PHM-Exch> Webinar Invite: Improving Drug Regulation for Greater Access to Biologics and Vaccines

Gargeya Telakapalli gargeya.t at phmovement.org
Sun Dec 3 23:30:00 PST 2023


*Webinar: Improving Drug Regulation for Greater Access to Biologics and
Vaccines*

*Friday, 08 December 2023*



* 8 am US Eastern Time/ 2 pm Central European Time/ 6.30 pm
IndiaRegistration:* CLICK HERE
<https://us02web.zoom.us/webinar/register/WN_45LTB35_QECBQEXAh8oqCg>

Third World Network invites you to a one-hour discussion (with Q&A) on how
we can improve the drug regulatory system to create better access to
biologics and vaccines. We will be discussing the second chapter from the
recent paper from TWN+AccessIBSA: Monopolies on Biologics, including
Vaccines.

In the immediate aftermath of a pandemic characterised by monstrous gaps in
access to life-saving biologics and vaccines, we will discuss a
lesser-known monopoly system, which is that conferred by the drug
regulatory agencies that regulate these pharmaceuticals. Beginning with
recent changes in the way biosimilars can be brought to market, we will
discuss the new WHO guidelines, which could reduce by almost two-thirds the
cost and time taken for bringing non-vaccine biologics to the market. We
will then move to vaccines, and discuss the lack of a similar reform in the
guidelines there, as well as the potential for abbreviation of this process
by immuno-bridging trials, rather than repeating the full suits of clinical
trials. We will also discuss the potential for comparing the equivalence of
mRNA vaccines, which stem from the lack of cell-based biology in these
products. The authors of the paper will present their analysis, followed by
commentary from our invited experts from around the world. The webinar will
be introduced by Gopakumar KM, and proceedings will be conducted in English.



*Featuring:*
*Chetali Rao *is a Biotechnologist and IP/trade Lawyer working on equitable
access to medicines, health technologies and pharmaceutical innovation
(India)

*Achal Prabhala *is the Coordinator of the AccessIBSA project for access to
medicines (Bangalore, India)

*Michel de Wilde* is an International Vaccines Expert (Belgium/USA)

*Soumya Swaminathan* is the Chair of the MS Swaminathan Research Foundation
in Chennai, India and former Chief Scientist, WHO (India)

*Barney Graham* is a Professor at Morehouse School of Medicine and former
Deputy Director of the NIAID's Vaccine Research Center (USA)

One hour long, with presentations followed by Q&A

Based on the recent TWN+AccessIBSA paper: Monopolies on Biologics,
including Vaccines- Click Here
<https://accessibsa.org/media/2023/09/Monopolies-on-Biologics-including-Vaccines.pdf>
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