An event that presents comparability strategies from leaders in the field for a range of therapeutic proteins with a strong emphasis on providing suitable data to the regulatory authorities to reduce difficulties and delays and to ensure safety and efficacy with every batch of drug. Industry case studies from various types of change implementation at different stages of development will be presented together with regulatory advice and plenty of opportunity for discussion.
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Thursday, April 7
8:25 Chairperson’s Opening Remarks
Gillian R. Woollett, M.A., D.Phil., Chief Scientist, Engel & Novitt, LLP
8:30 Comparability for Innovator Products from a European Perspective
Chris Holloway, Ph.D., Group Director, Regulatory Affairs, ERA Consulting Group
ICH Q5E was designed to cover requirements for changes to manufacturing processes of biological medicinal products, emphasizing the importance of evaluating the impact of the change. In this presentation, case studies will be presented to demonstrate how a comparability exercise should be designed, together with the issues that should be considered in such an exercise.
9:00 Expectations and Experiences of the FDA regarding Comparability
Ruth Cordoba–Rodriguez, Ph.D., Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA
ICH Q5E lays out the principles for assessing comparability between the pre-change and post-change material. Yet, reporting of comparability data can be difficult as the rationale for performing a comparability protocol and data evaluation are not always clearly presented. This talk will present some of the pitfalls of comparability exercises and some strategies on how to report adequate comparability data.
9:30 Focus on Comparability for Innovator Products
Panel Discussion with Speakers and
Brian Harvey, M.D., Ph.D., Vice President, US Regulatory Policy, Global Regulatory Affairs, Sanofi-Aventis
10:00 Networking Coffee Break
KEYNOTE PRESENTATION
10:30 EU Regulatory Approach towards Comparability for a Biosimilar
 Keith Chidwick, Ph.D., Senior Pharmaceutical Assessor, Biologicals Unit, MHRA
This talk will focus on the scientific principles of the comparability exercise for biosimilars, particularly with regard to clinical data requirements and extrapolation of efficacy and safety data to other indications of the reference product, not studied during the clinical development of the biosimilar. This talk will also include experiences with biosimilar applications in the EU, address concerns raised about biosimilars and, in this context, highlight the importance of proper communication of the biosimilar concept, consistent use of terminology, and a global agreement on data requirement for biosimilars.
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11:15 US Regulatory Approach Towards Comparability for a Biosimilar
Gillian R. Woollett, M.A., D.Phil., Chief Scientist, Engel & Novitt, LLP
In the US we must now address how standards for innovator products will compare to those for biosimilars and alternative and second generation biologics using the new 351(k) pathways described in BPCIA. This presentation will discuss the need for consistency in regulatory standards and what can be learnt from markets that already have biosimilars and how those approaches may or may not comply with the new US statute.
12:00 pm End of Part Two
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