Pre-Conference Workshop Day
Workshop A - 9:00 am - 12:00 pm
9:00 am Streamlining Patient Selection & Clinical Trial Design to Overcome Disease Heterogeneity in Autoimmunity
Synopsis
With the B and T cell industry improving on broad lineage depletion in autoimmunity, there is a need to align patient selection, recruitment and trial design with more targeted drug development strategies. Key considerations are required to overcome indication-specific heterogeneity whilst maintaining patient centricity when progressing the next wave of targeted tissue and antigen-specific therapeutics through a clinical setting.
This workshop will cover:
- Highlighting lessons learnt from oncology to streamline Phase 1 clinical trials in autoimmunity and limit off-target safety effects in healthy volunteers
- Understanding operational and logistical bottlenecks for patient recruitment in autoimmunity to ensure effective patient stratification
- Applying key precision medicine technologies to facilitate clinical biomarker identification and generate reliable clinical efficacy
- Streamlining sample collection to aid pharmacodynamic studies and move towards real time clinical sample analysis
- Bolstering clinical trial design to move towards robust clinical endpoints in autoimmunity
Workshop B - 1:00 pm- 4:00 pm
1:00 pm Looking Beyond Autoantibodies: Understanding Key Takeaways from B Cell-Directed Therapies to Inform Drug Development in Autoimmunity
Synopsis
Considerable progress has been made in the application of CD19 and CD20 B cell depletion therapies, demonstrating significant clinical efficacy in autoimmune conditions where B cells and autoantibodies play a significant role in the development of the disease. However, there remains a considerable knowledge gap concerning how to achieve maximum clinical efficacy in indications where factors other than pathogenic antibodies also contribute to disease. Through analyzing clinical precedents and setbacks, valuable insights into disease biology where pathogenic antibodies are not the primary drivers of the disease can be gained. Capitalizing on these learnings can offer a guide to drug development strategies with the goal of attaining broader therapeutic efficacy across diverse patient populations.
This workshop will cover:
- Assessing clinical data from B-cell directed therapies to propose mechanisms that break down disease pathology in autoantibody independent indications
- Comparing anti-FcRn and rituximab data to evaluate the role of T cell-directed therapies in autoimmunity
- Evaluating key therapeutic approaches that target B cell maturation, depletion & differentiation and assess their potential to achieve broader therapeutic efficacy in autoimmune patient populations