ABOUT US
“My commitment to curing T1D is deeply personal. Every day, I work to turn hope into reality for all families living with this disease, including my own.”
Khemraj Hirani, MPharm, PhD, RPh, MBA, CIP, CCRP, RAC
Assistant Professor of Medicine; Chief Regulatory and Operating Officer, Diabetes Research Institute; Associate Vice Chair of Research and Regulatory Compliance, Department of Medicine, University of Miami, Miller School of Medicine
DRI Affinity Group: Immunology, Device Transplant, and Beta cell robustness and augmentation, function enhancement and islet cross talk
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Dr Khemraj Hirani is an international leader in clinical research, drug development, and regulatory science with a focus on finding a cure for T1D. At the DRI, he directs the regulatory and operational efforts that bring promising treatments from the lab to clinical trials, ensuring patient safety and FDA compliance. As both Chief Regulatory and Operating Officer of the DRI and Associate Vice Chair of Research and Regulatory Compliance in the Department of Medicine, Dr Hirani’s work supports the discovery and delivery of innovative therapies aimed at restoring insulin independence for people living with T1D.
Dr. Hirani’s personal mission to cure T1D began when his child was diagnosed at just 16 months old. His life’s work is dedicated to creating safe, effective treatments and ultimately a cure. Outside the lab, he mentors future leaders and builds global collaborations to speed progress toward this goal to cure unmet medical needs.
Dr. Hirani’s research centers on safely and efficiently advancing new therapies for T1D, including immune therapies, beta cell replacement, and gene and cell-based treatments. He leads efforts to design and oversee clinical trials that test potential cures, making sure they meet the highest standards for safety and effectiveness. Dr Hirani works closely with scientists, doctors, and patients to turn groundbreaking discoveries into real treatments that can improve lives and bring us closer to a world without T1D.
The aim of this project is to help bring new T1D treatments safely and quickly to the people who need them. This includes making sure translational and clinical trials are designed with patients in mind and supporting the research needed to move closer to a lasting cure.

