The conference will be held at the Sheraton Fisherman’s Wharf, San Francisco, on March 8 – 10, 2017
Catalent Pharma Solutions has announced that two analytical experts from Catalent Biologics will be presenting a workshop on the development and validation of bioassays, at the upcoming BEBPA US Bioassay Conference.
The workshop, starting at 9am on Wednesday, March 8, is entitled: “The Course Awakens: Moving Bioassays from Development to Phase-Appropriate Validation.”
It will be hosted by Mike Sadick, Principal Scientist, Biologics Analytical Services, Development and Mike Merges, Director of Strategic Growth of Biologics Analytical Services.
The day-long workshop will present a number of topics covering all aspects of phase-appropriate validations, from Investigational New Drug/Phase I through to Phase III/post-Biologic License Application, and will include both practical and theoretical approaches to development.
Regulatory guidelines in the area, such as ICH Q2(R1) and USP <1033> will be addressed, compared and contrasted as part of the session, which will be an interactive forum where advice, challenges and practical tips can be discussed openly.
Sadick has an extensive background in cellular biology, cellular immunology, receptor signalling, molecular biology and biochemistry.
He has more than thirty years of experience in research and industry, with prior positions at Genentech, Eli Lilly and Aptuit before joining Catalent in 2012.
His current role sees him lead Catalent’s activities in potency assays, both cell-based and enzyme-linked immunosorbent assay (ELISA) based, as well as molecular biology (including cloning and quantitative polymerase chain reaction (qPCR) and protein/protein binding assessment.
He holds a bachelor’s in biology from John Hopkins University, and a master’s and doctorate, both in immunology, from the University of Washington.
Merges joined Catalent in 2011 as Director of Catalent Biologics Analytical Services, focusing on the transfer, development, validation, and performance of bioassays, immunoassays, microbiological assays, and viral clearance assays.
Prior to that, he was Associate Director of Bioservices for Lonza Biologics and has also held positions at the University of Maryland’s Institute of Human Virology, the National Cancer Institute and Johns Hopkins University, where he conducted viral immunology research.
He obtained his bachelor’s degree in microbiology from the Pennsylvania State University, and his master’s degree in microbiology/virology from Hood College.