PROGRAMME
Course Name: GENE and ADVANCED STEM CELL THERAPY RESEARCH IN THE UK – New
arrangements and future improvements. 29 APRIL 2013
Venue- BIS Conference Centre, 1 Victoria Street, London SW1H 0ET. 10:00-15:30
Aims:
To provide an opportunity for researchers, regulators and others to work together to improve the
research environment in gene and stem cell therapy research
 To communicate the new procedures
 Receive feedback on the new processes
 Discuss way forward
o How to best to peer review science
o How to provide early provision of advice
o Deal with difficult issues
 For Catapult to indicate how they can help researchers in the regulatory process
Who should attend:
 BSGCT board members
 Gene and stem cell therapy researchers, REC members and staff (from GTAC RECs and HRA)
 Cell Therapy Catapult
 Others involved in regulation – MHRA, HTA, R&D
10.00
10:30
12:55
13:10
Registration and Coffee
Professor Adrian Thrasher. Keynote speech on the state of cell and gene therapy in the UK
Objectives: to indicate the strength and nature of this research in the UK, especially to REC
members, to give context and background to the rest of the day.
Dr Elaine Godfrey. The MHRA and regulation of advanced therapies.
Objectives: to outline how the EAG can fit into the regulation and discussion about what counts
as advanced cell therapies.
Joan Kirkbride. The HRA and regulation of advanced therapies.
Objectives: to outline the REC process and to provide information about how that has changed
and outcomes of the change (eg timelines)
Dr Emma Morris. R&D Approvals in the NHS
Objectives: to outline how the proposed changes may impact upon gaining NHS permission
Dr Chris Perrett. Representative from the HTA
Objectives: to describe the role of the HTA and links with the regulators.
Dr Mark Sheehan. Ethical Issues
Objectives: to identify the ethical issues involved in research and how they can be resolved.
Questions for the panel
Professor Andrew George. Introduction to break out session
13:15
Lunch
11:10
11:40
11:55
12:10
12:25
13:30
14:30
15:00
15:30
Break out sessions(with lunch being eaten)
Three Groups
 Dr Emma Morris- Scientific review
 Dr Elaine Godfrey & Professor Andrew George – difficult issues
 Catapult- how to improve regulation
Plenary Feedback
Dr Natalie Mount. How to promote advanced cell therapies in the UK.
Objectives: to highlight how Catapult can help, and other ways to support research and
development.
Finish
Speakers:
 Professor Adrian Thrasher-President of British Society for Gene & Cell Therapy(BSGCT)
 Dr Elaine Godfrey – Deputy Clinical Manager, Clinical Trials Unit, MHRA
 Joan Kirkbride - Director of Operations, NRES
 Dr Emma Morris – Joint Director of R&D, Royal Free Hospital
 Dr Chris Perrett – HTA Regulations Manager
 Dr Mark Sheehan – Oxford NIHR Biomedical Research Centre Ethics Fellow
 Professor Andrew George – Vice Chair, NRES Committee, London-West London &
GTAC
 Dr Natalie Mount – Chief Clinical Officer, Catapult