Mike Keens


Mike is an experienced clinical trial operator and commercial leader, with over 20 years’ experience supporting companies advancing treatments for treating disease and enhancing patient care. His career has been focused equally between clinical trial operations and commercial strategy at both large CROs as well as niche service providers. Mike’s efforts and industry leadership have been recognized externally with his selection as a PharmaVoice Top 100 Most Influential Person in Pharma (Patient Advocacy), as well as selection by CenterWatch as a Top 20 Innovator in Pharma Development.

Mike earned his undergraduate degree in Biology and Psychology from James Madison University, his master’s degree in Public Health from the University of Virginia, and is a guest lecturer for the Master’s of Biotechnology programs at Georgetown University and The University of Virginia. In his free time, he is a burgeoning trail runner, and enjoys spending time with his family furiously trying to learn whatever new activity, lingo, or information teenagers are into at the moment.

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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.