Welcome to the home of ISoP’s new Special Interest Group (SIG) on Quantitative Systems Pharmocology. This SIG will be a forum for discussion and information sharing between members of ISoP with a interest in systems pharmocology.
Quantitative Systems Pharmacology (QSP)
To advance the development and utilization of safe and efficacious medicines through the application of Quantitative Systems Pharmacology (QSP)
Consistent with this Vision, we will:
- Advance the science of QSP by fostering a community for the exchange of ideas and knowledge
- Promote the application of QSP in drug development and regulatory decision-making
- Develop and maintain information resources for its members, including establishment of “best practices” for QSP approaches
- Facilitate communication and advance knowledge through sponsored sessions at professional meetings, white papers, discussion groups, and publications
QSP SIG Leadership Team
Valeriu Damian is leading the Modeling and Translational Biology group in GlaxoSmithKline and is responsible for providing translational modeling support for all therapeutic areas in GSK. This includes Quantitative Systems Pharmacology/Toxicology (QSP/QST) modeling, Physiological Based Pharmacokinetics and drug delivery modeling (PBPK), as well as PK/PD, TK/TD modeling. Valeriu holds a PhD in computer science from University of Iowa and a computer engineering diploma from Politehnica University of Bucharest in Romania. His carrier with GSK started over 17 years ago as a senior scientist in the Bioinformatics department initially responsible for the mathematical analysis and modeling of gene expression and proteomics data. As a manager in the Scientific Computing and Mathematical Modeling in GSK, he focused on developing tools for Systems Biology pathway modeling. Before taking the leadership role for the Modeling and Translational Biology he spent a few years as a director in the Open Innovation team in GSK where he worked on using sensors technologies to improve variability of clinical outcomes and non-invasive imaging technologies to validate model predictions. Valeriu focus has been on integrating diverse scientific ideas from multiple disciplines – mathematics, informatics, chemistry, physics, biology and engineering – into mechanistically based models and demonstrated their capability to interpret available data, to enhance understanding, to suggest testable hypotheses, to push the scientific boundaries and ultimately to bring better, faster and more affordable medication to the patients. Some of the areas of in which Valeriu has made significant contributions include: systems biology modeling, microarray data analysis, pathway and disease modeling, quantitative systems pharmacology models (QSP), powder modeling – applied to the inhaled drugs, lung deposition modeling, modeling of medical devices and packaging, drug stability modeling, physiology based modeling (PBPK) including detailed ocular, inhaled, long acting parenterals and transdermal drug delivery.
Dr. Brian J. Schmidt is a senior principal scientist in quantitative systems pharmacology within clinical pharmacology & pharmacometrics at Bristol-Myers Squibb. Brian earned his PhD in Biomedical Engineering at the University of Virginia. He received postdoctoral training in systems biology and computational biology at the University of Virginia; University of California, San Diego; and Sanford-Burnham Medical Research Institute. He also previously performed research as a dynamics engineer in QSP at Entelos, where he developed and applied mechanistic models in multiple therapeutic areas, including autoimmune, cardiovascular disease, and type 2 diabetes. He is currently leading a group responsible for the development and application of QSP platforms to support clinical development in oncology and immuno-oncology. His contributions cover multiple facets QSP, including model development, the development of new algorithms for calibrating mechanistic models to data, the development of software tools to support QSP, application of QSP to improve decision making throughout clinical development, and the application of QSP models in regulatory interactions.
Eric Sobie is a biomedical engineer by training and a systems pharmacologist by choice. He received his B.S. degree from Duke University, and his Ph.D. from Johns Hopkins, both in Biomedical Engineering. After postdoctoral training at the University of Maryland, he established an independent laboratory in the Department of Pharmacology at Icahn School of Medicine at Mount Sinai. At Mount Sinai, his NIH-funded laboratory aims to uncover fundamental mechanisms and improve drug development by combining physiological experiments with mathematical modeling. Specifically, his group has made important advances in understanding differences between individuals in response to pro-arrhythmic drugs, in using modeling to identify targets with improved anti-arrhythmic properties, and in developing algorithms to distinguish between dangerous and safe cardiac drugs. In addition to running a research laboratory, Eric also serves as Associate Dean for Programmatic Development in Mount Sinai’s graduate school.
