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Certara Creates Preeminent Global Strategic Modeling and Simulation Consultancy

New Entity Combines Certara’s Leading Model-based Drug Development Business with Scientific Powerhouse, Quantitative Solutions

PRINCETON, NJ – 2015年7月8日 – Certara®, the global biosimulation technology-enabled drug development company, today announced the merger of its consulting group, Pharsight Consulting Services (PCS), with Quantitative Solutions, a global pharmacometrics consulting company headquartered in Menlo Park, Calif. This move further strengthens Certara’s position in the burgeoning modeling and simulation/pharmacometric services field, broadening its modeling capabilities, deepening its therapeutic areas of expertise and adding new value-added services and clinical outcomes databases. The resulting organization is called Certara Strategic Consulting.

“Certara now offers the broadest array of modeling, simulation and strategic pharmacometric services from pre-clinical drug development through post-market approval,” said Certara Chief Executive Officer (CEO) Edmundo Muniz, M.D., Ph.D. “The breadth, depth and innovative strengths of our newly formed consultancy are unsurpassed in the industry and will be leveraged as we work alongside our clients to bring safer and more efficacious therapies to patients.”

“The merger of Quantitative Solutions with Certara’s consulting group is exactly the type of strategic move our organization was ready for,” said Jaap Mandema, Ph.D., former CEO of Quantitative Solutions, and new head of Certara Strategic Consulting. “Our integrated scientific consulting platform has the critical mass to allow for a quantum leap in the impact of modeling and simulation in drug development and beyond.”Dr. Mandema now reports directly to Dr. Muniz.

Certara Strategic Consulting has a strong presence in the US, Canada and Europe and early operations in Japan, Australia and China. Comprised of more than 70 scientists, consultants and industry professionals, Certara Strategic Consulting can now provide the most comprehensive range of outsourced modeling and simulation and strategic pharmacometric services to the global biopharma marketplace.

Certara Strategic Consulting currently serves more than 100 companies worldwide, including large pharmaceutical and established biotech companies, as well as medium and emerging biopharma companies, together with leading non-profit foundations and regulatory agencies.

This transaction increases Certara’s scientific strength. It broadens the company’s modeling capabilities by adding model-based meta-analysis (MBMA) – which uses highly-curated clinical trial data and parametric pharmacology models to increase drug development productivity, quantitatively inform portfolio management, and improve clinical trial success. A unique asset is the clinical outcomes databases for analyzing the comparative effectiveness of a new drug within its competitive landscape. These new offerings enhance Certara’s existing pharmacokinetic/pharmacodynamic (PK/PD) and physiologically-based pharmacokinetic (PBPK) modeling, clinical trial simulation, and regulatory writing services.

The merger also deepens Certara’s therapeutic and special population areas of expertise, which include oncology, cardiovascular, orphan/rare diseases, central nervous system, pediatrics, immunology, infectious disease, metabolic and endocrine disease, women’s health, pain, respiratory and ophthalmology.

Certara has four business units – Certara Strategic Consulting, Certara Software, Simcyp (which focuses on PBPK), and Synchrogenix (which specializes in regulatory writing).

Financial details about the transaction were not disclosed.

About Quantitative Solutions

Quantitative Solutions is a global pharmacometrics consulting company, which was founded in 2005. It develops quantitative models of preclinical and clinical pharmacokinetics, pharmacodynamics, efficacy, and safety data to enable better drug development decisions. In addition to these quantitative pharmacology consulting services, Quantitative Solutions also offers clinical trial outcomes databases (accessible through a web-based platform, KEEP) to help clients utilize the richness of publicly-available clinical trial data. For more information, visit http://www.quantitativesolutions.net.

Certara(サターラ)について

Certaraはバイオシミュレーション技術対応のグローバルな医薬品開発会社です。Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit www.certara.com.

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