Impact on technology integration on better and faster biosimilars pipeline

5^th European Biosimilars Congress

June 27-29, 2016 Valencia, Spain

Christelle Dagoneau

Catalent Biologics, USA

Scientific Tracks Abstracts: J Bioanal Biomed

Abstract :

By 2020, patents will be 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.

Biography :

Christelle Dagoneau, PhD, is Director, Business Development for Catalent Pharma Solutions where she has been heavily involved in the design of biosimilar development programs for the past 5 years. Prior to joining Catalent, she served as Head of Marketing and Sales at PX'Therapeutics (France) for 6 years and has held additional commercial, marketing and research funding roles in France and in the United Kingdom between 2001 and 2005. She holds a PhD in Organic Chemistry as well as a Master in Technology & Business Management obtained from Grenoble Business School.

Email: christelle.dagoneau@catalent.com