Global evaluation of cellular therapy processing facility medical director and laboratory director training: The BEST...

Cell processing facility accreditation requires Medical Directors and Laboratory Directors, but formal training pathways are not systematically delineated. This study provides information on cell processing facility Medical Directors and Laboratory Directors' role-specific education (RSE) worldwide.

Data collected on cell processing facilities included country, staff, regulatory and accreditation status, institutional affiliation, cellular therapy product types, and volume. Questions regarding Medical Directors included country, clinical specialty and subspecialty, year completed, and formal RSE. Laboratory Director questions included country and training focus, year completed, and formal RSE.

Surveys completed (n = 123) included Medical Directors (n = 70) and Laboratory Directors (n = 71) across 30 countries over 6 continents. Medical Directors reported 101 clinical specialties, and 72 clinical subspecialties, of which 34 (33.3%) and 39 (54.2%) included RSE, respectively. Laboratory Directors (n = 71) held MD (n = 20), PhD (n = 34), MD/PhD (n = 7), or other (n = 11) academic degrees. Laboratory Directors with MDs completed 42 clinical specialties and 27 clinical subspecialties, 15 (35.8%) and 13 (48.1%) of which included RSE, respectively. Six of 52 (11.5%) Laboratory Directors with graduate or other academic degrees (n = 52) included RSE. Role-specific educational experiences varied highly across all training programs. Notably, most responses for any given role and educational activity indicated no experience at all.

Standardized role-specific educational programs for cell processing facility Medical Directors and Laboratory Directors are lacking and, when present, are highly variable. Coordinated development of educational content and reciprocally acknowledged curricula and certificates could help standardize training for future cell processing facility leaders.