FDA renews and expands use of Certara’s PBPK simulators

Decision support technology and consulting organisation, Certara, has revealed that the US Food and Drug Administration (FDA) has renewed and expanded its use of the company’s physiologically-based pharmacokinetic (PBPK) Simcyp population-based simulator and its paediatric and cardiac safety simulators.

Under the new agreement, the FDA has increased its number of licences (almost triple), which will equip the modelling and simulation (M&S) review team with nearly 60 PCPK licences.

“M&S is increasingly being recognised as a smart scientific stride toward reducing drug development costs, making the drug review process more efficient, and ultimately helping to cut the costs of new medicines,” explained Stephen Toon, BPharm, PhD, president and managing director of Certara’s Simcyp division. “We are delighted to see the agency recognising in both the PDUFA and GDUFA the value that mechanistic PBPK M&S can provide by answering ‘what if’ drug development questions and informing drug labels. Certara’s primary goals are to improve the efficiency of the drug development process and help get safer, more effective medications to patients who need them. We are partnering with the FDA and other global regulatory agencies to achieve those shared goals.”

Additionally, the FDA’s Center for Drug Evaluation and Research is currently using M&S to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms.

The agency’s Office of Generic Drugs has also awarded a multi-year research grant to Certara and the University of Leuven, Belgium, in October 2016 to create and validate a PBPK M&S framework that will enable the Simcyp Simulator to simulate and predict the behaviour of supersaturating orally-dosed drug products in the human gastro-intestinal tract. This research facilitates virtual bioequivalence assessments that can potentially speed up the process of bringing newer, complex generic drugs to market.

Furthermore, the FDA has granted Certara a GDUFA grant for the development of a multi-phase, multi-layer skin model to facilitate the virtual bioequivalence assessment of two drug formulations.