Think Lab Roundtables: Defining Durable Tolerance & Building Regulatory Pathways to Approval

This interactive Think Lab Roundtable will bring together attendees to exchange perspectives and identify practical strategies for improving durability assessment and regulatory alignment.

Think Lab Roundtable: Durable Immune Tolerance Therapies

Analyzing Long-Term Follow-Up Data & Distinguishing Durable Tolerogenic Signals from Therapies that May Require Redosing to Explore How Durability Data Could Shape Future Trial & Retreatment Design

• Reviewing the long-term follow-up data available across current antigen-specific approaches, to assess how consistently a tolerogenic effect is maintained beyond the initial treatment period
• Comparing single-dose and repeat-dosing strategies
• Considering how longer-term patient monitoring could shape expectations around retreatment to inform how future trials are designed to capture durability

Think Lab Roundtable: Aligning on FDA Guidance

Initiating Early FDA Engagement & Aligning on Endpoints Regulators Need to See to Reduce Late-Stage Surprises & Accelerate the Path to Market

• Learn how to initiate dialogue with the FDA during Phase I to align on Phase II and Phase III endpoints, ensuring you’re measuring what regulators need for approval
• Understand which clinical endpoints demonstrate disease modification versus symptomatic relief, and how to design trials that prove durable tolerance
• Discover why early-stage FDA engagement prevents costly late-stage surprises and accelerates the path to market