Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that Sandra Suarez-Sharp, Ph.D., has joined the company as Vice President, Regulatory Affairs to oversee the new Regulatory Strategies team supporting companies in their interactions with global health authorities.
“My service at the FDA allowed me to see the ‘big picture’ with both the drug product development and the regulatory decision-making processes,” said Dr. Suarez-Sharp. “Our goal with the Regulatory Strategies team is to translate these experiences to identify, articulate, address, and resolve areas of high versus low risk and delineate a tailored path forward for the approval of drug products supported by modeling and simulation. For our clients, this means incorporating clinical relevance into drug product development and achieving patient-centric drug product quality and flexibility in regulatory assessment (e.g., reduce the need for human studies), which leads to medicines getting to market faster.”
Dr. Suarez-Sharp 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. Food and Drug Administration in 1999. She spent time as a reviewer in the Office of Clinical Pharmacology, Office of Generic Drugs, and Office of Pharmaceutical Quality, where she most recently served as Master Reviewer and Scientific Advisor for the Division of Biopharmaceutics. She was actively involved in the development of many 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).
John DiBella, President of the Lancaster division for Simulations Plus, added: “Sandra is a world-class scientist and leader who has acquired expertise and knowledge evaluating a wide variety of products, including new molecular entities, novel and complex dosage forms, and drug-device combinations. Adding her to the Simulations Plus team demonstrates the progress we have made as an organization. Her extensive experience in reviewing numerous applications across several offices at the FDA provides her a rare and unique perspective. In the last several years, there are over 30 approved drug products which have been supported by an assortment of GastroPlus® modeling and simulation results, and we expect that number to increase substantially with Sandra on board qualifying sponsor data and models to streamline regulatory success. She will also take a leading role in organizing collaborations with regulatory agencies, academia, and industry worldwide to drive innovation and continued adoption of modeling and simulation. We are proud to welcome her to Team Simulations Plus and are eager to have her start engaging with clients.”