Michael J Bargfrede
Michael Bargfrede joins PRI with 20 years of pharmaceutical research and drug development experience, most recently with Millennium and Takeda Pharmaceuticals. An accomplished Clinical Pharmacology analyst, Michael specializes in PK/PD Non-compartmental Analyses with expertise across multiple therapeutic areas, including Oncology, Gastrointestinal, CNS, and Immunology.
Michael brings extensive experience as a Lead Analyst supporting programs at all stages of development and has been involved in numerous international approvals of small molecule, biologic, and antibody-drug conjugate therapies, including ENTYVIO®, NINLARO®, ADCETRIS®, and VELCADE®. Michael holds a B.Sc. in Biology from the University of Massachusetts at Dartmouth.
Immanuel is an independent consultant in Systems, Signals & Algorithms. His consulting services for pharmaceutical companies include modeling and simulation, preparation and presentation of findings in pharmacometrics and quantitative systems pharmacology. In particular, he integrates knowledge using pharmacometric models and quantitative systems pharmacology to design and analyze clinical and pre-clinical trials and experiments by translating exposure-response relationships across diseases, phases, and species.
Immanuel earned a doctorate in Physics from the University of Durham, England and is qualified as Chartered Physicist and as Senior Member of the Institute of Electrical and Electronics Engineers. He chairs the American Association of Pharmaceutical Scientists Pharmaco-Imaging Community and is licensed as a United States Registered Patent Agent.
Cliff Grant has worked in bio-medical research since 1984 in fields ranging from hypertension, respiration physiology, cerebral hypoxia to the pharmacokinetics of analgesics and anaesthetics. His M. Med. Sc from the University of Adelaide investigated the role of alpha-2 agonists for the treatment of common painful husbandry procedures in sheep. Recent work has focused on patient safety during the peri-operative process. From examining intra-operative adverse events to developing and validating a computer led process for patient health assessment and decision making prior to surgery. This work was acknowledged with a Best Scientific Paper for 2012 award from the journal Anaesthesia and Intensive Care. The software and assessment model developed by Cliff have been trialled in 4 major teaching hospitals within Australia and are currently being migrated in to the existing patient pre-operative process for ongoing implementation in at least one of these. hospitals. Cliff has authored and co-authored over 70 peer-reviewed publications.
Paul received his PharmD degree in 1981 from the University of Tennessee. Dr. Hutson also has an MS degree in chemistry (1976, University of Washington, Seattle) as well as two BS degrees. He serves as both a pharmacy educator and as an independent and collaborative clinical researcher. He is responsible for clinical and didactic instruction in at the University of Wisconsin School of Pharmacy. His research includes the treatment of symptoms associated with cancer or its treatment in collaborative group trials as well as population pharmacokinetic and pharmacodynamic modeling. Dr Hutson has published 34 manuscripts and 5 book chapters. Curriculum Vitae
Kaori Ito received her MS in Pharmaceutical Sciences from University of Tokyo, Japan in 1994 and PhD in Pharmaceutical Sciences from Kyusyu University, Japan in 2003. She also obtained her pharmaceutical MBA from the University of Rhode Island, USA in 2016. She is currently attending a MS program in biostatistics at Brown University, scheduled completion in 2020.
She started her career at Eisai Ltd (Japan) in 1994, and moved to Pfizer Japan in 1998, working as a clinical pharmacology lead, planning Phase 1-3 studies and performing pharmacokinetic and/or pharmacodynamics analysis. She moved to Pfizer Inc. Groton, CT USA in 2005, dedicated to modeling and simulations, supporting quantitative decision making and drug development as a member of the global pharmacometrics group. She served as a Director of Global Pharmacometrics/Point of Contact (PoC) from 2010 to 2017; Sr. Director/PoC in 2017 at Pfizer. Her research interests focus on applied PKPD modeling and disease progression modeling. She led efforts in developing model-based meta-analysis and knowledge management in Alzheimer’s disease (AD). Her work is extended to collaboration with CAMD (Coalition Against Major Diseases), serving as one of the major contributors to the M&S working group. She also served as a mentor for her colleagues, summer interns and post-doc, as well as providing R training internally and externally.
