Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|June 4, 2020
Almac Group Supports Two COVID-19 Clinical Studies in Sub-Saharan Africa
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Almac Group, the global contract development and manufacturing organization, has received a $288,000 grant to support a clinical study in Sub-Saharan Africa in efforts to find a treatment for Coronavirus. This was awarded from the COVID-19 Therapeutics Accelerator, an initiative by the Bill & Melinda Gates Foundation, Wellcome and Mastercard.
Almac Clinical Services is providing a full range of clinical trial solutions from protocol through to patient delivery, whilst Almac Sciences is providing analytical support, direct from its global headquarters in Craigavon, Northern Ireland. In an effort to expedite the drug development process, Almac Clinical Services has received the active drug and is providing over encapsulation services, manufacturing a placebo match, packaging and labelling the supplies to support this blinded clinical trial. Almac Sciences is conducting rigorous analytical and stability testing for the investigational drug.
Dr. Robert Dunlop, Managing Director and President, Almac Clinical Services commented. “This virus is threatening peoples’ lives and livelihoods and nowhere worse than in the poorer regions of the world. Almac’s global capabilities and expertise enables us to play our part and support efforts to find a vaccine and/or treatment for Coronavirus. We are delighted to be awarded this grant from the COVID-19 Therapeutics Accelerator and to be supporting these clinical studies in Sub-Saharan Africa.”
Almac Clinical Services will ship all supplies to the clinical site with onward management of logistics and distribution of quality drug for delivery safely to patients. This Covid-19 study is being led by an African Principal Investigator. In addition, Almac is supporting a second open label clinical study through the distribution of commercial packs to a pharmacy in South Africa. Due to its comprehensive range of innovative and flexible services, Almac was approached to support these urgent clinical studies by R&D Supply Chain Advisors, Brizzey LLC.
The COVID-19 Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard, with funding from an array of public and philanthropic donors to speed up the response to the COVID-19 pandemic by funding the identification, assessment, development and scale up of treatments.
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