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
 

09:10-09:30  CTC01: Paula Walker, Roche/Genentech

Good clinical practice: Clinical trials with gene therapies

09:30-09:50  CTC02: Fiona Thistlethwaite, The Christies NHS Foundation Trust 

Clinical trial acceleration, the ATTC Network, a UK model with international applicability

09:50-10:10  CTC03: Declan Noone, European Haemophilia consortium, EMA PRAC

Putting the patient at the centre of clinical trial design

10:10-10:30  CTC04: TBC

10:30-10:50  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

11:10-11:30  CTC06: Laura Beswick Cell and Gene Therapy Catapult

Planning for product development to generate necessary evidence for Health Technology Assessment

11:30-11:50  CTC07: TBC

11:50-12:10  CTC08: Jan Ohotski, Medpace 

Introduction to, and practical aspects of, the Clinical Trials Regulation

12:10-12:40

Panel discussion

Overcoming barriers to commercialisation of ATMP's

Anji Miller, LifeArc

Marc Turner, SNBTS

Maria Ester Bernardo, SR Tiget, Milan

Owen Marks, Pfizer