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Second announcement Program + information
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)

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                  Siège social : BP 563 27005 Evreux cedex France
            S.F.P.T., association à but non lucratif – J.O. du 22 mars 2003
Second announcement Program + information
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

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                      Siège social : BP 563 27005 Evreux cedex France
                S.F.P.T., association à but non lucratif – J.O. du 22 mars 2003
Second announcement Program + information
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

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Second announcement Program + information
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

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                          Siège social : BP 563 27005 Evreux cedex France
                    S.F.P.T., association à but non lucratif – J.O. du 22 mars 2003
Second announcement Program + information
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

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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€

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                       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.

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      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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