Accelerating Clinical Development with Expanded Access

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