MMS, a global, data-focused clinical research organization (CRO), announced that Somya Dunn, MD, has joined the company as Senior Medical Director, Safety Risk Management, further advancing the company’s leadership in risk-benefit assessments for submissions, pharmacovigilance and Risk Evaluation and Mitigation Strategies (REMS).
Dr. Dunn is a board-certified pediatrician with more than two decades of experience across drug safety, regulatory science, and pharmacovigilance. She joins MMS after 17 years at the U.S. Food and Drug Administration (FDA), where she provided senior risk management leadership within the Center for Drug Evaluation and Research (CDER), advising on benefit–risk strategy and the design, development, and implementation of complex risk management programs, including REMS.
In addition to her regulatory work in close collaboration with the pharmaceutical industry, Dr. Dunn is an Assistant Professor of Pediatrics at the Georgetown University School of Medicine and holds a clinical position at MedStar Montgomery Medical Center. Her career also includes roles at the National Institutes of Health (NIH) and service in the United States Public Health Service Commissioned Corps.
“I am very excited to join MMS at a time when sponsors are navigating increasingly complex safety and regulatory expectations,” said Dr. Dunn. “MMS combines deep scientific expertise with practical, execution-focused support, allowing sponsors to move forward with confidence across development and post-approval. I am particularly looking forward to partnering with sponsors early in development and regulatory discussions to help anticipate regulatory expectations, strengthen benefit–risk strategy, and build safety and risk management programs that are both effective and sustainable. This approach supports efficient global approvals while maintaining the highest standards of patient safety and regulatory accountability.”