Publications by authors named "Jacquelyn Awigena-Cook"
Article Synopsis
- To speed up the creation of Advanced Therapy Medicinal Products (ATMPs) for patients with serious cancers, regulatory strategies must be regularly reviewed and adapted, focusing on balancing risk with early clinical research.
- The T2EVOLVE consortium is exploring ways to fast-track CAR and TCR-engineered T cell therapies in the EU by using existing regulatory tools to support an adaptable learning process for different product versions.
- As knowledge about the connections between product quality, manufacturing, clinical effectiveness, and safety increases, there are emerging opportunities to simplify regulatory submissions and clinical studies, potentially applying these insights to other engineered cell therapies like CAR NK cell products.
The hospital exemption (HE) (Article 28(2) of Regulation (EC) No 1394/2007; the "ATMP Regulation") rule allows the invaluable opportunity to provide patients with access to innovative, potentially life-saving treatments in situations of unmet clinical need. Unlicensed, developmental advanced therapy medicinal products (ATMPs) - cell-, gene- or tissue-based therapies - can be used to treat patients under certain conditions. Such products should be produced on a non-routine basis, custom-made for an individual patient under the responsibility of the requesting physician, for use in a hospital setting within the same Member State in which they are manufactured.
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