Paul B. Watkins, M.D.
Chairman, Board of Directors
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 a MERIT award from the National Institutes of Health, the 2014 Agilent Thought Leader Award, and the 2015 Rawls-Palmer Innovation in Medicine Award and 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.
M. Bud Nelson, Ph.D., JD
General Counsel, Director of Operations
M. Bud Nelson, Ph.D., J.D., is focused on building an innovative technology-based culture around software development and the life sciences in North Carolina through his current roles as Director of Operations and General Counsel at DILIsym Services, Inc.
Dr. Nelson has served on the management teams of numerous healthcare startups, including a Duke University-based incubator (MedBlue Incubator, Inc.), several life science companies, and in his current role as part of the management team and as a board member of DILIsym Services, Inc. He has more than 20 years of experience with intellectual property matters and has served as the intellectual property counsel for several biotech companies, including BioCrystal Ltd., Trimeris, Inc., Affinergy Inc., b3 bio, inc., as well as for The Hamner Institutes for Health Sciences. Additionally, Dr. Nelson is an inventor on several patents and published patent applications.
Dr. Nelson holds a law degree, and Master’s & Ph.D. degrees in Immunology and Microbiology, from the University of Buffalo. He also has Bachelor’s degrees in Medical Technology from SUNY Upstate Medical Center, and Biology from SUNY Geneseo. He is a member of the American Intellectual Property Law Association, a member of the State Bar of North Carolina, and is a registered attorney with the United States Patent and Trademark Office.
Brett Howell, Ph.D.
Chief Executive Officer
Brett A Howell, Ph.D., is the chief executive officer of DILIsym Services, Inc., a company developing and using DILIsym® software to improve the development of safer drug therapies, and has served on the Board of Directors of the company since 2016. He is also an associate director of the DILI-sim Initiative since 2011. In addition to being involved in operations, training and software architecture, Dr. Howell contributes technically in the areas of PBPK modeling, immune response, consulting project leadership and biomarkers.
Dr. Howell has published over 20 scientific papers in the areas of PBPK/PD modeling, in vitro toxicity testing, novel drug delivery systems, and drug safety. He has given invited scientific presentations at numerous national and international meetings, including the Society of Toxicology annual meeting, the Japanese Society of Toxicology annual meeting, the annual FDA/AASLD Drug-Induced Liver Injury meeting, the American Conference on Pharmacometrics (ACOP) annual meeting, the European Microsomes and Drug Oxidations annual meeting, and the Drug Information Association (DIA) annual safety meeting. He serves on the editorial board for the prominent Quantitative Systems Pharmacology (QSP) journal, “CPT: Pharmacometrics & Systems Pharmacology,” published by the American Society for Clinical Pharmacology and Therapeutics.
Prior to joining DILIsym Services, Dr. Howell was a research investigator and research scientist at The Hamner Institutes for Health Sciences, a non-profit organization that focused on translational biomedical research. He holds a Ph.D. in chemical engineering from the University of Florida and Bachelor of Science degrees in chemical engineering and textile engineering from North Carolina State University.
Scott Q. Siler, Ph.D.
Scott Q Siler, Ph.D. is the president of DILIsym Services, Inc., a company developing and using DILIsym® software to improve the development of safer drug therapies. He has served on the Board of Directors of the company since 2016. He is also an associate director of the DILI-sim Initiative since joining in 2011. He is co-project lead on the development of the DILIsym® software and is a project manager for DILIsym® services projects contracted by pharmaceutical companies. In addition to his duties in helping manage and advance the business of DILIsym Services, Dr. Siler continues to be a scientific contributor to DILIsym® services projects and development. Dr. Siler is leading the company’s efforts in the development of NAFLDsym™ software, computational model of non-alcoholic fatty liver disease (NAFLD) that can be used to predict efficacy for treatment modalities developed for treating NAFLD.
Dr. Siler worked for more than 12 years integrating physiology and mathematics with Entelos, a provider of in silico modeling and simulation products and consulting services. Dr. Siler also managed and contributed to the development of the Metabolism PhysioLab. Additionally, while at Entelos, he led multiple projects evaluating potential treatments for type 2 diabetes.
Dr. Siler graduated with a Ph.D. in nutrition and a bachelor of arts in biochemistry and molecular biology from the University of California, Berkeley.
Daniel Weiner, PH.D.
Dr. Weiner has extensive drug development experience and has served as an expert consultant to the U.S. Food and Drug Administration (FDA) on pharmacokinetic modeling and bioequivalence assessment. Prior to his previous tenure with Certara/Pharsight as a Senior Vice President and Chief Science Officer, Dr. Weiner held several management positions with Merrell Dow Pharmaceuticals; Statistical Consultants, Inc.; Syntex Development Research; Quintiles; and IVAX Research. Dr. Weiner graduated from the University of Kentucky with a doctoral degree in Mathematical Statistics, with emphasis on compartmental modeling. He is the original designer/author of the WinNonlin family of PK/PD Modeling Software now used by over 1,000 institutions. He is the co-author of Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, now in its 5th ed. Dr. Weiner is an Adjunct Associate Professor with Division of Pharmacotherapy and Experimental Therapeutics in the School of Pharmacy, University of North Carolina and is an Affiliate Professor of Pharmacometrics, Center for Translational Medicine in the School of Pharmacy at the University of Maryland.