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Reinhold G. Erben. 1 Department of Biomedical Sciences, University of Veterinary Medicine, Vienna, Austria.
Beatriz Silva-Lima. 2 iMED. UL, University of Lisbon, Lisbon, Portugal.
Ilona Reischl. 3 Austrian Medicines and Medical Devices Agency, BASG/AGES, Vienna, Austria.
Gustav Steinhoff. 4 Reference and Translation Center for Cardiac Stem Cell Therapy ( RTC) , University of Rostock, Rostock, Germany.
Gudrun Tiedemann. 4 Reference and Translation Center for Cardiac Stem Cell Therapy ( RTC) , University of Rostock, Rostock, Germany.
Wilfried Dalemans. 5 TiGenix, Leuven, Belgium.
Alexander Vos. 6 Pharmacell, Maastricht, The Netherlands.
Rob T.A. Janssen. 7 Scalable Life Sciences, Zoetermeer, The Netherlands.
Katarina Le Blanc. 8 Division of Clinical Immunology, Karolinska University Hospital, Stockholm, Sweden.
Gerjo J.V.M. van Osch. 9 Department of Orthopaedics and Otorhinolaryngology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Frank P. Luyten. 10 Skeletal Biology and Engineering Research Center, and Prometheus, KU Leuven, Leuven, Belgium.
Address correspondence to: Reinhold G. Erben, MD, DVM, Department of Biomedical Sciences, University of Veterinary Medicine, Veterinärplatz 1, Vienna 1210, Austria, E-mail: [email protected]
Introduction
This white paper is a summary of the discussions and exchange of experiences during the first European Interdisciplinary Summit on Cell-Based ATMPs held at the Billroth-Haus in Vienna, Austria, May 02-03, 2013. The meeting was supported by the Research Networking Programme REMEDIC (regenerative medicine), funded by the European Science Foundation and by the British Medical Research Council. Scientists in academia, members of the Alliance for Advanced Therapies (AAT), and individuals from national regulatory authorities have contributed to the Summit. Some elements of this white paper are not necessarily endorsed by all these organizations.
As defined by the European Commission, Advanced Medicinal Therapy Products (ATMPs) are new medical products based on genes (i.e., recombinant nucleic acids, gene therapy), cells (cell therapy), and tissues (tissue engineering).1 This white paper focuses on cell-based therapeutics in the form of injectable cells and tissue engineering approaches. The target audience are translational researchers, especially young researchers and those embarking on the drug development process, as well as policy makers.
The biggest challenges and hurdles that need to be overcome to improve the competitiveness of Europe in the field of cell-based ATMPs are
National Hurdles, Harmonization
Both European2 and US3 legislative frameworks have laid down rules...