It’s been pretty clear for some time that there’s a big need to improve the efficiency of drug R&D. By industry’s count, drugs cost over $1 billion to develop, and most of them fail. A big reason why is the preclinical studies in petri dishes and animals don’t accurately predict how a drug will behave in humans.
That problem has prompted a slew of companies to innovate new ways to test drugs in a more human-representative fashion, and perhaps even change how preclinical testing is done. The latest to come along is Tara Biosystems, a New York-based Columbia University spinout whose founders say they’ve found a novel, stem-cell based approach that can simulate how a human heart would react to a drug.
Tara recently started up with the help of seed funding from New York-based Harris & Harris Group (NASDAQ: TINY), a publicly-traded venture firm that invests in early-stage companies. Misti Ushio, a managing director and executive VP of Harris & Harris, is leading the company, which is being incubated within the firm.
Regulatory filings show that Harris & Harris has invested around $300,000 in Tara. Ushio says the seed funding gives the company about a year’s worth of runway to prove itself—to validate its technology, convince pharmaceutical companies of its worth, and essentially earn an additional investment, like a full-fledged Series A round.
Tara is based on the work of two researchers: Columbia professor Gordana Vunjak-Novakovic and University of Toronto professor Milica Radisic. They met several years ago at Bob Langer’s lab at MIT and have since worked together to turn stem cells into mature heart tissue that can be tested as if it were an adult heart.
At the core of Tara’s technology are what the founders call “biowire.” Two parallel polymer wires are attached to the wells of a 96-well microplate (pictured above), a common piece of research equipment; the wells function as small test tubes.
The idea is that a researcher would put stem cells into the wells, and then mature them with the help of electrical stimulation. The stem cells grab on to the polymer wires and grow across them as they mature, eventually forming what amounts to tiny micro-hearts, with all of the different cell types that constitute adult heart tissue. Those tiny hearts beat, and pull on the wires when they do. The wires allow for tension, which is important, because by measuring how those wires move, a researcher could determine how the heart contracts, and what, specifically, is causing it to contract in the way it does.
The idea is that these measurements, on mature heart tissue, would give pharmaceutical companies a more accurate read on how drugs affect a human heart before they’re tested in people and potentially cause cardiotoxicity, or damage to the heart—a death knell for many drugs, not to mention hazardous for patients.
“People want all the features of the heart in one place, so you can see the interactions and how one thing influences the other,” says Ushio. “And then you can test new medicines to see how that changes.”
Tara envisions researchers using any stem cell type for this process, either grown in their own labs or purchased from a company such as Madison, WI-based Cellular Dynamics (NASDAQ: ICEL).
The biowire concept piqued the interest of Harris & Harris, which, Ushio says, has been looking for ways to harness 3-D tissue for commercial use. Ushio worked in Columbia’s tech transfer office for one year and is on the executive committee of a Columbia review body that funds translational research.
She’s known Vunjak-Novokovic for years and formed Tara a few months ago after gauging the interest of various pharma and biotech companies. The company was named Tara after a mountain in western Serbia, where both Vunjak-Novokovic and Radisic are from originally.
As with many fledgling biotechs with intriguing technology, Tara is still figuring out its business model. The founders don’t know whether they’ll simply make and sell their hearts-on-a-chip, or help their customers use them to get the data they need as well.
Tara has a lot of competition in trying to change the way preclinical testing is done. The idea of organs on a chip has been around for years, but it’s never been scalable, comprehensive, or user-friendly enough to make an impact on preclinical drug testing.
Now, however, advances in technology have led to a number of startups and academic groups with competing systems that are either already on the market, or on their way. A Boston startup called Emulate was just spun out of the Wyss Institute this past summer; it’s making a lung-on-a-chip, and has designs for an integrated body-on-a-chip.
Others include Seattle startup Nortis, a University of Washington spinout; North Brunswick, NJ-based Hurel Corp., which uses an organ-on-a-chip method to replicate liver tissue; and the Dutch firm Mimetas. San Diego-based Organovo Holdings (NYSE: ONVO) and others also aim to use 3-D printing techniques to help speed up preclinical drug development.
“We’re all trying to tackle the same problem,” Ushio says. “But Tara is trying to just tackle the heart first, and nail that. It’s pretty clear that people have been looking for the technology to do this, and they can’t find it.”