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Biosimulation Entelos Takes Step in Drug Development on Its Own

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As one of the (relatively) older hands at developing simulations for use in drug discovery and development, Entelos should be fairly knowledgeable about what pharma needs to move a drug down the pipeline. Now, Foster City, Calif.-based Entelos is planning to take a stab at drug development itself. This January the company plans to announce that it and an unnamed pharma partner will sign a co-development deal to bring a drug to market based on a target discovered by Entelos. “This will be a true demonstration of Entelos’ technology, as we apply our models across the various areas of drug development,” says James Karis, the company’s president and CEO.

Last summer, Entelos told Genome Technology’s sister publication BioInform that it planned to adapt for drug development its PhysioLab models for metabolism, rheumatoid arthritis, asthma, and HIV, which so far Entelos has employed only for contract research efforts with pharma. The strategy, the company says, is to plug a target into one of the disease models and attempt to predict the pharmacological characteristics an effective small molecule against that target would require.

Entelos’ announcement comes soon after the company was buoyed by the FDA’s interest in evaluating the potential for biosimulations to contribute to the drug approval process. In a white paper published last summer, the agency cited “computer-based predictive models” as one of several new technologies that pharma should adopt as part of its “new product development toolkit.” An FDA white paper does not bear the same weight as a guidance document, but signals the FDA’s willingness to consider new technologies and data sources in order to speed the drug approval process. “There’s no question, what’s happened at the FDA has heated up [the environment for biosimulations],” Karis says.

Tom Paterson, co-founder and senior vice president of Entelos, says one way his company’s models could provide useful data to the FDA is by predicting the potential ramifications of a drug’s on-target effect on a patient’s body, and estimating the likelihood of adverse effects for various patient subpopulations. Paterson, trained as an aerospace engineer, says the company’s simulations aren’t so good at modeling off-target effects, but that the company’s researchers are making progress.

FDA white paper urging pharma to adopt new technologies: "Innovation or Stagnation — Challenge and Opportunity on the Critical Path to New Medical Products:"
http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf

Entelos corporate website:
http://www.entelos.com

— John S. MacNeil

 

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