Virgilio Garcia Lerma

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Virgilio Garcia, Senior Director, Regulatory Pre-Award Strategy, has advised on regulatory strategies and supported implementation for more than two decades. With experience spanning from early development to commercialization and life cycle management, Virgilio has worked in sectors such as pharma, biotech, CMOs, and CROs. He has extensive knowledge of the clinical development industry and regulatory pathways, an education in chemistry and engineering, and an Executive MBA in Business Management. He has also accrued a wealth of knowledge in regulatory pathways and deep expertise in CMC to help clients streamline regulatory strategies.

Virgilio leads the Regulatory Strategy Pre-award Team, a group of accomplished professionals who provide strategic regulatory services to successfully implement clinical trials. He is passionate about developing comprehensive strategies for commercialization in the most streamlined way possible. As Senior Director, he supports the development of manufacturing and engineering foundations, advises on CMC for biologics and ATMPS, and maximizes the value of assets.

Virgilio has held various positions in his clinical research career, including leading regulatory support for projects and portfolios, heading up a strategic regulatory consultancy focused on marketing authorizations and life cycle management, and implementing innovative multiplatform regulatory intelligence systems. His vision is to use personalized medicine with AI-supportive tools to develop treatments and devices faster to reach a wider population in less time.