Cell and gene therapy is an emerging field in healthcare demonstrating promising results to treat and potentially cure serious, life-threatening conditions. Under the FDA Cures Act, a regenerative medicine therapy, including cell and gene therapy, can receive a regenerative medicine advanced therapy (RMAT) designation, which accelerates their FDA approval timeline. However, while there is excitement about the potential approval of more cell and gene therapies within the next few years, stakeholders are concerned about the high upfront costs of these therapies and extremely limited evidence of their long-term value. In addition, many cell and gene therapies will be launched based on the results of single-arm Phase 1 or 2 trials with small sample sizes targeting rare diseases. This may introduce additional uncertainties for policymakers and payers when assessing the value of these therapies and making reimbursement decisions. In light of this landscape, this education symposium aims to introduce attendees to the common considerations when valuing and pricing cell and gene therapies, as well as those concerning reimbursement access. The presenters will discuss potential approaches to assess the value of cell and gene therapies and facilitate a discussion of how to prepare the healthcare system for the coming wave of potentially curative medicine from the perspectives of policymakers, clinicians, and payers.