At Cellular Dynamics, The Beat Goes On Under Fujifilm Ownership

Xconomy Wisconsin — 

Arne Thompson, an application support manager at Cellular Dynamics International, places a culture of manufactured human cells under a microscope. He points to a large screen above his head showing a close-up view of the lab dish contents. The cells are alive, pulsating in near perfect unison at a rate of about one beat per second.

With just a cursory glance at the screen, most people could probably infer these cells are related to the heart, given their rhythmic behavior. More precisely, they’re cardiomyocytes, the cells that constitute cardiac muscle.

Thompson takes out a beaker containing a red liquid, and draws a sample with an eyedropper. He explains that the compound he’s about to apply to the cells is in the same class as adrenaline, and behaves similarly.

“This might remind you of ‘Pulp Fiction,’” he says, referencing a scene from the 1994 Quentin Tarantino film in which a character is revived with a hypodermic needle after a drug overdose.

Thompson spatters some of the substance onto the cells and almost immediately they begin to palpitate. Eventually, the throbbing becomes more sporadic, as the compound wears off and the effect of a less temperate environment—in storage, these cells are kept at 98 degrees Fahrenheit—sets in.

Simply watching these heart cells thump together is captivating and instructive. But ask Chris Parker, executive vice president at Madison, WI-based Cellular Dynamics, and he’ll tell you the magic—and much of the money—is in determining how different types of cells react to particular substances.

“Our cells are just cells unless you can find an application,” says Parker, occasionally chiming in during Thompson’s demonstration. “The cell itself just sits there and beats. But when he squirts the drug on it, all of a sudden it becomes a drug discovery tool. Now, we can measure that response and see what that drug will do for that patient.”

In 2004, James Thomson, a stem cell pioneer and professor at the University of Wisconsin-Madison, co-founded the company, known as CDI. The business was built to further research and development of induced pluripotent stem (iPS) cells, which Thomson helped discover and can be differentiated into any type of cell found in the human body.

Since then, CDI has concentrated primarily on producing iPS cells to be used in safety and toxicity testing on new drug candidates. Purchasers of these cell lines are typically academic researchers or companies like Roche, the Swiss pharma giant that this month inked a deal with CDI that could be worth up to $83 million.

That model could shift toward in-house drug development, now that CDI is under new ownership. In March, Tokyo-based Fujifilm acquired the company for $307 million. About two months later, Kaz Hirao, who previously managed business development for Fujifilm’s pharmaceutical division, became CDI’s chief executive.

“The technology of the iPS cells was a key reason for acquiring CDI,” Hirao says in an interview at the company’s Madison office. “Fujifilm has the clear goal of becoming the number one company in regenerative medicine,” a field into which the multinational has been making a push though acquisitions and in-house research.

Hirao says that given Fujifilm’s “highly industrialized production and engineering technologies,” there may come a day when CDI not only makes the cells used in drug discovery, but also leverages the infrastructure of its parent company to conduct the research, development, and clinical trials necessary to commercialize a new therapy. But, he says, CDI’s decision on whether to go that route or continue focusing on cell production will depend on weighing the costs and risks against the promise seen in any in-house drug development projects.

Such a change would also need to make monetary sense. Hirao says CDI is aiming to become profitable in three years. Last year, the company reported a $30.6 million loss on $16.7 million in revenue. Following the acquisition, CDI is no longer publicly traded, meaning it doesn’t have to report earnings.

The potential damage to short-term financial performance is one reason CDI may opt to expand its footprint slowly, if it does so at all. Another might be that the 155-employee company has a good reputation for creating cell lines, says Thorsten Schlaeger, head of the Human Embryonic Stem Cell Core Facility at Boston Children’s Hospital and an expert in pluripotent stem cells.

“There are still very few companies that offer iPS-derived cells as a product,” Schlaeger says in an e-mail. “CDI is known as a reliable provider of high-quality cells. They are one of the first to use this business model, and they are a leader.”

Whether CDI decides to create its own drug development pipeline will hinge in part on how deeply it and Fujifilm are willing to reach into their pockets, says Cade Hildreth, president and CEO at BioInformant, a stem cell market research firm. She points to a 2014 study from the Tufts Center for the Study of Drug Development that estimated the cost of a new drug to be about $2.6 billion.

“However,” says Hildreth in an e-mail, “cellular products will be the future of medicine, because we are not made of drugs, we are made of cells. There has never been greater opportunity for the development of cell therapy products. In the long run, it could be very lucrative.”

According to a case study on CDI Hildreth authored earlier this year, competitors also working to develop iPS cell therapies include Marlborough, MA-based Ocata Therapeutics (NASDAQ: ACTC), which the Japanese drug firm Astellas Pharma recently bought for $379 million, and two San Diego companies: Fate Therapeutics (NASDAQ: FATE) and ViaCyte.

Parker joined the company in 2007, long before the acquisition. He says before Fujifilm entered the picture, cash flow and fundraising were often top of mind for leaders at CDI. To insulate itself from financial risk, he says, it usually made the most sense to find partners to co-fund clinical studies, which can be long and expensive.

“The big difference between now and then is now we have more choices,” Parker says. “Now, we have an internal large stakeholder that has the ability to fund activities, should [it] choose. Fujifilm has allowed us to accelerate things.”

CDI currently has a consignment agreement with the UW-Madison allowing the company to use a campus lab that the FDA has approved for clinical trials and drug manufacturing, Parker says. If CDI were to ramp up its operations significantly, it might need to find another facility—or build its own.

“The questions now are where, when, and how big?” Parker says. “Is it a Fujifilm facility? Is it a CDI facility? Is it an external facility? We’re evaluating all those options right now. It’s going to be dependent on scale.”