Collaboration Focused on Training the Next Generation of Pharmacometric Leaders
ST. LOUIS, MO – 2012 年 06 月 25 日 – Certara™, a market-leading provider of software and scientific services to improve productivity and decision-making in clinical drug development, announced today that the University of Maryland School of Pharmacy’s Center for Translational Medicine (CTM) has been named as the latest Phoenix® Center of Excellence, expanding the program created by Pharsight (now Certara), and continuing the company’s collaboration with academic departments and research organizations worldwide.
The Phoenix Centers of Excellence Program is an initiative designed to enhance research and training in pharmacometrics at several elite academic centers. Under this program, the Center for Translational Medicine will collaborate with Certara to promote excellence in pharmacometrics through topical lectures and webinars on the application of model-based approaches to improve drug development knowledge and decision making. Additionally, the Center for Translational Medicine will also participate in other activities designed to recognize important contributions to the field of pharmacometrics through expanded access to Certara software, including the Phoenix® desktop software platform for pharmacokinetic and pharmacodynamic (PKPD) data analysis and modeling.
The Center for Translational Medicine is led by Dr. Joga Gobburu, a world-renowned scientific leader in the area of quantitative disease models and their application to decisions. Dr. Gobburu is best known for transforming the field of pharmacometrics across the world into a decision-supporting science, and his background includes a stint at the FDA, where, under his direction, the Division of Pharmacometrics (DPM) was formed.
“We are very pleased to announce this relationship with the Center for Translational Medicine.” said Daniel Weiner, Ph.D., Senior Vice President and General Manager of Software at Certara. “There is a widely recognized global shortage of tomorrow’s pharmacometrics practitioners, and we believe that the unique thought leadership of Joga Gobburu, coupled with the resources of the University of Maryland’s School of Pharmacy, will be instrumental in creating the experts of tomorrow and filling this unmet need.”
“CTM is excited to be a Phoenix Center of Excellence,” noted Dr. Gobburu, Director, CTM. Collaboration with Certara allows CTM to achieve its mission to train the next generation Pharmacometrics leaders through our graduate programs. We envision that the relationship will also contribute to enhancing Phoenix software.”
“Designation as a Phoenix Center of Excellence by Certara is recognition of the excellence that our Center for Translational Medicine brings to clinical trial design and pharmacometrics,” says Natalie D. Eddington, PhD, FAAPS, FCP, professor and dean of the University of Maryland’s School of Pharmacy. “As initiatives to expedite smart clinical trial design move forward, our Center will play a substantial and important role in improving the quality of the decision-making process related to therapeutic choices for patients. We look forward to collaborating with Certara and value their support of our Center’s work.”
Phoenix is Certara’s desktop software platform that supports model-based drug development and its utility in translational science. Phoenix® WinNonlin® is the next generation of WinNonlin, the industry standard software for PKPD modeling and noncompartmental analysis. Phoenix® NLME™ provides powerful new data processing and modeling tools for population PKPD analysis, including the new Quasi-Random Parametric Expectation Maximization (QRPEM) algorithm designed to be faster and more accurate than existing mixed effects modeling methods. For certain test cases, QRPEM has been found to be between 2X and 5X faster than other similar EM methods due to its novel Sampling Importance Resampling algorithm, currently unavailable in any other population PK/PD EM software. Phoenix® Connect™ integrates applications built on the Phoenix platform with commonly used third-party analysis and modeling tools such as NONMEM®, R®, SAS® and S-PLUS®.
Certara is dedicated to improving human health through a broad spectrum of software products and consulting services, from molecular discovery through clinical development, with special focus on supporting translational approaches to drug development. Certara was formed by uniting industry leaders Tripos, provider of innovative scientific software solutions and services enabling life science researchers to improve the efficiency of molecular discovery; Simcyp, a research-based company providing predictive pharmacokinetic and pharmacodynamics tools, workshops, and consultancy services; and Pharsight® Corporation, provider of software and scientific consulting services to improve productivity and decision-making in preclinical and clinical drug development. Each Certara family brand has a primary focus on a key phase within the drug discovery and development process; combined, they offer a unique set of capabilities for modeling, analysis, and simulation with scientific informatics that can enable the cross-disciplinary approaches necessary for translational science initiatives. For more information, visit http://www.certara.com.
Diana O’Rourke, Director of Marketing
In today’s world, research into pharmaceutical innovations is conducted in silos. The field of translational medicine and the University of Maryland School of Pharmacy’s Center for Translational Medicine (CTM), a part of the Department of Pharmacy Practice and Science, aim to eliminate the silos and integrate information across development platforms. Here’s how:
- Using its unique ability to employ advanced and innovative analyses to create intelligence from information, the CTM analyzes and summarizes data from experiments and clinical trials using quantitative disease, drug, and trial models.
- These quantitative models, along with cutting-edge development techniques such as adaptive and enrichment trials, are integrated into tools that drug developers, regulatory agencies, and other research organizations can use to guide decisions pertaining to “go/no-go”, dosage, patient population, design, endpoint, analyses, and therapeutics choices.
The Center for Translational Medicine at the University of Maryland’s School of Pharmacy (CTM) also works with leaders in the field of translational medicine to further their education and develop their skills in order to foster innovation in medical product development.
For more information visit us at http://www.pharmacy.umaryland.edu/ctm/
Jeffrey Barbers, MS, RS
トランスレーショナル医療センター（Center for Translational Medicine）
20 N. Pine Street, room N522
Baltimore, Maryland 21201