Dinner Short Courses – Detailed Agenda

Thursday March 12, 2015, 6:00-9:00pm

SC5: Comparability and Biosimilarity: Principles and Case Studies

Instructors:
Ashvin Patel, Ph.D., Director, Regulatory Affairs, ERA Consulting (UK) Ltd.
Marjorie Shapiro, Ph.D., Chief, Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies/OBP/OPS, CDER, FDA

The focus of this short course is on CMC issues around comparability and (bio)similarity, on the one hand covering expectations for an analytical comparability exercise accompanying process changes during development as well as post-marketing changes of a biologic and, on the other hand, addressing the analytical and functional tests used to establish (bio)similarity between a biosimilar product and the reference product. The course will offer both the US FDA and the EU perspectives and experiences on these subjects. The impact of the implementation of a design space and continual process verification on post-marketing comparability will also be discussed. Apart from the principles of comparability and (bio)similarity, practical advice on frequently asked questions, such as “how many batches?” will be discussed in detail, in the context of the attributes of the respective analytical methods, their variability, and the consistency of the datasets. Where possible, case studies will be presented, to highlight the potential pitfalls that have been encountered with comparability and (bio)similarity exercises. The particular problems arising from process changes during development of a biosimilar product will be discussed, as this adds the complication of a comparability exercise alongside the demonstration of (bio)similarity.

Topics will include:

• Principles and practice of a comparability exercise according to ICH Q5E
• Case studies in comparability accompanying process changes, during development and post-approval, what is required when?
• Comparability protocols (US) and change management protocols (EU)
• Comparability versus (bio)similarity exercises, definitions
• Demonstrating (bio)similarity between a biosimilar and reference product at various stages of development
• Experiences to date with biosimilar products, successes and failures
• The complication of process changes during clinical development of a biosimilar product

Instructor Bios:

Ash Patel is a “Director of Regulatory Affairs (CMC Biologics)” at ERA Consulting’s based at the London office, providing regulatory and consultancy services to the biopharmaceutical industry. Ash provides particular expertise on early and late stage product development of therapeutic monoclonal antibodies, biosimilar, proteins and gene therapy products. Prior to joining ERA, Ash was CMC Product Development Director & Leader at GlaxoSmithKline, leading multidisciplinary teams to develop medicines from pre-clinical studies through to Phase 3 studies. He held postdoctoral positions at the Medical Research Council Laboratories as well as at the Medical School, Cardiff. Ash obtained his first degree and completed a Ph.D. at the University of Liverpool.

Dr. Marjorie Shapiro received her Ph.D. in immunology in 1987 from the University of Pennsylvania where she studied molecular mechanisms underlying antibody diversity. Her current research continues towards understanding antibody repertoire development. She joined the Division of Monoclonal Antibodies (DMA) in 1993 and is currently Chief of the Laboratory for Molecular and Developmental Immunology in DMA where she supervises regulation of novel and biosimilar monoclonal antibodies and Fc fusion proteins.