharmacokinetic, immunogenicity, and biomarker assays for multiple drug candidates. As an active participant in broad cross-functional project teams from early pre-IND phases through BLA submissions and post-marketing support, Eric has acquired a broad understanding of the drug development process. He has also interacted with Health Authorities via direct face-to-face interactions as well as teleconferences and written query responses. Currently Eric is a self-employed consultant to support bioanalytical strategies and review of assays development and data interpretation for a number of small companies.
Dr. Xiaorong Liang - Dr. Xiaorong Liang is a senior scientist and the head of regulated bioanalytical group for small molecule at Genentech in South San Francisco, California, USA. He obtained his Ph.D. degree in analytical chemistry from Purdue University under the supervision of Prof. Scott McLuckey. Dr. Liang has over 13 years of industry experience working on the bioanalytical method development, validation, and sample analysis. He leads an internal group of scientific staff supporting all the small molecule drug development projects and also manages metabolomics group at Genentech. His group also oversees an external full time equivalent (FTE) team at a contract research organization (CRO) supporting the GLP and GCP studies. He has represented Genentech at the IQ consortium for dried blood spot and ICH M10 and is currently representing Genentech at the metabolite bioanalysis working group. Dr. Liang also serves as a reviewer for various bioanalytical journals. He has published more than 50 peer-reviewed papers in the bioanalytical/analytical field.
Kristopher King - Kristopher King is a bioanalytical scientist and DMPK Project Lead at Biogen. He obtained his BA in Chemistry from Colby College in 2007 and his MBA from Worcester Polytechnic Institute (WPI) in 2018. He has over 12 years of experience specializing in discovery and GLP mass spectrometric assays for small molecules and biomarkers at CROs (Tandem Labs 2007-2011) and pharmaceutical companies (Biogen 2012-Present) and has particular interests in tissue analysis and process improvement. Kris also serves as a member of the AAPS Bioanalytical Community leadership, is Chair of the AAPS Bioanalytical Community Open Scientific Discussion, and is Co-lead of the AAPS Bioanalytical Community Non-liquid Matrices sub-team focused on chromatographic assay validation.
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