Pre-Conference Day

Monday 2nd October 2023

7:45 am Registration & Coffee

08:30 – 10:30am
Workshop A

Improving Regulatory & Clinical Strategies Going Forward to Pave the Way for iPSC Next Steps

  • Kapil Bharti Senior Investigator, National Institute of Health Science

Synopsis

A deep-dive session, providing insights from industry leader, Kapil Bharti, reflecting on his experience with moving to the clinic and detail learnings that

can be drawn upon as the clinical pipeline progresses

Join to:

  • Benchmark data package requirements for regulatory strategies to facilitate a successful move to IND readiness stage
  • Clarify data package requirements to secure funding for your project
  • Reflect on patient selection & clinical data to increase regulatory confidence

10:30 am Morning Break & Networking

11:30- 1:30
Workshop B

Considerations of Quality Control Strategies to Increase Confidence in Preclinical Processes and Advance Candidates to the Clinic

  • Yu Qian Associate Director, Oncology Cell Therapy Technology and Product Engine, Takeda
  • Zhonghua Liu Director of Analytical Development and QC, Vita Therapeutics

Synopsis

In this focussed session, learn how to create a more efficient analytical strategy to harmonize the initial development of stem cells to accelerate the iPSC field.

Topics to be covered:

  • What reference and control materials should we be using for our QC and potency assays?
  • Best practices for defining your endpoints for QC/potency assessments to highlight the effect on end products
  • Identifying ways QC and the manufacturing process can be commonly optimized to increase regulatory acceptance

1:30 pm Lunch Break & Networking

2.30-4.30
Workshop C

Fulfilling Funding Requirements to Accelerate iPSC Therapies to the Clinic

Synopsis

This intimate session is dedicated to exploring the mechanical, data and presentation deck expectations from investors across the investment chain from pre-seed to series A/B to manufacturing/industrial investments. This session provides an exclusive opportunity to deep-dive into all things money with expert investors in the space.

Topics to be covered:

  • Revealing the vision of the iPSC landscape from an investors perspective to understand priorities and white spaces
  • Clarifying investors’ expectations throughout the clinical pipeline
  • Reviewing cost-analyses of the iPSC production process to understand where to concentrate investments

End of Pre-Conference Workshop Day

EVENT GUIDE
DAY ONE