Creating Conditions for the Success of The French Industrial Advanced Therapy Sector

¹ CELLforCURE, Les Ulis, France
² Assistance Publique – Hôpitaux de Marseille, Service de Pharmacologie, Marseille, France
³ Assistance Publique – Hôpitaux de Marseille, Laboratoire de Culture et Thérapie Cellulaire, Marseille, France
⁴ Unité Inserm 1076 : Endothélium, Pathologies Vasculaires et Cibles Thérapeutiques, Faculté de Pharmacie, Marseille, France
⁵ Ministère de l’Economie, de l’Industrie et du Numérique, Paris, France
⁶ Genethon, Evry, France
⁷ Laboratoire Boehringer-Ingelheim, Reims, France
⁸ Laboratoire Novartis, Rueil Malmaison, France
⁹ Hospices Civils de Lyon, Lyon, France
¹⁰ SATT Sud Est, Marseille, France
¹¹ ANSM, Saint Denis la Plaine, France
¹² Assistance Publique – Hôpitaux de Paris, Paris, France
¹³ Centre Hospitalier Régional Universitaire, Lille, France
¹⁴ Inserm Transfert, Paris, France
¹⁵ Sup’Biotech/CEA, Montrouge, France

Correspondence and offprints: Jérémy Magalon, Laboratoire de Culture et Thérapie Cellulaire, Hôpital de La Conception, AP-HM, 147 boulevard Baille, 13005 Marseille, France. E-mail: jeremy.magalon@ap-hm.fr

Received: 18 November 2014
Accepted: 24 November 2014

Abstract

Although the European Union merely followed the initiatives of the United States and Japan by introducing special regimes for orphan medicinal products, it has introduced a special status for a new category of biological medicinal products, advanced therapy medicinal products (ATMPs), adopting specific associated regulations. European Regulation (which constitutes the highest legal instrument in the hierarchy of European law texts) [EC] No. 1394/2007, published in 2007, uses this term to define somatic cell therapy medicinal products, tissue-engineered products, and gene therapy medicinal products, possibly combined with medical devices. The stated objective was two-fold: both to promote their industrialization and market access, while guaranteeing a high level of health protection for patients. Since publication of the regulation, few marketing authorizations have been granted in Europe, and these have not been accompanied by commercial success. However, certain recent studies show that this is a growing sector and that France remains the leading European nation in terms of clinical trials. This round table brought together a panel of representatives of French public and private protagonists from the advanced therapy sector. The discussions focused on the conditions to ensure the success of translational research and, more generally, the French advanced therapy sector. These enabled a number of obstacles to be identified, which once lifted, by means of recommendations, would facilitate the development and success of this sector.