Innovations in development for the biosimilar industry
Post-Conference Workshop, Friday 2 March 2012
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The evolving quality (chemistry and manufacturing) paradigm for biosimilars | |||
| 9am |
Welcome & workshop introduction
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| 9.30am |
How is process development for a biosimilar different from that of the innovator drug?
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| 10.30am | Morning refreshments | ||
| 11am |
Defining critical product quality attributes
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| 12.15pm | Lunch | ||
| 1.15pm |
Managing the interface between the CMC dimension and immunogenicity risk assessment for biosimilar products
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| 2.15pm |
Patent issues unique to the manufacturing of biosimilars
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| 3.15pm |
Panel discussion, Q & A, interactive session with delegate questions/CMC problems ANITA O'CONNORAnita M. O’Connor, MS, PhD, has over 20 years of experience in regulatory affairs and drug development for the pharmaceutical, medical device, food, and animal drug industry. She worked for FDA for 16 years in the Center for Biologics Evaluation... more.. Niamh KinsellaI am currently working at NDA Regulatory Science Ltd as a Senior Consultant. Prior to joining NDA, I worked at two regulatory consulting groups and have over 10 years experience in the biopharmaceutical industry within the fields of regulatory... more.. Paul ChamberlainPaul CHAMBERLAIN is a biopharmaceutical product specialist who specialises in presenting immunogenicity risk assessments to European and North American regulatory agencies. He works with Sponsors to develop strategies for evaluating the probability... more.. Jennifer FoxMs. Fox focuses her practice on counseling pharmaceutical and biotechnology companies in patent and related transactional matters. As both a research scientist and patent attorney, she has over 15 years of experience in the pharmaceutical and... more.. Karin SewerinKarin Sewerin is Sr VP of Quality and Regulatory Strategy at BioPharmaLinx AB working with quality and regulatory advice for development and registration of Biopharmaceuticals. She has over 30 years of industrial experience from Kabi-Pharmacia and...
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