Certara, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, has partnered with the 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 C-Path president and CEO Dr Martha Brumfield. “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,” she explained.

“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.”

This TB project will result in another tool to help drug development similar to the Alzheimer’s disease (AD) clinical trial simulation platform from C-Path’s Coalition Against Major Diseases. That tool, which uses a computer model to simulate “what if” clinical trial scenarios, was the first of its kind to receive a regulatory decision as “fit-for-purpose” from the US Food and Drug Administration, and formal qualification from the European Medicines Agency, in July 2013. It is now available as a resource for sponsors developing AD drugs.

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

C-Path will be exploring further the benefits of using population-based simulations to enhance the drug development process during its “Modeling and Simulation for Medical Product Development and Evaluation Workshop,” which will be held on Sept. 26 at the W Hotel in Washington, DC.

C-Path  is an independent, non-profit organization committed to improving health and saving lives by accelerating the development of safe, effective medicines.