CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy
23rd March 2022 | 10:00am EST / 2:00pm GMT / 3:00pm CET | Sarah Thomas, Vice President of Quality at REGENXBIO Inc. and Joanna Zmurko, NGS specialist at PathoQuest |WATCH FOR FREE
The principles for developing traditional biologics are well established, but do not always translate well to cell and gene therapy products. Creative yet practical adaptations are necessary to advance gene therapy programs toward licensure. During this presentation we will explore three key areas where practical adaptations are required:
- Building toward the commercial process: change control and managing product evolution for non-traditional development pathways, comparability challenges and clinical exposure
- Maturation of analytics – the level of product understanding expected as programs advance, method advancement from early to late phase, evolving regulatory expectations
- Finding the right partners – finding the right match in terms of not just technical ability, but also phase-appropriate GMP compliance and client service infrastructure; the impact of the Covid-19 pandemic on material and service providers
Presented by Sarah Thomas, Vice President of Quality at REGENXBIO Inc.
Sarah Thomas is the Vice President of Quality at REGENXBIO, responsible for the Quality Assurance, Quality Control and Analytical Development organizations. She has over 30 years’ experience in pharmaceutical, biotech & gene therapy Quality. She has experience working with products at all phases of development, from early clinical phases to commercial distribution. She has led Quality teams through the transition from clinical to commercial operations, and through multiple product approvals. Ms. Thomas received an MBA from George Washington University and a BS in chemistry from Butler University.
Followed by Joanna Zmurko, NGS specialist at PathoQuest
Joanna Zmurko has over ten years of professional experience in virology in the CRO environment. She combines a strong scientific background with a broad technical knowledge in molecular biology. She was able to develop her compelling business acumen while serving as Virology Biosafety Scientist at Merck KGaA. Before joining PathoQuest, Joanna held a Business Development role at Q2 Solutions (IQVIA’s testing laboratory). Joanna Zmurko is now a Sales Manager, NGS Specialist at PathoQuest. In her role, she advises on and provides solutions for pharma, biotech, and C(D)MO clients on NGS-based assays as viral safety testing for biologics, vaccines, and AMTPs. Joanna trained as a virologist through Marie Curie Research Fellowship in Virology at Katholieke Universiteit Leuven in Belgium, focusing on flaviviruses such as dengue and Zika.
Sponsored by PathoQuest
PathoQuest Your genomic expert for biologics testing
Robust and efficient Quality Control testing is critical for the development of biologics to reduce time to market and improve patient outcomes.
Developers and producers need QC testing solutions that help de-risk their product development pipeline by preventing adventitious agent contamination and cell line misidentification.
To meet those objectives, PathoQuest offers advanced Next Generation Sequencing (NGS) solutions that supplement or replace traditional methods and support the strategic decision-making process. This innovative approach allows for a robust and unambiguous level of testing and for faster turnaround time and is available with R&D, GLP and GMP grade.