XXVI Congress

59 days

6 hours

15 mins


Clinical Trial and Commercialisation Workshop
Tuesday 16 October 2018
Organisers: Alessandro Aiuti (TIGET) - Robin Ali (UC, London)
9:30-11:00 Planning and running a clinical trial
Kim Champion - UCL Clinical Trials Centre: General considerations for setting up a clinical trial
Paola Albertini - SR-TIGET: Quality Requirements for GLP tox testing and GCLP clinical testing
Marco Anelli – PRAC, EMA–Pharmacovigilance from a sponsor, CRO point of view
Chiara Bonini  - SR-TIGET – Registry platform for gene and cell therapy: the EBMT approach
11:00-12:30 Manufacturing of gene and cell products
Jean -François Brunet– Building academic GMP facility 
TBC, Novartis – Scaling up of GMP manufacturing of a TIMPS from Pharma perspective
Xin Swanson, Lonza – Scaling GMP AAV production
James Miskin, Oxford Biomedica –Scaling GMP lentiVirus production
12:30- 13:30 LUNCH
13:30-14:30 Gene therapy and commercialisation challenges
Ron Philip, Spark Therapeutics – Patient access worldwide
         TBC–  Commercialisation challenges for gene editing    
14:30-16:00 Regulatory and reimbursement challenges
Ilona Reischl, CAT Vice-Chair–Update on new ATMP guidelines for GMP production: focus on the risk based approach
Martina Schüssler-Lenz, CAT chair- Risk management planning in the development of ATMP
Michela Gabaldo, Telethon Italy – Market access for ATMP in Europe 
ASGCT representative–Market access for ATMP in US