The FACT initiatives highlighted in this newsletter demonstrate a continued commitment to advancing quality and progress in cellular therapy. When FACT was formed 20 years ago, its founders were pioneering the inclusion of quality principles and peer-to-peer accreditation in cellular therapy. Their efforts expanded access to transplant, protected transplant from over-regulation, and improved processes to promote good patient outcomes.
This year, we have seen an inflection point in cellular therapy and FACT is leading efforts to take our abilities to the next level:
- Clinical Programs now have increased guidance to evaluate one-year survival and take action when it does not meet expectations.
- FACT’s focus on data management has evolved into a continuous improvement process to build upon findings during CIBMTR audits.
- Transplant centers and hematology/oncology departments will soon have peer-developed Standards to guide their immune effector cell programs.
- Our voices have been heard by the U.S. Food and Drug Administration and several collaborative societal initiatives.
- FACT Consulting Services meets the needs of cellular therapy organizations that desire a higher level of assistance.
- New specialties, such as cardiology, are beginning to see the benefits of a culture of quality.
- Underserved regions, such as Latin America, are poised to meet our Standards.
This is an exciting time to be a part of FACT, and we hope everyone who has participated on a FACT committee, served as a FACT inspector, prepared an organization for FACT inspection, and complied with FACT Standards is proud to be a part of our enduring but growing movement. The world is watching us, and we are honored to play a part in improving the lives of our patients.
Dennis Gastineau, MD