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FDA and Pharsight to Collaborate on Drug-Disease Modeling Repository Under Critical Path Initiative

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Drug-development informatics firm Pharsight said this week that it has signed a Cooperative Research and Development Agreement with the US Food and Drug Administration's Center for Drug Evaluation and Research to develop a data repository that will support drug-disease modeling within the agency.

The project falls under the FDA's Critical Path initiative, which has highlighted computational modeling and simulation as areas that it expects to help speed drug development.

Under the terms of the CRADA, for which financial details were not disclosed, FDA will use a number of Pharsight's software products for analyzing, storing, and managing pharmacokinetic/pharmacodynamic data, including Pharsight Knowledgebase Server, PKS Validation Suite, WinNonlin Validation Suite, Drug Model Explorer, and Pharsight Trial Simulator.

Mark Hovde, senior vice president of marketing at Pharsight, said that in return for access to the company's tools, FDA will provide "feedback on the utility of the tools in their environment."

Hovde said that Pharsight is "keen" to hear what FDA has to say about its technology, because while the company claims that all of the top 50 pharmaceutical firms license at least one of its products, the agreement marks the company's first deal with the regulatory agency.


"As FDA looks at its need to do more modeling, to better understand sponsored drugs, it needs the infrastructure to support that modeling."

FDA serves as "a new group of people to analyze data, and potentially a different type of data; for example, looking at data maybe more broadly than the sponsors have an opportunity to," Hovde said.

He added that Pharsight may upgrade its products based on FDA feedback, and is also considering modifying the system "to foster better collaboration between sponsors and FDA."

The primary purpose of the agreement is to develop PKS into a repository for clinical trial data, particularly related to clinical pharmacology and clinical safety reviews, that FDA can use for modeling and simulation.

Hovde said that under the Critical Path, FDA is asking pharmaceutical companies to do more in the area of modeling and simulation, which requires computational modeling tools, but also poses "a significant data-management problem."

In order to do effective modeling, "you're looking at issues across studies, and even across drugs … So you get these data sets, and you would like to be able to federate those datasets and incorporate them into a modeling analysis," he said. "So as FDA looks at its need to do more modeling, to better understand sponsored drugs, it needs the infrastructure to support that modeling."

Robert Powell, head of pharmacometrics in FDA's Office of Clinical Pharmacology, said in a statement that the CRADA with Pharsight is "concrete evidence of the FDA's commitment to the Critical Path Initiative," and that FDA expects Pharsight's software to "help us in applying model-based drug development skills to regulatory decisions, recommendations, and knowledge sharing."

In an interview with BioInform, Powell said that FDA's interest in drug-development modeling extends well beyond PK/PD.

"That's a part of it, but it's more going at disease modeling," he said. In the case of chronically degenerative diseases like Parkinson's or Alzheimer's, for example, "there can be a number of different subtypes of patients that can be partially explained by genotype, or it could be racial, or males versus females, but it's understanding the covariates, the factors that really characterize the disease."

Currently, Powell said, FDA is gathering data from prior NDAs, NIH databases, and the scientific literature to help develop disease models. "What we'd like to do is make this information more freely available and have people share it," he said, "although there are no concrete plans to do so at this time."

Nevertheless, Powell said, the field of model-based drug development "is a lot broader than what PK/PD was 15 or 20 years ago."

— Bernadette Toner ([email protected])

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