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Gustavo Mendes Lima Santos Joins the Simulations Plus Regulatory Fellowship Program

By: via Business Wire

Ex-Anvisa General Manager will contribute to global regulatory strategies involving pharmacometrics

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that Gustavo Mendes Lima Santos has joined its Regulatory Affairs team on a one-year fellowship appointment. Mendes Lima Santos will collaborate with global health regulatory agencies, industry, and academia on the development and validation of mechanistic modeling and simulation strategies to support regulatory interactions.

“We are incredibly fortunate and thrilled to have Gustavo as a member of our team,” said Sandra Suarez-Sharp, vice president, Regulatory Affairs at Simulations Plus. “He is a world-class scientist and leader with vast expertise and knowledge evaluating a wide variety of products, including small molecules, biologics, and novel and complex dosage forms. His appointment marks an expansion of our accomplished team, and we welcome his experience to help mentor and advance the Latin American markets to accelerate drug development programs by leveraging modeling and simulation. He will also offer strategic direction for our regulatory affairs initiatives to drive success in today’s complex pharmaceutical landscape.”

Mendes Lima Santos joined the Brazilian Health Regulatory Agency (Anvisa) in 2003 and gained expertise in numerous fields, including bioequivalence assessment, marketing authorizations, and clinical research. In 2019, he assumed the role of General Manager of Medicines and Biological Products at Anvisa, where he was responsible for managing drug and biological product submission review teams. During the COVID-19 pandemic, he became Anvisa’s chief spokesperson, regularly communicating the agency’s work to the Brazilian people as well as supporting other South American countries. Gustavo is a Ph.D. candidate at the State University of Maringa in Brazil and recently embarked on a 2-year sabbatical from Anvisa. In addition to joining Simulations Plus, he is contributing to the International Vaccine Institute (IVI) as a Research Scientist, and he is the first Brazilian regulator to be invited to this prestigious organization.

“It is a moment of great honor for me to work with the team of highly motivated and talented scientists at Simulations Plus,” said Mr. Santos. “My experience at Anvisa provides me with a rare and unique perspective on both the drug development and regulatory decision-making processes. An area of great personal interest has always been to promote and support the use of modeling and simulation to improve patient outcomes. As part of this fellowship program, I will have the opportunity to join a multidisciplinary team to advise regulatory strategy planning for drug product development programs in Latin America and around the globe while also expanding my knowledge and understanding of modeling and simulation applications. I will also actively contribute to research collaborations and seek partnerships to advance the science. It is this extraordinary opportunity to work with the team at Simulations Plus, with its 25-year track record of success improving global health through innovative solutions, which was so appealing to me.”

About Simulations Plus

Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.

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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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