Sita Somara
Drug Development, Regulatory Affairs, AI, Bench to Bedside
- Role
- Founder Program Director at Soma Life Science Solutions Soma
- Location
- Winston-Salem, NC, US
- LinkedIn followers
- 500 followers
About Sita Somara
Leveraging extensive expertise in operations, management, and a deep understanding of regulatory requirements, I am passionate about developing treatments that improve quality of life and community health. I strive to make therapies more affordable and accessible, approaching every challenge with empathy for patients and healthcare communities. With a strong commitment to advancing innovation, collaboration, and excellence in drug development, I am dedicated to contributing to cutting-edge treatments for unmet medical needs and enhancing healthcare outcomes.With over 20 years of progressive experience in basic research—including cell biology, signal transduction, regenerative medicine, and translational science—I bring a wealth of expertise in driving the development of innovative healthcare and medicinal products, translating technologies from bench to bedside. My extensive experience spans the entire regulatory process, from early-stage development to regulatory submissions and approvals, with a thorough understanding of both FDA and global regulatory requirements. I am adept at navigating highly regulated environments, ensuring that products meet rigorous standards while crafting lean, strategic development plans that enable the efficient and cost-effective production of high-quality therapies.I have led the development of a wide range of therapeutic technologies, including biologics, combination products, tissue-engineered products, cell and gene therapies, devices, and vaccines. My experience encompasses all stages of drug development, from identifying therapeutic targets to working with cross-functional teams to bring technologies from proof of concept to clinical trials. My in-depth knowledge of regulatory and quality compliance allows me to ensure that all products meet the highest standards.Driven by a passion for advancing healthcare solutions that make a difference, my leadership is focused on delivering targeted, patient-centered solutions that drive product success. I hold both a PhD and an MBA, which provide me with a unique perspective that integrates scientific expertise with business acumen.
Experience
Founder Program Director
Soma Life Science Solutions Soma
Mar 2021 — Present · Lewisville, NC, US
Lead the transformation of drug development at SOMA through the implementation of AI-driven solutions, revolutionizing regenerative medicine therapies. Through advanced AI technology• accelerate innovation and improve therapeutic product quality • streamline drug development processes • optimize regulatory submissions to drive industry advancements
Education
Sri Krishnadevaraya University (SKU), Anantapur
Master's degree
1989 — 1991
Duke Translational Medicine Institute
Internship, DTMI General Regulatory Training Program
2015 — 2015
LSU Shreveport
Master of Business Administration - MBA
2018
Duke Translational Medicine Institute
Internship, DTMI Medical Device Regulatory Training Program
2016 — 2016
Sri Krishnadevaraya University (SKU), Anantapur
Doctor of Philosophy (PhD)
1993 — 2001
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