Clinical development of ATMPs: hospitals as an exemption?

The ATMP landscape continues to be characterized by the fact that academia represents the major source of innovation. Undoubtedly, academic institutions do not possess an industry-like capacity to vigorously pursue the full developmental pathway to market authorization. At the same time, Industry has brought the first products to marketing authorization and defined novel modes of interaction with academia regarding the procurement of starting materials, manufacturing steps including storage of the product, clinical application and performance of trials. With ATMP development set to continue attracting and also challenging clinicians and scientists, this opinion papers aims to discuss logistical, financial and regulatory issues that might help to reshape the academic environment and to resuscitate some concepts that may have contributed to the original idea of the Hospital Exemption Clause.

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