MADISON, Wis.—Although it initiated the commercial launch of its iCell Cardiomyocytes in mid December, Cellular Dynamics International (CDI) says the story of its breakthrough launch is still very much a work in progress, as it rolls out the commercialization of the induced pluripotent stem cell-derived line in stages, with an expectation that the iCell Cardiomyocytes program will be fully up-and-running by the time of the 49th Annual Meeting and ToxExpo of the Society of Toxicology (SOT) that is being held March 7 to 11 at Salt Lake City's Salt Palace Convention Center.
The iCell Cardiomyocytes are designed for use in testing of new drug candidates by the pharmaceutical industry, and these human heart cells are intended in particular to aid drug discovery and "improve the predictability of drug compound efficacy and toxicity screens, weeding out ineffective and potentially toxic compounds early in the pharmaceutical pipeline process before significant time and resources have been invested."
"We've aimed for a phase launch because we wanted to make sure the early adopters will be supported appropriately, and that we're set for the later adopters as well," says Chris Kendrick-Parker, chief commercial officer of CDI. "To be honest, demand for this product has been quite brisk, and we're actually holding off some customers right now."
In fact, he reports, CDI is in the process of expanding the sales and marketing force to handle the expected high demand for iCell Cardiomyocytes.
The iCell Cardiomyocytes are derived from induced pluripotent stem (iPS) cells, spontaneously beat in vitro, and they are said to exhibit the electrophysiological and biochemical properties of normal human heart cells. Thus, iCell Cardiomyocytes are expected to provide significant advances over non-human cell models, which may exhibit a different response than human tissue; tumor-derived cell models, which are genetically different than normal cells; and cadaveric cells, which exhibit batch-to-batch variability, de-differentiate under in vitro conditions, and exhibit non-cardiomyocyte behaviour.
"One of the exciting things is that as we've launched this product, we've really had the opportunity to set the standards for this particular market and industry," Kendrick-Parker says. "This is the first commercial product ever developed from iPS cells."
The iCell Cardiomyocytes come from iPS cells discovered by CDI senior research fellow Dr. Junying Yu, who are the time of the discovery in 2007 was a postdoctoral research associate in the University of Wisconsin–Madison laboratory of Dr. James Thomson. The iCell Cardiomyocytes are produced in-house by CDI from a master cell bank of iPS cells expanded from a single clonal population reprogrammed from fully mature human cells using Thomson's patented technology.
Thomson, who is now chief scientific officer of CDI, says, "Rapid application of stem cell technology has been a goal both of my laboratory at the University of Wisconsin and CDI. Utilizing human iPS cells for new drug toxicity testing should improve the drug discovery process in a timeframe that has an effect on human healthcare now, not 10 years from now. Ultimately applications of stem cell technology in drug discovery will provide great utility and enable movement toward a long-term goal of cellular-based therapeutics and personalized medicine."
CDI executives note that, "Based on strong intellectual property and exclusively licensed patents from several universities, [we have] developed a proprietary process to industrialize iCell Cardiomyocytes production so that the cardiomyocytes are manufactured at the high quantity, quality and purity required by pharmaceutical companies."
CDI has successfully engaged in pre-launch validation testing with several pharmaceutical customers, Kendrick-Parker, and is happy to see additional validation coming from customers who have begun using the product more recently. "We'll be opening the doors completely on this product as of the SOT show in March. That conference was pretty significant for us last year as we were beginning to build demand for the product, and it will be even bigger this year as we can confirm things through our validation studies and those of customers that have used the cells."
"Drug toxicity testing is an important part of early-stage drug development," adds Kendrick-Parker. "The problem our pharmaceutical customers face today is that current cell models to test drugs are inadequate, because they are either non-human, cadaveric, or tumor-derived cells. They miss toxicities that might have manifested themselves in a human cell model. With the launch of iCell Cardiomyocytes, we hope to improve the efficiency and effectiveness of preclinical research studies, so that our pharmaceutical customers are more assured of the safety and efficacy of their drug candidates and a better return on their research investment."
