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

  • 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

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

  • 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

10:30 am - 11:10 am Securing your Commercialisation Strategy through Data Utilisation

  • Look at the realities of data trending in the cell and gene industry: how can data secure your development?
  • Discuss expectations around product data for the move towards commercialisation
  • Analyse how you can utilise your data to generate proactive product insight and stay ahead of your development timeline

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

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

  • 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

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

  • 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

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

  • 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

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

3:50 pm - 4:30 pm The Differences Between US and EU Regulatory Landscapes through the Lens of Building an iPSC Master Cell Bank

  • Examine the current regulatory landscape for ATMPs and where our regulatory framework is falling short
  • Discuss the realities and key differences of building an iPSC Master Cell Bank under the European and US landscape
  • Challenge the existing framework; where do we need to be looking for additional help and guidance from regulators and how can we try to standardise our global approach

4:30 pm - 5:00 pm Summative Panel Discussion

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!

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