Certara, a provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, is partnering with the independent nonprofit Critical Path Institute (C-Path) to develop a physiologically-based pharmacokinetic (PBPK) model of the human lung.

Built to work in conjunction with Certara’s Simcyp Population-based Simulator, the model will be used to predict the disposition of drugs within the lungs and the potential impact of disease-progression on drug kinetics at different stages of tuberculosis (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,” said Dr. Martha Brumfield, C-Path president and chief executive officer. “The majority of drugs currently used to treat TB are more than 40 years old, have significant side effects and drug interactions and require a long treatment period. They are becoming less effective as TB strains are growing increasingly drug resistant.” 

“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,” said Daniel Weiner, Ph.D., senior vice president and general manager at Certara. “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.”  

Development of the lung model is being supported by the Critical Path to TB Drug Regimens (CPTR) Initiative, a collaboration of pharmaceutical companies; government, regulatory and multilateral agencies; academia; civil society; advocates; and non-government organizations that aims to accelerate the development of new, safe and highly effective TB treatment regimens with shorter therapy durations.