CAR-TCR Summit - Yescarta Case Study
Diamond's Associate Director of Regulatory Affairs, Maria Fernandez, presented today as part of the Yescarta Case Studies session at the CAR-TCR Summit Europe (Hammersmith, London).
Maria described the EU regulatory considerations for Yescarta on the pathway to MAA. The presentation dealt with strategic considerations for CAR-T products, and real life examples of the regulatory journey for products of this type, drawing on experience from the YESCARTA programme.
Maria was joined in the session by additional speakers from Kite Pharma.
Marc Kamp discussed the novel supply chain routes to enhance accessibility and cost efficiency, and Adrian Bot provided an update on the two year follow up in the registrational study for Yescarta, revealing key learnings to date.