As the number of FDA-approved advanced therapies continues to rise—and with more patients becoming eligible for these innovative treatments—ensuring their safe and efficient distribution is paramount. This session will highlight the distinct operational and compliance considerations that both pharmacy and cell therapy labs bring to managing advanced therapies, while underscoring the critical role AABB Standards play in preserving product integrity, patient safety, and quality assurance.

Attendees will gain insights into how pharmacies approach the storage, handling, and dispensing of biotherapies, focusing on challenges such as cold-chain logistics, precise documentation, and seamless communication with clinical teams. In turn, experts from cell therapy labs will share their unique approach to addressing similar tasks within specialized, tightly controlled environments that emphasize chain of custody, product traceability, and working with stringent manufacturing and administration timelines.

Drawing on real-world examples, this session will offer actionable guidance on applying AABB Standards to address the regulatory, logistical, and clinical complexities that arise when providing advanced therapies. Attendees will learn strategies for identifying risks, fostering collaboration between diverse stakeholders, and building robust quality and safety systems that support optimal patient outcomes. By the conclusion of this session, participants will be equipped with valuable tools and knowledge to navigate the evolving landscape of advanced therapy distribution, ensuring the highest standards of safety, efficacy, and patient care.

Kimberly Villar MLS(ASCP), CLS

Manager, Quality Assurance & Regulatory Compliance, UC San Diego Health Stem Cell Processing Laboratory

Appearances