December 17, 2024 Kigali, Rwanda and San Francisco, USA

Bio Usawa, Inc., a leading biotechnology company committed to delivering affordable and accessible monoclonal antibody-based therapies for cancer, ophthalmic, autoimmune, and infectious diseases in Africa, has named Mr. Eric Karikari-Boateng its Head of Global Regulatory Strategy.

Mr. Karikari-Boateng brings extensive expertise in regulatory affairs, pharmaceutical manufacturing, and quality assurance, with a proven track record of strengthening regulatory frameworks and building capacity across Africa. Prior to this role, he served as Director of Laboratories at the Ghana Food and Drug Authority, where he played key roles as a senior assessor of biologics and small molecules, a GMP auditor, and a lead reviewer for clinical and non-clinical data. Under his leadership, Ghana became the first country to approve the R21 malaria vaccine.

He has been a prominent figure in regulatory forums, including the African Medicines Regulatory Harmonization initiative and the African Vaccine Regulation Forum, where he chairs the Biologics Regulation Forum. His contributions with the World Health Organization and the European Medicines Agency include evaluating groundbreaking products such as the RTS,S (Mosquirix) malaria vaccine and Pyramax, a combination therapy to treat malaria. Furthermore, Mr. Karikari-Boateng chairs the Expert Working Group for Biologics in the West African Health Organization.

Certified as a cGMP inspector by the American Society for Quality and a lead Good Clinical Practice trainer, Mr. Karikari-Boateng has trained regulators across Africa in biologics dossier review and clinical data evaluation.

“Mr. Karikari-Boateng’s unmatched regulatory expertise and commitment to public health align with our mission to transform healthcare across Africa,” said Dr. Patrick Lukulay, Chief Regulatory Officer at Bio Usawa.

“As Head of Global Regulatory Strategy, he will guide efforts to build next-generation regulatory capacity for ensuring timely approval and delivery of the biotech industry’s innovative, life-saving biotherapies.”