Simulations Plus Announces Leadership Changes at Cognigen

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 Jill Fiedler-Kelly has been named President of the Cognigen division in addition to other leadership changes to support the ongoing growth of the Company’s Cognigen division.

Ms. Jill Fiedler-Kelly, a co-founder of Cognigen who served as Vice President of Pharmacometric Services since 1992, has been promoted to President of the Cognigen division of Simulations Plus. Ms. Fiedler-Kelly has more than 25 years of experience in the design and implementation of pharmacometric modeling and simulation approaches in drug development programs and in providing training and instruction in pharmacometric modeling. She is an Adjunct Professor of Pharmaceutical Sciences at the University at Buffalo and co-authored the book Introduction to Population PK/PD Analysis with Nonlinear Mixed Effects Models with Joel Owen. In 2016, Ms. Fiedler-Kelly was named Fellow of the International Society of Pharmacometrics.

In July 2019, Dr. Kevin Dykstra joined the Company as Vice President, Consulting Services, and has assumed a key leadership role in the Company’s consulting services. Dr. Dykstra has more than 25 years of cumulative experience in the Pharmaceutical and Biotechnology industry providing strategic pharmacometric modeling and simulation services. Prior to joining the Company, Dr. Dykstra co-founded qPharmetra in 2010, and before that spent 10 years with Pharsight Corporation and Certara. He conducted post-doctoral work as a Staff Fellow at the National Institutes of Health. He holds MS and PhD degrees in Chemical Engineering from the University of Michigan and undergraduate degrees in Chemical Engineering and German from the University of Colorado with additional training in Biostatistics from Boston University. Dr. Dykstra is a Fellow of the American College of Clinical Pharmacology.

Dr. Joel Owen has been promoted to Vice President, Pharmacometric Services. Dr. Owen has been at Cognigen since 2017 and previously served as Director of PK/PD at Cognigen from 2001 to 2008. From 2008 to 2017, Dr. Owen was Professor of Pharmaceutics at Union University in Jackson, Tennessee, where he is currently an Adjunct Professor. Dr. Owen co-authored Introduction to Population PK/PD Analysis with Nonlinear Mixed Effects Models with Ms. Fiedler-Kelly. He holds a BS degree in Pharmacy and a PhD degree in Pharmaceutical Sciences from Auburn University. Dr. Owen was a Fulbright Specialist from 2013 to 2017 and has regularly taught workshops at Makerere University in Kampala, Uganda.

Dr. Alexander (Al) Berg has been promoted to Vice President, Operations. Dr. Berg joined Cognigen earlier this year from the Critical Path Institute (C-Path) where he served as scientific director for the Critical Path to Tuberculosis Drug Regimens Initiative, a global health partnership with the Bill and Melinda Gates Foundation. Prior to C-Path, Dr. Berg was a clinical pharmacology and pharmacometrics lead at Upsher-Smith Laboratories and completed a fellowship in Clinical Pharmacology at the Mayo Clinic. Dr. Berg holds BS, PhD and Doctor of Pharmacy degrees in Pharmaceutical Sciences from North Dakota State University. He is a Fellow of the American College of Clinical Pharmacology, an Adjunct Professor at the University of Minnesota, and an Invited Lecturer to the Mayo Clinic.

Dr. Ted Grasela, Founder and former President of Cognigen, continues with the Company as Executive Vice President. In this role, Dr. Grasela will provide support to Ms. Fiedler-Kelly and continue to provide strategic consulting support to our key clients.

“Jill Fiedler-Kelly has been a key member of the Cognigen team from its beginning as a Founder through to leadership of the consulting practice since its acquisition by Simulations Plus,” said Shawn O’Connor, chief executive officer of Simulations Plus. “Her knowledge of the business, the respect of Cognigen staff she has earned during her tenure with the company, and her stature in the industry and amongst our clients, uniquely positions her to assume leadership of the division. Under Ms. Fiedler-Kelly’s leadership, combined with the other recent promotions and additions announced today, we are well positioned to continue our success at Cognigen.”

“I am both honored and excited to take on this new challenge of leading the outstanding and dedicated team at Cognigen through the next stage of our growth,” said Ms. Fiedler-Kelly. “I am truly grateful for the excellent mentorship and guidance Dr. Grasela has provided over the years and am very happy for his continuing support. I look forward to working together with the leadership of Simulations Plus and DILIsym Services to support new and existing clients in overcoming their drug development and regulatory hurdles using advanced modeling and simulation services and software, and to continuing to grow and expand our services.”

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of drug discovery and development software as well as a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions and quantitative systems pharmacology models for drug-induced liver injury and nonalcoholic fatty liver disease. The company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical, biotechnology, and chemical agents. Our software is licensed and used in the conduct of drug research by major pharmaceutical, biotechnology, chemical, and 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 software provider for physiologically based pharmacokinetic modeling and simulation. For more information, visit our website at 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 as filed with the U.S. Securities and Exchange Commission.

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