Food and Drug Administration researcher conducts drug safety studies for public health

During his time as a medical doctor in Burkina Faso, West Africa, from 2010 to 2013, Zakaridja Guiriansoro provided care to people living with chronic diseases or conditions like diabetes, HIV/AIDS, Tuberculosis, etc. He began to realize that, often, these patients’ treatment outcomes were lower than expected. After investigation, he found that the main reason was a low level of patient compliance when it came to taking the treatment drugs.

Guiriansoro tried alternative prescriptions (which helped some patients) but found that the low socio-economic status and lack of affordable insurance made it difficult for patients to receive proper care.

Guiriansoro’s time as an MD led him to his future path as a researcher.

“That experience inspired me to learn more about drug safety and how I can contribute to improving it,” he explains.

Guiriansoro moved to the U.S. in 2013 and pursued a Master of Public Health at the George Washington University in Washington, D.C. During his time at GWU, he heard about the ORISE program.

“I attended a career fair during my MPH program, where I learned about the ORISE Fellowship program,” he remembers. “After that event, I went over to the ORISE booth and learned more about the available opportunities.”

Guiriansoro accepted an opportunity with the U.S. Food and Drug Administration (USDA) at the Center for Drug Evaluation and Research (CDER).

The ORISE Research Participation Program at the U.S. Food and Drug Administration is an educational and training program designed to provide college students, recent graduates, and university faculty opportunities to connect with the unique resources of the FDA.

Working with his mentor Tatiana Oussova, M.D., Guiriansoro began his research project on FDA safety studies.

“The purpose of my research was to conduct a comprehensive analysis of long-term postmarketing safety studies conducted for drugs used to treat inflammatory or autoimmune conditions,” he explains. “I sought to evaluate the regulatory impact for these safety studies and to inform regulatory decision-making.”

Guiriansoro included 26 safety studies in his analysis: 10 nonpregnancy registries, 12 open-label extension studies, and four pregnancy registries. After review, he determined that none of the submitted final study reports, including from the four pregnancy registries, identified new or unexpected safety signals that would warrant a safety-related labeling update. He noted several study limitations which may have contributed to the lack of safety signal detection in most studies.

Speaking on the impact of his research, Guiriansoro emphasizes the importance of safety studies for the wider public.

“My research will inform regulatory decision-making related to long-term postmarketing safety studies,” he says. “This will help ensure that approved drugs available to the American public remain safe for as long as the drugs remain on the U.S. market.”

Guiriansoro emphasizes just how much he gained from his time with the FDA.

“I learned how collaboration within the FDA is important and even crucial for achieving project objectives and goals,” he says. “There are great people throughout the agency who are ready to help and support you throughout the process.”

He highly recommends the ORISE experience to prospective applicants.

“This program provides a unique opportunity to engage with highly skilled scientists who are experts in their fields and to learn from them,” he says.

During his appointment, Guiriansoro won the “1^st Place Senior Level Award” in the 2021 Office of New Drugs ORISE Scientific Poster Day competition for his poster, for “Excellent analysis of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) and their use in the regulatory decision-making process.”

He wants to give thanks for those who helped him during his opportunity.

“I have been fortunate to have a wonderful mentor who supported and guided me through my program, as well as helping with my transition into a full-time employee position at the agency,” he says. “Thank you so much Dr. Tatiana Oussova, for everything. Also, special thanks to my co-mentor, Dr. Joel Weissfeld, for his expertise, guidance, and support throughout my fellowship program.”

The CDER Research Participation Training Program is administered through the Oak Ridge Institute for Science and Education (ORISE) under an agreement between the FDA and the U.S. Department of Energy (DOE). ORISE is managed for DOE by Oak Ridge Associated Universities.