Profitability in a $50 Billion Market: Fujifilm Projections and Cellular Dynamics

A Japanese firm that is the beneficiary of a $16 million award from the California stem cell agency was the subject yesterday of a piece in the Wisconsin State Journal.

The article by Judy Newman involved Fujifilm and Cellular Dynamics International (CDI) of Madison, Wis. The Japanese business bought Cellular Dynamics last April for $307 million. By that time, Cellular Dynamics had received the California cash to help create the world's largest public stem cell bank at the Buck Institute north of San Francisco. 

The stem cell agency has pumped more than $32 million into the project.

The occasion for the Wisconsin story was an interview with Kazuyoshi Hirao, CDI’s new chairman and CEO, and Chris Parker, executive vice president and chief business officer. The story also reported that Jamie Thomson, the famed University of Wisconsin researcher who founded the firm, is no longer employed by it. The newspaper did not elaborate.

Here are some highlights from the Q&A.

Parker said that Fujifim intends to bring to bear large-scale manufacturing practices on cellular production. He continued,

"Fujifilm believes regenerative medicine (using stem cells to treat diseases) will be a $50 billion market by 2025. Manufacturing will have to ramp up with it. We will have to look at leveraging other technologies to scale the business.

"The concept is that some day, we’ll each have our own iPS cells made and banked. So that when you need heart cells after a heart attack or you have eye damage from age-related macular degeneration, you pull your own cells out of the stem cell bank. Or you can use them to test drugs for toxicity before you take them.

"We’re envisioning replacing existing cells that will stay in the body and not be sloughed off later."

Hirao said, 

"We have a very aggressive target: 60 percent growth in revenue each year, for the next five years. We want our cells to be used for drug research and screening and for cell therapy — treating diseases."

Parker said, 

"CDI already has three cell therapy programs going — for age-related macular degeneration; Parkinson’s disease; and to replace scarred heart muscle after a heart attack — all using our iPS-derived cells. We anticipate being profitable by the end of 2017.

"CDI has 160 employees, about 120 of them in Madison. We expect to hire another 15 to 20 by the end of 2016, at least 10 of them in Madison.

Hirao said,

"We are trying to change the model. Current drug testing is performed, mostly, using animal cells. By 2019, we want the majority of drug testing to use iPS cells instead.

"Once the market is created, there will be a big jump in sales. That’s why Fujijilm has great expectations for this."

Moderate Media Coverage of California's New, $32 Million Stem Cell Bank

The California stem cell agency this week scored moderately well in media coverage of the announcement of its $32 million stem cell bank, the world’s largest such public effort.

Most of the coverage was based in California but, of course, all of the stories can be read globally. The San Francisco Chronicle, The Sacramento Bee and a chain of newspapers in the Bay Area carried articles, among others.

Missing was coverage from major national outlets, such as the New York Times. Also absent was coverage by television news outlets, according to a search this morning on Google. A spokesman for the agency said the Buck Institute, which houses the bank, has restrictions on video coverage.

Ron Leuty of the San Francisco Business Times called the bank opening a “big win” for the $3 billion agency.  

A story by Stephanie ONeill of  KPCC  carried a factoid missing from all other stories – the cost of the cells from the bank in Marin County, north of San Francisco. O'Neill reported,

"The cost of each vial will range from $750 for researchers affiliated with nonprofit research organizations to $1,500 for those who work  for-profit companies, says (California) Institute for Regenerative Medicine spokesman Kevin McCormack."

The Bee story reported much larger figures, which the stem cell agency today said are incorrect.

Jeff Buchanan, who is based in Wisconsin for xconomy, wrote a story with a headline that reflected his focus on the Wisconsin firm involved,

“Cellular Dynamics Launches ‘World’s Largest’ Public Stem Cell Bank”

Buchanan also wrote that the company’s executive vice president, Chris Parker, said that the bank offers more than other banks. Buchanan reported,

“’The diseases, the demographic information that’s associated with them, the clinical data, the genetic and genomic data available—that’s what’s really making these lines valuable,’ (Parker) says. Donors gave consent for their tissue samples to ‘be used for a variety of research purposes,’ giving investigators considerable latitude, says Parker.”

