Disease-Focused Development of Pediatric Formulations
Bench-to- Bedside Translational Research
Currently Focused Diseases
- Sickle Cell Anemia
Fixed Dose Anti-retroviral Pediatric Formulations
- Toward Affordable Treatment of HIV/AIDS Children: University-Based Development and Clinical Trials of Affordable Pediatric Anti-retroviral Drug Products
The Calling: I started developing affordable HIV/AIDS formulations that children can tolerate in 2004 at my previous employment, Duquesne University. This led to intellectual property filing and submission of an investigational new drug (IND) application to the Food and Drug Administration (FDA) through a socially conscious small start-up company, Elim Pediatric Pharmaceuticals Inc. (www.elimpedpharma.com). The IND was approved 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 that access to the drugs could be realized soon for children in developing countries.
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. (www.elimpedpharma.com), a specialty small business dedicated to developing and manufacturing children’s medications. The company has a cooperative research agreement with Roosevelt University. All of our drugs are designed to be age-appropriate for children
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 a seed grant from Mr. Joseph Hanauer (a Roosevelt University trustee), to conduct the clinical trial that took place at Bowen University Teaching Hospital (BUTH), Ogbomoso, in Nigeria. Pictures of the clinical site and some clinical research team members can be seen at:
Phase 1 clinical trial research (Bioequivalence) was conducted at Roosevelt University for the two products under study. Two other products are being developed for a pediatric sub-population. . The successful clinical trial has led to invitation from FDA to submit a new drug application for possible 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.
Our lab in the College of Pharmacy is very active in pediatric drug product research and development of drugs to combat HIV/AIDS. Our translational research is being conducted in partnership with different hospitals and health systems and FDA-approved companies for the clinical batch manufacture. The on-site lab has Research & Development capacity for preformulation, assay development for pharmaceutical or biological medium, formulation and stability studies using ICH conditions
With adequate funding, children from day 1 to age 16 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.
- Characterization of a Pediatric Complementary Alternative Medicine (Natural Products) for Treatment of Sickle Cell Anemia
Phytochemistry, Anti-sickling and Antibacterial Studies
Development of Convenient Solid Dosage Forms form the Liquid Extract
- Development of Children-Friendly Anti-malarial Dosage Forms
Preformulation (Characterization of Drugs and Excipients), Assay Method Development and Development of the Dosage Forms