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Sita Somara

Director, CMC and Regulatory Program, Drug Development


PhD, Biochemistry, Sri Krishnadevaraya University

MBA, International Business, Louisiana State University

Sita Somara, PhD, MBA, is a senior drug development professional with over ten years of experience in translating technologies from bench to beside. In addition, Dr. Somara has over twenty years of progressive experience in basic research involving cell biology, signal transduction, regenerative medicine, and translational science. Her expertise lies in creating lean product development strategies and leading activities for regulatory submissions.

Dr. Somara serves as the Project Director for Qura Therapeutics (HIV Therapy) as well as Atelerix Life Science (OIRD Treatment), which merges her technical, regulatory, and managerial expertise. She is also a technical and regulatory lead on the National Heart, Lung, and Blood Institute (NHLBI) funded Catalyze Program. In addition to this work, she supports other projects as a regulatory and chemistry, manufacturing, and controls (CMC) specialist.

Dr. Somara has managed and led drug development projects from preclinical studies to cGMP manufacturing to regulatory submissions with an emphasis on CMC operations. She has overseen multidisciplinary teams and coordinated with external CRO’s and CMO’s, while supporting the development of a wide range of therapeutic products from drugs to biologics.  

Prior to joining RTI, Dr. Somara worked at CDMO, AstraZeneca, and Wake Forest Institute for Regenerative Medicine. She presently holds memberships in the International Society for Cell and Gene Therapy (ISCT) and the Regenerative Medicine Manufacturing Society (RMMS).

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