20-year FDA Master Reviewer will advise the planning of drug development programs with sponsor companies
LANCASTER, Calif.–(BUSINESS WIRE)–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.”
About Simulations Plus, Inc.
Simulations Plus, Inc., is a premier developer of drug discovery/development software and a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions and quantitative systems pharmacology models for drug-induced liver injury, drug-induced kidney injury, and nonalcoholic fatty liver disease. Our software is used to conduct drug research by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading provider for physiologically based pharmacokinetic modeling and simulation. Visit us online www.simulations-plus.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.
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Contacts
Simulations Plus Investor Relations
Ms. Renee Bouche
661-723-7723
renee@simulations-plus.com
Hayden IR
Mr. Cameron Donahue
651-653-1854
cameron@haydenir.com