EOAR SEMINAR, JUNE 2024
THE LIMITS OF REGULATORY PHARMACEUTICALI-SATION? GLOBAL DEVELOPMENTS SUPPORTING CLINICAL INNOVATION WITH ADVANCED THERAPIES
Dr Michael Morrison (Faculty of Law, University of Oxford)
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Advanced therapies, including (stem) cell and tissue-based medicines, are typically envisaged as medicinal products whose development is best left to the private sector. This is reinforced by regulatory frameworks that treat advanced therapies as a specialised form of pharmaceuticals, requiring market authorisation and approval prior to use, and by widespread concern about the dangers of unproven cell therapies offered by unscrupulous clinics. However, commercially available advanced therapies are often expensive and target a narrow range of conditions. In this presentation I will review a range of alternative pathways for (stem) cell therapies from around world and examine the case for clinically-led innovation in this field.
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When: Tuesday, 11th June 2024, 5:30-6:30 PM (ACST)
Where: Online. Please RSVP to openstemcells@adelaide.edu.au
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Dr Michael Morrison is a Senior Researcher in Social Science in the Faculty of Law at the University of Oxford. Michael has recently acted as Principal Investigator on the ESRC-funded project 'Biomodifying technologies and experimental space’ (2017-2020) and its 'sister' project 'BioGov: Governing biomodification in the life sciences'. Both projects involved collaboration between researchers from the Universities of Oxford, Sussex and York to examine three 'gateway technologies’ with wide-ranging applications in medicine and the life sciences; gene editing, induced pluripotent stem cells, and 3D printing of living material.