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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