29 - 31 October, 2019 | Twickenham Stadium, London, United Kingdom

Conference Day 2

8:30 am - 8:55 am Registration and Coffee

8:55 am - 9:00 am Pharma IQ Welcome Address

9:00 am - 9:10 am Chairman's Summary of Day 1

- Recap of the current industry paradigm: Where are we now and where do we want to be in the next five years?
- Discuss the need for cross-boarder and crosscompany collaboration to drive therapy commercialisation
- Examine the reality of achieving CMO – sponsor harmonisation: How realistic is this given the industry fragmentation?
- Identify the critical success factors in building industry capability and collaboration and how this can be translated into process optimisation for efficient therapeutic development
Matthew Cobb, Clinical Account Manager at Miltenyi Biotech

Matthew Cobb

Clinical Account Manager
Miltenyi Biotech

Stuart Curbishley, Group Lead, Midlands and Wales Advanced Therapy Treatment Program & head of Business and Project Development, Advanced Therapies at University of Birmingham

Stuart Curbishley

Group Lead, Midlands and Wales Advanced Therapy Treatment Program & head of Business and Project Development, Advanced Therapies
University of Birmingham

Stephen Elliman, Chief Scientific Officer at Orbsen Therapeutics Limited

Stephen Elliman

Chief Scientific Officer
Orbsen Therapeutics Limited

9:45 am - 10:20 am Manufacturing Of TCR-Based T-Cell Therapies For Solid Cancers To Enable Late Stage Clinical Trials

- Hear how Immatics proprietary discovery platforms, XPRESIDENT® and XCEPTOR®, identifies the targets and TCRs that are used as the basis of the various Immatics adoptive cell therapy programs
- Examine the development of autologous and allogeneic T-cell products for solid cancers using Immatics targets and TCRs
- Discuss the products that have been developed and manufactured under cGMP conditions to meet the pre-set release criteria for patient infusion of the Immatics 4 active Phase I clinical trials
- Develop the next generation of manufacturing processes for implementation in late stage clinical trials and commercialisation
Zoe Coughlin, Associate Director CMC at Immatics

Zoe Coughlin

Associate Director CMC
Immatics

10:20 am - 10:55 am Scaling Up Or Scaling Out: How Oxford Biomedica Ensured Their Manufacturing Process Was Market Ready

- Examine how Oxford BioMedica performed a gap analysis to identify critical areas of development for their manufacturing strategy to meet market demand
- Hear how Oxford BioMedica assessed market requirements and current manufacturing capabilities to assist in identifying whether to scale up or scale out their manufacturing process.
- Discuss the ramifications of selecting a scale up or scale out approach: How Oxford BioMedica managed this transition to minimise process disruption and delay
Lee Davies, Director, Process R&D at Oxford BioMedica

Lee Davies

Director, Process R&D
Oxford BioMedica

10:55 am - 11:25 am Morning Coffee Break

11:25 am - 12:00 pm Ensuring Scalability Of T-Cell Therapy Manufacturing Processes: A Gammadelta Therapeutics Case Study

- Identify the key challenges and inherent process limitations when moving from academia to manufacturing
- Develop a scalable manufacturing process for efficient autologous production at scale
- Ensure successful bridging to GMP suitable materials when building large scale production processes
Louisa Mathias, Group Lead, Process Development and Manufacturing at GammaDelta Therapeutics

Louisa Mathias

Group Lead, Process Development and Manufacturing
GammaDelta Therapeutics

12:00 pm - 12:35 pm Delivering Curative Gene Therapies To Patients Through Integrated Manufacturing And Supply Chain Operations

- Examine the promise and challenges of ex-vivo autologous gene therapy
- Discuss strategies to translate academic excellence to industrialised medicine
- Build an integrated manufacturing and supply chain model to increase process efficiency
Ran Zheng, Chief Technical Officer at Orchard Therapeutics

Ran Zheng

Chief Technical Officer
Orchard Therapeutics

12:35 pm - 1:10 pm Identifying The Value Of Collaboration In Achieving Scalable Manufacturing Processes

- Discuss the rise of ‘clusters’, innovation hubs and centres for excellence in promoting CGT industry development
- Examine how collaborative relationships can generate reliable process insights and help to drive efficient manufacturing process development
- Identify industry trends in manufacturing technology adoption and how these adoption pathways can generate scalable manufacturing capacity
Qasim Rafiq, Associate Professor, Bioprocessing of Regenerative, Cellular and Gene Therapies at UCL

Qasim Rafiq

Associate Professor, Bioprocessing of Regenerative, Cellular and Gene Therapies
UCL

1:10 pm - 2:10 pm Networking Lunch

2:10 pm - 2:45 pm Optimising Your Process Lifecycle Management To Support Efficient Transition Towards Commercialisation

- Map out the critical steps to building a compliant and flexible process lifecycle strategy
- Discuss how to translate your lifecycle management strategy into a compliant filing and reporting structure to enable the commercial approval process
- Examine lessons learned from the approval of Kymriah and where Novartis is looking to implement future process developments
Simon Briggs, Product Steward, Cell and Gene Therapy Unit - Kymriah, C&G Technical Operations at Novartis

Simon Briggs

Product Steward, Cell and Gene Therapy Unit - Kymriah, C&G Technical Operations
Novartis

- Discuss the Cost of Goods (COGs) pressure on SME manufacturing processes, and where outsourcing fits into the cost-efficiency equation
- Examine the risks to outsourcing ATMP-based manufacturing processes, particularly pertaining to extractables and leachables, process compatibility and regulatory compliance
- Analyse the management of external partners and CMOs across the product development lifecycle to ensure alignment from early stage development through to commercialisation
Stuart Curbishley, Group Lead, Midlands and Wales Advanced Therapy Treatment Program & head of Business and Project Development, Advanced Therapies at University of Birmingham

Stuart Curbishley

Group Lead, Midlands and Wales Advanced Therapy Treatment Program & head of Business and Project Development, Advanced Therapies
University of Birmingham

3:20 pm - 4:00 pm TECHNOLOGY SPOTLIGHT: Scalability Strategy and Implementation Dragon's Lair

4:00 pm - 4:15 pm Chairman's Closing Address

4:15 pm - 4:45 pm Afternoon Closing Coffee Break