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Réunion Scientifique et Assemblée Générale Annuelle May 23-24, 2019 Ipsen Innovation 5 avenue du Canada 91940 Les Ulis France MAP Thérapie cellulaire, thérapie génique : de la recherche aux aspects réglementaires Cell therapy, Gene therapy: From Discovery to Regulatory Considerations Second announcement Program + information (Presentations will be held in English) 1/8 Siège social : BP 563 27005 Evreux cedex France S.F.P.T., association à but non lucratif – J.O. du 22 mars 2003
Jeudi 23 mai 2019 / Thursday 23rd May 2019 9:30 – 13:00 Educational Session for Residents in Pathology (in French) 13:15 – 13:30 Accueil et introduction / Welcome and introduction Stephane Lezmi / Catherine George (Ipsen, Les Ulis) 13:30 – 14:15 Visual restoration by retinal prosthesis and optogenetic therapy: validation on non-human primates Serge Picaud (Institute of vision, France) 14:15 – 15:00 Gene therapy medicinal products (GTMPs): Ex-vivo Hematopoietic Stem Cell Gene Therapy Franck Chanut (Sanofi, France) 15:00 – 15:30 Pause-café / break 15:30 – 16:15 Cell and gene therapy: new challenges in safety assessment Patrizia Cristofori (GSK, UK) 16:15 – 17:00 Cell therapy: Study design and pathologist input. Alys Bradley (Charles River Laboratories, UK) 17:00 – 18:30 Assemblée Générale (réservée aux membres de la SFPT) 20:00 – 22:00 Repas amical / friendly dinner MERCURE HOTEL 3 rue Du Rio Salado – 91252 LES ULIS Autour d’un bon repas / Time to enjoy good food & company 2/8 Siège social : BP 563 27005 Evreux cedex France S.F.P.T., association à but non lucratif – J.O. du 22 mars 2003
Vendredi 24 mai 2019 / 24th May 2019 08:30 Accueil / Welcome 09:00 – 09:45 Preclinical safety evaluation of AAV-mediated gene therapy: importance of nonhuman primates Juliette Hordeaux (University of Pennsylvania, USA) 9:45 – 10:30 Preclinical evaluation of hASC (human Adipose-Derived Stromal Cells) biodistribution in mice: place of immunohistochemistry and qPCR Isabelle Raymond (ENVT & Stroma Lab, Toulouse, France) Biodistribution assessment studies, adressing the fate and persistence of administrated therapeutic cell products, remain a key issue for regulatory authorities. The comparison of qPCR and immunohistochemistry results in a preclinical study of human ASC biodistribution in mice after IV injection will be presented. 10:30 – Pause-café / break 11 :00 11:00 – 11:45 Cell therapy: understanding the model system to properly assess the risk for tumorigenicity Guy Klaiman (Envigo, Israel) 11:45 – 12:30 Regulatory approaches for advanced therapies Nicolas Ferry (Servier, France) Based on selected examples, the presentation will review the main provisions of the european regulation regarding the preclinical requirements for the development of clinical applications of gene therapy. Specific issues such as classification of gene editing approaches will also be addressed. 12:30 – 12:45 Remarques finales / closing remarks 12:45 – 13:30 Lunch sponsored by Ipsen 3/8
Educational Session for residents, in French Jeudi 23 mai, Session pédagogique pour les étudiants du DESV (Présentations en français, ouvert sur inscription aux membres de la SFPT) 9:30 – 10:30 Introduction générale sur le développement des médicaments biothérapeutiques Béatrice Gauthier (Sanofi, Montpellier, France) 10:30 – 12:00 Toxicité induite par les oligonucléotides thérapeutiques en développement préclinique Pierluigi Fant (Charles River Laboratories, Lyon, France) 12:00 – 13:00 Lunch time (for people present in the morning only); Lunch will be offered by Ipsen for residents and morning speakers. DETAILED INFORMATION Organised by The french society of toxicologic pathology on the site of Ipsen Innovation, 5 avenue du Canada, 91940 Les Ulis France. How to register Before the May 10th, 2019 Please fill the separate registration form in and send it back to the local organizer with copy for local assistant. All registrations will be acknowledged to confirm attendance or position on the waiting list. Registration fee Before March 20th Meeting Dinner (Optional) Total Residents in pathology - 40 40 SFPT Members 50 40 90 Non-Members 100 40 140 After March 20th Meeting Dinner (Optional) Total Residents in pathology - 40 40 SFPT Members 85 40 125 Non-Members 120 40 160 4/8 Siège social : BP 563 27005 Evreux cedex France S.F.P.T., association à but non lucratif – J.O. du 22 mars 2003
