Evolution of comparability for biologics: Uncovering important scientific and regulatory considerations

Presenting on the above topic is Dr Wassim Nashabeh, Global Head, Technical Regulatory Policy & Strategy, Genentech, Inc., United States. He will be speaking at Biologic Manufacturing World Asia 2012, part of a series of conferences in the 5th Annual BioPharma Asia Convention 2012, held on 19-22 March at Marina Bay Sands, Singapore.

Dr Wassim Nashabeh received his Ph.D. in Analytical Chemistry from Oklahoma State University in 1993, and his post-doctoral fellowship from ?Barnett Institute of Chemical and Biological Analysis? at Northeastern University where he developed new approaches for the separation of closely related recombinant protein variants. Thereafter, he joined PerSeptive Biosystems as a Senior Scientist from 1994-1996, where he co-developed new schemes for antibody modification with fluorescent and enzymatic labels for use in micro-fabricated chips based immunoassays. In 1996, Dr Wassim Nashabeh joined Genentech (A member of the Roche Group) as a Scientist and had since held several positions of increasing responsibilities including Associate Director, Methods validation group, Director Quality Control Clinical Development Group, Director in the CMC Regulatory Affairs Group and most recently Sr. Director of the Technical Regulatory Policy & Strategy Group. His current primary responsibilities include the development of global innovative regulatory strategies for biotechnology products as well as key positions on a variety of subjects of significant impact to Pharma Technical Development. Dr Nashabeh is also responsible for the regulatory support for the Biotechnology drug substance global manufacturing network.

Dr Nashabeh is the author/co-author of over 30 scientific publications, reviews and patents in the field of separation science and biotechnology. Dr Nashabeh is a member of the Board of Directors of CASSS (an International Separation Science Society), co-founder and chair of the ?International Symposium of CE in the pharmaceutical and Biotechnology Industries?, a permanent committee member of the CMC strategy forum conference series, co-founder of the CMC Forum Europe Conference Series as well as a member of the program committee for the WCBP conference series. Dr Nashabeh has co-chaired several biotechnology forums and events that focused on a variety of CMC related issues over the last 10 years including ‘Lifecycle approach of Setting Product Specifications’, ‘Changing paradigms for process validation’, ‘Design of Stability Studies’, ‘Quality by Design in Biotechnology’ and ‘Comparability for Biotech Products’

Dr Nashabeh will be presenting on the following subject:

Evolution of comparability for biologics: Uncovering important scientific and regulatory considerations
1. Mapping the technical and regulatory evolution of comparability for biologics
2. Discussing current considerations in comparability for the continued development of the Biosimilars market
3. Assessing recombinant biologics therapeutics: what makes them different from a CMC perspective

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