How to increase speed from project initiation to IND filing for CGT products

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

Many early phase projects in the CGT space have extremely long lead times from project initiation to IND filing. This is due to the absence of standard technology platforms, a lack of clear understanding of the product quality attributes, and unclear regulatory requirements.

For many smaller companies, the inability to initiate clinical trials to gather safety and efficacy data impacts survival in a capital constraint economy. For bigger companies this results in increased cost, decreased revenue opportunities, and an inability to stay at the forefront of the industry and meet current and future demands. Finally and most crucially, there are patients waiting at the end of the process.

Attendees will learn about:

• Common reasons for early phase CGT project delays
• Creative ways to overcome these challenges from technical, quality, and regulatory points of view
• Current regulatory trends in cell and gene therapy
• Regulatory services for lentiviral vectors and cell therapy

Jennifer Cheung

Vice President, Global Quality and Regulatory, 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.

Watch now

SPEAKERS

Jennifer Cheung

Vice President, Global Quality and Regulatory, WuXi Advanced Therapies

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