Mastering the journey from initial method transfer to successful lot release for cell & gene therapies

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Mastering the journey from initial method transfer to successful lot release for cell & gene therapies

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

Method transfer, common in translational science and cell and gene therapy, involves moving analytical methods between labs as the therapeutic moves through the development pathway. It is crucial to maintain performance consistency, tackle challenges like instrument variation, and ensure thorough stakeholder communication for success.

Once a method is successfully transferred, it must also be qualified and potentially validated, depending on the clinical phase and intended use of the data and product. It is crucial to understand the perspective of the regulators, as well as to understand industry standards and best practices in order to ensure your data and methods will gain approval. This will also support your Investigational New drug Application, expansion, and ultimately Biologic License Application.

This journey is complex with many stakeholders and parties involved, from analytical method development to QC analysts, regulatory experts, and supply chain personnel. Streamlined project management and effective communication are key to success.

Join this webinar to hear from a panel of experts who will share potential pitfalls and lessons learned from their many years of experience across a wide array of projects in the cell and gene therapy space.

How to avoid common challenges in method transfer
Approaches to ensure performance consistency and ensure assay qualification
Standard questions and issues identified by regulators during submission review, and how to answer or avoid them
Key success factors for effective planning and communication during assay transfer

Audrey Chang

Executive Director at WuXi Advanced Therapies

Dr Chang has over 28 years of government and industry experience in conducting biological product testing and in managing laboratories. Audrey earned her PhD 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 Wuxi Advanced Therapies, Audrey was VP of QC at Vigene BioSciences which was acquired by Charles River Laboratories. In her current role at ATU, Audrey leads the Testing Operations Organization where her group focuses on providing 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 WuXi Advanced Therapies.

Heather Malicki

Executive Director, Analytical Development and Testing Technologies at WuXi Advanced Therapies

Dr Heather Malicki is Executive Director, Analytical Development and Testing Technologies at WuXi Advanced Therapies. Following an undergraduate degree in biology from The University of Indianapolis and a PhD in Microbiology and Molecular Virology at Thomas Jefferson University, Heather began her career in industry at Dupont Pharmaceuticals and Merck, before joining WuXi AppTec in September 2006.

Jennifer Cheung

Vice President, Global Quality and Regulatory at WuXi Advanced Therapies

Jennifer brings nearly 27 years of quality, compliance and regulatory experience in biotechnology and pharmaceutical manufacturing prior to joining WuXi Advanced Therapies, a contract testing, development, and manufacturing organization (CTDMO) in 2020. In her current role, she is supporting many cell and gene therapy clients by interpreting and applying the phase appropriate GMP regulations and requirements to accelerate development and manufacturing timeline, focusing on client satisfaction and the right first-time performance. She is passionate in promoting GMP convergence, inspection reliance, and data driven, risk-based decision-making to maximize patients’ benefit.

Melissa McDonnell

Testing Product Director at WuXi Advanced Therapies

Melissa McDonnell has nearly 20 years of experience in biologics, pharmaceutical and medical device manufacturing and testing. As Product Director for Testing Services at WuXi Melissa is responsible for client delivery and manages the Project Management and Supply Chain Planning teams. Melissa has an undergraduate degree in Biomedical Engineering and a master's in Systems Engineering from Penn State and is a Lean Six Sigma Certified Black Belt. Prior to joining WuXi in 2011, Melissa held Engineering and Project Management positions at Johnson & Johnson, Stryker and Becton Dickinson.