Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products

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

(2022) Esteve Trias et al.   BONE MARROW TRANSPLANTATION

Is Hospital Exemption an alternative or a bridge to EMA for developing Academic CAR-T in Europe? Our experience with ARI0001.

(2021) Manel Juan et al.   HUMAN GENE THERAPY

Value-based pricing for advanced therapy medicinal products: emerging affordability solutions

(2021) Elisabete Gonçalves   European Journal of Health Economics

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

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

(2020) Allison Hills et al.   CYTOTHERAPY

Ethical development of stem-cell-based interventions

(2019) Amanda MacPherson et al.   NATURE MEDICINE

Rapid change of a cohort of 570 unproven stem cell clinics in the USA over 3 years

(2019) Paul S Knoepfler   Regenerative Medicine

Concise Review: The High Cost of High Tech Medicine: Planning Ahead for Market Access

(2017) Dawn Driscoll et al.   Stem Cells Translational Medicine

Global Distribution of Businesses Marketing Stem Cell-Based Interventions

(2016) Israel Berger et al.   Cell Stem Cell

Prices, Costs, and Affordability of New Medicines for Hepatitis C in 30 Countries: An Economic Analysis

(2016) Swathi Iyengar et al.   PLOS MEDICINE

Positioning a Scientific Community on Unproven Cellular Therapies: The 2015 International Society for Cellular Therapy Perspective

(2015) Massimo Dominici et al.   CYTOTHERAPY

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

(2014) Natividad Cuende et al.   CYTOTHERAPY

Business oriented EU human cell and tissue product legislation will adversely impact Member States’ health care systems

(2013) Jean-Paul Pirnay et al.   CELL AND TISSUE BANKING

Vaccine supply, demand, and policy: A primer

(2009) Jagannath M. Muzumdar et al.   JOURNAL OF THE AMERICAN PHARMACISTS ASSOCIATION