Xiuli Chen, Ph.D., Rac Email and Phone Number

Prepare CMC modules for AAV Gene therapy product, resulted in IND clearance by US FDA..Involved in the design of CDMO cGMP manufacturing facilities, enhancing compliance and operational efficiency.

CAR-T Allergenic Cell Therapy IND development. Head of Regulatory Affairs, Quality, and Quality Control.

Responsible for directing and overseeing Analytical Development, Stability, and Quality Controlactivities.

Develop regulatory strategies to support IND submission and BLA filing of the First-in-Human allogeneic Cell and Gene Therapeutic product for osteoarthritis. Provide regulatory intelligence and guidance on all aspects of IND development and product portfolio expansion. Evaluate optimal regulatory route to BLA approval, develop strategies for priority review designation and accelerated regulatory pathways. Manage regulatory projects for regulatory writing and eCTD submissions.

Manage a group of Sr. Scientists. Lead projects for analytical assay development, technology transfer, and validation. Maintain lifecycle of analytical methods according to FDA/EMA/ICH/USP guidelines. Create product specifications and ensure regulatory requirements are met.

Manage a team of 14-18 highly efficient professionals. Responsible for department staffing, budgeting, and performance metrics. Manage all aspects of sample and product release testing for the Molecular Biology department. Maintain a high cGMP testing volume of about 200 studies per month with excellent metrics of on-time delivery and right first time rate. Validation of testing method, equipment, software, and process. Ensure the testing facility and process is in compliance with FDA and global regulations.Represent the department for client and regulatory agent interactions. Prepare responses to inspections and regulatory findings. Manage all non-conformance deviations and investigations. Develop CAPA plans and monitor CAPA effectiveness. Advocate for continued process improvement, introduced lab automation, validated and launched a number of new assays for testing of adventitious agents and ensure product safety. Designed optimal process workflow and led two lab renovation projects to ensure improved workflow and reduced process related contamination events.