The PRI Team
Bill Frame
Bill holds a BS degree in Pharmacy (FSU) and MS degrees (Applied Math and Biostatistics) from the University of Michigan, and has active licensure as a Pharmacist and a Preceptor. He worked inpatient hospital pharmacy at Metropolitan Hospital in Grand Rapids Michigan for seventeen years and served as the Pharmacy Clinical Coordinator for seven years.
Bill spent 9 years working as a Clinical Scientist at Parke-Davis Warner Lambert / Pfizer Global Research and now works with Projections Research Inc. His research interests include hierarchical models, categorical data analysis and Bayesian estimation methods. He has published 9 peer reviewed articles and one book chapter.
Bruce Green
Bruce studied for his pharmacy degree at Kings College London, which was followed by a registration year at Guys Hospital London. He completed his residency at St Thomas' Hospital London and was then appointed as the Directorate Pharmacist to Internal Medicine at the Royal Sussex County Hospital while studying for a Masters of Science at the University of Brighton (UK). He moved to Australia as a conjoint lecturer at the University of Queensland while completing his Doctoral studies in pharmacostatistical modeling and now holds a permanent academic position at the School of Pharmacy, University of Queensland.
Since completion of his doctoral studies he has gained industry experience in modeling, simulation and regulatory science and has served as a guest reviewer at the Food and Drug Administration. Bruce is the author of over thirty peer reviewed publications in the fields of clinical medicine and pharmacostatistical modeling and has made numerous presentations at various international conferences.
Paul Hutson
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 oncology and pharmacokinetics at the University of Wisconsin School of Pharmacy. He also serves the UWCCC Phase I cytotoxic research program by designing the pharmacokinetic components of the trials and processing the resulting data. His own research includes the treatment of symptoms associated with cancer or its treatment and population pharmacokinetic and pharmacodynamic modeling. Dr Hutson has published 27 manuscripts and 3 book chapters.
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 20 years experience in drug development and contributed to the approvals of a variety of (5) new Drug Products (small molecule, protein, and oligonucleotide).
He has been a consultant for 11 years and typically provides project management expertise while contributing directly to the Chemistry, Manufacturing and Controls content of the IND, NDA, or BLA submission.
Glynn Morrish
Glynn has received a Bachelor of Science majoring in Pharmacology and Physiology with an Honors degree in Pharmacology from the University of Adelaide, Australia. Following this he studied for his PhD degree in the area of drug metabolism and population pharmacokinetics, focusing on the prediction and quantification of drug-drug interactions. From 2006-2008 Glynn worked as a Research Fellow with the Modeling and Simulation Group at the University of Queensland. Since this time he has worked as an independent pharmacometric consultant for both the pharmaceutical industry and academia and also continues to supervise post-graduate students.
Glynn's current interests are centered on population analysis of pharmacokinetic and pharmacodynamic data and clinical trial design. He is a keen contributor to this field with a number of peer reviewed publications, conference and invited speaker presentations as well as providing review for scientific journals. Glynn is also involved in education of others, teaching courses in population modeling theory and analysis for the Population Approach Group Australia & New Zealand (PAGANZ) and the Population Approach Group of India (PAGIN), of which he also assisted in establishing.
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 in 1989. She has spent 19 years as a pharmacokineticist in the pharmaceutical industry where she specialized in population pharmacokinetic and pharmacodynamic modeling and worked as an associate Research Professor at Georgetown University. During this time, she has conducted population PK/PD analyses of hematopoietic agents, monoclonal antibodies, anti-cancer and anti-viral agents, antipsychotic and sedative/hypnotic agents. Dr Mould has also been 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 the development of their clinical trial simulation software package.
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 in 1989. She has spent 21 years as a pharmacokineticist in the pharmaceutical industry where she specialized in population pharmacokinetic and pharmacodynamic modeling and worked as an associate Research Professor at Georgetown University. During this time, she has conducted population PK/PD analyses of hematopoietic agents, monoclonal antibodies, anti-cancer and anti-viral agents, antipsychotic and sedative/hypnotic agents. Dr Mould has also been 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 the development of their clinical trial simulation software package.
Currently, Dr Mould is the president of Projections Research Inc, a consulting company offering pharmacokinetic and pharmacometric services to the pharmaceutical industry. She has published 33 peer-reviewed articles, 10 book chapters, and has made 66 national and international presentations on advanced modeling approaches and simulation work. Dr Mould has authored and presented 53 posters at both national and international meetings. She currently holds a position as an adjunct professor at the University of Rhode Island at Providence and teaches an annual class on disease progression modeling at the National Institutes of Health. Dr Mould had taught 8 short courses at three universities (Ohio State University, University of Rhode Island and SUNY at Buffalo) on specialized aspects of population pharmacokinetic and dynamic modeling.
Daniel Normolle
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. He has served on numerous NIH Special Emphasis Panels since 1989, 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 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.
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 Thomas
Tracey received her Masters in Information Science at the University of Florida in 1998 and is a member of the Phi Kappa Phi honors organization. For the past 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 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 120 papers and supervised a number of postgraduate students and post-docs.
Mango Solutions
Programming and Software Support
www.mango-solutions.com