Here are links to the other stories that turned up in the Google search this morning: San Francisco Chronicle, San Jose Mercury News and other papers in its chain, KGO, California Healthline, Philadelpha Business Journal and Latino Health.

California's Stem Cell Bank and Its Fujifilm Moment

A CIRM slide from last week on the Cellular Dynamic stem cell bank project.

Remember the “Kodak Moment?” California’s $3 billion stem cell agency yesterday experienced a “Fujifilm Moment.”

It came when the Japanese firm announced it was buying Cellular Dynamics International (CDI) for $307 million. That doubled the price of the company stock overnight, probably leading to moments of ecstatic celebration in some circles. The stock closed at $16.43 today, well above its 52-week low of $4.72.

The purchase was part of what FierceBiotech today called a “fresh frenzy of biotech-related buyouts.”

Cellular Dynamics is a Wisconsin firm that has a $16 million grant from CIRM, as the stem cell agency is known, to create what could be the world’s largest bank of induced pluripotent stem cells (iPSCs). The firm was founded by noted University of Wisconsin researcher Jamie Thomson. The bank is located at the Buck Institute in Novato, north of San Francisco. The 155-employee CDI is also the prime subcontractor on a related $10 million award to the Coriell Institute.

At the CIRM board meeting last week, Uta Grieshammer, a science officer at the agency, gave an update on the $32 million project that directors approved in March 2013. From the tenor of her briefing, the effort seems to be on track. (Here is the CIRM-CDI contract dated Oct. 25, 2013.)

It is not entirely clear what, if anything, the Fujifilm purchase means for the CIRM contract with CDI.  Sometimes new owners have different views of previous business arrangements and seek modifications. The Fujifilm press release said CDI work will continue in California and Wisconsin. But the release also said Fujifilm will “seek synergies and efficiencies,” which can be industry-speak for cutbacks and layoffs.

The California Stem Cell Report yesterday queried the agency about its thoughts but no response has been forthcoming.

In June 2014, Kerry Grens of The Scientist magazine wrote about the stem cell banking business. The article said,

“The California Institute for Regenerative Medicine (CIRM) has the ambitious goal of creating the world’s largest iPSC bank. This will include cell lines from people with cardiomyopathy, blinding eye diseases, and Alzheimer’s, among other things. Michael Yaffe, the associate director for research activities at CIRM, said it was important not to duplicate the efforts of other iPSC banking initiatives. In planning the program, Yaffe explained, 'We wanted to make as many [cell lines] as possible. Then it became an economic argument: How many could we afford and how much could we push a deriver to handle?' 

“CIRM settled on a goal of 9,000 lines derived from 3,000 individuals. Yaffe said he anticipates that the first of these will be available for distribution by the end of the year or early 2015. What’s still unsettled, however, is the cost. It’s a tricky calculation, given that the utilization of the lines is unknown. 

“'If a few large pharmaceutical companies buy a complete set of all the lines, that would keep the bank established and running for many years,’ Yaffe said. ‘If academic researchers are going to buy a few lines at a time or a few lines each, it will create some challenges for the sustainability of the bank.’”

In December 2013, CIRM’s staff recommended a $2 million addition to the stem cell banking program. The CIRM governing board rejected the proposal after one board member called the plan dodgy. Jeff Sheehy, who serves on the grant review committee, said it needed to be peer reviewed and competitive.

The Fujifilm purchase attracted considerable news coverage but little mention of the CIRM connection. Here are links to some samples: Madison.com, ipscell.com, xconomy. Here is a link to CDI’s one-year progress report with CIRM.

'Immortal' Stem Cells and Informed Consent in California

The California stem cell agency is looking for some help in connection with a $32 million stem cell banking program to be sure that people who donate tissue understand that their cells will be transformed and made “immortal.”

The agency has issued a $150,000 request for proposals (RFP) for a 12-month study dealing with informed consent matters in the banking effort. The agency's RFP said it is “a unique program because it involves the creation of 9,000 iPS cell lines, from 3,000 individuals” that could increase to 5,000.

The RFP requests a report that will provide “in-depth analysis of donors' current understanding with respect to the informed consent process” and “recommendations for education materials that may improve program performance over time.”

