title: Turning Regenerative Medicine Breakthrough Ideas and Innovations into Commercial Products.
abstract: The TERMIS-Europe (EU) Industry committee intended to address the two main critical issues in the clinical/commercial translation of Advanced Therapeutic Medicine Products (ATMP): (1) entrepreneurial exploitation of breakthrough ideas and innovations, and (2) regulatory market approval. Since January 2012, more than 12,000 publications related to regenerative medicine and tissue engineering have been accepted for publications, reflecting the intense academic research activity in this field. The TERMIS-EU 2014 Industry Symposium provided a reflection on the management of innovation and technological breakthroughs in biotechnology first proposed to contextualize the key development milestones and constraints of allocation of financial resources, in the development life-cycle of radical innovation projects. This was illustrated with the biofuels story, sharing similarities with regenerative medicine. The transition was then ensured by an overview of the key identified challenges facing the commercialization of cell therapy products as ATMP examples. Real cases and testimonies were then provided by a palette of medical technologies and regenerative medicine companies from their commercial development of cell and gene therapy products. Although the commercial development of ATMP is still at the proof-of-concept stage due to technology risks, changing policies, changing markets, and management changes, the sector is highly dynamic with a number of explored therapeutic approaches, developed by using a large diversity of business models, both proposed by the experience, pitfalls, and successes of regenerative medicine pioneers, and adapted to the constraint resource allocation and environment in radical innovation projects.
authors.affiliation: 1 Medtronic-Sofradim Production , Trévoux, France .
authors.forename: Yves
authors.initials: Y
authors.lastname: Bayon
authors.affiliation: 2 London Business School , London, United Kingdom .|3 NxR Biotechnologies GmbH , Basel, Switzerland.
authors.forename: Alain A
authors.initials: AA
authors.lastname: Vertès
authors.affiliation: 4 College of Pharmacy UNT Health Science Center , Fort Worth, Texas.
authors.forename: Vincent
authors.initials: V
authors.lastname: Ronfard
authors.affiliation: 5 London Regenerative Medicine Network , London, United Kingdom .
authors.forename: Emily
authors.initials: E
authors.lastname: Culme-Seymour
authors.affiliation: 6 Advanced Centre for Biochemical Engineering, University College London , London, United Kingdom .
authors.forename: Chris
authors.initials: C
authors.lastname: Mason
authors.affiliation: 7 ReNeuron Ltd. , Guildford, United Kingdom .
authors.forename: Paul
authors.initials: P
authors.lastname: Stroemer
authors.affiliation: 8 Institute of Experimental and Clinical Research , Université catholique de Louvain and Cliniques St-Luc, Brussels, Belgium .|9 PROMETHERA Biosciences, Mont-St.-Guibert, Belgium .
authors.forename: Mustapha
authors.initials: M
authors.lastname: Najimi
authors.affiliation: 8 Institute of Experimental and Clinical Research , Université catholique de Louvain and Cliniques St-Luc, Brussels, Belgium .|9 PROMETHERA Biosciences, Mont-St.-Guibert, Belgium .
authors.forename: Etienne
authors.initials: E
authors.lastname: Sokal
authors.affiliation: 10 CellCoTec, Bilthoven, The Netherlands .
authors.forename: Clayton
authors.initials: C
authors.lastname: Wilson
authors.affiliation: 11 Juventas Therapeutics, Inc. , Cleveland, Ohio.
authors.forename: Joe
authors.initials: J
authors.lastname: Barone
authors.affiliation: 11 Juventas Therapeutics, Inc. , Cleveland, Ohio.
authors.forename: Rahul
authors.initials: R
authors.lastname: Aras
authors.affiliation: 12 Holostem Terapie Avanzate, Srl, Modena, Italy .
authors.forename: Andrea
authors.initials: A
authors.lastname: Chiesi
mesh_terms: D006801:Humans; D044968:Regenerative Medicine / Q000191:economics / Q000379:methods / Q000639:trends; D023822:Tissue Engineering / Q000191:economics / Q000379:methods / Q000639:trends