Creating conditions for the success of the French industrial advanced therapy sector.
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.
CELLforCURE, Les Ulis, France.
Pierre Noel
PN
Lirsac
Assistance Publique - Hôpitaux de Marseille, Service de Pharmacologie, Marseille, France.
Olivier
O
Blin
Assistance Publique - Hôpitaux de Marseille, Laboratoire de Culture et Thérapie Cellulaire, Marseille, France - Unité Inserm 1076 : Endothélium, Pathologies Vasculaires et Cibles Thérapeutiques, Faculté de Pharmacie, Marseille, France.
Jérémy
J
Magalon
Ministère de l'Economie, de l'Industrie et du Numérique, Paris, France.
Pierre
P
Angot
Genethon, Evry, France.
Estelle
E
de Barbeyrac
Laboratoire Boehringer-Ingelheim, Reims, France.
Pascal
P
Bilbault
Laboratoire Novartis, Rueil Malmaison, France.
Elisabeth
E
Bourg
Hospices Civils de Lyon, Lyon, France.
Odile
O
Damour
SATT Sud Est, Marseille, France.
Patrick
P
Faure
ANSM, Saint Denis la Plaine, France.
Nicolas
N
Ferry
Ministère de l'Economie, de l'Industrie et du Numérique, Paris, France.
Bénédicte
B
Garbil
Assistance Publique - Hôpitaux de Paris, Paris, France.
Jérôme
J
Larghero
Assistance Publique - Hôpitaux de Paris, Paris, France.
Marina
M
Nguon
Centre Hospitalier Régional Universitaire, Lille, France.
François
F
Pattou
Inserm Transfert, Paris, France.
Stéphane
S
Thumelin
Sup'Biotech/CEA, Montrouge, France.
Frank
F
Yates
D001688:Biological Products / Q000145:classification; D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000639:trends*; D064987:Cell- and Tissue-Based Therapy; D002568:Certification / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D005062:European Union; D005602:France; D015316:Genetic Therapy / Q000331:legislation & jurisprudence; D006291:Health Policy; D006801:Humans; D062069:Inventions / Q000191:economics / Q000639:trends; D066192:Manufacturing Industry / Q000191:economics / Q000331:legislation & jurisprudence / Q000458:organization & administration; D030781:Organisms, Genetically Modified; D009965:Orphan Drug Production / Q000331:legislation & jurisprudence; D023822:Tissue Engineering / Q000331:legislation & jurisprudence; D014495:Universities / Q000331:legislation & jurisprudence
D001688:Biological Products