Management Strategies for Advanced Therapy Medicinal Product Services: Integrating Hospital Administration, Business Models, and Regulatory Frameworks.

Abstract

Advanced Therapy Medicinal Products (ATMPs) including  gene therapies, somatic cell therapies, and tissue-engineered products represent a transformative frontier in regenerative medicine. However, their clinical integration poses unprecedented managerial challenges across hospital administration, financing, and regulatory compliance. This narrative review synthesizes evidence identified through a structured literature search of PubMed, Scopus, and Web of Science databases, supplemented by relevant regulatory and policy documents. Publications addressing ATMP management, reimbursement, regulatory frameworks, and service delivery models were screened and selected based on their relevance to the review objectives. We examine operational workflows and infrastructure requirements for hospital-based ATMP programs, analyze evolving business models including value-based pricing and managed entry agreements, and compare regulatory frameworks across the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and emerging jurisdictions such as Indonesia’s BPOM. Case studies of CAR T-cell therapy implementation and hub-and-spoke organizational models illustrate practical pathways. A conceptual framework integrating clinical, business, and regulatory domains is proposed. Key insights include the necessity of centralized GMP infrastructure, multi-stakeholder reimbursement innovation, and adaptive regulatory pathways to balance patient access with sustainability. Recommendations emphasize early health technology assessment engagement, performance-based contracting, and international harmonization efforts to support scalable and equitable ATMP service delivery.