Biosimilar Experts Roundtable Discussion:
"Knowledge-based" Biologics Development- Part 1
Watch biosimilar industry expert Dr. Fiona Greer as she is joined by Dr Andrew Reason, an analytical characterization expert and Dr Ash Ramzan, a regulatory expert, to discuss the importance of understanding regulatory expectations from the very start of product characterization to ensure smooth passage through to the clinic.
Regulatory authorities have an expectation that biologics developers will utilize as much existing knowledge concerning their product and process as possible. Listen to our experts discuss ways to “fast-track” development, starting at early stages, by using prior knowledge of both the product and regulatory expectations. Topics discussed during this roundtable include:
In Part 2, our experts continue the discussion by sharing their thoughts on how to streamline development with fit-for-purpose characterization methods.
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
Woodley BioReg
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!
