Webinar Reminder: Alternative Pathways for Patient Access to Advanced Therapies
Dear colleagues,
Please find enclosed an invitation to the next webinar of the Global Pharmaceuticals and Society Studies (GPSS) network taking place the 23rd of April at 15:00 CET / 1400 BST / 900 EST
The topic: Alternative Pathways for Patient Access to Advanced Therapies (see more in the invite and below)
Registration: https://vive.nemtilmeld.dk/122/
A zoom-link will be sent to all who register just before the webinar.
Hope to see many of you and feel free to share the invitation with others in your network who might be interested in joining.
Conor Douglas Associate Professor Department of Science, Technology & Society, Faculty of Science 307 Bethune College |York University | 4700 Keele St. | Toronto ON, Canada M3J 1P3 Tel: 416.736.2100 extension 30104 | cd512@yorku.ca | https://www.yorku.ca/science/profiles/faculty/conor-douglas/ Project Leader - Social Pharmaceutical Innovation: https://www.socialpharmaceuticalinnovation.org/
Join us for this webinar arranged by the Global Pharmaceuticals and Society Studies (GPSS) Network where we will discuss alternative pathways for patient access to advanced therapies.
Advanced therapies, which include cell and gene therapies and related technologies such as bioprinting, are recognised to have significant potential to address unmet medical needs. In some cases, they may afford cures for chronic or degenerative conditions that at present can only be managed through ongoing treatment.
Large-scale commercial manufacturing of these novel therapeutics has so far proven resource intensive and expensive. As a result, advanced therapy products typically present high costs to healthcare payers, whether these are private insurers or state coverage schemes, and are usually targeted at subsets of patients with the highest disease burdens as these afford the greatest levels of reimbursement.
A number of countries around the world are exploring alternative innovation pathways for advanced therapies, as a way to try and address some of the areas of medical need. These innovation pathways involve alternative configurations of actors such as universities, hospitals, regulators, and companies from those seen in the conventional commercial pharmaceutical innovation pathway and may also give rise to novel infrastructures and networks. The three speakers in this session will present and discuss a range of examples of alternative innovation pathways from around world and reflect on the challenges and opportunities offered by different approaches.
Speakers:
Conor Douglas (York University, Toronto, Canada) will discuss a Phase II/III clinical trial of CAR-T treatment for B-cell acute lymphoblastic leukaemia and relapsed/refractory large B-cell lymphoma that is being developed entirely in Canada and entirely in the public sector. Other international examples of non-commercial translation will be drawn on to inform the prospects for this treatment to be integrated regular clinical practice in Canada.
Isabel Briz Hernndez (The Chinese University of Hong Kong, Hong Kong SAR) will present an overview of the "dual-track" regulation that the National Medical Products Administration (NMPA), the Chinese regulatory institution for drugs and medicinal devices, issued in 2017 for advanced therapies with a special focus on how this regulation has shaped the development of gene and cell therapy in China.
Michael Morrison (University of Oxford, UK) will outline Japan's endeavours to provide an alternative regulatory framework for clinical innovation under the 2014 Act on the Safety of Regenerative Medicine and consider the possibility for similar regulatory experimentation in post-Brexit UK.
[demime 1.01d removed an attachment of type application/pdf which had a name of Invitation GPSS webinar - alternative pathways for patient access to atmp.pdf]
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