PEGS Boston 2018 | How to Interpret and Implement FDA Guidelines for Biologics? episode artwork

EPISODE · Jan 19, 2018 · 9 MIN

PEGS Boston 2018 | How to Interpret and Implement FDA Guidelines for Biologics?

from CHI Podcasts · host Cambridge Healthtech Podcasts

Dr. William Hallett outlines what he considers some of the greatest obstacles to assess immunogenicity of biologics. He also comments on the reason behind the new requirement for lower cut-point in assays, how to accelerate Biobetters to the market in the world of Biosimilars, and advice for the industry in biologic development to accelerate FDA approval. For more information, please visit http://www.PEGSummit.com/Immunogenicity/

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PEGS Boston 2018 | How to Interpret and Implement FDA Guidelines for Biologics?

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