Biosimilar Experts Roundtable Discussion:
"Knowledge-based" Biologics Development- Part 2
Join biosimilars industry expert Dr. Fiona Greer in discussion with Dr Andrew Reason, an analytical characterization expert and Dr Ash Ramzan, a regulatory expert, in Part 2 of this discussion focused on "knowledge-based" biologics development. In this instalment, our experts discuss how to use the product and regulatory knowledge available to develop analytical methods that are fit-for-purpose and will therefore provide meaningful and appropriate results to accelerate the development process.
Continuing the discussion on the topic of robust and reliable methods for early characterization, our experts share their thoughts on:
In Part 1, our experts discussed ways to “fast-track” development by utilizing prior knowledge of both product and regulatory expectations.
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.
CEO and MD at BioPharmaSpec
Andrew is the founder, CEO and MD of BioPharmaSpec. He has 25 years of experience in analysis of both novel and biosimilar biopharmaceuticals and has been involved in the commercialization of a number of analytical methods for characterizing proteins. Andrew has contributed to many industry publications and is a regular presenter at conferences. He is also currently a Visiting Professor at the University of Warwick and recently joined the Macquarie University Scientific Advisory Board.
Founder and Principal Consultant
Ash is founder and principal consultant of Woodley BioReg, a global regulatory consultancy. He has a specialist interest in biologics / biosimilars and vaccines, and is a member of the British Pharmacopoeia Working Party, advising the government on the development of biosimilar standards. With over 30 years of hands-on expertise, Ash continues to work extensively in developing regulatory strategies for global registration of biologics and biosimilars including mAbs, vaccines and toxins. Ash is also a fellow of TOPRA as well as serving on their Editorial Board.
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!