Erben Reinhold G, Silva-Lima Beatriz, Reischl Ilona, Steinhoff Gustav, Tiedemann Gudrun, Dalemans Wilfried, Vos Alexander, Janssen Rob T A, Le Blanc Katarina, van Osch Gerjo J V M, Luyten Frank P
1 Department of Biomedical Sciences, University of Veterinary Medicine , Vienna, Austria .
Tissue Eng Part A. 2014 Oct;20(19-20):2549-54. doi: 10.1089/ten.TEA.2013.0589. Epub 2014 Jun 3.
The current White paper summarizes the discussions and exchange of experiences during the first European Interdisciplinary Summit on Cell-Based ATMPs held 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. To improve the competitiveness of Europe in the field of cell-based Advanced Medicinal Therapy Products (ATMPs), the following key issues were identified during the meeting: removal of national hurdles in the European Union, harmonization of national and subnational differences in Hospital Exemption rules, improved treatment algorithms for reimbursement, better knowledge on the mode of action, predictive preclinical efficacy and safety testing, need for innovative systems for preclinical testing, appropriate product characterization, manufacturing with cost of goods in mind, and appropriate design of clinical trials.
本白皮书总结了2013年5月2日至3日在奥地利维也纳举行的首届欧洲基于细胞的高级治疗用医药产品（ATMPs）跨学科峰会期间的讨论和经验交流。该会议由欧洲科学基金会资助的研究网络计划REMEDIC（再生医学）以及英国医学研究理事会提供支持。为提高欧洲在基于细胞的高级治疗用医药产品（ATMPs）领域的竞争力，会议期间确定了以下关键问题：消除欧盟内的国家障碍、协调国家和次国家层面在医院豁免规则方面的差异、改进报销治疗算法、更好地了解作用模式、进行预测性临床前疗效和安全性测试、需要创新的临床前测试系统、进行适当的产品特性描述、在考虑商品成本的情况下进行生产以及进行适当的临床试验设计。
