Kevin Laliberte, PharmD

Kevin leads SciLucent’s Clinical Development & Regulatory Affairs practice.  He has more than 20 years of experience in clinical research, drug development, and regulatory affairs in pharmaceutical and biotechnology organizations as well as an independent consultant. Kevin develops and oversees the implementation of international regulatory strategies and clinical development plans for pharmaceuticals, biologics, and combination products across a diverse range of therapeutic areas.  He has extensive experience interacting with regulatory agencies and attending meetings with the US and worldwide authorities.  Kevin has authored and/or provided high level scientific oversight of regulatory submissions including pre-meeting packages, Investigational New Drug (IND), Clinical Trial Application (CTA), Orphan Drug Designation (ODD), Pediatric Study Plans (iPSP), and Marketing Applications in multiple countries.  His early experience was in the design and implementation of clinical pharmacology studies, which eventually expanded to include design, implementation and oversight of global Phase 2 and 3 clinical studies.  Kevin has a PharmD from the University of Michigan.