IPFSYM - Key Persons
Job Titles:
- Member of the Senior Leadership Team
- VP, Operations Details
Job Titles:
- Senior Human Resources Generalist
- HR Generalist Details
Amber Ramirez is the Senior Human Resources Generalist for Simulations Plus. She has a variety of human resources experiences across different industries. Amber brings 15 years of experience in several different areas of Human Resources including talent acquisition, compensation, benefits, and employee relations.
Job Titles:
- Member of the Senior Leadership Team
- Vice President, Pharmacometric Services
- VP, Pharmacometric Services Details
Dr. Amparo de la Peña is a native of Montevideo, Uruguay, where she graduated as a Pharmaceutical Chemist from the University of the Republic; and then earned a Ph.D. in Pharmaceutics (2000) from the University of Florida.
Amparo has over 21 years of experience in the pharmaceutical industry, both as a PK/PD scientist and as an Asset Manager. She has led cross-functional teams in diverse therapeutic areas (including diabetes, neuroscience, oncology and COVID-19) to design, optimize and implement integrated development plans for internal and external partners. As a scientist, her strategic pharmacometric approaches have supported global drug development from the early stages to regulatory approval and post-marketing.
Dr. de la Peña has published extensively in peer-reviewed journals in several languages and presented at scientific conferences worldwide. One of her passions is to mentor and develop diverse people, and to foster inclusion. Besides work, Amparo divides her time between her family, and her involvement in scientific and community organizations as a volunteer, peer reviewer, or Board member.
Job Titles:
- Scientific Lead / Simulations Plus, Inc.
- Scientific Lead Details
Anant Ketkar joined the Simulation Studies Team in April 2022 as a Principal Scientist taking on the role of Scientific Lead - India. He is involved in the application of PBPK/PBBM modeling and simulation to meet the objectives of various client projects. He also provides scientific input both in terms of software applications and project proposals to the Indian distributor to support their marketing and sales efforts.
Anant, in partnership with our Indian distributor, Electrolab, supports Simulations Plus' many customers in India and serves as a thought leader to increase awareness and adoption of PBBM/PBPK modeling throughout the country. He also delivers modeling and simulation projects to address client objectives and inform regulatory interactions.
Anant earned his doctorate in Pharmaceutical Sciences from Poona College of Pharmacy (Bharati Vidyapeeth Deemed University), Pune, India. He carries 20 years of experience in formulation research, including 6+ years of experience in PBPK/PBBM modeling and biorelevant dissolution method development for modified complex generics and enabled formulations for poorly soluble NCEs.
Prior to joining Simulations Plus, Anant was Head of Technical Services at IQGEN-X Pharma, where he led a team of formulation team leaders and scientists for development of solid and liquid orals, and injectables for the global market. Prior to that he worked in positions of increasing seniority with pharmaceutical research companies, including Bioved Pharmaceuticals Inc., Ranbaxy (now Sun Pharma), Pfizer Animal Health (now Zoetis), Sandoz and Sun Pharma Advanced Research Company (SPARC).
Besides his professional work, Anant enjoys singing Bollywood songs and participates in live musical events and concerts in Mumbai and nearby areas. He is also passionate about learning portrait and street photography.
Anant's Patent Applications include:
Job Titles:
- Dir., Business Development Details
- Director, Business Development / Simulations Plus, Inc.
Andrew Mueller has approximately 17 years' experience in the pharmaceutical development industry. He joined Simulations Plus in 2020 as a Project Coordinator, Technical Writer, and Coordinator for Learning Services and now serves as a Director for Business Development. Prior to his employment with Simulations Plus, Andrew spent the majority of his career with Covance Laboratories (LabCorp) in Toxicology, as a Lead Scientist in Bioanalytical Chemistry, and as a Pharmacokineticist in Drug Metabolism.
Job Titles:
- Vice President, Information Technology / Simulations Plus, Inc.
- VP, IT Details
Andrew is the Vice President of Information Technology and is responsible for guiding Simulations Plus' IT and cybersecurity strategy, maintaining regulatory compliance, and ensuring the integrity and availability of our data and systems. Andrew's team is focused on the continuous optimization of our analysis and software development platforms, as well as the exploration of emerging technologies to provide better security, faster results, and a more seamless work experience for our employees who reside throughout the world.
Andrew joined Cognigen in 2001 as a Systems Administrator and had been managing Cognigen's IT department since 2007. During his tenure, Andrew has led the company through two successful data center relocations, supported the merger of DILIsym and Cognigen into Simulations Plus, and facilitated the company's transition to a largely remote workforce. Additionally, Andrew is one of the co-creators of the KIWI system - a web-based platform that allows our pharmacometricians to perform their analyses with much greater efficiency.
