54gene, whose mission is to advance inclusive precision medicine through research, advanced molecular diagnostics, and clinical programs, has launched its Clinical Program Services (CPS) division.

The new business division will provide end-to-end clinical development services, intelligence, logistics, and infrastructure to enable successful conduct of clinical trials in Africa, starting out of Nigeria. The launch comes at the same time as the appointment of 54gene as the Nigeria country partner for the International Registry of Healthcare Workers Exposed to COVID-19 (UNITY Global) Study. In partnership with Certara, a global leader in biosimulation, 54gene will provide clinical trial management oversight and support for all aspects of the study conducted in Nigeria.

54gene’s Clinical Program Services division is focused on partnering with global pharmaceutical and biotechnology companies, and multilateral health organizations to discover, develop, and commercialize new therapeutic and diagnostic products. The research division is led by Kemi Williams, VP, Clinical and Regulatory Affairs, who brings years of driving clinical excellence, delivering regulatory competency, and ensuring operational efficiency to the company.

On the launch of the Clinical Program Services division, 54gene Chief Commercial Officer, Jessica Rich said, “The inclusion of Africans in clinical programs is critical to the production of medicines 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 essential that more research takes place on the continent and we are ready to be part of that change.

“Alongside key partners like Certara and other important stakeholders across the continent, the UNITY Global Study is a great opportunity for some of the best clinical teams across Sub-Saharan Africa to come together and ensure outcomes of any COVID-19 studies are relevant to Africans. The insights generated from this program could potentially unlock breakthrough clinical discoveries that can 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 nature of the virus and its 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.  

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.* 

Roman Casciano, general manager of Certara’s evidence and access group added: “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.”