Assessing Challenges in Existing Regulatory Frameworks for Rare Diseases to Facilitate CDx Approval Across Diverse Therapeutic Domains & Navigating the Complex Landscape of Diagnostics in Gene Therapies
Time: 9:00 am
day: day 2
Details:
- What are the critical challenges associated with obtaining patient samples for rare diseases to meet the validation requirements for regulatory approval?
- Navigating innovative approaches in overcoming evidentiary hurdles specific to rare diseases within the CDx regulatory framework- a shift from oncology, evolving global regulatory landscape, decision on centralized versus point of care testing
- Analysing the complex nature of companion diagnostics in rare diseases, for e.g., gene therapy space to support accelerated approvals, increased need for patient testing in certain indications
- Reimbursement challenges for CDx in rare disease setting
