Advanced Therapy Medicinal Products

Overview

Regulatory category encompassing gene therapies, cell therapies, and tissue-engineered products; facing development bottlenecks around data reuse and regulatory pathways that EU initiatives like Joint for ATMP are working to address. ATMP development faces persistent bottlenecks including difficulty duplicating and reusing clinical data, difficulty reintroducing innovation into established development pathways, and challenges across multiple domains that prevent the field from moving at full speed. The EU-funded Joint for ATMP project was created to map bottlenecks in ATMP development and propose solutions to policymakers and regulators to accelerate development pathways; the Agora initiative in London serves a complementary function. (Segment 3 (10:00-11:52))