Christelle Dagoneau
Catalent Biologics, USA
Title: Impact on technology integration on better and faster biosimilars pipeline
Biography
Biography: Christelle Dagoneau
Abstract
By 2020, patents will have expired for originator biologics accounting for about $100bn and Biosimilars are expected to take over on about 25% of this market. Today, 250 companies are focusing on follow-on biologics therapies and, looking at the key players, strategic alliances are now in place and recent acquisitions have further structured this new and expanding market. Still, a swarm of new biosimilar developers plan to enter the game and will rely on stategic partnership with Biosimilar expert solution provider like Catalent to support their with innovative and virtual business models. In this talk, the author will give an overview of the standard development strategies applied to the development of biosimilar products from innovator’s characterizationn through to Phase I manufacturing stage including general timelines and budget estimates. She will also describe how the end-to-end integration of development, analytical and manufacturing activities combined with customized and high-throughput design of experiments (DOE) for cell line/process development stages can accelerate development timelines and help select better biosimilar molecules.