Early-stage analytical development strategies for cell therapy

Currently, Ramon is supporting the cell & gene therapy portfolio by leveraging his ATMP expertise to ensure robust technical strategies are developed. He is also developing holistic control strategies for new modalities in the cell and gene therapy space.

Prior to joining Johnson & Johnson Innovative Medicine, Ramon worked for Bristol Myers Squibb (Celgene), Orchard Therapeutics, Rocket Pharma, Bayer Pharma, and Analytical Lab Group now part of Element Materials Technology. During this time, Ramon had the responsibilities of leading analytical and commercial GMP quality teams, developing process and analytical control strategies for AAV, LV, RNP’s, and CAR-T drug products. He has experience supporting Cell & Gene Therapy programs from early /late-stage development, well into the commercial lifecycle. He has authored many submissions and participated in agency inspections and meetings, leading to successful commercial approvals of new CAR-T drug products.

Ramon has a PhD in Cell & Molecular Biology from the University of Washington and held postdoctoral positions at the Fred Hutchinson Cancer Research Center in Seattle WA.

Kyle Carter is a seasoned biopharmaceutical professional with over 15 years of experience in quality control, project management, and bioprocessing. Kyle holds an MBA and an MS in Biotechnology from the University of Maryland and a BS in Biology from West Virginia University. Currently, as the Director of Quality Control at Kite Pharma in Frederick, MD, he leads the Analytical Lifecycle Management for the Global Quality Control organization. In this role, he oversees commercial cell therapy vector and final product analytical testing, including flow cytometry, PCR, and ELISA-based methods. He manages a team focused on laboratory software alignment, global change controls, CAPAs, method performance monitoring, and analyst proficiency assessments. Additionally, he is the Global Business Process Owner of the LabVantage Laboratory Information Management System (LIMS), responsible for the global implementation of a 21 CFR Part 11 enterprise LIMS across multiple commercial and clinical manufacturing sites.

Darren has been leading the Potency and Functional Characterization team in Cell Therapy Analytical Development at BMS, since 2022, focusing on functional assays for both vector and drug product. Prior to his role in cell therapy, Darren led the strategic design and development, validation, and transfer of QC-ready cell-based potency assays used to support clinical development and commercialization of biologics at BMS (2017) and Eli Lilly and Company (2009). His development experiences include therapeutics of varying complexity ranging from peptides to insulins to monoclonal and multispecific antibodies and has utilized potency assays to identify critical quality attributes and better understand control of the manufacturing process. Darren holds a Bachelor’s degree from the University of British Columbia, a PhD from McGill University and completed a post-doctoral fellowship at the Fred Hutchinson Cancer Research Center.

Seth Peterson, Senior Manager of Application Support at Thermo Fisher Scientific, is a seasoned professional in the field of Pharma Analytics. With a dedicated focus on supporting and advancing novel genomic methods, Seth brings a wealth of experience and passion to his role.

In his capacity at Thermo Fisher, Seth oversees application support initiatives, playing a crucial role in developing and implementing innovative genomic methods tailored for both research and regulated environments within the pharmaceutical industry. His commitment to excellence is reflected in his diverse experience, where he has provided support to teams in Clinical Oncology, Pharmaceutical Manufacturing, and Agricultural biology.

Seth's career spans over a decade in the field with Thermo Fisher Scientific, during which he has directly engaged with customers, leveraging Next-Generation Sequencing (NGS) applications. His expertise particularly shines in the areas of Epigenetic profiling and Genotyping methods, showcasing a deep understanding of the intricacies of genomic research and its applications in various domains. With a focus on supporting and developing novel genomic methods, Seth Peterson stands as a dedicated leader and advocate for advancements in Pharma Analytics.