She has published more than 20 manuscripts at peer reviewed journals and 50+ abstracts/posters. She also received several awards in the pharmacometrics field, including “AAPS outstanding manuscript in modeling and simulation award” in 2008, “ACoP outstanding modeling and simulation abstract award” and “ISoP Quality Award” in 2009 and 2011. In addition, she received the “CAMD lifetime achievement award” in 2013 based on her leadership working with CAMD/Consortia and her dedication for developing CDISC standards database and a clinical trial simulation tool for Alzheimer’s disease; CAMD was the first to achieve regulatory endorsement (with FDA and EMA) for the “fit-for-purpose” Drug-Development Tool (DDT) guidance for quantitative models.
She started her consulting company and joined PRI in September of 2017. Additional information can be found at: www.appliedpmx.com
John read Mathematics at Cambridge University, England and has subsequently held various positions that have involved mathematics and computing. Initially John was involved in Sonar Systems research study theoretical and practical aspects of sound in dispersive mediums. Subsequently he worked for the Oil and Gas industry, both on the machinery and platform aspects. He then spent time in the Middle East working on refinery and equipment optimisation and planning.
He then became more involved with software development methods working on collaborative projects in Berlin, Germany and Paris, France before joining a company that developed S, the precursor to R. Subsequently he has remained very active in the R community supporting systems developments that include R (and other data modeling languages).
He is experienced in R, Python, C# as well as modern web development techniques.
Steven A Molnar
Steven A. Molnar received a BS in secondary education from Northeastern Illinois University and a PhD in biochemistry from The Ohio State University. Steve has 22 years experience in drug development and contributed to the approvals of a variety of new Drug Products (small molecule, protein, and oligonucleotide).
He has been a consultant for 13 years and typically provides project management expertise while contributing directly to the Chemistry, Manufacturing and Controls content of IND, NDA, or BLA submissions.
Diane R Mould
Dr Mould obtained her bachelors degree at Stevens Institute of Technology in 1984 in Chemistry and Chemical Biology. She received her PhD in Pharmaceutics and Pharmaceutical Chemistry at The Ohio State University (OSU) in 1989. She spent 30 years as a pharmacokineticist in industry where she specialized in population pharmacokinetic / pharmacodynamic modeling and was an associate Research Professor at Georgetown University. She has conducted population PK/PD analyses of hematopoietic agents, monoclonal antibodies, anti-cancer and anti-viral agents, antipsychotic, cardiovascular, and sedative/hypnotic agents. Dr Mould is involved in clinical trial simulation and optimal study design in drug development. She was a member of the Scientific Advisory Group for PharSight, where she assisted in development of clinical trial simulation software.
Currently, Dr Mould is president of Projections Research Inc., a consulting company offering pharmacokinetic and pharmacometric services. She is also the founder of Baysient LLC, a company that develops systems to individualize doses of drugs that are difficult to manage. She has published 96 peer-reviewed articles, 18 book chapters, made 124 national and international presentations and presented 6 podium sessions on advanced modeling and simulation approaches. Dr Mould has authored presented 112 posters at both national and international meetings. She is an adjunct professor at the University of Rhode Island (URI), OSU, and the University of Florida, and teaches an annual class on disease progression modeling at the National Institutes of Health. Dr Mould taught 9 courses (OSU, URI and SUNY Buffalo) on specialized aspects of population pharmacokinetic and dynamic modeling. She is a member of the editorial board for Journal of Pharmacokinetics and Pharmacodynamics, Clinical Pharmacology and Therapeutics, and Clinical Pharmacology and Therapeutics Pharmacometrics and Systems Pharmacology. She is a Fellow of the American College of Clinical Pharmacology and of the American Association of Pharmaceutical Sciences.
Daniel Normolle obtained his B.S. in Mathematics at Wilkes College, and his M.A. and Ph.D. in Statistics at the State University of New York at Binghamton (now Binghamton University).
He served as a faculty member in the Departments of Biostatistics and Radiation Oncology at the University of Michigan between 1989 and 2009. Currently, he is an Associate Professor in the Department of Biostatistics of the University of Pittsburgh Graduate School of Public Health and the Director of the Biostatistics Facility of the University of Pittsburgh Cancer Institute. He has served since 1989 on numerous NIH Special Emphasis Panels, and has been Biostatistics Core Director for a number of NIH-funded Program Projects and SPOREs.
