Fireside Chat: Exploring the Potential Opportunities & Risks of Expanded Access for Cell & Gene Therapies
Time: 3:30 pm
day: Conf Day One
Details:
- Is it appropriate to consider cell and gene therapies in the same or similar to drugs and biologics?
- When is the right time to provide expanded access for cell and gene therapies?
- What are the specific considerations related to expanded access for these modalities, including cost, supply chain logistics and drug availability?
- What are the potential risks of providing expanded access for single dose treatments, such as impact on addressable commercial market and reimbursement challenges for these costly therapies?
- How do issues of immunogenicity factor into patient decisions to pursue pre-approval access for cell and gene therapies?
