When Ann M. Gronowski, PhD, a professor at Washington University School of Medicine in St. Louis, decided in 2008 to start a biobank of specimens from pregnant women, the start-up money was relatively easy to find. Her biobank, like many others, received grants, including a Clinical and Financial Sustainability Translational Science Award (CTSA) from the National Institutes of Health (NIH). “In the glory days when we started, when we had a big CTSA grant, it was great,” Gronowski said. “We had a lot of staff.”

But, as with so many biobanks created in the past decade, financial reality set in once the grants ended. Collecting, storing, and maintaining samples is expensive, and fees collected from researchers didn’t cover the costs. “We’ve had to downsize staff,” Gronowski said. “We have to choose the studies that we can help with very carefully.”

While biobanks still hold tremendous promise for discovery of biomarkers and new diagnostics, the biobanking community is quickly realizing that the traditional financial model for biobanks isn’t working. “It’s very expensive to maintain large biobanks, and if they’re totally dependent on NIH grants and contracts, then it becomes sort of a risky proposition over the long term,” said Jim Vaught, president of the International Society for Biological and Environmental Repositories (ISBER) and retired chief of the Biorepositories and Biospecimen Research Branch of the U.S. National Cancer Institute.

Financial sustainability is now a common concern for biobanks, Vaught said. Gronowski and others, including ISBER and a commercial biobank in Alabama called Conversant Bio, are now exploring strategies to make biobanks stronger financially.

Conversant Bio offered a $50,000 grant this year in hopes of creating a case study in biobank viability. The grant paid for consultants to help the recipient, Aurora Health Care in Milwaukee, analyze various aspects of its Biorepository and Specimen Resource Center at Aurora St. Luke’s Medical Center. The grant will also help the biobank implement changes.

“This was a unique idea,” said Vaught, who is on the advisory committee for the project. “I think it’ll be a really good exercise and I hope to see more things like this done.”

Meanwhile, some biobanks are already finding success with new business strategies. One approach Conversant Bio advocates—and implemented itself, after first collecting tens of thousands of samples nobody wanted—is waiting to collect samples until a researcher requests them.

“We realized very early that the Field of Dreams model—if you build it they will come—isn’t sustainable,” said Marshall Schreeder, chief executive officer of Conversant Bio. “We completely switched our business to focus on prospective, just-in-time collections that match our effort to active research projects.”

Now only about a third of the samples Conversant Bio sends to researchers come from inventory, Schreeder estimates. Most are acquired from donors or patients only after a researcher makes a request. Until about 3 years ago, nearly all samples were collected on demand, he says. It was only after the company got a strong sense of the market that it began rebuilding an inventory.

“I think there is a hoarding mindset at many biobanks. Biobank managers can be like dragons sitting on their stash of gold,” said Larson Hicks, Conversant Bio’s consulting services manager. “This mentality has to change if biobanks are going to have a chance at financial sustainability. A biobank’s value is not in the sample—it is in the service it provides.”

Gronowski, too, has switched to this type of collection model at the pregnancy biobank, the Women and Infants Health Specimen Consortium (WIHSC) at Washington University School of Medicine in St. Louis. “You have this kind of lofty idea, ‘I’m going to start a bank, OK lets collect specimens and put them away,’” Gronowski said. “But the thing is that you collect a bunch of specimens and then they effectively collect dust in liquid nitrogen.”

Sometimes that is because the biobank didn’t collect, process, or store the specimens in exactly the way the researcher needs, Gronowski explained. “So what we found—and I never expected this—is that most of our specimens actually walk out the door right away. We collect them for hypothesis-driven projects and we give them to the researcher and we don’t store them.”

Over time donors have consented to let WIHSC keep any extra specimens the researcher doesn’t need, enabling the biobank to build inventory without spending extra money. It has taken about 8 years, she says, but “now we have a big enough bank with enough outcomes of interest that we can start selling what we have stored.”

Gronowski said she is now learning about things like Web design and public relations, hoping to keep WIHSC viable. “We’ve really developed into a lot more than a biobank,” Gronowski says. “We’re a service for getting specimens from pregnant patients, at all the points through pregnancy.”

Specimens from WIHSC have been used by researchers in many specialties, all for the purpose of improving women’s and infants’ health. Gronowski herself is using urine samples from the biobank to study human chorionic gonadotropin (hCG), hoping to better understand why some women have such high concentrations of hCG beta core fragment that it causes false-negatives in certain point-of-care pregnancy test devices.

According to Daniel Simeon-Dubach, MD, of medservice biobanking consulting and services in Switzerland, many biobanks are beginning to try new strategies like prospective collection. “A lot of researchers now are aware of this situation,” he said. “They’re struggling because the environment is changing so rapidly. I mean, five years ago nobody talked about sustainability.”

The critical step is for any biobank, no matter what its strategy, to make a business plan, Simeon-Dubach said. “A biobank is an infrastructure. Lots of the time a biobank is established by researchers because they have a research grant. They’re not thinking about this as an infrastructure.

Simeon-Dubach says he is optimistic about biobanks, “but only for those biobanks that will pay attention to this issue.” He predicts that there will be fewer biobanks in the next 5 to 10 years as some run out of money to maintain their collections.

Vaught sees the focus on business plans as a good sign for the future of biobanking. “It’s just the realization that business has to be an integral part of it,” he said, “and on equal footing to the scientific part.”

Julie Kirkwood is a freelance writer who lives in Rochester, New York.
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