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

The mission of Castle IRB is to protect the rights and welfare of human participants in gene and cell therapy clinical trials while providing efficient, compliant IRB review of research. Using our portfolio of expertise, we strive to be the leading IRB partner in advancing safe, ethical and compliant gene and cell therapy clinical trials to accelerate the next evolution in advanced therapies.