Issues dealing with informed consent and research were highlighted a few years ago in a book, "The Immortal Life of Henrietta Lacks," that was on the New York Times hardcover bestseller list for more than 40 weeks. 

The California stem cell agency's RFP said,

“Unique aspects of the tissue collection for disease modeling awards that is critical for donors to understand include that researchers intend to:
“• Test donors blood and skin samples for infectious disease
“• Transform donor cells and make them into immortal iPSC lines
“• Record the genetic sequence of donor their cells
“• Distribute donor cells and associated medical and genetic information widely
“• Use cells and associated information to develop commercial medical products with no financial compensation to donors.
“In addition, minors and/or individuals with cognitive impairments will be recruited for this research and consent may be obtained from their legal guardian."

The proposed California study is linked to a $4 million segment of its $32 million stem cell banking effort approved in March of 2013. Former CIRM President Alan Trounson said at the time,

“This initiative will provide scientists with access to multiple cell lines that should have much of the genetic variations that represent the variety within any human disease such as Alzheimer’s, heart disease, lung fibrosis and autism.”

The deadline for applications is June 1. Here is a link to a 2010 CIRM report on issues involved in the stem cell banking program, which was only a proposal at the time.

Researcher Alert: First Look at Proposed Rules for California's Stem Cell Bank

The California stem cell agency today unveiled initial details of how it plans to run its $30 million bank of reprogrammed adult stem cells.

The proposed regulations are the first step this year in the $3 billion agency's project to make IPS cells available worldwide at low cost. It is part of an effort to stimulate the science and develop commercial cures by removing research roadblocks.

As Amy Adams, CIRM's communications manager wrote earlier this year on the agency's research blog,

"One way for CIRM to accelerate research is by creating more of a library system for stem cells – except we don’t want the cells back."

The agency expects to issue its first RFA next month in the stem cell banking initiative, which consists of three grant rounds to be approved by the CIRM board no later than Feburary of next year.

To clear the way for the first round, CIRM plans to revise its IP regulations to ensure that they don't hamper the distribution of stem cells in its bank and their wide use.  The revisions will come before the CIRM directors' IP/Industry Subcommittee next Tuesday. The six-member panel is co-chaired by co-chaired by Stephen Juelsgaard, former executive vice president of Genentech, and Duane Roth, CEO of Connect in San Diego, a nonprofit that supports tech and life sciences entrepreneuers. Sites where the public can participate in the meeting will be available in San Francisco, La Jolla, Los Angeles and two in Irvine.

Under the new IP rules, CIRM will retain ownership of the cells in its bank instead of the grantee, as the current IP rules state.

In a memo to directors, Elona Baum, general counsel for the agency, said,

"This permits CIRM to have complete control of this valuable resource and is consistent with the practice of NIH’s Center for Regenerative Medicine which is also creating a repository for iPSC lines and derived materials."

Baum also said,

"The (current) IP regulations were drafted to address conventional drug discovery activities and did not contemplate creation of a comprehensive repository of cell lines intended for broad distribution. As a result, the IP regulations contain a number of provisions which are either not applicable or worse could impede the success of the hiPSC bank. For instance, IP regulations permit the exclusive licensing of CIRM funded inventions and technology. This would be counterproductive to the goals of the hiPSC repository which are predicated on wide spread access."

Baum provided the following summary of the $30 million banking initiative:

"These lines will serve as valuable tools in drug discovery and will be available to researchers worldwide. The Tissue Collection RFA No. 12-02 will fund clinicians and other scientists to identify, recruit and consent sufficient numbers of affected individuals within a disease population so as to effectively represent the disease’s manifestations. Tissues will be collected and appropriate clinical, medical or diagnostic information, will be obtained to enable informed discovery of disease-related phenotypes and drug development activities using hiPSC-based models. These tissue samples will be provided (without charge) to the recipient of the CIRM hiPSC Derivation Award (RFA No. 12-03) for the production of the hiPSC lines. Once derived, characterized and released, the lines will be deposited in the CIRM hiPSC bank funded under RFA No. 12-04."

Specific addresses for the public meeting locations can be found on the agenda.