Quality agreements, tech transfer, and risk management in cell and gene therapy

Thursday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

Sponsor

Quality agreements, tech transfer, and risk management in cell and gene therapy

Join this expert discussion to hear quality assurance (QA) leaders discuss practical, data-backed approaches to maintaining compliance and product quality across the cell and gene therapy lifecycle – from clinical development through to commercial manufacture. Panelists will share real-world insights on what drives successful quality agreements, technology transfer, and proactive quality risk management (QRM).

The panel will also cover key findings and examples from ongoing QA collaborations, highlighting measurable improvements in transfer efficiency, decision-making agility, and regulatory alignment across diverse biological modalities.

Key questions the panel will address include:

What should a robust quality agreement between sponsor and CDMO include, and how can lifecycle thinking be embedded from the start?
How can QA teams reduce time and risk during technology transfer and validation?
Which quality challenges have the greatest impact on advanced therapy manufacturing, and how are industry leaders addressing them?
How can data-led QRM approaches improve decision quality and maintain compliance throughout development?

Attend this webinar to:

Hear direct insights from QA experts actively managing complex cell and gene therapy programs from early clinical through commercial stages, in a global regulatory environment
Learn how clear quality agreements and proactive risk management translates to faster, smoother tech transfers
See real-world examples of how structured QA frameworks can reduce delays, strengthen partnerships, and improve regulatory outcomes
Take away practical actions for embedding quality and compliance across development stages and global markets.

Luciana Mansolelli

Chief Quality Officer at Minaris Advanced Therapies

Dr Luciana Mansolelli serves as our Chief Quality Officer at Minaris Advanced Therapies, bringing over 29 years of global leadership experience in quality, development and manufacturing for advanced therapies, including biologics, medical devices and cutting-edge cell and gene therapies. She has a proven track record of building robust quality systems, driving operational excellence and guiding teams through complex regulatory landscapes. She has extensive experience working with global health authorities and non-governmental bodies on drug development, manufacturing and commercial compliance, as well as legal frameworks across multiple GxP disciplines and products. Dr. Mansolelli leads our global quality strategy, ensuring the highest standards are met across all programs and sites. Dr. Mansolelli’s career includes global senior leadership positions at Johnson & Johnson Innovative Medicine and Novartis. Earlier in her career, she served as Director of QA for Novartis, leading R&D quality and compliance at Eurofarma and Hexal do Brasil. She began her career as a production supervisor at Boehringer Ingelheim. Dr. Mansolelli holds a Doctor of Pharmacy from Universidade Estadual de Maringá and an MBA from Fundação Getulio Vargas.

Audrey Chang, PhD

CMC Advisor at Minaris Advanced Testing

Dr Chang has over 28 years of government and industry experience in conducting biological product testing and in managing laboratories. Audrey earned her Ph.D. at the Johns Hopkins University in Biology, and after a post doc at the FDA, joined BioReliance where she held various positions of increasing responsibilities. Prior to joining Minaris Advanced Therapies, Audrey was VP of QC at Vigene BioSciences which was acquired by Charles River Laboratories. In her current role, Audrey provides technical solutions and support to clients for both traditional biologics and novel modalities. Audrey has always had a passion for driving innovative products to commercialization and is happy to bring her experience to the testing division at Minaris Advanced Therapies.

in 23

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