He is currently co-PI on an NCI-funded R01 studying the design of dose-escalation trials, and has published methodology papers on assay calibration, organ motion and biomarker-adaptive clinical trial design. He has over 100 per-reviewed publications, has taught Introduction to Statistics, Regression and Statistical Modeling at the graduate level, and has presented invited talks on biomarker validation, dose-escalation trial design, and biomarker-adpative trial design.
Dr. Olson obtained a Bachelor of Science degree in Chemistry from Southern Oregon State University in 1976. He then transferred to Oregon State University with a major focus on Pharmaceutics and a minor in Statistics with a focus on applied multivariate and pattern recognition methodology. He received his PhD in Pharmacy in 1982.
Steve moved to Ann Arbor, Michigan in 1982 to work at Warner-Lambert/Parke-Davis holding bench, group and section leader positions in preclinical Pharmacokinetic and Drug Metabolism and Clinical Pharmacokinetics/Pharmacology departments. Shortly after joining WL/PD, in 1983, he attending one of the first NONMEM workshops in San Francisco. Steve remained closely associated with the discipline, contributing as a workshop leader for Stuart Beal for several years and co-founded and moderated MUFPADA, a Midwest US based Pharmacometrics forum that met annually from 1993 through 2007 and ultimately drew an international audience. He remained in Ann Arbor through the merger with Pfizer and held positions in Clinical Pharmacology and Pharmacodynamics and in the newly formed Clinical Pharmacometrics group. He left Pfizer and Ann Arbor in 2009 to pursue independent consulting in Boulder, Colorado. He then accepted an offer to move to Connecticut and establish a US based Pharmacometrics group for Boehringer-Ingelheim in 2011. He officially retired from industry in 2016 joined PRI that same year.
Timothy J. Taylor
Dr. Taylor obtained his bachelors degree in Pharmacy at the University of Connecticut in 1990 and has been a Registered Pharmacist since 1991. Tim received his Master of Science in Biotechnology also at the University of Connecticut in 1994 and received his Doctorate in Pharmacy at Shenandoah University in 2010.
Tim has spent 17 years in pharmaceutical research. He started his career at Pfizer Global Research and Development in 1994 performing preclinical research in the Pharmacokinetics, Dynamics and Metabolism Department using a multidisciplinary approach to predicting the human pharmacokinetics of candidate compounds. In 2001 Tim moved to the Clinical Pharmacokinetics and Pharmacodynamics Group at Pfizer in Groton, CT where he primarily performed non-compartmental pharmacokinetic analysis of phase 1-3 clinical trials. Since leaving Pfizer, Inc. in 2004, Tim has focused his career on Population Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of preclinical and clinical data by working as a consultant for various pharmaceutical and biotechnology companies. Tim has co-authored 6 peer-review articles, 1 book chapter and personally presented 7 posters at various scientific meetings and conferences.
Tracey received her master’s degree in information science at the University of South Florida. For 10 years she has been the Vice President of Communications at Viper Days. She is published in Viper Magazine and Viper Quarterly. She is currently working with Projections Research Inc. in business development and management.
Richard N. Upton
Dr Richard N. Upton has a BSc degree in general biology from Flinders University. He completed a PhD in 1989 at the Flinders Medical Centre, South Australia under the supervision of Professors Laurie Mather and Bill Runciman. His thesis investigated the physiological basis of drug disposition in specific organs and regions of the body using a chronically instrumented sheep preparation. From 1989 to 2009 at the Royal Adelaide Hospital, Dr Upton continued this large animal work investigating the physiological mechanisms underlying the absorption, distribution, metabolism and elimination of a number of drugs used in anaesthesia. Dr Upton also developed physiologically based pharmacokinetic-pharmacodynamic models to analyse data from this laboratory. He has contributed to pre-clinical drug development, including modelling and scaling of animal data to predict first dose in man. Clinical studies have included conducting Phase I and other clinical trials, and particularly the population pharmacokinetic analysis of data from clinical trials using NONMEM and other software. Dr Upton has published over 130 papers and supervised a number of postgraduate students and post-docs.
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