Event presentations Agenda Speaker biographies
Explore analytical approaches to innovative cell and gene therapies at the annual USP Biologics Stakeholder Forum. Each year, industry, regulatory, and scientific experts gather to discuss pressing challenges at the interface of biotherapeutic quality and innovation. USP, an independent, nonprofit, science- and mission-driven standards development organization, gathers and explores the ideas from the forum to develop impactful quality standards that help ensure access to safe and efficacious medicines.
This year’s forum will focus on the analytical challenges associated with cell and gene therapy products, including shortened development timelines due to accelerated regulatory review, small production batches, and in some cases, short shelf lives. Sessions will explore analytical innovations that efficiently and cost-effectively support process and product understanding, process validation, and product release.
- The morning session features USP, FDA, and industry speakers, followed by a discussion of new and innovative analytical approaches.
- The afternoon session features speakers and discussions that focus on the application and validation of NGS-based techniques.
- Introduction and Objectives for today's Biologics Stakeholder Forum, Edward Chess, Ph.D., USP Biologics Stakeholder Forum Planning Committee, Chair
- USP Standards to Support Gene Therapy, Ben Clarke, Ph.D., USP
- Minimizing the Impact of Stability Studies on Gene Therapy Batch Yield, Gaël Debauve, UCB Pharma S.A.
- EDQM/Pharmacopeia Europe Activities in the Field of NGS/HTS, Gwenael Cirefice, EDQM, European Pharmacopeia
- FDA Perspectives on NGS in Adventitious Virus Testing, Arifa Khan, US FDA
- NGS Transcriptome Analysis in Cell Banking, Colette Cote, Pathoquest
- Off-Target Analysis: Identification, Verification and Compliant Testing, Aaron ZC, GeneGoCell
- Recommendations for the Validation of rAAV Identity by Next Generation Sequencing, Jarrod Dean, Sanofi