The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001

Point-Of-Care CAR T-Cell Production (ARI-0001) Using a Closed Semi-automatic Bioreactor: Experience From an Academic Phase I Clinical Trial

(2020) Maria Castella et al.   Frontiers in Immunology

Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries

(2020) Delphi G.M. Coppens et al.   CYTOTHERAPY

Evolving therapy of adult acute lymphoblastic leukemia: state-of-the-art treatment and future directions

(2020) Bachar Samra et al.   Journal of Hematology & Oncology

An assessment of the hospital exemption landscape across European Member States: regulatory frameworks, use and impact

(2020) Allison Hills et al.   CYTOTHERAPY

CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19+ Relapsed/Refractory Malignancies

(2020) Valentín Ortíz-Maldonado et al.   MOLECULAR THERAPY

Clinical trials of dual-target CAR T cells, donor-derived CAR T cells, and universal CAR T cells for acute lymphoid leukemia

(2019) Juanjuan Zhao et al.   Journal of Hematology & Oncology

Innovation and competition in advanced therapy medicinal products

(2019) Enrique Seoane‐Vazquez et al.   EMBO Molecular Medicine

Chimeric Antigen Receptor Therapy

(2018) Carl H. June et al.   NEW ENGLAND JOURNAL OF MEDICINE

Development of a Novel Anti-CD19 Chimeric Antigen Receptor: A Paradigm for an Affordable CAR T Cell Production at Academic Institutions

(2018) Maria Castella et al.   Molecular Therapy-Methods & Clinical Development

Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia

(2017) Hagop Kantarjian et al.   NEW ENGLAND JOURNAL OF MEDICINE

Acute lymphoblastic leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

(2016) D. Hoelzer et al.   ANNALS OF ONCOLOGY

Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia

(2016) Hagop M. Kantarjian et al.   NEW ENGLAND JOURNAL OF MEDICINE

Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States

(2016) Tatjana Ivaskiene et al.   Current Stem Cell Research & Therapy

The puzzling situation of hospital exemption for advanced therapy medicinal products in Europe and stakeholders' concerns

(2014) Natividad Cuende et al.   CYTOTHERAPY

Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis

(2012) Philippe Van Wilder   Frontiers in Pharmacology