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 - 9:45 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

9:45 am - 10:25 am Case Study: Development Of TCR Based T Cell Therapies For Solid Cancers

Ali Mohamed - VP - CMC, Immatics

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Ali Mohamed

VP - CMC
Immatics

 - 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

11:00 am - 11:30 am Morning Coffee Break

11:30 am - 12:10 pm Case Study: Optimising Manufacturing Opportunities for Allogenic Production

David Sourdive - Executive Vice President Technical Operations, Cellectis
  • 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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David Sourdive

Executive Vice President Technical Operations
Cellectis

12:10 pm - 12:45 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

12:45 pm - 1:45 pm Networking Lunch

1:45 pm - 2:20 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


2:20 pm - 3:00 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

3:00 pm - 3:30 pm Afternoon Coffee Break

3:30 pm - 4:10 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

4:10 pm - 4:50 pm Addressing the ATMP Challenges; A UK Biopharmaceutical Industry Perspective

Bryan Deane - Head of Production and Process Innovation, ABPI
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Bryan Deane

Head of Production and Process Innovation
ABPI

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