Clinical Trials and Commercialisation Workshop
Tuesday 11 October
08:30-09:00
Registration
09:00-10:50
Session 1
Clinical trials
09:00 - 09:10 - Claire Booth, UCL & Juan Bueren Ciemat Madrid
Welcome
09:10-09:35 CTC01: Paula Walker, Roche/Genentech
Good clinical practice: Clinical trials with gene therapies
09:35-10:00 CTC02: Fiona Thistlethwaite, The Christies NHS Foundation Trust
Clinical trial acceleration, the ATTC Network, a UK model with international applicability
10:00-10:25 CTC03: Declan Noone, European Haemophilia consortium, EMA PRAC
Putting the patient at the centre of clinical trial design
10:25-10:50 CTC05: Maria Ester Bernardo, SR-Tiget, Milan
Development of an ex-vivo GT platform for Lysosomal Storage Disorders with skeletal involvement
10:50-11:10
Coffee Break
11:10-12:10
Session 2
Regulatory & reimbursement challenges
11:10-11:35 CTC06: Laura Beswick Cell and Gene Therapy Catapult
Planning for product development to generate necessary evidence for Health Technology Assessment
11:35-12:00 CTC08: Jan Ohotski, Medpace
Introduction to, and practical aspects of, the Clinical Trials Regulation
12:00-12:10 CTC09: Claire Booth, UCL London
The ‘Agora’ Initiative
12:10-12:45
Panel discussion
Overcoming barriers to commercialisation of ATMP's
Anji Miller, LifeArc
Marc Turner, SNBTS
Maria Ester Bernardo, SR Tiget, Milan
Owen Marks, Pfizer