We are pleased to announce that we have taken another significant stride in line with our mission to advance precision medicine with the launch of our Clinical Program Services (CPS) division. This new business unit will oversee end-to-end clinical development services, intelligence, logistics, and infrastructure that will ensure the success of clinical trials being conducted in Africa, starting with Nigeria. The launch also coincides with 54gene’s appointment as the Nigeria country partner for the International Registry of Healthcare Workers Exposed to COVID-19 (UNITY Global Study). We are partnering with global leader in biosimulation, Certara, to supervise clinical trial management and support for every aspect of the study conducted in Nigeria.
The newly launched unit is geared towards partnering with global pharmaceutical and biotechnological companies, and multilateral health organizations to discover, develop and commercialize more inclusive therapeutic and diagnostic medical products. The division is led by Kemi Williams, VP, Clinical and Regulatory Affairs, who brings her years of driving clinical excellence, delivering regulatory competency, and ensuring operational efficiency to the company.
The inclusion of Africans in clinical programs is critical to the production of treatments and health products that are more efficacious and safe for people of African descent. It is vital that we continue to collaborate with African researchers and institutions to generate data that meets the scientific rigor found in worldwide studies and to increase African inclusion in global studies. It is also essential that more research takes place on the continent and we are ready to be a part of that change.
In the same vein, partnerships such as the one with Certara, and other important stakeholders across the continent, make the UNITY Global Study a great opportunity for some of the best clinical teams across Sub-Saharan Africa to come together and ensure outcomes of COVID-19 studies are relevant to Africans. The insights generated from this program could potentially unlock breakthrough clinical discoveries that could improve health outcomes for millions of people globally.
The UNITY Global study aims to develop prevention policies based on real-world data collected from 10,000 healthcare workers in low and middle income countries, including Pakistan, Nigeria, South Africa, Kenya, Uganda, Senegal, Zambia and Zimbabwe. The registry’s primary objective is to examine the link between the use of preventive treatments and the occurrence of SARS-CoV-2 infection in healthcare workers providing care to patients with COVID-19. With the enigmatic nature of the virus and its profound impact on the global healthcare system, it is crucial to develop guidance and policies for protecting healthcare workers, who are at the frontline of combating the disease.
Laying emphasis on the significance of this study, Roman Casciano, general manager of Certara’s evidence and access group stated: “Healthcare workers have a high incidence of severe COVID-19 as they are repeatedly exposed to individuals infected with SARS-CoV-2. With limited evidence on the effectiveness of the preventative measures and treatments currently being used, collaborating with key partners such as 54gene is invaluable for expanding the current body of research.”
“Through our country partners’ support and findings from the registry, we hope to provide meaningful data to inform decision making that will help protect healthcare workers worldwide battling COVID-19 on the frontlines.”
The registry will collect information on a weekly basis from enrollees across a 12-week period. Data collection includes medications being taken by healthcare workers, their level of exposure to COVID-19 patients, their health status, and other factors such as the use of personal protective equipment (PPE), which would likely mitigate their risk of SARS-CoV-2 infection. In addition, the registry will record SARS-CoV-2 antibody test results. The study is funded by a grant from the COVID-19 Therapeutics Accelerator.