SPEEDY DISCOVERY - C&EN Global Enterprise (ACS Publications)

Those robots are part of Kalypsys' effort to solve one of the pharmaceutical industry's biggest quandaries: how to get drugs into the clinic ... spin-...
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BUSINESS company reeling from information overload. Kalypsys has developed data processing, storage, and analysis tools that enable the company to make quick and informed decisions about drug candidates. Armed with this collection of tools, Kalypsys has set lofty goals for its drug discovery operations. The company believes it NTERING THE SCREENING LABORAhandle the heavy flow of data that emerges can shrink the time it takes to move from tories at the San Diego-based drug from its system. "You can go fast, but ifyou concepts and theories to the filing of an Indiscovery company Karypsys is like don't improve the odds ratio, then essentially vestigational New Drug (IND) application stepping into a sciencefictionnovel you're spinning your wheels," he adds. with the Food & Drug Administration. On A brigfit yellow robotic arm whizzes average, it takes companies five to seven around a shiny metal platform, transporting ONE CRITICAL FACTOR, Noble says, is t h e years to go from idea to I N D , McKearn plates containing hundreds of tiny wells filled company's starting materials. Traditional says. The company is on track to complete with compounds that could, one day, become drug discovery efforts force researchers to its first I N D application in less than three treatments for any number of diseases. choose either a biochemical or a cell-based assay, but Kalypsys' system enables its entire years, he notes. "And I think we can do Those robots are part of Kalypsys' effort better than 34 months." With that pace, collection of compounds to be run against to solve one of the pharmaceutical industry's Kalypsys intends to file one to two I N D biggest quandaries: how to get drugs into the both types of assays in a single day, saving applications each year. clinic faster and at a lower cost, while also time and avoiding the variability of sepaimproving the odds that they will prove to rate campaigns. In addition to time, the company is also be safe and effective in patients. confident it can significantly cut costs. And rather than interrogating a ranKalypsys believes that it will spend $12 Kalypsys, a privately held, 125-person dom assortment of interesting compounds, million to bring a drug from idea to I N D , firm, was founded in 2001 as one of three Kalypsys' internal chemical library contains about one-fifth of the $70 million indusspin-offs from the Genomics Institute of about 900,000 compounds that have been try average. Part of its ability to trim costs the Novartis Research Foundation. The cherry-picked on the basis of their adherence is its technology's miniature company inherited from Novar| scale, which enables the comtis a suite of drug discovery tech< pany to stretch its compound nologies, including its futuristicsupplies. looking ultra-high-throughput screening (uHTS) system, which Those time and investment can run a million samples per targets remain to be proven: day, and a library of 2.2 million Though Kalypsys has an interchemical compounds. nal pipeline of drug leads and preclinical compounds focused Screening at a big pharma on cardiovascular and metabolic company is typically a four- to diseases, inflammation, and onsix-month process, from idea to cology, the company has yet to decision-making, says Stewart file its first I N D application. Noble, Kalypsys' vice president of discovery chemistry. At KalypMeanwhile, Kalypsys is alsys, the u H T S system allows a lowing other firms to tap into campaign to be collapsed into its technology as a means of both 24 hours, a time frame that chal- ROBOTICS Engineer Benjamin Baumann operates generating revenue and adding lenges most drug companies' tra- Kalypsys' uHTS system. to its pipeline. Early relationditional views of drug discovery. ships were generally focused on Even Noble, whose previous stints include a single target, such as a 2003 deal with CV to Christopher A. Lipinski's "Rule of Five," senior director of chemistry at Pharmacia Therapeutics to develop high-throughput a rule of thumb that helps researchers preand discovery posts at Searle and Glaxo, screens for a cardiovascular target. dict whether a small molecule will be orally admits that it took him a while to come to More recently, the strategy has shifted bioavailable. terms with the approach. "It's been enlightto signing multiyear R&D collaborations Furthermore, the company maintains ening for me to have our technology comacross a therapeutic area, cluster of targets, that it never takes a cookie-cutter approach pletely change my mind-set," he adds. or disease pathway, McKearn says. The first by performing screens without regard to the Though the uHTS technology enables such deal was established inJanuary, when target. Instead, Kalypsys builds a chemical the company to zip through a million sameye-care company Alcon signed on for a profile that incorporates all the known inforples each day, executives at Kalypsys stress four-year stint to develop and commercialmation about a target into each drug-seeking that speed does not automatically translate ize ophthalmic drug candidates. mission. The process is iterative, so that the into success in the drug discovery business. Kalypsys intends to establish two more first batch of drug candidates to come out of a "MichaelJordan didn't just have a good jump similarly structured partnerships over the screening campaign can be winnowed down shot," says John McKearn, the firm's presinext 18 months, McKearn says. Between based on issues like safety, drug-drug interacdent and chief executive officer. its internal efforts and its partners, the tions, and selectivity for the target. Noble believes Kalypsys differentiates firm's goal is to retain one or two specialty The last piece of the equation is data itself by the quality of the questions being drugs, develop them, and bring them to management. Generating more than a milasked in each campaign and by its ability to market.-LISAJARVIS lion data points per day could easily leave a

SPEEDY DISCOVERY

Kalypsys hopes to accelerate the flow of high-quality drug candidates into the clinic

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C & E N / AUGUST 28, 2006

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