Biosimilars Roundtable Discussion:
"Front-Loading Biosimilar Development with Analytical Characterization"
Watch the video below and join three analytical experts and Roundtable Chair Dr Fiona Greer as they discuss how detailed structural and functional investigations, as part of a comparability exercise, can be front-loaded in a biosimilar development program to give greater confidence in the nature of the biosimilar, reduce development costs and, in certain circumstances, reduce the requirement for full clinical trials.
As our collective experiences of Biosimilars are drawn from years of product development, the process of getting this class of drugs to market is being continually examined. Questions are now being asked regarding the need for extensive clinical trials and if it is more appropriate to front-load biosimilar drug investigations with risk-based analytics. Watch our expert panel discuss topics such as:
Independent Consultant & Roundtable Chair
Following a Ph.D. in Protein Biochemistry from Aberdeen University (1984) Fiona became a founding Director of M-Scan. Upon their acquisition in 2010, she became Global Director, Biopharma Services Development, SGS. With over 35 years’ experience in glycoprotein analysis she has been involved with a diverse range of biotechnology products, both novel and biosimilar, and now consults to companies worldwide.
Technical Director for Structural Analysis
Richard obtained his PhD in glycoprotein structural characterization using mass spectrometry from Imperial College of Science, Technology and Medicine. Following postdoctoral research in the field of glycan elucidation, Richard worked at GlaxoSmithKline and then M-Scan Limited, where he held the position of Principal Scientist. At BioPharmaSpec, Richard manages all aspects of carbohydrate and glycoprotein characterization.
Founder and President
Dan is founder and president of Toronto-based contract testing laboratory Custom Biologics, a global service provider of functional testing and characterization of biotherapeutics, biosimilars and antibody drug conjugates. Dan has a background in microbiology, immunology, and protein biochemistry and over 20 years’ experience in developing and validating reliable and reproducible cell-based bioassays to measure the functional properties of biotherapeutic drugs.
Marius obtained his doctoral degree in physical chemistry from Universität Konstanz. He subsequently worked with virus-like particles as a Postdoctoral Research Scientist at the National Center of Molecular Hydrodynamics in Nottingham. In 2015, he joined Coriolis Pharma, where he led the AUC and AF4 unit. Marius cofounded ZentriForce Pharma Research GmbH in 2019, a CRO with expertise in hydrodynamic analysis techniques.
Would you like to speak to one of the panel members or a biosimilars expert about your analytical requirements or biosimilar development projects? Email us today!