This session is a continuation of Wednesday’s Speed to Patient Plenary Session. This session includes talks on novel strategies for manufacturing and testing products. It will also include a session from the EMA to discuss opportunities to gain approval for these novel strategies.
Speed pursued without considering the impact to people (burnout) and resources (shortages) is not sustainable. During the session we will hear input on strategies to take on manufacturing and testing in a new way. You are encouraged to share your experiences and to ask questions to determine how these strategies could be applied to others within industry. Our shared goal is to ensure patients have sustainable and fast access to safe and efficacious therapies.
Session Speakers: 08:30 - 08:55 Process Analytics for mRNA Process Development - Letting the Data Do the Work V Elliott Schmitt, Moderna, Inc.
08:55 - 09:20 Translating Innovation in Pharmaceutical Manufacturing and Technologies for the Benefit of Patients - An EU Perspective V Veronika Jekerle, European Medicines Agency
09:20 - 09:45 Opportunities and Challenges for Decentralized Manufacturing V Christine Moore, ORGANON