"Launching iCell Cardiomyocytes to the pharmaceutical industry is an important step for Cellular Dynamics," says Robert Palay, chief executive officer of CDI. "We have shown that we can manufacture and provide validated human iPS cell-derived terminally differentiated cardiomyocytes in the quantity and quality needed by our customers. We look forward to growing this product with our pharmaceutical customers and developing line extensions of iCell Cardiomyocytes, including panels with multiple iPS starting materials, as well as launching other iPS cell-derived iCell products."
The iCell Cardiomyocytes are designed for use in testing of new drug candidates by the pharmaceutical industry, and these human heart cells are intended in particular to aid drug discovery and "improve the predictability of drug compound efficacy and toxicity screens, weeding out ineffective and potentially toxic compounds early in the pharmaceutical pipeline process before significant time and resources have been invested."
"We've aimed for a phase launch because we wanted to make sure the early adopters will be supported appropriately, and that we're set for the later adopters as well," says Chris Kendrick-Parker, chief commercial officer of CDI. "To be honest, demand for this product has been quite brisk, and we're actually holding off some customers right now."
In fact, he reports, CDI is in the process of expanding the sales and marketing force to handle the expected high demand for iCell Cardiomyocytes.
The iCell Cardiomyocytes are derived from induced pluripotent stem (iPS) cells, spontaneously beat in vitro, and they are said to exhibit the electrophysiological and biochemical properties of normal human heart cells. Thus, iCell Cardiomyocytes are expected to provide significant advances over non-human cell models, which may exhibit a different response than human tissue; tumor-derived cell models, which are genetically different than normal cells; and cadaveric cells, which exhibit batch-to-batch variability, de-differentiate under in vitro conditions, and exhibit non-cardiomyocyte behaviour.
"One of the exciting things is that as we've launched this product, we've really had the opportunity to set the standards for this particular market and industry," Kendrick-Parker says. "This is the first commercial product ever developed from iPS cells."
The iCell Cardiomyocytes come from iPS cells discovered by CDI senior research fellow Dr. Junying Yu, who are the time of the discovery in 2007 was a postdoctoral research associate in the University of Wisconsin–Madison laboratory of Dr. James Thomson. The iCell Cardiomyocytes are produced in-house by CDI from a master cell bank of iPS cells expanded from a single clonal population reprogrammed from fully mature human cells using Thomson's patented technology.
Thomson, who is now chief scientific officer of CDI, says, "Rapid application of stem cell technology has been a goal both of my laboratory at the University of Wisconsin and CDI. Utilizing human iPS cells for new drug toxicity testing should improve the drug discovery process in a timeframe that has an effect on human healthcare now, not 10 years from now. Ultimately applications of stem cell technology in drug discovery will provide great utility and enable movement toward a long-term goal of cellular-based therapeutics and personalized medicine."
CDI executives note that, "Based on strong intellectual property and exclusively licensed patents from several universities, [we have] developed a proprietary process to industrialize iCell Cardiomyocytes production so that the cardiomyocytes are manufactured at the high quantity, quality and purity required by pharmaceutical companies."
CDI has successfully engaged in pre-launch validation testing with several pharmaceutical customers, Kendrick-Parker, and is happy to see additional validation coming from customers who have begun using the product more recently. "We'll be opening the doors completely on this product as of the SOT show in March. That conference was pretty significant for us last year as we were beginning to build demand for the product, and it will be even bigger this year as we can confirm things through our validation studies and those of customers that have used the cells."
"Drug toxicity testing is an important part of early-stage drug development," adds Kendrick-Parker. "The problem our pharmaceutical customers face today is that current cell models to test drugs are inadequate, because they are either non-human, cadaveric, or tumor-derived cells. They miss toxicities that might have manifested themselves in a human cell model. With the launch of iCell Cardiomyocytes, we hope to improve the efficiency and effectiveness of preclinical research studies, so that our pharmaceutical customers are more assured of the safety and efficacy of their drug candidates and a better return on their research investment."
"Launching iCell Cardiomyocytes to the pharmaceutical industry is an important step for Cellular Dynamics," says Robert Palay, chief executive officer of CDI. "We have shown that we can manufacture and provide validated human iPS cell-derived terminally differentiated cardiomyocytes in the quantity and quality needed by our customers. We look forward to growing this product with our pharmaceutical customers and developing line extensions of iCell Cardiomyocytes, including panels with multiple iPS starting materials, as well as launching other iPS cell-derived iCell products."
