title: White paper on how to go forward with cell-based advanced therapies in Europe.
abstract: 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.
authors.affiliation: 1 Department of Biomedical Sciences, University of Veterinary Medicine , Vienna, Austria .
authors.forename: Reinhold G
authors.initials: RG
authors.lastname: Erben
authors.forename: Beatriz
authors.initials: B
authors.lastname: Silva-Lima
authors.forename: Ilona
authors.initials: I
authors.lastname: Reischl
authors.forename: Gustav
authors.initials: G
authors.lastname: Steinhoff
authors.forename: Gudrun
authors.initials: G
authors.lastname: Tiedemann
authors.forename: Wilfried
authors.initials: W
authors.lastname: Dalemans
authors.forename: Alexander
authors.initials: A
authors.lastname: Vos
authors.forename: Rob T A
authors.initials: RT
authors.lastname: Janssen
authors.forename: Katarina
authors.initials: K
authors.lastname: Le Blanc
authors.forename: Gerjo J V M
authors.initials: GJ
authors.lastname: van Osch
authors.forename: Frank P
authors.initials: FP
authors.lastname: Luyten
mesh_terms: D001317:Austria; D064987:Cell- and Tissue-Based Therapy; D002986:Clinical Trials as Topic; D003226:Congresses as Topic; D005062:European Union; D006801:Humans; D044968:Regenerative Medicine
references.citation: Blood. 2001 Apr 1;97(7):1951-9
references.pmid: 11264158
references.citation: Nat Med. 2013 Jan;19(1):35-42
references.pmid: 23296015
references.citation: BMC Biotechnol. 2007 Jun 08;7:30
references.pmid: 17559647
references.citation: Mol Ther. 2012 Mar;20(3):479-82
references.pmid: 22378030
references.citation: Cytotherapy. 2013 Mar;15(3):362-83
references.pmid: 23579061
references.citation: Blood. 2003 Jun 1;101(11):4305-12
references.pmid: 12576326