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FDA Launches Informal Initiative to Explore Biosimulation in the Regulatory Process


An informal effort is underway within the US Food and Drug Administration to study the potential applications of in silico modeling in the drug approval process, an agency official told BioInform last week.

Donald Stanski, scientific advisor to the director of FDA’s Center for Drug Evaluation and Research, said he is leading an emerging effort to “look critically at the degree to which in silico information can be useful in terms of both industry and agency decision making.”

The initiative falls under Stanski’s broader purview, which he described as “bringing new quantitative methodology into the agency … to facilitate regulatory review and clinical drug development.” Stanski said that the bulk of this work involves drug and disease modeling, exposure response modeling, and pharmacokinetic/pharmacodynamic modeling — empirical methods that rely on statistical software and are much more well established within the agency. In silico simulation of biological processes, however, “is just emerging” as an area of interest, he said, as part of the FDA’s recent “Critical Path” initiative to encourage the use of new technologies in the drug development process.

Most new biosimulation technologies, such as those being developed by companies like Entelos, Gene Network Sciences, and Genomatica, have grown out of drug discovery, so for now, Stanski said, “the only application that would be relevant for the FDA would involve pre-IND type meetings and dialogue, where these tools are used to provide some rationale or understanding as to the basis for whatever decisions were made.” Nevertheless, he said, it will be important for the agency’s medical reviewers to familiarize themselves with the technology, so he has begun introducing “several different individuals and companies who have in silico efforts to various parts of the agency to gain further exposure and understanding.”

In addition, he said, the agency is exploring the possibility of setting up CRADA opportunities for software vendors with products that may be of “value” for the FDA.

Stanski said that the agency has no plans just yet to issue a guidance document or other regulation regarding the use of data derived from in silico modeling. “At this point,” he said, “we’re in the process of learning more about it and bringing it to people’s attention and trying to internally define the value of it, both from a regulatory point of view and also from a drug development point of view.”

— BT

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