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Regulatory Perspective on Comparability Assessments of Biotechnology Products
Audrey Jia, M.D., Ph.D.
Division of Monoclonal Antibodies
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IBC's Well Characterized Biologicals conference is the leading industry conference to provide multiple, detailed case studies of the challenges, strategies and technologies involved in characterization and comparability of new biological molecules. Consistently rated as one of IBC's most in-depth and information-packed conferences, this case-study driven event also features multiple FDA speakers who present regulatory perspectives on a wide range of issues to help you with your analytical characterization efforts.
Top 10 List of Analytical Inadequacies in IND or BLA Submissions
Alfred Del Grosso, Team Leader- Analytical Chemistry, Division of Biological Standards and Quality Control, CBER, US FDA
Functional Assays as a Measurement of Vaccine Effectiveness
Cara Fiore, Ph.D., Master Reviewer, Office of Vaccines Research and Review, CBER, US FDA
Particulate Testing and Specifications for Sub-visible and Visible Particulates
Ewa Marszal, Ph.D., Chemist, Laboratory of Plasma Derivatives, Division of Hematology, CBER, US FDA
High Resolution NMR Fingerprinting the Higher Order Structure of Biosimilars: A Comparability Tool
Yves Aubin, Ph.D., Research Scientist, Centre for Vaccine Evaluation, Biologics and Genetic Therapies Directorate, Health Canada
Regulatory Perspectives on Host Cell Protein Characterization and Control
Laurie Graham, Acting Team Leader, Product Quality/CMC, Division of Monoclonal Antibodies, CDER US FDA
Update on the United States Biosimilars Program
Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), CDER, US FDA
Regulatory Considerations in the Safety Assessment of Vaccine Adjuvants and Adjuvanted Vaccines
Carmen M. Collazo-Custodio, Ph.D., Microbiologist, Primary Reviewer, Division of Vaccines and Related Product Applications, CBER, US FDA
Changing the Manufacturing Process to Remove Impurities and Monitoring Product Quality Using Relevant Lot Release Assays
Mikhail V. Ovanesov, Ph.D., Visiting Scientist, Principal Investigator, Laboratory of Hemostasis/Division of Hematology, Office of Blood Research and Review, CBER, US FDA
(This presentation is part of the co-located Product and Process Variants & Impurities program.)
Session Topics Include:
"Great conference! I learned a lot and got some great ideas for the development of in-house methods. I thought the FDA presentations were terrific…and put the fear of God in me. Amazing job keeping the conference going in the face of a hurricane" - Jacqueline McGourty, Associate Director, Emergent Biosolutions
"A conference with REAL information that is readily applicable to real issues with biologicals" - Sheila Magil, Senior Consultant, Bioprocess Technology Consultants"
"Even with obstacles from Mother Nature (namely Hurricane Sandy), the conference went on and I had a wonderful experience attending" - Wing-Yee Fu, Associate Scientist, Momenta Pharmaceuticals
"Both the organizers and the presenters did an excellent job - great content, variety and relevance to today's industry needs…despite Hurricane Sandy" - James D. Mendoza, Staff Scientist, Beckman, Coulter, Inc.
"Well organized and balanced conference" - Parag Goyal, Principal Scientist, Dr. Reddy's Lab
"I enjoyed the conference. There was plenty of new knowledge gained from the presentations and new opportunities for networking with colleagues in the industry" - Bridgitte Speights, Director, CMC Regulatory Affairs, Cephalon
"This conference was very relevant with current events and trends. It provided a good arena for industry leaders to network and share ideas and best practices" - John Alvino, Manager, MedImmune
"It's a great conference in the biologics arena" - Shenjiang Yu, Associate Director, Merck & Co.
"A great conference where statistical experts and process SME's meet" - Tom Geyskens, Process Engineer, Genzyme