Dr. Burke holds a BS and MS in Applied Mathematics from the University of Massachusetts, Lowell as well as a PhD degree in Applied Mathematics from Arizona State University. Prior to co-founding Applied BioMath, Dr. Burke joined Boehringer Ingelheim in 2008 as Associate Director, Head of Systems Biology. In 2011, he was promoted to Senior Principal Scientist. At Boehringer Ingelheim, he started, developed and managed the Systems Biology group, portfolio, and strategy. The group was responsible for applying systems techniques to the drug discovery process across all Research sites, and supporting Development and Medicine. Prior to Boehringer Ingelheim, Dr. Burke was at Merrimack Pharmaceuticals, Co-Scientific Director of the Cell Decision Processes Center, Systems Biology Department, HMS, and was a Sr. Postdoctoral Fellow in Douglas A. Lauffenburger’s lab, Biological Engineering Department, MIT. While at MIT and HMS, Dr. Burke provided consulting or advising for various companies, including AstraZeneca, Pfizer, Momenta, Matlab, and RES Group. Presently he is an on the advisory boards for the MIT “Human Physiome on a Chip” MIT-DARPA Program, and the Mathematics Department at the University of Massachusetts, Lowell.
Zinnia Parra is a postdoctoral researcher at the group of Pharmacometrics and Systems Pharmacoloy at the University of Navarra. Pharmacist by training, she obtained her PhD degree in Pharmacy in 2013 focusing on the field of Pharmacometrics applied to preclinical development of therapeutic proteins. Then, Zinnia worked for 2 years as a postdoctoral fellow at the Freie Universitaet Berlin applying pharmacometric concepts in clinical drug developement. She is currently working on QSP approaches in oncology and immune related diseases.
Michael G. Zager
Dr. Zager is an associate scientific director in the clinical pharmacology organization at Janssen Pharmaceutical Companies of Johnson & Johnson. Starting at Janssen in November 2013, Mike has primarily focused on partnering with discovery and early development project teams, assisting in preclinical PKPD plans and analyses, quantitatively assessing exposure-response relationships, and providing human efficacious exposure and dose projections. Mike’s passion is in the preclinical space and loves working with teams to hunt for drugs. Mike relies on a variety of modeling methods for drug hunting, from basic PKPD to quantitative systems pharmacology. Prior to Janssen, Mike spent 8 years at Pfizer, where he was part of a team of PKPD modelers that successfully created a paradigm where quantitative PKPD modeling and human efficacious dose projections are now standard practice for preclinical compounds nominated for NME status. Prior to Pfizer, Mike was a postdoctoral trainee at the U.S. EPA human health research center in North Carolina, and he received his Ph.D. in computational mathematics at North Carolina State University in 2003.
Steering Committee Members
- Darrell Abernethy
- Masoud Jamei (AAPS QSP Chair)
- Rukmini Kumar
- Don Mager (ISoP Executive Committee)
- Mark Peterson
- Matthew Riggs (ASCPT QSP Chair)
- Julio Saez-Rodrigues
- Stephan Schmidt (FIP QSP Chair)
- Vikram Sinha
- Craig Thalhauser
- Piet van der Graaf
- Paolo Vicini
- Cynthia J. Musante
What is Quantitative Systems Pharmacology?
The white paper below represents the NIH’s attempt to define the opportunities and challenges facing the field of quantitative systems pharmacology (QSP). The paper recommends the adoption of a holistic approach to understanding the interaction of drugs with human biology. The paper further notes that this will require the collaboration and training of scientists from multiple disciplines, from pharmacology to chemistry to computer science. We look forward to hearing from ideas from our SIG members about how these disciplines can be effectively synthesized so that QSP can continue to grow as a field.
Are you interested in receiving updates and participating in SIG discussions? Join the ISoP QSP SIG today, click here. You can also participate in the QSP discussion forum at http://discuss.go-isop.org/c/systems-pharmacology