Carlisha Gentles, PharmD, BCPS, CDE
Carlisha Gentles, PharmD, BCPS, CDE
Risk Management Analyst
Food and Drug Administration
LCDR Carlisha Gentles is a Commissioned Officer of the United States Public Health Service. Currently, she is stationed at the Food and Drug Administration as a scientific analyst within the Division of Risk Management responsible for reviewing and developing complex risk mitigation and elimination strategies (REMS) for medications with significant toxicity concerns. As the scientific analyst, she led the development of a REMS program for Fintepla (fenfluramine) REMS collaborating with team of 30 reviewers. Development of REMS is the ONLY way fenfluramine would be approved due to its withdrawal from the market due to cardiovascular toxicity in adults. As a subject matter expert, the nominee led the successful revision of the FDA’s Pharmacokinetics Guidance for Industry which directly impact industry and the foundation of how generic drug studies are conducted. LCDR Gentles graduated with her Doctor of Pharmacy degree from the Howard University College of Pharmacy in 2008. With over 10 years of practice experience, she successfully completed a post-graduate residency with a focus in Community Pharmacy and Ambulatory Care at Mercer University in Atlanta, GA and is a Board Certified Pharmacotherapy Specialist and Certified Diabetes Educator. Pursuing an opportunity to work in remote underserved communities, she subsequently served as the Chief Pharmacist on the Navajo Reservation in Arizona overseeing an ambulatory care center. As the Chief Pharmacist, she was instrumental in establishing a robust immunization program and developing a successful pharmacist-run chronic disease management program. Being a resident in Washington, DC and having a passion for eliminating health disparities, she is one of only 2 Public Health Pharmacists who have established clinical pharmacy services at an FQHC in Ward 8. As one of the most underserved regions in the city, she translated her clinical skills from her tour of duty with Navajo patients to develop a transition of care program and chronic disease health literacy initiative. Most recently, she was selected to as a Community in Health Innovator as part of the Ward Infinity initiative sponsored by Sibley Memorial and John Hopkins University to develop an innovative solution to improve health literacy in underserved communities. In her personal time, she established a successful 501 (c)-3 organization, Dissipating Disparities, Inc. (DDI), in 2014 with a focus on eliminating disparities in rural Georgia. DDI has eliminated barriers to care for 1200 participants by focusing on primary care linkage, health literacy, mental health awareness as well as live Q & A panels with healthcare providers. A mother, wife and active duty officer, she enjoys spending time with her family, doing her part to give back to others, and taking the time to dance to the latest Reggae or Go-Go beat. LCDR Gentles is a member of Delta Sigma Theta Sorority, Inc. and Kappa Psi Pharmaceutical Fraternity, Inc.