13 - 15 November, 2018 | Hilton London Kensington, 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

9:10 am - 9:50 am It May Sound Crazy But… Addressing Scalability at the Beginning NOT the End

Lior Raviv - Vice President Of Development Pluristem Therapeutics
  • Conduct a cost-benefit analysis of the differences between proactive automation for scale and reactive scalability
  • Create a manufacturing process that is flexible enough to deliver lean production across pre-clinical and clinical development
  • Adopt best-in-class technology to assist in in-house manufacturing rather than outsourcing your production
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Lior Raviv

Vice President Of Development
Pluristem Therapeutics

9:50 am - 10:30 am Ensuring a Robust and Flexible Development Pathway for Cell Therapeutics Through Process Automation

Fabio Fachin - VP, Cell Therapy Manufacturing Torque Therapeutics
  • Discuss the common roadblocks and bottlenecks associated with cell therapy development and manufacture
  • Examine the role of automation and technology adoption in Torque’s development of Deep-Prime immune cell therapeutics
  • Analyse the costs and benefits associated with process automation – how to decide where to automate to see the greatest production gains
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Fabio Fachin

VP, Cell Therapy Manufacturing
Torque Therapeutics

10:30 am - 11:10 am Data Utilization Strategy for Successful Manufacturing and Commercialization

Simon Briggs - Product Steward, Cell and Gene Therapy Unit - Kymriah, C&G Technical Operations Novartis - Pending Final Confirmation
 - Discuss the realities of data trending in the cell and gene industry;
 - Examine expectations around process data and the move towards commercialization; 
 - Map key considerations for data to generate proactive product insight and stay ahead of your development timeline
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Simon Briggs

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

11:10 am - 11:40 am Morning Coffee Break

11:40 am - 12:20 pm Case Study: Optimising Manufacturing Opportunities for Allogenic Production

Andrew Finnerty - General Manager Centre for Cell Manufacture Ireland (CCMI)
  • Analyse how to ensure sterility and non-contamination for large scale production
  • Discuss the most efficient methodology to produce “off the shelf” industrial product
  • Examine the current regulatory aspects that need to be considered when moving towards standardised production
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Andrew Finnerty

General Manager
Centre for Cell Manufacture Ireland (CCMI)

12:20 pm - 1:00 pm Managing Cost Of Goods in Cell Therapy for Large Scale Orthopaedic Indications

Anne-Sophie Lebrun - PhD Production Associate Director Bone Therapeutics
  • Approach your COGs as a driver for excellence, not a limitation to development
  • Discuss strategies to shorten the timeline to generating product on a large scale
  • Using a COGs analysis as a means of deciding manufacturing strategy and avoiding unexpected costs when scaling towards commercialisation
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Anne-Sophie Lebrun

PhD Production Associate Director
Bone Therapeutics

1:00 pm - 2:00 pm Networking Lunch

2:00 pm - 2:40 pm Interactive Roundtable Discussions

Choose from 3 different round table discussions to participate in and exchange industry best practice to drive your development forward

Roundtable 1: Cost of Goods Optimisation Strategies – where can you invest to generate return?

Roundtable 2: Creating and Managing a Logistics Strategy to Satisfy the Unique Requirements for Cell and Gene Therapy Products

Roundtable 3: Effective therapy manufacturing through the move to product standardisation


2:40 pm - 3:20 pm A Cause and Effect Analysis: Balancing Your Quality of Materials and Cost of Goods

Carol Knevelman - Head of Process Development Oxford BioMedica
  • Define the practical difference between fit for purpose and GMP compliant raw and starting materials
  • Discuss how to balance the cost of goods analysis and the process requirements to streamline your development process and minimise waste
  • Analyse where GMP compliant materials are absolutely necessary to continued development - and where you can look to optimise your cost of goods in investing in high quality materials
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Carol Knevelman

Head of Process Development
Oxford BioMedica

3:20 pm - 3:50 pm Afternoon Coffee Break

3:50 pm - 4:30 pm ATMP Process Development and Optimisation Using Multi-parameter Combinatorial Screening

Yen Choo - CEO and Executive Chairman Plasticell and Progenitor Labs
• Combinatorial screening of diverse variables in process development for optimisation of cell and gene therapies
• Expansion of hematopoietic stem cells for allogeneic autologous and allogeneic transplantation
• Enhancement of viral transduction efficiency for autologous gene therapy to treat rare diseases    

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Yen Choo

CEO and Executive Chairman
Plasticell and Progenitor Labs

Facilitated by the event chair, use this last opportunity to engage with our presenters and audience and ask those
questions you’re still seeking answers to. Based on prior sessions our chairman will also recap the key topic areas of this
year’s forum and take away learnings to make sure you’re driving your therapeutic development forward while we wait
for next year’s summit!
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David Sourdive

Executive Vice President Technical Operations
Cellectis

4:50 pm - 5:00 pm Chairman's Closing Address