Designing Clinical Trials in Alignment with Efficient BLA Approval to Accelerate Therapeutic Development & Therapeutic Access
Time: 9:00 am
day: Pre-Conference Workshop Day Teal Track P1
Details:
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
Speakers:
