Can Modeling & Simulation Inform Personalized Medicine?

Pharma faces an existential crisis. The cost and time lines of developing new medications have been growing exponentially for decades, with no end in sight. Could modeling and simulation approaches be the Next Great Hope for ending this madness and restoring sustainability to drug development? At the same time, can it deliver on the promise of … Continued

Certara Honored with 2015 R&D 100 Award for Its Muse Invent Software

PRINCETON, NJ – Dec. 14, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that it has been honored with a 2015 R&D 100 Award in the Software/Services category for Muse® Invent™. This awards program recognizes the 100 most innovative technologies and services of the past year. Muse Invent allows researchers to … Continued

Mechanistic and Conventional IVIVC: Complementary or Clashing Approaches?

Drug developers frequently use in vitro-in vivo correlations (IVIVCs) to: Serve as a surrogate for human bioequivalence (BE) studies. Support and/or validate the use of dissolution methods and specifications. Assist in quality control during manufacturing and selecting appropriate formulations. Conventional IVIVC uses deconvolution methods such as Wagner Nelson, Loo-Riegelman and numerical deconvolution to estimate the … Continued

The Ultimate Guide to the Biosimulation Revolution

In my work with biopharmaceutical companies, universities, and regulatory agencies, I fly a lot. Looking out the airplane window, the revolutionary impact of biosimulation on drug development struck me. Unfamiliar with the concept of biosimulation, or modeling and simulation (M&S)? You can think of it as the vast improvements in air travel that have been … Continued

Certara Launches Version 15 of Its Simcyp Population-based Simulator

PRINCETON, NJ – Dec. 8, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced the release of version 15 of its Simcyp® Population-based Simulator. The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically-based pharmacokinetic (PBPK) modeling and simulation platform for determining first-in-human dose selection, predicting drug-drug interactions (DDIs), understanding drug disposition … Continued

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions between drugs and patients, including beneficial effects and adverse effects. I recently had the pleasure of talking to a thought leader, Dr. Lawrence Lesko, about the history of pharmacometrics and how it will continue to shape drug development in the … Continued

Certara Appoints Prof. Piet van der Graaf to Lead New Quantitative Systems Pharmacology Organization

PRINCETON, NJ – Dec. 1, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that it has appointed Professor Piet van der Graaf, PharmD, PhD, as its vice president of quantitative systems pharmacology (QSP) and the head of its new Simcyp® QSP organization. Van der Graaf is professor of systems pharmacology, chair … Continued

Certara Acquires Quantitative Systems Pharmacology Consultancy, XenologiQ

PRINCETON, NJ – Dec. 1, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that it has acquired XenologiQ, a UK-based quantitative systems pharmacology (QSP) consultancy. “This transaction strengthens Certara’s modeling and simulation capabilities, increases its leadership in mechanistic pharmacology, and supports the company’s precision medicine vision,” said Certara Chief Executive Officer … Continued