Means of payment 1 Secure credit card payment Via the SFPT website (members only): https://toxpathfrance.org/gen.php3?id_rubrique=157 Direct link : https://www.helloasso.com/associations/societe-francaise-de-pathologie- toxicologique/paiements/cell-therapy-gene-therapy-from-discovery-to-regulatory-considerations 2 Bank transfer in EURO to : Crédit Mutuel CCM Évreux, 10 rue Chartraine, 27000 Évreux, France Account : Société Française de Pathologie Toxicologique BIC / SWIFT : CMCIFR2A IBAN : FR76 1027 8021 6000 0208 3084 569 Please indicate name and company to allow easy identification 3 Cheque (only french account) : Cheque payable to the treasurer of the SFPT: to be sent to: Frédéric Gervais (Frederic.Gervais@fr.citoxlab.com) Citoxlab BP563 27005 Evreux France Contacts Local organizer Venue address Name: Stephane Lezmi email: stephane.lezmi@ipsen.com Phone: +33 (0)6 11 23 08 07 Assistant Google Maps Name: Anne-Christine Teillet email: anne-christine.teillet@ipsen.com MAP Phone: +33 (0)1 60 92 70 30 5/8
Languages The scientific meeting will be held in English. The educational session dedicated to the residents in pathology (Thursday morning from 9:30 to 13:00) will be held in French. The Annual General Meeting of the SFPT will be held in French and access will be limited to members. Access to congress venue By car: - Porte d’Orléans: Take highway A6-A10 direction Chartres-Orléans Exit ‘Les Ulis – ZA Courtaboeuf’ and ‘ZA Courtaboeuf 1, 2, 3, 7’ Turn right, direction ‘Centre distribution de la Poste – Acadie’, Avenue de la Baltique Turn right at the traffic light and then turn left direction ‘Courtaboeuf Nord’ - Pont de Sèvres: N118, exit No. 13: Montdétour – ZA de Courtaboeuf At the crossroad, turn left (Avenue des Tropiques) Pass over the N118 and turn left (Avenue du Canada) By public transportation: Take RER B direction ‘Saint Remy les Chevreuses’ or ‘Massy-Palaiseau’ Exit at station Massy-Palaiseau and then take the bus 22 (Nord) toward the ZA de Courtaboeuf, stop at ‘Canada’ By taxis: Local company: radios taxis des Ulis/Bures: 01.69.07.48.88 Approximate travel time/cost by taxi to Orly: 40 minutes – 45€ Approximate travel time/cost by taxi to Roissy: 1:30 to 2:00 – 100€ 6/8 Siège social : BP 563 27005 Evreux cedex France S.F.P.T., association à but non lucratif – J.O. du 22 mars 2003
Accommodation suggestions Name Rate Website / booking code Hôtel Mercure Paris Sud 122€ to 160€ Les Ulis Courtaboeuf **** (breakfast 3 Rue Rio Solado included) 91952 Les Ulis Tel. 01 69 07 63 96 https://www.accorhotels.com/fr/hotel-0376-hotel- mercure-paris-sud-les-ulis-courtaboeuf/index.shtml 20 rooms pre-reserved (up to May 9th) ; indicate « IPSEN » when doing your reservation Hôtel : Comfort Hotel Acadie 109€ Les Ulis *** (breakfast ZA de Courtaboeuf, Avenue de included) l'Islande, 91140 Villebon-sur-Yvette http://www.comforthotellesulis.com/fr/index.php Tel. 01 64 46 98 01 20 rooms pre-reserved (up to April 30th) ; indicate « IPSEN » when doing your reservation Hôtel : Hôtel Première Classe 65€ + 5,90€ Les Ulis *** breakfast 2 ZA de Courtaboeuf, 13 Avenue des Tropiques - 91955 Les Ulis Tel. 01 69 07 69 96 https://www.premiereclasse.com/fr/hotels/premiere- classe-les-ulis-courtaboeuf Others recommended addresses: Please note that the bus, for the restaurant, will not stop by these other hotels - Hôtel Best Western Paris Val de Bièvre: https://www.bw-parisvaldebievre.com/ 1 Rue de la Libération, 78356 Jouy-en-Josas Tel. 01 69 35 43 21 - Hôtel Mercure Paris Massy Gare TGV: https://www.accorhotels.com/fr/hotel-1176-hotel-mercure-paris- massy-gare-tgv/index.shtml 21 Avenue Carnot, 91300 Massy Tel. 01 69 32 80 20 - Hôtel Campanile Les Ulis: https://www.campanile.com/fr/hotels/campanile-les-ulis 10 Avenue des Andes, 91940 Les Ulis Tel. 01 69 28 60 60 Deadline for booking It is highly recommended to book as early as possible after receiving confirmation of registration by the local organizer. 7/8
8/8 Siège social : BP 563 27005 Evreux cedex France S.F.P.T., association à but non lucratif – J.O. du 22 mars 2003
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