Cell Therapy Manufacturing: Getting it Right From the Start

4-6 March 2014

Cell Therapy Catapult, Guy’s Hospital, London 

£495* per delegate*plus VAT

A 3 day training course by amc/Cell Therapy Catapult/UCL Biochemical Engineering

This course is designed for cell therapy professionals from both industry and academia, currently involved in cell therapy research, process development and early manufacture, whose passion is to develop commercially viable cell therapy products.

The course objective is to challenge delegates to think about the commercial product, market, and process from the outset and to use that information to inform the process development and manufacturing strategy for clinical trials.

This will be achieved through lectures from a wide range of experienced, successful, international industrialists building on a solid framework of regulatory requirements. The experience gained will be put to use in developing case study processes and understanding how these processes relate to cost of goods models and what factors most impact the cost of goods.

A final presentation to the panel of industrialists with feedback will round off the training course experience.

The training course is CPD accredited by the UCL MBI® Programme and the Institute of Biology.

Download the flyer here.

Agenda

Day 1 Commercialisation challenges Speakers

08:30 Registration and coffee

08:50 Welcome Chris Mason, Chair of Regenerative Medicine Bioprocessing, UCL

09:00 Agenda Angela Osborne, Managing Director, eXmoor Pharma, AMC

09:10 Achieving commercial success with cell therapies

Geoff Mackay, President and Chief Executive Officer,

Organogenesis

10:00 Implications of Auto vs Allo therapies Maria Pascual, VP of Regulatory Affairs and Corporate QA, TiGenix

10:50 Coffee

11:10 Regulatory pathway: ph 1 to commercial EU Regulatory authority invited

12:00 Regulatory pathway: differences between US and EU

Robert Deans Executive Vice President, Regenerative Medicine,

Athersys

12:50 Designing and running clinical trials for cell therapies Natalie Mount, Chief Clinical Officer, Cell Therapy Catapult

13:30 Lunch

14:15 - 17:00

Case study 1 develop process and cost of goods for a Led by Suzanne Farid, Farlan Veraitch and Ivan Wall,

phase I/II product UCL Department of Biochemical Engineering

17:30 Travel to KCH for evening wine reception and KCH tour

Day 2 Manufacturing experience Speakers

09:00 Review of day 1 and agenda day 2 Stephen Ward, Chief Operating Officer, Cell Therapy Catapult

09:20 Impact on manufacturing strategy of build/buy decisions for

Gregg Sando, Chief Executive Officer, Cell Medica

early phase trials

10:10 Phase I/II manufacturing experience Dave Smith, Head of Lonza Biosciences Clinical Services, Lonza

11:00 Coffee

Mark Lowdell, Director of Cellular Therapy & Biobanking

11:20 Phase I/II manufacturing experience at Royal Free Hampstead NHS Trust Assistant Professor/Senior

Lecturer, Haematology, UCL

12:10 Phase III/commercial manufacturing experience Geoff Mackay, President and Chief Executive Officer, Organogenesis

13:00 Lunch

13:45 Case study 2 develop process and cost of goods for a

Led by Angela Osborne, eXmoor Pharma and Lucy Foley, CPI

commercial product

16:30 Lessons learnt and revisit case study 1

18:00 Conference dinner, UCL

Day 3 Manufacturing challenges Speakers

09:00 Review of day 2 and agenda day 3 Chris Mason, Chair of Regenerative Medicine Bioprocessing, UCL

09:20 Process validation

Kim Warren, Head of Research and Development, Cell Therapy,

Lonza

10:10 Practical experience of storage and distribution

Kevin Price, Regional Manufacturing and Operational Improvement

Manager, NHS Blood and Transplant

11:00 Coffee

11:20 Opportunities to extend shelf life of cell therapies

Aby Matthew, Senior Vice President & Chief Technology Officer,

Biolife Solutions

12:10 Market access for cell therapies: opportunities and challenges

Panos Kefalos, Senior Business Development – Healthcare,

Cell Therapy Catapult

13:00 Lunch

13:45 Finalise case studies 1 and 2 and develop presentations

15:30 Present back to panel

16:30 Feedback and close

Page last modified on 28 jan 14 15:25