Expanded Access can be leveraged to advance and even accelerate clinical development of treatments for serious or life-threatening conditions. For example, an appropriately executed Expanded Access program can gather early data that can help plan a label expansion, accelerate a pediatric development plan, or gather real-world data useful for post-approval pricing and reimbursement.

Focusing on strategic considerations for a product development program, this webinar will discuss the following:

• Regulatory framework and processes for Expanded Access
• Sponsor support for Individual Patient Expanded Access and Emergency Use
• Execution of studies under treatment protocols or treatment INDs
• Therapeutic area considerations
• Regulatory utility of clinical data generated by Expanded Access programs
• Myths about Expanded Access