Identifying and addressing key regulatory risks affecting cell therapy programs

Chien-Chung Chen currently works as Senior Director in Analytical Development at Cabaletta Bio in Philadelphia USA. The main product rese-cel aims to treat a broad spectrum of autoimmune patients and moves to late stage of clinical development now. He has been in the biotech industry for over 12 years, focusing on analytics for cell and gene therapy products (CAR-T and TIL) and viral vectors (lentiviral vector and AAV). He has been a CMC regulatory contributor for regulatory submissions to health authorities globally, as well as CMC strategy contributor in the company.

Michael Brewer is the Director, Global Principal Consultant, Regulatory for the BioProduction Group (BPG) at Thermo Fisher Scientific. In this role, Michael is responsible for providing global support to BioProduction customers and serving as the regulatory thought leader and expert across all technology areas within BPD. Prior to moving to this role, he led the Pharma Analytics business, a team responsible for development and commercialization of testing applications for Microbiology, Analytical Sciences and Quality control. The products are fully integrated solutions for Glycan profiling, Bacterial and Fungal identification, Mycoplasma and Viral detection and host cell DNA and protein quantitation. Michael has over 30 years’ experience in the Biopharma industry, including, Scios, Synergen and Amgen in a variety of roles including Discovery Research, Analytical Sciences and Quality Control. Prior to joining Thermo Fisher Scientific, he led a group at Amgen that developed qualified, validated and implemented molecular methods for host cell DNA quantitation, contaminant (Mycoplasma, Virus and Bacteria) detection, contaminant identification, strain typing and genotypic verification of production cell lines. Additionally, his group supported regulatory submissions including IND, NDA, and CMC updates, Regulatory inspections, NC/CAPA investigations, contamination investigations and remediation and developed regulatory strategy for implementation of new methods.

Max Tejada currently serves as the Executive Director of Analytical Development and Quality Control for Individualized and Cell Therapies at Genentech. In this role, he leads a multi-site organization dedicated to helping advance the next generation of medicine, including allogeneic CAR T-cell therapies, stem cells, and mRNA-based programs. Throughout his career, Max has held executive leadership positions at some of the world’s most innovative biopharmaceutical companies. He previously served as the Vice President of Analytical Development at Sana Biotechnology and held the role of Executive Director of Analytical Operations at Kite Pharma, where he provided leadership through the complex landscape of viral-vector and autologous CAR T-cell therapy manufacturing. His extensive background also includes senior leadership roles at AstraZeneca, Gilead Sciences and Genentech, where he was instrumental in bridging the gap between pre-clinical development and global commercialization. Max holds a PhD in Biochemistry from Queen’s University and completed his post-doctoral work in the laboratory of Napoleone Ferrara at Genentech.