FDA renews and expands portfolio of drug modelling licenses

Published: 16-Nov-2017

The increased use of physiologically-based pharmacokinetic (PBPK) modelling and simulation (M&S) is a priority in both the prescription drug user fee act and for generic drug user fee amendments

Certara, a specialist in model-informed drug development and regulatory science, announced that the US Food and Drug Administration (FDA) has greatly expanded its use of Certara’s PBPK Simcyp population based simulator and its paediatric and cardiac safety simulators.

Under the new agreement, the FDA has almost tripled Certara’s number of licenses, equipping its M&S review team with almost 60 PBPK licenses.

FDA has been a Simcyp Consortium affiliate since its inception in 2003. The Consortium, which now has 36 leading biopharmaceutical member companies and numerous global regulators and academic centres as affiliates, serves as a collaborative research centre for PBPK and mechanistic modelling focused on the prediction of pharmacokinetic/pharmacodynamic outcomes in virtual patient populations.

“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,” said Dr Stephen Toon, BPharm, 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.”

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, optimise dosing, predict product safety and evaluate potential adverse event mechanisms.

FDA’s Office of Generic Drugs awarded a multi-year research grant to Certara and the University of Leuven in Belgium in October 2016 to create and validate a PBPK M&S framework to 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 expedite bringing newer, complex generic drugs to market.

Certara was also awarded an FDA GDUFA grant to develop a multi-phase, multi-layer skin model. This new model facilitates the virtual bioequivalence assessment of two drug formulations such as cream versus gel or the same formulation type with a different pH, viscosity or base.

The model takes into account a range of mechanisms that play an important role in dermal absorption, such as skin surface pH, dermal hydration, skin appendages, binding to keratin and drug-physiology interactions.

In addition, FDA’s Center for Veterinary Medicine has a Cooperative Research and Development Agreement (CRADA) with Certara until 2020 to create additional Simcyp PBPK canine models to help streamline veterinary drug development and evaluation.

Certara’s Simcyp Simulator is a sophisticated platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating new drug formulations and predicting drug-drug interactions, and pharmacokinetic outcomes in clinical populations.


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