FRIDAY, SEPTEMBER 30, 2016

Certara announces partnership with C-Path to test TB drugs

Certara, a provider of software and scientific consulting services, announced a new partnership on Tuesday with the Critical Path Institute to develop a model of the human lung for tuberculosis drug testing.

C-Path, an independent non-profit organization committed to accelerating the development of safe medicines, will help Certara develop a physiologically-based pharmacokinetic model of the lung. The model will work in conjunction with Certara's Simcyp Population-based Simulator to predict the disposition of drugs within the lungs and the possible impact of disease progression on drug kinetics at different stages of TB infection.

"This model can be used by drug developers to define dose regimens that will produce clinical concentrations of anti-TB drugs at target sites in the lungs and help to expedite the development of new TB treatments," Martha Brumfield, the president and CEO of C-Path, said. "The majority of drugs that are currently used to treat TB are more than 40 years old have significant side effects and drug interactions and require a long treatment period. Furthermore they are becoming less effective as TB strains are growing increasingly drug resistant."

According to the World Health Organization, there were an estimated 8.7 million new cases of TB in 2011, including 1.4 million deaths.

"This lung simulation tool will allow pharmaceutical companies to simulate a wide range of variables in terms of drug dose disease state and concomitant medications for a much more efficient clinical trial design process," Daniel Weiner, a senior vice president and general manager at Certara, said. "Our Simcyp Simulator can already model population variability in PK, pharmacodynamic and cardiotoxicity responses. We are now building models to study different aspects of drug activity in the liver, heart and lungs."

The Critical Path to TB Drug Regimens Initiative, a collaboration of multiple entities meant to accelerate the development of new, safe and effective TB treatment regimens, is supporting the development of the lung model.

C-Path previously developed a similar model to simulate hypothetical clinical trial scenarios for Alzheimer's disease. In July, the tool was the first of its kind to receive a regulatory decision as fit-for-purpose from the U.S. Food and Drug Administration.