Marian Hemmelgarn

Associate Partner & Gene Therapy Biosafety Officer

Marian Hemmelgarn is a Certified Clinical Research Professional with over a decade's experience in research coordination, regulatory compliance, proposal development, and data interpretation. She has a BS from University of Massachusetts, and an MPH from Boston University. Throughout her engagements within the medical and healthcare sector, she has been involved in the end-to-end management of clinical programs, coordinating with patients and doctors, and ensuring consistent project progress. She has managed clinical research projects for pioneering institutions including Harvard University, Dana Farber Cancer Institute, and UCLA. Originally from Puerto Rico, she now resides in the southeastern United States. In her free time, she enjoys dancing, all things sci-fi and exploring the outdoors with her two boys.

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Mission Statement

Our mission and expertise at Clinical Biosafety Services is to provide accelerated, compliant review of gene transfer/gene therapy clinical trials to a convened review of a site-specific Institutional Biosafety Committee (IBC). We do this by understanding the challenges in the two client relationship of serving an institution and a sponsor.

Our focus is to accelerate the trial, and remove regulatory burden and uncertainty by having our highly trained experts provide friendly, knowledgeable support during the review process. We understand these therapeutics will change medicine, and our service is to bring the trial to enrollment fruition, quickly and compliantly.