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Challenges in Specimen Procurement Hold Back Progress: Mandates to keep biospecimens in house are among the factors inhibiting better specimen sharing today.

In 2018, it has become radically easy for readers to procure books, travelers to reserve hotel rooms, and singles to arrange dates. All the consumer needs are a phone and an app, and the Internet does the rest.

But in biomedicine, an industry employing some of the smartest people on the planet, it's still difficult for researchers to find the human biospecimens they need from the patients they want in order to conduct research leading to breakthroughs.

Unfortunately, biospecimen procurement has long required researchers to cobble together specimen collections from different labs, hospitals, and biobanks around the country or beyond.

Researchers typically work by email, phone, and complicated forms to obtain biobanked biofluids, tissue, or cells that will help them to develop next-generation diagnostics, treatments, and vaccines. In addition to being laborious, time-consuming, and costly, this procurement approach has typically failed to produce the quantity, quality, and specific types of specimens that researchers need.

This missed opportunity is especially costly in the age of precision medicine when data extracted from large volumes of specimens identifies critical molecular pathways, biomarkers, and other biologic insights that can lead to surprising therapies.

Precision medicine also has made the specimen procurement challenge more complex, since researchers now need samples with unprecedented specificity.

Researchers Limit Scope of Their Work

Because of the difficulties that plague a researcher's ability to procure high-quality specimens, four out of five researchers in one National Cancer Institute study reported limiting the scope of their work. Other researchers may even fail to realize they are constrained: By institutional habit or policy, they design their research around the samples that exist in their own organization's biobank.

But the supply is there. It is estimated that there are more than 400 million biospecimen samples currently held within more than 800 United States biorepositories. The majority of biobanks like these are collecting more samples--and in some cases, 10 times as many samples--as are released for research, according to a recent biobank survey.

If unused, these samples can quickly become degraded or obsolete. Approximately 42 percent of biobanked specimens are at least five years old, according to the survey. Consider a five-year-old sample of a breast cancer tumor. In the five years since the sample was collected, at least three critical breast cancer biomarkers have been discovered.

Since the sample was collected prior to the biomarker discoveries, it's impossible to know whether that sample possesses any of those biomarkers--unless researchers retest it, which consumes not only time but a portion of the sample itself. Ideally, such samples would have been used shortly after collection and replenished several times over, using up-to-date testing and characterization each time.

The Sharing Imperative

The mission of a biobank should not be "banking" or "storage," but rather a targeted, quality collection of samples and the efficient conversion of collected samples to useful data.

This is clearly what the patient would want. Yet only 4 percent of the biobank survey respondents said the number one goal of their organization is "to support the wishes of the philanthropic patient." Some 65 percent selected reasons reflecting the prestige of the organization.

Although these goals aren't mutually exclusive, it is worth remembering that when consenting to submitting a sample of their tumor, a patient hopes that a motivated researcher may use the sample in important research, may achieve a breakthrough, and may cure their disease.

Thus, the organization requesting the sample and the consent is expected to be a steward to the overall research process and not simply hold material for an internal project someday.

Policy Issues

Policy problems are another factor inhibiting better specimen sharing.

One frequent biobanking policy is the mandate to keep biospecimens "in house," i.e., within the university or health system operating the biobank. This policy treats specimens as the institution's intellectual property instead of the patient's. From a philosophical perspective, the patient's biomaterial is at least partly the patient's IP.

A second policy problem is a failure of some biobanks to actively seek to recover their costs despite documented concern about their financial sustainability.

Biobanks need to understand that charging for the service of providing biospecimens to the research community at large absolutely is fair play and, I'd argue, essential to operational and economic sustainability.

When biobanks choose not to offer samples to bona fide external researchers, they are disregarding a viable path to sustainability.

Technology is a third policy consideration. According to the survey, more than half of biobanks are using primitive ad hoc systems to manage their specimen inventory, e.g., spreadsheets or SQL databases.

In a Google-driven world, these applications pose challenges for average computer users--including researchers in their own organizations. In fact, nearly three out of four respondents to the biobank survey said they lack any system to search for cases or specimens they require.

Ideally, they would have a commercial laboratory information management system (LIMS) designed for the task, as well as a technology solution for searching for and ordering specimens.

Solutions

The biomedical industry is capable of doing for research what e-commerce has done for consumers: bring specimens online, enable highly specific searches, and eliminate unnecessary friction.

Using a marketplace model, researchers more easily could procure:

1) Biobanked specimens ready for research

2) Specimens from patients willing and able to prospectively provide them

Specimens would be annotated with de-identified electronic medical record and laboratory data from a supplier network of hospitals, labs, biobanks, blood centers, and other healthcare institutions.

Researchers would see detailed information about individual specimens and the patients who donated them in a single, harmonized view. The marketplace would embed consent, compliance, and contracts.

And it would sync with commercial medical record systems, laboratory information management systems, laboratory information systems (LIS), and researchers' procurement systems.

For medical breakthroughs to accelerate, and patients to experience the "miraculous" outcomes that are just around the corner, researchers need quicker, better, smarter, more affordable access to the specimens they need from the biobanks that have them.

With book buying, travel planning, romance, and so much more, we've seen this work before. This should be easy.

By Dr. Christopher J. Ianelli, iSpecimen

About the Author

Dr. Christopher J. Ianelli, M.D., Ph.D., is Founder & CEO of iSpecimen.
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Title Annotation:Specimen Supply
Author:Ianelli, Christopher J.
Publication:Pharmaceutical Processing
Date:Jul 1, 2018
Words:1033
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