Sandra Suarez-Sharp

Dr. Sandra Suarez-Sharp is Vice President, Regulatory Affairs at Simulations Plus, Inc.. She received her Ph.D. from the University of Florida and spent two years as a postdoctoral fellow at the University of North Carolina (Chapel Hill) before joining the U.S. FDA in 1999. At that time she was actively involved in the development of several internal procedures for FDA reviewers and guidance documents for industry, and she is recognized as one of the preeminent thought leaders for Physiologically Based Biopharmaceutics Modeling (PBBM). She co-chaired various workshops including, Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls REdI and CERSI Workshop and In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality CERSI Workshop and Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development.