Speed from Gene to Market

New for BPI 2018, the Speed from Gene to Market track covers the key industry insights you need to accelerate speed to IND and BLA submissions. Case studies and new data presentations will focus on strategies to compress timelines across process characterization, validation, and comparability. Industry leaders will demonstrate how to implement novel approaches in process and analytical sciences.

Why Speed to IND Can Cause Major Issues and Risks Later in Development

Regina Au, MBA, MIM, Principal, New Product Planning/Strategic Commercial Consultant, BioMarketing Insight
Full Presentation: 8:25 am, Fri. Sep. 7, 2018

Regina Au talks about the need for a product to be better than the competition, and the importance of its commercial profile in determining which product specifications are needed to be successful in the market.

Seamless Integration of Projects Between R&D and Manufacturing

Gene Lee, PhD, Senior Director and US Site Head Protein & Cell Sciences/NBE, EMD Serono
Full Presentation: 10:15 am, Weds. Sep. 5, 2018

He spoke to us about the difference in mentality and operations between R&D and manufacturing teams, and how overcoming these can improve efficiencies for the whole drug development process. The podcast highlights some of the results from initiatives taken by EMD Serono to identify its own deficiencies in CMC, which, after following the recommendations, has now placed the firm right at the industry benchmark.