As the cell and gene therapy (CGT) field evolves, standardized processes have emerged as a popular method to accelerate development timelines, reduce costs, and improve scalability, all contributing to faster patient access to breakthrough therapies. However, the adoption of these processes may present challenges, including potential inflexibility and restrictive protocols that can limit optimal performance and robustness.
In this webinar, experts in CGT development, regulatory affairs, and CMC strategy will provide practical guidance on evaluating the potential risks and rewards of leveraging standardized processes and how to assess what approach is best for your unique product. Attendees will also gain insight into Thermo Fisher’s Rapid Development Framework™, an alternative to traditional platform processes for viral vectors and cell therapies designed to expedite the development and manufacturing process while remaining adaptable to customized methods.
Mathieu Boxus
Senior Director, Process Development, Thermo Fisher Scientific
Mathieu Boxus is an accomplished leader in the biopharmaceutical industry with 20+ years of experience in virology, oncology, and immunology. He has a proven track record in management positions in pharmaceutical companies with a focus on bioprocessing as well as preclinical and clinical development of vaccines and viral vectors. Mathieu currently serves as Senior Director, Process Development for Thermo Fisher Scientific’s Viral Vector Services. In this role, he drives innovation through implementation of process and analytical development capabilities across multiple sites to meet customer and regulatory expectations. Prior to joining Thermo Fisher, he held various leadership roles in R&D and Regulatory Affairs for Novasep and GSK. Mathieu holds a Ph.D in Genetic Engineering from University of Liege (Belgium).
Jesse Bishop
Senior Manager, Regulatory Affairs, Viral Vector Services, Thermo Fisher Scientific
Jesse Bishop is the Head of Regulatory Affairs at Viral Vector Services, where he oversees the development, implementation, and maintenance of key regulatory submissions including site master files and drug master files. With a career spanning over 15 years in regulatory affairs, quality/compliance, and research, Jesse has established himself as an expert in cell and gene therapy CMC. He plays a crucial role in partnering with clients to develop and strategize CMC information supporting their regulatory submissions for advanced therapy medicinal products. Jesse's leadership extends to preparing and participating in pivotal meetings with major regulatory agencies such as the FDA, EMA, and Health Canada. His profound understanding of global CMC requirements from early phase through to commercialization has made him a key leader in his field.
Diane Blumenthal
President, Dianthus Biopharma Consulting
Diane I. Blumenthal has more than 35 years in the biopharmaceutical industry as a leader in process and product development and clinical and commercial manufacturing. Her breadth of knowledge also includes quality control, scientific facilities, program management, and CMC regulatory. She has extensive expertise in building and transitioning companies from a start-up research and development organization to a fully integrated biopharmaceutical company with approved commercial manufacturing operations and products. Diane has played a key role in the development and commercialization of six well-known pharmaceutical products, including Erbitux®, Cyramza®, and most recently Luxturna®. Prior to forming Dianthus Biopharma Consulting, Diane was SVP/Head of Technical Operations at Spark Therapeutics, where she built and led the team responsible for the late-stage technical development which resulted in the approval of Luxturna®, the first gene therapy product approved for the treatment of a genetic disorder. She has also served as Vice President of Manufacturing Sciences and Technology for Eli Lilly and Company, and held various scientific leadership positions at Zymquest, Inc., Scios, Inc. (a.k.a California Biotechnology), and the Eastman Kodak Company. Diane received her M.S.E. in Chemical Engineering from Lehigh University and a B.S.E. in Bioengineering at the University of Pennsylvania.