Cell and Gene Therapy Manufacturing – Getting it Right From the Start

The objective of this workshop 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 and routine manufacture.

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.

AGENDA

Day 1

Cell therapy

09:50

Welcome

Stephen Ward
Cell and Gene Therapy Catapult

10:00

Industry keynote

Sven Kili
GlaxoSmithKline

11:00

Cell therapy fundamentals

Ivan Wall
University College London

12:00

Process diagnostics – reducing cost and increasing quality into an autologous cell therapy

Ryan McCoy
Cell and Gene Therapy Catapult

12:30

Lunch

13:20

Allogeneic cell therapy bioprocessing

Sharon Grimster
ReNeuron

14:10

Uh oh, my process doesn’t work anymore! What do I do? An autologous cell therapy case study

Jerrod Denham
Dark Horse Consulting

15:00

Break

15:30

Case study 1

Developing the process and cost of goods for a commercial allogeneic cell therapy product

Suzanne Farid
University College London

17:30

Close

 

Day 2

Gene therapy

08:50

Welcome day 2

 

09:00

Gene therapy fundamentals

Steven Howe
GlaxoSmithKline

10:00

Equipment development to support the cell and gene therapy industry

Phil Vanek
GE Healthcare

11:00

Break

11:30

Setting up a commercial gene therapy manufacturing business

James Christie
MeiraGTx

12:30

Lunch

13:30

Towards large scale production of viral vectors

Amanda Weiss
NightstaRx

14:30

Challenges in viral vector manufacturing and commercialisation

Madhu Sachidananda
Cranfield University

15:30

Break

16:00

Case study 2

Manufacturing challenges and CoGs for an ex vivo gene therapy product

Angela Osborne and Lucy Foley

Advanced Therapy Medicinal Products Manufacturing Community

18:00

Close

 

Day 3

Cell and gene therapy enablers

08:50

Welcome day 3

 

09:00

CMC and quality challenges

Alexis Cockroft
GlaxoSmithKline

10:00

Analytical challenges for cell and gene therapy

Damian Marshall
Cell and Gene Therapy Catapult

11:00

Break

11:30

Reimbursement considerations for ATMPs

Panos Kefalas
Cell and Gene Therapy Catapult

12:30

Supply chain management

Simon Ellison
Fisher BioServices

13:30

Lunch

14:30

Case study 3

Dragons den

Stephen Ward and Damian Marshall

Cell and Gene Therapy Catapult

16:30

Workshop closes

 

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