Beyond the breakthrough: expanding patient access to cell and gene therapies

Andrew Tustian is a Senior Director of Preclinical Manufacturing and Process Development at Regeneron Pharmaceuticals, where he leads the viral vector process development group focused on Adeno-associated virus (AAV)-based vectors for gene therapy.

Michael Paglia is Chief Technology Officer at ElevateBio, where he leads manufacturing operations, CMC regulatory activities, process and analytical development, and the advancement of innovative technologies to accelerate the development of genetic medicines. He played a key role in designing, building, and operating ElevateBio’s BaseCamp manufacturing facility, which received ISPE’s 2021 Facility of the Year Award for Operational Excellence.

With more than 20 years of experience in biopharmaceutical process development, manufacturing, and facility operations, Michael has held leadership positions across the cell and gene therapy industry. Prior to ElevateBio, he served as Vice President of CMC Operations at Oncorus and previously led technical operations, process development, manufacturing, and global technology transfer activities at bluebird bio, contributing to the development of multiple approved autologous cell therapies. Earlier in his career, he led process development and late-stage manufacturing of therapeutic antibody products at Tolerx.Michael holds a bachelor’s degree from Providence College and a Master of Science in Biochemistry and Cellular Biology from the University of New Hampshire. In 2023, he received the Distinguished Alumni Award from the University of New Hampshire’s College of Life Sciences and Agriculture in recognition of his contributions to STEM workforce development.

Steven Binninger is Head of Emerging Technology & Business Ventures at Sartorius, where he focuses on identifying, developing, and commercializing innovative technologies, including the Eveo® Cell Therapy Platform, that advance bioprocessing and next-generation medicines. With more than a decade of experience in biotechnology, cell and gene therapy, and process development, he has led technology innovation, strategic partnerships, and commercialization initiatives across the life sciences industry.

Prior to joining Sartorius, Steve held leadership roles at Autolomous, ScaleReady, and Fresenius Kabi, supporting the development and scale-up of advanced therapy manufacturing technologies.

Carl leads DeciBio’s advanced therapies practice. He brings experience across biopharma, manufacturing / bioprocessing, and supply chain considerations for his clients. He has executed on projects ranging from pipeline prioritization / life cycle management, indication road mapping, growth strategy, and M&A projects across healthcare, life science tools, and pharma (cell and gene therapies). Carl holds a B.S. from the University of California, Berkeley, and a Ph.D. from MIT where he trained with Professor Robert Langer.

Sharon Anderson is Vice President of Scientific Affairs at the Alliance for Regenerative Medicine (ARM), where she leads a team that engages ARM’s members to overcome obstacles to innovation and improve patient access to life-changing treatments. Recently, her work has focused on convening CAR-T developers, treatment centers, and patient organizations around concrete efforts to expand access, including developing a playbook for community treatment centers.

Sharon brings more than 20 years of experience in the cell and gene therapy sector. At Vertex Pharmaceuticals, she built and led internal and external manufacturing operations for stem cell-derived islet cell therapies for type 1 diabetes. Earlier roles at Astellas, OvaScience, the Cystic Fibrosis Foundation, and Dana-Farber Cancer Institute spanned basic research, process development, analytical testing, and manufacturing.