Job Titles:
- Programmer
- Programmer Details
Asanka has been working as a programmer and engineer for the last decade and currently serves as the main User Interface developer for GastroPlus® (version 10.0 or GPX). He specializes in C++, Javascript and python languages. He graduated from University of Moratuwa, Sri Lanka and completed his Master of Engineering at University of Western Ontario Canada.
Job Titles:
- Assoc. Dir., Sim. Studies Team Details
- Associate Director of the Simulations Studies Team
- Associate Director, Simulations Studies Team
Becky Graves is the Associate Director of the Simulations Studies Team at Simulations Plus where she works on consulting projects alongside mentoring scientists, providing mechanistic absorption and physiology-based pharmacokinetic (PBPK) models for the pharmaceutical industry. She uses her 10+ years of modelling experience to develop mechanistic models in various pre-clinical species and human populations, and to apply these to guide drug development at various stages of pre-clinical and clinical development.
Prior to joining Simulations Plus she worked at GlaxoSmithKline in positions of increasing seniority within Drug Metabolism and Pharmacokinetics (DMPK), progressing from bioanalytical work, through designing DMPK studies to providing the strategy for various drug discovery projects. Finally, Becky moved into a team dedicated to providing end-to-end mechanistic modelling for drug discovery and development, including predicting efficacious human doses prior to First Time in Human studies and supporting drug product development with physiologically based biopharmaceutics modelling (PBBM).
Besides her professional work and family, Becky enjoys playing field hockey and spending time in the great outdoors.
Job Titles:
- Principal Scientist Details
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- Member of the Executive Management Team
- President Details
Job Titles:
- Member of the Senior Leadership Team
- VP, Corp. Cnsl. & PDPO Details
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- Asst. Corp. Controller Details
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- Accounting Ops. Mgr. Details
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- Member of the Senior Leadership Team
- VP, Corporate Controller Details
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- Dir., Business Dev. Details
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- Member of the Simulations Plus Scientific Advisory Board
- Adjunct Professor Details
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- Member of the Senior Leadership Team
- VP, Cheminformatics Details
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- Principal Scientist Details
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- Dir., Learning Services Details
- Director of Learning Services
Denise Morris transitioned to Director of Learning Services at Simulations Plus in April of 2021. Prior to this, she served as a Director of Quantitative Pharmacology at Cognigen, Senior Quantitative Pharmacologist at Gilead Sciences, Associate Director of Quantitative Pharmacology at Cognigen, and as a Staff Scientist in Pharmacokinetics at Covance.
Dr. Morris has over 10 years of experience in clinical pharmacology. Her current focus is leveraging her extensive knowledge in modeling and simulation to assist in physiologically based pharmacokinetic training.
She has co-authored many publications in peer-reviewed journals and has presented abstracts and posters at national meetings on topics relating to these areas. Dr. Morris has a Ph.D. in Pharmacy (Clinical Pharmaceutical Sciences) from the University of Iowa and a Bachelor of Science in Biochemistry and Molecular Biology from the University of Miami. She is a member of both the American Society for Clinical Pharmacology & Therapeutics and the International Society of Pharmacometrics.
Job Titles:
- Mkt. Res. Analyst Details
Job Titles:
- Dir., Business Dev. Details
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- Principal Scientist Details
Job Titles:
- Exec. Dir., Sim. Studies Details
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- Dir. of Sim. Technologies Details
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- Member of the Simulations Plus Scientific Advisory Board
- Adjunct Professor Details
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- Principal Scientist Details
Job Titles:
- Member of the Simulations Plus Scientific Advisory Board
- Professor Details
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- Digital Content Creator Details
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- Principal Scientist Details
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- Staff Engineer, Operations Details
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- Operations Specialist Details
Job Titles:
- Member of the Executive Management Team
- President Details
Jill Fiedler-Kelly awarded with ISoP Fellowship for her professional excellence and superior impact in pharmacometrics, and for substantial volunteering work for ISoP on October, 2016.
