Regulatory Science for Advanced (Gene & Cell) Therapy: Advanced Therapies - Bench to Medicine
Monday 4 July - Friday 8 July 2016, UCL, Roberts Building, Torrington Place, London WC1E 7JE
Day 1
9.15 - 9.45
04/07/2016
Monday
Tea & Coffee
Overview
Roberts Foyer
G02
9.45 - 10.45
10.45- 11.45
11.45 - 12.00
12.00 - 13.00
Preclinical data: What do you need?
Ethics: special issues for ATMPS
GMP production requirements
Julie Daniels, University College London
(UCL)
Martin Gore, Royal Marsden Hospital
(RMH)
Ian Rees, Medical and Healthcare
Products Regulatory Agency (MHRA)
Professor of Regenerative Medicine and
Cellular Therapy, Institute of
Ophthalmology
Consultant Medical Oncologist and
Professor of Cancer Medicine
Break
Manager for the Inspectorate Strategy
and Innovation Unit
Roberts G06 Sir Ambrose Fleming LT
Roberts G06 Sir Ambrose Fleming LT
Roberts Foyer
G02
Roberts G06 Sir Ambrose Fleming LT
13.00 - 14.00
14.00 - 15.00
15.00 - 16.00
Clinical Trials: advice and approval
EMA licensing
Angela Thomas (MHRA)
Christiane Niederlaender (MHRA)
Vice-chair of Commission on Human
Medicines; Chair of the Clinical Trials,
Biologicals and Vaccines Expert Advisory
Group
Senior Quality Assessor, Biologicals at
MHRA
Roberts Foyer
G02
Roberts G06 Sir Ambrose Fleming LT
Roberts G06 Sir Ambrose Fleming LT
13.00 - 14.00
14.00 - 15.00
15.00 - 16.00
Animal models: biodistribution
Panel Q&A
Lunch
The day will conclude with an evening drinks reception in Roberts Foyer G02
Day 2
9.15 - 9.45
9.45 - 10.45
10.45- 11.45
Challenges with ATMPs
Non-clinical development of ATMPs as a
paradigm for translational research
Animal models: efficacy, toxicity
Christian K Schneider, National Institute
for Biological Standards and Control
(NIBSC)
Christian K Schneider (NIBSC)
Sian Harding, Imperial College London
(ICL)
Director Designate,
Director Designate
Break
Professor of Cardiac Pharmacology at the
National Heart and Lung Institute
Roberts Foyer
G02
Roberts G08 Sir David Davies LT
Roberts G08 Sir David Davies LT
Roberts Foyer
G02
Roberts G08 Sir David Davies LT
Roberts Foyer
G02
Roberts G08 Sir David Davies LT
Roberts G08 Sir David Davies LT
9.15 - 9.45
9.45 - 10.45
10.45- 11.45
11.45 - 12.00
12.00 - 13.00
13.00 - 14.00
14.00 - 15.00
15.00 - 16.00
Vector GMP
Cell GMP
QA/QC and release
Scale up of production
Panel Q&A
Lucas Chan, Kings College London (KCL)
Glyn Stacey, UK Stem Cell Bank (UKSCB)
Farzin Farzaneh (KCL)
Tarit Mukhopadhyay (UCL)
Head of Production for Advanced
Therapy Medicinal Products
Director
Break
Professor of Molecular Medicine
Lunch
Dept of Biochemical Engineering
Roberts Foyer
G02
Roberts G08 Sir David Davies LT
Roberts G08 Sir David Davies LT
Roberts Foyer
G02
Roberts G08 Sir David Davies LT
Roberts Foyer
G02
Roberts G08 Sir David Davies LT
Roberts G08 Sir David Davies LT
9.15 - 9.45
9.45 - 10.45
10.45- 11.45
11.45 - 12.00
12.00 - 13.00
13.00 - 14.00
14.00 - 15.00
15.00 - 16.00
Trial design
Patient monitoring
Larger scale trials
Commercialisation
Panel Q&A
Dominic Bowers, Cell and Gene Therapy
Catapult (CGT)
Martijn Brugman (GSK) Medicines
Research Centre
Michael Linden (KCL/Pfizer)
Martin Pule (UCL)
Head of Clinical Development and
Operations
Manager Vector Integrations and Genome
Analysis
Break
Professor of Virology, Department of
Infectious Diseases, KCL / VP Gene
Therapy, Pfizer
Lunch
Research Department of Haematology,
Cancer Institute
Roberts Foyer
G02
Roberts G08 Sir David Davies LT
Roberts G08 Sir David Davies LT
Roberts Foyer
G02
Roberts G08 Sir David Davies LT
Roberts Foyer
G02
Roberts G08 Sir David Davies LT
9.15 - 9.45
9.45 - 10.45
10.45- 11.45
11.45 - 12.00
12.00 - 13.00
13.00 - 15.00
How to license
Current world products
Panel Q&A
Lunch
Keith McDonald (MHRA)
Anthony Lodge (CGT)
&
Regulatory Affairs Manager
Break
The course will conclude with Student posters in Roberts
Foyer G02
Roberts G08 Sir David Davies LT
Roberts Foyer
G02
05/07/2016
Tuesday
Tea & Coffee
Development of
ATMPs
Day 3
06/07/2016
Wednesday
Tea & Coffee
Production
Day 4
07/07/2016
Thursday
Tea & Coffee
Clinical Trials
Day 5
08/07/2016
Friday
Tea & Coffee
Products to market
Deputy Director of Licensing Division
Roberts Foyer
G02
Roberts G08 Sir David Davies LT
11.45 - 12.00
12.00 - 13.00
Roberts G08 Sir David Davies LT
Lunch
Simon Waddington (UCL)
Reader in Gene Transfer Technology, Inst
for Women's Health
Roberts G08 Sir David Davies LT