Certara Promotes Prof. Amin Rostami to Senior Vice President of R&D and Chief Scientific Officer

Rostami is recognized for his scientific leadership, original thinking, and commitment to knowledge sharing with his colleagues and students PRINCETON, NJ – Jan. 29, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that it has promoted Amin Rostami, Pharm.D., Ph.D. to senior vice president (SVP) of R&D … Continued

Common Misconceptions About Computer System Validation

Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and pharmacodynamics (PD) of an investigational drug. To satisfy regulatory expectations, these computer systems should be validated. As a recent article points out, failure to do computer system validation for the software functionality that a user intends to use, with data … Continued

Certara Updates Phoenix WinNonlin Validation Suite to Streamline Computer System Validation

Phoenix® WinNonlin® Validation Suite™ 4.0 can help ensure compliance, reduce total cost of ownership and improve work efficiency PRINCETON, NJ – Jan. 27, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced the launch of Phoenix WinNonlin Validation Suite 4.0 for automatic validation of the recently released Phoenix … Continued

Clinical Data Transparency Mandates Are Reshaping Regulatory Writing

New European and U.S. clinical trial data transparency initiatives—such as EMA Policy 70, which goes into effect this month—are creating additional disclosure compliance requirements for pharma and biotech companies. In this blog post, I’ll discuss the implications of these data transparency initiatives and present how Synchrogenix, powered by ClinGenuity and a Certara company, is addressing this emerging … Continued

Certara Appoints Gavin Nichols as President of Technology and Head of its Software Business Unit

Nichols brings more than 25 years of technology leadership in clinical informatics and advanced analytics to the company PRINCETON, NJ – Jan. 20, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that it has appointed Gavin Nichols to the newly-created position of president of technology. Mr. Nichols … Continued

Synchrogenix, Certara’s Regulatory and Medical Writing Consultancy, Acquires ClinGenuity

Deal provides Synchrogenix with proprietary technology, expert staff, and new capabilities to become the dominant player in life science regulatory and medical writing PRINCETON, NJ – Jan. 6, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that its regulatory and medical consultancy, Synchrogenix, has acquired ClinGenuity, the … Continued

Strategic Regulatory Writing for Drug Development Success

Happy New Year! The start of a new year brings the promise of new opportunities for growth—both personally and professionally. As the CEO for Synchrogenix, Certara’s regulatory writing consultancy, I’ve been thinking a lot lately about how changes in the regulatory writing landscape will shape the drug development process in 2015. It’s becoming more and more … Continued

Prediction of the Pharmacokinetics, Pharmacodynamics, and Efficacy of a Monoclonal Antibody, Using a Physiologically-based Pharmacokinetic FcRn Model

Although advantages of physiologically based pharmacokinetic models (PBPK) are now well established, PBPK models that are linked to pharmacodynamic (PD) models to predict pharmacokinetics (PK), PD, and efficacy of monoclonal antibodies (mAbs) in humans are uncommon. The aim of this study was to develop a PD model that could be linked to a physiologically based mechanistic FcRn model to predict PK, PD, and efficacy of efalizumab. The mechanistic FcRn model for mAbs with target-mediated drug disposition within … Continued