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
This webinar is for professionals in clinical development, regulatory, medical affairs, clinical operations, and program management in pharma and biotech, working on products to treat serious conditions in areas such as rare disease, oncology, infectious disease, and neurology.