A while ago, we sat with Marc Lallemant – the scientific coordinator of the UNIVERSAL project led by Penta, for a quick chat. It was an eye-opening discussion that delved into the early beginnings and the birth of the project.
According to Marc, TUTI pronounced as “tutti” in Italian (meaning everyone) was the name initially settled for. He further went on to clarify that TUTI had no Italian origin and was an acronym with a full meaning – Towards Universal Treatment of children in Africa. It was from this acronym the name of the project – UNIVERSAL was born. The word UNIVERSAL is a manifesto for the Consortium, who will be able to introduce two fixed-dose combinations of anti-HIV drugs into the market, thanks to its strategic partnership.
Marc continued by highlighting the role of Penta in GAP-f, where it oversees the activities of the clinical research working group, including clinical trials, pharmacokinetics modelling and simulations as well as post marketing safety and effectiveness monitoring for the drugs in GAP-f portfolio. He also reiterated that UNIVERSAL is “the first product development project born out of GAP-f”, the collaborative framework led by World Health Organization to promote a faster, more efficient, and more focused approach to paediatric formulation development, in order to provide better medicines to children in low-and middle-income countries.
Thanks to the collaborative framework set up by GAP-f, UNIVERSAL is partnering with the Clinton Health Access Initiative (CHAI) – a global health organization committed to saving lives and reducing the burden of disease in low-and middle-income countries and globally.
CHAI will play a key role in the project by enabling engagement with relevant pharmaceutical originator and generic companies and leading on the regulatory activities that will allow for the introduction of the two new antiretroviral formulations developed by UNIVERSAL into the market .
About UNIVERSAL project:
UNIVERSAL, an European Union funded research project will develop, evaluate and register two new antiretroviral formulations for infants and children newly diagnosed with HIV initiating antiretroviral therapy, and for children failing first-line therapy who need to switch to a new treatment regimen.