Spring School 2019

109 days

11 hours

29 mins

 

Clinical Trial and Commercialisation Workshop
Tuesday 16 October 2018
Organisers: Alessandro Aiuti (TIGET) - Robin Ali (UC, London)
9:15-11:00 Planning and running a clinical trial
INV001 Kim Champion - UCL Clinical Trials Centre: General considerations for setting up a clinical trial
INV002 Paola Albertini - SR-TIGET: Quality Requirements for GLP tox testing and GCLP clinical testing
INV003 Marco Anelli – PRAC, EMA – Pharmacovigilance from a sponsor, CRO point of view
INV004 Chiara Bonini  - SR-TIGET – Registry platform for gene and cell therapy: the EBMT approach
Discussion
11:00-11:30 COFFEE BREAK
11:30-
13:00
Manufacturing of gene and cell products
INV005 Jean -François Brunet– Building academic GMP facility 
INV006 Xin Swanson, Lonza – Scaling GMP AAV production
INV007 James Miskin, Oxford Biomedica –Scaling GMP lentiviral vector production
Discussion
13:00- 14:00 LUNCH
14:00-16:30 Patient access, regulatory and reimbursement challenges
 INV008 Ron Philip, Spark Therapeutics – Establishing gene therapy as a medicine and a business
INV009 Ilona Reischl, CAT Vice-Chair–Update on new ATMP guidelines for GMP production: focus on the risk based approach
INV010 Martina Schüssler-Lenz, CAT chair- Risk management planning in the development of ATMP
INV011 Michela Gabaldo, Telethon Italy – Market access for ATMP in Europe 
INV012 Eric Auger – Market access for ATMP in US
Discussion