Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective

Maja Pizevska; Jaspal Kaeda; Enrico Fritsche; Hisham Elazaly; Petra Reinke; Leila Amini

doi:10.3389/fmed.2022.757647

Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective

Front Med (Lausanne). 2022 Feb 3:9:757647. doi: 10.3389/fmed.2022.757647. eCollection 2022.

Authors

Maja Pizevska¹, Jaspal Kaeda², Enrico Fritsche², Hisham Elazaly¹, Petra Reinke^{1

2}, Leila Amini^{1

2}

Affiliations

¹ Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin Institute of Health Center for Regenerative Therapies, Berlin, Germany.
² Berlin Center for Advanced Therapies (BeCAT), Charité-Universitätsmedizin Berlin, Berlin, Germany.

Abstract

Advanced Therapy Medicinal Products (ATMPs) comprising cell, gene, and tissue-engineered therapies have demonstrated enormous therapeutic benefits. However, their development is complex to be managed efficiently within currently existing regulatory frameworks. Legislation and regulation requirements for ATMPs must strike a balance between the patient safety while promoting innovations to optimize exploitation of these novel therapeutics. This paradox highlights the importance of on-going dynamic dialogue between all stakeholders and regulatory science to facilitate the development of pragmatic ATMP regulatory guidelines.

Keywords: European Medicines Agency; Paul-Ehrlich-Institute (PEI); advanced therapy medicinal product (ATMP); cell and gene therapies; legislation; regulatory affairs; regulatory science.