Strategic Consulting and Advisory Services
Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. Our multidisciplinary team works alongside clients to inform key drug development decisions and expedite the processes around achieving regulatory milestones.
Software Portfolio: 'End-to-end' Modeling
Certara biosimulation (model based drug development and informatics) software portfolio is the most wide-ranging in the industry. Certara technology is relied upon by over 1,500 biopharm companies and academic institutions for drug research and development.
Certara's Programmatic Consulting Approach Delivers Unquestionable Value to Sponsor Companies
Certara combines its industry renowned pharmacometric and regulatory consultants with our vast software portfolio to provide services that focus on specific outcomes, therapeutic areas, regulatory milestones, and specific populations.
Leading Edge Science: Resource Library
Check out the latest brochures, case studies, white papers, webinars, and more! Search by keywords and/or filter results.
Certara Expands Senior Scientific Team
September 06, 2012
Christine Garnett joins as Principal Scientist to lead cardiac safety software tool development and cardiac safety assessment consulting practice
ST. LOUIS, MO – September 6, 2012 – Certara™, a leading provider of scientific software and consulting services to improve productivity and decision-making from drug discovery through drug development, today announced that Christine E. Garnett, PharmD will join the organization as Principal Scientist. In this role, Dr. Garnett will lead development of next-generation cardiac safety modeling tools on the Phoenix™ software platform and will also work closely with Pharsight’s global consulting services team on predictive modeling engagements that leverage early clinical study data to assess the cardiac proarrhythmic risk of new drug candidates.
Dr. Garnett brings more than 15 years of scientific leadership in the area of clinical pharmacology and cardiovascular safety, including exposure-response modeling for regulatory decisions, population pharmacokinetic analysis, and evaluation of concentration-QTc (C-QT) data for optimal trial design and dose selection. Dr.Garnett most recently served as Team Leader in the Division of Pharmacometrics, Office of Clinical Pharmacology, at the US Food and Drug Administration. Since 2007, she has served as Scientific Leader of FDA’s Interdisciplinary Review Team for QT Studies. Dr. Garnett has led pharmacometrics teams in multiple therapeutic areas, including oncology, metabolism, and gastroenterology, and has contributed extensively to the advancement of model-based drug development approaches through peer-reviewed publications, scientific presentations, and teaching.
In making the announcement, Dan Weiner, Ph.D., Certara’s Senior Vice President and General Manager for Software Products and Consulting Services, said, “Christine’s experience and leadership in the field of cardiac safety assessment will be particularly valuable as we execute on our plans to advance the capabilities of Phoenix, our platform of pharmacometric analysis and modeling tools, and to further enhance the services that we provide to our clients to improve drug development productivity and decision-making. We are very excited to welcome Christine to Certara and look forward to her contributions.”
“I’m very pleased to be part of the Certara team,” added Dr. Garnett. “The stakes around proper thorough QT study design and timing are critically high for drug development organizations where scrutiny of the QTc safety signal impacts development, regulatory approval and labeling of every drug in its pipeline. I look forward to working with the Certara senior management team and its world-class scientific and technical groups to further strengthen the company’s cardiac safety software and service offerings.”
About Certara
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.
Certara Contact:
Diana O’Rourke, 314-951-3310
Director of Marketing
diana.orourke@certara.com