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Newer and highly effective orphan drugs, such as Chimeric Antigen Receptor T-Cell (CAR-T) therapies, highlight the need for alternative innovation models that can offer greater affordability and accessibility. This case study examines Hospital Cl\u00ednic Barcelona\u2019s (HCB) alternative innovation model to develop ARI-0001 (varnimcabtagene autoleucel), a novel CAR-T therapy for certain forms of leukemia, at a price two-thirds lower than comparable therapies from the pharmaceutical industry.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted background research, and performed twenty-one semi-structured interviews with HCB staff, representatives of regional Health Departments, the Spanish Ministry of Health and regulatory agency, academics, civil society and patient groups. We used a framework drawing on concepts from complex adaptive systems, incorporating the resources used (i.e., funding, knowledge, and manufacturing capacity), the practices implemented (i.e., knowledge management, access practices and transparency), and the rules and norms that shaped HCB\u2019s interactions with other actors in the system. We then identified the concept of institutional logics as well-suited to explain how HCB\u2019s model overcame various barriers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>HCB\u2019s model builds from three competing institutional logics \u2013 healthcare, academic and industrial \u2013 while also addressing each logic\u2019s weaknesses. The healthcare logic shaped HCB\u2019s affordable pricing of ARI-0001, but also posed organizational challenges. The academic logic drove HCB\u2019s willingness to share knowledge and technology with peers, but posed barriers to fund late-stage clinical trials and regulatory processes. Lastly, HCB adopted an industrial logic by identifying in-house regulatory expertise and developing partnerships for production. The hospital exemption clause, a European regulatory pathway that allows hospitals to develop and produce treatments under certain conditions, allowed HCB to span the boundaries of the three competing logics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Our findings underscore the potential of academic hospitals to develop more affordable advanced therapies, the importance of conducive regulatory frameworks, and the challenges that academic hospitals face to expand this model. Through increased regulatory and financial support to academic hospitals, strengthened coordination, and public funding with requirements for access, this model could achieve innovation with affordability in a cutting-edge technological area.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13023-026-04320-7","type":"journal-article","created":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T12:44:21Z","timestamp":1775825061000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Increasing access to CAR-T therapy: a case study of an academic hospital\u2019s alternative innovation model"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8670-0096","authenticated-orcid":false,"given":"Adri\u00e1n Alonso","family":"Ruiz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika","family":"Shinabargar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iulia","family":"Slovenski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaitlin","family":"Large","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcela","family":"Vieira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suerie","family":"Moon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,4,10]]},"reference":[{"issue":"6","key":"4320_CR1","doi-asserted-by":"publisher","first-page":"359","DOI":"10.1038\/s41571-023-00754-1","volume":"20","author":"KM Cappell","year":"2023","unstructured":"Cappell KM, Kochenderfer JN. 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