Opening Plenary

Opening Plenary - Challenges and Opportunities in the Manufacturing of New Treatment Modalities This year, the 2020 ISPE Biopharmaceutical Manufacturing Conference will focus on advances in manufacturing, facilities, and analytics important to bring new therapies to patients. Now more than ever, manufacturing is on the critical path as many new treatments in the area of personalized medicines and individualized batch production present the challenge to bring these medicines through rapid development, reliable manufacturing, and availability to patients a pace with the advances clinical research is bringing to address unmet needs. At the same time, biosimilars are advancing with the opportunity to provide more access to medicines. In this opening session, we will hear an important regulatory perspective from FDA on gene therapy drug development and a reflection from industry on 10 years of Biosimilars.