Episode 112
Regulatory Landscape for CAR T-cell Therapy
Join us for an interview with Professor Julio Delgado from the Hospital Clinic de Barcelona (Spain), the first academic centre to achieve the authorisation to treat patients with a CAR T therapy developed 100% by academia.
Prof Delgado discusses the complexities of obtaining regulatory approval for CAR T-cell therapy, under the EU regulation for advanced therapy medicinal products (ATMPs).
In this episode, Prof Delgado shares his own experience learning to navigate the EU regulatory expectations while working at the European Medicines Agency (EMA). He emphasizes the importance of scientists understanding these regulations and regulators understanding the specific position of academia in the approval pathway for ATMPs. Listen and take advantage of his valuable insights!
Host: Isabel Olivera-Martinez, Medical Writer
Guest: Prof Julio Delgado
This episode is part of a series recorded at the joint EHA-EBMT 6th European CAR T-cell meeting in Valencia in February 2024, more podcasts will be available in the future. Stay tuned!
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