SAVE THE DATE!
Characterization & Comparability of Biologics 2012
March 19-22, 2012 | Intercontinental Harbor Court Baltimore | Bethesda, MD
Characterization and Comparability for Biologics was a huge success with 150+ industry, regulatory and biosimilar professionals gaining insight into analytical characterization and comparability for change implementation through case studies, interactive break-out discussions, networking opportunities and more!
This year’s event featured three representatives from the FDA who provided Regulatory Perspectives regarding Quality by Design, New Characterization Technologies and Comparability Expectations. Moreover the European Regulators were also represented with a presentation and discussions on European Perspectives on Comparability for Biosimilars.
With 38 industry and regulatory presentations together with choices of 12 break-out discussions, attendees were able to share their experiences and work out their own protocols and means of overcoming challenges: Topics included Bioassays, Physicochemical Characterization Technologies, PTM Hot Spots, Technology Transfer, Comparability Case Studies after Change Implementation, Impact and Characterization of the Impurity Profile, Quality by Design, and Biosimilars.
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Manager, Business Development
What people are saying about Characterization & Comparability
“I think this is the perfect conference for me – size and content wise”: Senior Scientist, Analytical, Takeda
“An excellent event encompassing leading regulatory and industry strategies for comparability”: Senior Scientist, Process Development, Shire HGT
“Liked just about everything – all presentations were valuable”: Director, Analytical Development, J&J
“A fantastic forum for the latest analytical technologies and characterization techniques”: Deputy Director, Global Regulatory Affairs, Bayer HealthCare
“A valuable meeting that assessed emerging analytical tools and their applications in understanding Biopharm critical quality attributes” Associate Director, Analytical Development / Characterization, UCB
“It was a well organized meeting with a lot of good topics and speakers.” Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, FDA/CDER/OPS, FDA
“The conference was well-organized and very informative from all aspects. I am glad that I was part of it.” Senior Principal Scientist, Analytical Research & Development, Pfizer, Inc.
“Really great presentations and speakers”: Group Leader, Development Analytics, Roche Diagnostics GmbH
“Great Opportunity to hear from the regulators and innovators”: Research Scientist, Analytical Development, Lupin Ltd
“A valuable meeting where Biopharm and agencies reviewed strategies to establish comparability after inevitable product life-cycle changes”: Associate Director, Analytical Development, Biologicals, UCB-Celltech
Following inaugural success, Cambridge Healthtech Institute presents a two part conference focusing on advances in analytical characterization and on comparability case studies for change implementation and for biosimilars. The event includes a strong regulatory component and plenty of opportunity for discussions with the regulatory authorities and industry regulatory experts.
Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, FDA/CDER/OPS, FDA
Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, USP
John O’Hara, Ph.D., Associate Director, Analytical Development, Biologicals, UCB-Celltechbr
Pat Cash, Ph.D., Senior Director, Analytical Biochemistry, MedImmune, Inc.
Alain Bernard, Ph.D., Vice President, Biopharmaceutical Process Sciences, UCB Group
Keith Chidwick, Ph.D., Senior Pharmaceutical Assessor, Biologicals Unit, MHRA