SOMERSET, N.J. – March 2, 2017 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that two leading analytical experts from Catalent Biologics will be presenting a workshop on the development and validation of bioassays, at the upcoming first BEBPA U.S. Bioassay Conference, to be held at the Sheraton Fisherman’s Wharf, San Francisco, on March 8 – 10, 2017.
The workshop, starting at 9 a.m. on Wednesday, March 8, is entitled “The Course Awakens: Moving Bioassays from Development to Phase-Appropriate Validation,” and will be hosted by Mike Sadick, Ph.D., 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.
Dr. Sadick has an extensive background in cellular biology, cellular immunology, receptor signaling, 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.
Mr. 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.
For more information on the conference, visit: http://www.bebpa.org/conferences/, and to arrange a meeting with any of the Catalent executives attending the event, contact Richard Kerns at NEPR - firstname.lastname@example.org
For more information on Catalent Biologics, visit www.catalentbiologics.com
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com