Anyone who has experience in drug development knows how unreliable preclinical animal studies can be. After a therapy has pushed on into Phase II and Phase III, investigators commonly stumble across unexpected side effects that can torpedo a drug after the developer has spent millions of dollars on the program.
But a pair of companies--iPierian and Cellular Dynamics International--are taking a new approach, using stem cells to create human tissue that promises to be far superior to rats and mice or other animals. And some Big Pharma companies like Roche and GlaxoSmithKline have been putting the technology to the test in their early-stage work. In Roche's case, investigators found that heart cells were able to flag an irregular heartbeat for one shelved drug--an important proof-of-concept test. By mimicking the reaction of human tissue to a drug, researchers can go a long way to identify potential risks while still in the lab.
"This is a transformative technology that puts human disease in a dish," Stanford stem cell expert Christopher Scott tells Bloomberg. "It can help companies see the drugs that work and also the ones that are toxic."
In iPierian's case, the company is making stem cells from patients with diabetes, heart disease and other conditions that investigators are closely focused on. CDI is making heart cells and plans to add liver and nerve cells in the near future. Both companies have won Fierce 15 awards and both earned some high-profile investors eager to take part in the drug research revolution.
- here's the story from Bloomberg BusinessWeek