Pre-Conference Workshop Day
Tuesday, December 2

8:00 am Check-In & Coffee

Preclinical & Translational

Workshop A

9:00 am Deploying Assays to Demonstrate Effective Cell Depletion & Immunosuppression

  • Adil Duru Director - Business Development, Glycostem Therapeutics

Synopsis

Assays are critical for demonstrating early efficacy prior to clinical entry. With uncertainty of requirements across cell therapies and how best to measure cell depletion and immune suppression, this workshop will explore the use of cytokine release profiles and targeted biomarker assays, offering insights into selecting the right approach and outlining requirements for approval.

  • Discuss contrasting evidentiary hurdles for immunosuppression and cell depletion to streamline preclinical data packages ahead of approval
  • Highlight strategies to demonstrate Treg functionality, considering optimized release assays or assay combinations
  • Explore suppression assays and cytokine release profiles to evaluate their role as translational efficacy markers
  • Utilize targeted biomarker assays to effectively detect cell depletion and immunosuppression signatures

Clinical

Workshop B

9:00 am Designing Clinical Trials in Alignment with Efficient BLA Approval to Accelerate Therapeutic Development & Therapeutic Access

Synopsis

It is key that autoimmune patients get their therapies as fast as possible, especially those with rare autoimmune conditions that have poor prognosis. This workshop will discuss strategies to design clinical trials with BLA regulatory approval in mind, ensuring you can create an effective therapy and accelerate regulatory approval.

  • Evaluate IND timeline strategies to build towards a successful BLA approval
  • Consider patient population, number and long-term followup requirements to meet FDA standards, to demonstrate durability
  • Address key safety considerations and expectations for BLA approval
  • Highlight strategies to validate treatment mechanism of action using cytokines and T-cells
  • Discuss strategies for evidencing deep tissue depletion, considering biopsy sites in the tissues, bone marrow, lymph nodes and the impact on patient engagement

12:00 pm Lunch & Networking Break

Workshop C

1:00 pm Navigating IIT & Subsequent FDA/EMA Regulatory Pathways to Accelerate Cell Therapy Global Development

  • Ed Zhang Co-Founder & Chief Executive Officer, Overland Pharmaceuticals
  • Christopher Tehlirian Executive Medical Director, Legend Biotech
  • Timmothy Taps Head of Regulatory Strategy & Operations Senior Director, Regulatory Affairs, Century Therapeutics

Synopsis

With mounting FDA regulatory hurdles and a move towards clinical trials outside the US, this workshop explores IIT and EMA development and clinical trial pathways, with comparisons to FDA experiences, to evaluate the optimal location for therapeutic development and clinical trial execution.

  •  Compare regulatory and development challenges for the FDA and EMA, to effectively evaluate the optimal agency to initiate clinical trials 
  • Decode the EMA and IIT pathways to master cross-border compliance
  • Leverage the IIT pathway to accelerate development timelines, maintain capital, and generate reliable clinical data 
  • Investigate cross-border collaboration strategies to streamline clinical development

4:00 pm End of Pre-Conference Workshop Day

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