MMS, a global, data-focused clinical research organization (CRO), today 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.
Dr. Uma Sharma, CEO of MMS, said, “At MMS, we play a critical role in supporting sponsors with regulatory submissions and end-game activities including NDA/BLA submissions, REMS, label negotiations, and advisory committee meeting support. As a clinician and safety expert, Dr. Dunn brings rare frontline experience shaped by evaluating some of the most complex therapies in development today, and her perspective will be invaluable as we help sponsors navigate safety strategy from early development through lifecycle management including REMS for evolving high-risk indications.”
Jeffrey Wiese, Senior Director, Safety and Risk Management at MMS, added, “Somya’s leadership in the design and implementation of landmark REMS programs with the FDA and her track record of safeguarding patient safety at scale further strengthens our ability to support global pharma and biotech sponsors with comprehensive safety risk management solutions.”
Dr. Dunn’s appointment follows a period of significant growth and innovation for the MMS pharmacovigilance and risk management team. As a leading submissions (NDA/BLA) provider and full-service provider of REMS solutions, MMS provides pharmaceutical and biotech sponsors with the right technology infrastructure, expertise, and proactive support needed to effectively navigate FDA requirements and build sustainable, high-impact risk management approaches.
“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.”
Dr. Dunn’s appointment reinforces MMS’ commitment to building industry-leading teams, strengthening its end-to-end data, regulatory, and risk management solutions for pharmaceutical and biotech sponsors from early phase development through post-approval.
Dr. Dunn and the MMS team will be attending the annual REMS Industry Consortium conference in Arlington, Virginia, on March 11th-12th, 2026. To arrange a discussion either onsite or virtually, get in touch: https://mmsholdings.com/contact/
Learn more about MMS’ solutions across the product life cycle here: https://mmsholdings.com/
About MMS
MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, a 20-year track record, AI technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner. With a global footprint across four continents, MMS maintains an industry-leading customer satisfaction rating. For more information, visit www.mmsholdings.com.
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