Why GAO did this study. The field of regenerative medicine and advanced therapies—including cell, gene, and tissue-based therapies—is evolving and interdisciplinary. Practitioners believe these therapies have the potential to revolutionize patient care and improve lives. The promise of such therapies to ameliorate, or cure, previously untreatable diseases and conditions depends, in part, on the existence of a robust, well-trained workforce. The Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies (TRANSPLANT) Act of 2021 included a provision for GAO to study the regenerative medicine and advanced therapies workforce in the commercial and academic sectors. This report provides information on (1) the makeup of this workforce, (2) education and training for this workforce, and (3) current and future workforce and education and training needs. GAO interviewed officials from the Department of Health and Human Services (HHS), and eight stakeholder organizations selected for representation across the occupational areas GAO identified for this work, as well as other criteria. GAO also reviewed related reports and job postings. Existing workforce and education data do not contain information specific to the regenerative medicine workforce. To quantify the number of stakeholders who made certain statements, “some” means two to four stakeholders and “many” means five to seven stakeholders.
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