Toward AffordableTreatment of HIV/AIDS Children: University-Based Development and Clinical Trials of Affordable Pediatric Anti-retroviral Drug Products
The Calling: At my previous employment, Duquesne University, I started developing affordable HIV/AIDS formulations that children can tolerate in 2004. This led to submission of an investigational new drug (IND) application to the Food and Drug Administration (FDA) and approval to proceed to conduct a clinical trial. My calling indeed found me based on my passion for children suffering from HIV/AIDS, my gift or vocation of making/manufacturing formulations and the opportunity (to which God called me almost 40 years ago) of being a pharmacist from Nigeria, the country with the third largest number (not prevalence) of people living with HIV/AIDS. I am pleased to say we have made considerable progress in developing some products for the FDA-approved clinical trials, so access to the drugs could be realized soon for children in developing countries. For all these efforts, I was recognized with the Duquesne University’s President’s Award for Excellence in Service in 2008.
Clinical Trials at Roosevelt University: My relocation to Roosevelt University expedited Phase I clinical trials of the products. The FDA approval to conduct Phase I of the clinical trial was obtained in partnership with a socially conscious small start-up company, Elim Pediatric Pharmaceuticals Inc., a specialty small business dedicated to developing and manufacturing children’s medications. All of our drugs are designed to be age-appropriate for children. A successful clinical trial will allow the products to be given consideration for early marketing and access to children who need treatment all over the world, especially Africa where more than 75 percent of children with HIV/AIDS reside.
Benefits to Roosevelt University and the College of Pharmacy: My calling has now led me to being an inaugural faculty member and founding Chair at Roosevelt University’s new College of Pharmacy in Schaumburg where I have an opportunity to continue my social justice work. Roosevelt University added to the wind beneath my wings by giving me a seed grant from Mr. Joseph Hanauer, a Roosevelt University trustee, to initiate a clinical trial that has begun at Bowen University Teaching Hospital (BUTH), Ogbomoso, in Nigeria. Pictures of the clinical site and some clinical research team members can be seen at:
Further clinical trial research will be conducted at Roosevelt University for the two products under study plus five other products that are yet to be scaled up. Through this work, the College of Pharmacy can become a center for pediatric drug product research and development of drugs to combat HIV/AIDS. We also plan to create a Translational Research Laboratory. The lab will be involved with the following: good laboratory practice (GLP) assay development for analysis of the drugs in pharmaceutical or biological medium; scaling-up formulations and translating the technology to an FDA-approved company for clinical batch manufacture, and screening volunteers to participate in clinical trials. With adequate funding that is desperately needed, children from day 1 to age 14 years can have access to the HIV/AIDS drug products. The plan is for other faculty and our pharmacy students to become involved in the lab or/and gain clinical practice experience during future trials. All of these, I believe, will underscore the College of Pharmacy’s commitment to social justice while we educate committed, competent and compassionate pharmacy practitioners.