Job Titles:
- Member of the Executive Management Team
- President Details
Job Titles:
- Member of the Executive Management Team
- President Details
Job Titles:
- Member of the Executive Management Team
- VP, Business Dev. Details
Job Titles:
- Project Coord. / CRM Admin
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- Member of the Senior Leadership Team
- VP, Biz. Integration & Transformation Details
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- Computer Scientist Details
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- Member of the Senior Leadership Team
- Exec. Dir., HR Details
Job Titles:
- Distinguished Scientist of Pharmacometrics
Luann Phillips has 29 years of experience in population PK and PK/PD modeling. She has been a population PK/PD scientist at Cognigen for 25 years, where she is currently a Distinguished Scientist of Pharmacometrics. Prior to her work at Cognigen, Ms. Phillips was a research assistant in the Clinical Pharmacokinetics/Dynamics Department at Burroughs Wellcome Company. Ms. Phillips has a master of science degree in biomathematics from North Carolina State University in Raleigh and a bachelor of arts degree in mathematics from Hendrix College in Conway, Arkansas. She has co-authored and contributed scientific expertise for many research papers, posters, and presentations. She has assisted with the development and instruction of basic NONMEM courses and has developed advanced NONMEM training materials. Ms. Phillips has also given a guest lecture on the methodology of covariate analyses at AAPS which later served as reference material in the book "Pharmacokinetic-Pharmacodynamic Modeling and Simulation" written by Peter Bonate.
Job Titles:
- Principal Scientist Details
Job Titles:
- Dir. of Alliance Mgmt. Details
Job Titles:
- Member of the Senior Leadership Team
- VP, Simulation Sciences Details
Job Titles:
- Principal Scientist Details
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- Professor
- Professor of Pharmacy
Paul B. Watkins, M.D., is a professor of pharmacy, medicine, and public health at The University of North Carolina at Chapel Hill (UNC), and the director of the UNC Eshelman School of Pharmacy Institute for Drug Safety Science (IDSS) since its formation in 2009. He serves as chairman of the Board of Directors for DILIsym Services, Inc., a company creating and using DILIsym software to improve the development of safer drug therapies, and director of The DILI-sim Initiative, a public-private partnership consisting of major life science companies charged with developing the DILIsym software.
As an internationally recognized expert in drug safety and a clinically trained hepatologist, Dr. Watkins has extensive research experience in drug-induced liver injury (DILI), which includes basic investigation in drug metabolism and transport, clinical studies, causation assessment, and regulatory affairs. He has been continuously funded for over 30 years by the National Institutes of Health for basic and translational research, and he is one of the most frequently cited authors in the field of pharmacology. He is chair of the steering and genetics committees for the U.S. Drug-Induced Liver Injury Network supported by the National Institutes of Health. Dr. Watkins is the recipient of numerous awards including the 2018 Toxicology Career Award from the American Society of Pharmacology and Experimental Therapeutics (ASPET), a MERIT award from the National Institutes of Health, the 2014 Agilent Thought Leader Award, and the 2015 Rawls-Palmer Innovation in Medicine Award; he has been elected to several honorary societies including the Association of American Professors (AAP). He has served on many advisory boards, including almost a decade on the GlaxoSmithKline Scientific Advisory Board.
Prior to serving as director of the IDSS, Dr. Watkins was director of the UNC Translational and Clinical Sciences (TrACS) Institute and principal investigator on the university's $60 M Clinical and Translational Science Award (CTSA) supported by the National Institutes of Health. His academic career started at the University of Michigan where he became Professor of Medicine and Professor of Pharmacology and director of the General Clinical Research Center.
Job Titles:
- Member of the Simulations Plus Scientific Advisory Board
- Assistant Professor Details
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- VP, Regulatory Affairs Details
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- Member of the Board of Directors
- Chief People Officer / Myrtle Consulting Group
- Chief People Officer Details
Ms. Evans has a proven track record in executing large-scale improvement projects across complex, multi-site organizations for Fortune 500 clients. She is an experienced practice leader driving business development, people management and development, and methodology and collateral stewardship. Ms. Evans most recently served as the Chief People Officer at Myrtle Consulting Group, a change management and sustainability consulting firm that is now part of Accenture. At Myrtle, she was responsible for the internal people processes to support Myrtle employees, and she also led the team responsible for the development and delivery of the people and organization capabilities and service offerings that are provided to Myrtle clients. Immediately prior to joining Myrtle, she was the Vice President of People and Organization at SSA & Company. Prior consulting experience also includes Hitachi Consulting, Celerant Consulting, and Ernst & Young Consulting. Sharlene earned a bachelor's degree in Industrial Engineering from Auburn University and a Master's degree in Industrial Engineering from Purdue University..
Sharlene Evans was appointed on November, 2021 as a Board of Director.
Job Titles:
- Member of the Executive Management Team
- CEO Details
Shawn M. O'Connor appointed as Chief Executive Officer(CEO) effective from June 26, 2018. Learn More
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- Marketing Coordinator Details
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- Member of the Senior Leadership Team
- CSO Details
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- Member of the Board of Directors
- Chairman Details
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- Member of the Executive Management Team
- CFO Details
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- Member of the Simulations Plus Scientific Advisory Board
- Professor Details
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- Associate VP, Regulatory Affairs Details
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- VP, Strategic Consulting Services Details