Every medical breakthrough starts with the study of afflicted patients, often through their blood, tumor tissue, or other biological material. Thus, it’s critical for the advancement of life science research that scientists can easily procure the human biospecimens they need in the right form and quantity from specific patient populations – both those with the medical condition being studied and healthy normal controls. Medical progress depends on it.
iSpecimen has created the iSpecimen Marketplace to address the urgent need for high-quality specimens from specific patient populations. The iSpecimen Marketplace connects suppliers of biospecimens with researchers who need them to streamline specimen procurement and, consequently, help accelerate medical breakthroughs. Biobanking.com recently spoke with iSpecimen Chief Operating Officer Jill Mullan to learn more about iSpecimen, the challenges the iSpecimen Marketplace addresses and her views on the future of the biobanking industry.
When was iSpecimen founded? What was the unmet need in the field of biobanking?
iSpecimen was founded in 2009 after it became clear that researchers were struggling to obtain the high-quality human biospecimens – biofluids, tissues and cells – that they needed for their research. This struggle often caused researchers to scale back their work. Ironically, at the same time, healthcare providers and biobanks were sitting on hundreds of millions of biospecimens, either lying idle in biobanks or collected as part of clinical care but then discarded after testing was complete.
We thought there was a great opportunity to bring those who needed specimens together with those who had access to them via an online marketplace, making it as easy to obtain biospecimens as it is to buy any product online. This was a challenging goal because of the inherent complexity and variability of the specimen needs of researchers and the associated legal and compliance requirements of biospecimen procurement – but we think we made the entire process pretty easy.
What are some of the biggest challenges in biospecimen procurement?
The entire process, from identifying enough organizations that can supply specimens with ever-more-specific requirements, to contracting with these organizations, to actually managing the specimen procurement workflow – researchers struggle all along the biospecimen procurement process. In fact, in a paper published in 2011, National Cancer Institute researchers described survey results where four out of five researchers responded that they limited the scope of their work because of their inability to access sufficient numbers of high-quality specimens. Although that NCI research was conducted years ago, the problem still exists today, and our own survey from 2019 showed almost identical results.
This biospecimen procurement challenge is growing every day. Precision medicine is driving a need for greater quantities of specimens from more specific patient populations, making it even more difficult for researchers to obtain the necessary quantity of specimens for their research. Meeting this challenge requires access to an ever-larger patient population and healthcare provider network to obtain adequate supply of specimens.
Unfortunately, specimen suppliers – including healthcare providers, biospecimen brokers, and commercial or nonprofit biobanks – typically operate independently, which often forces researchers to contact dozens of organizations to identify enough providers that can provide samples for their studies.
Each of these potential provider relationships then requires a contracting process to execute a material transfer agreement, and compliance processes to ensure IRB protocols and informed consent forms are in place and comply with the needs of the researcher. Once the contracting and compliance processes are complete, researchers can request specimens but each specimen request may involve dozens of emails or phone calls per provider to understand patient and specimen availability. This manual and siloed process consumes an enormous amount of time and resources, and as specimen requests increase in complexity, it just gets even more difficult to manage.
How long does it typically take a researcher to get the samples they need?
Assuming relationships already exist, the request is fairly small and simple, and it is for biospecimens that exist in a biobank, it typically takes days to weeks to obtain the requested specimens. If one of these variables changes – the right supplier relationships do not exist, the request is large or complex, or specimens must be collected prospectively – then it could take months or even years to set up relationships and collect the requested specimens.
How does this wait time affect medical research?
Delays or challenges in specimen procurement can cause an organization to delay or scuttle a project entirely. This difficulty can harm not only medical progress, but the research organization itself, eliminating opportunities in the future. The pandemic certainly has illustrated the value to all of us of expedited research and development. By helping to remove delays in R&D pipelines at diagnostics and therapeutics organizations, so many more lives can be saved.
How does iSpecimen help streamline the procurement process?
The iSpecimen Marketplace aims to simplify the procurement process by bringing together specimen providers and researchers in one online marketplace. It works comparably to arranging travel online via a site like kayak.com. We first take in and harmonize data from our network of global providers so we gain visibility into their available specimens and patient populations. Researchers then can come to the iSpecimen Marketplace to search these inventories, select specific specimens that meet their requirements, or request a custom collection when specimens do not exist that meet their needs. Via a single agreement with iSpecimen, researchers gain instant access to all providers in our network. The process works similarly for providers – they sign one agreement with us which gives them access to all the researchers in our network. We also handle compliance management to help ensure that specimens delivered through our network were collected with ethical oversight and proper consent.
The iSpecimen Marketplace consolidates the procurement experience and currently has more than 160 specimen contributors who have provided us data on more than 55 million biospecimens, 450 million test results, and 11 million patients across a global network of hospitals, biobanks, pathology labs, blood centers, private practices, health information exchanges, clinical labs, and patient recruitment organizations.
How do you ensure people who collect specimens and people who study them comply with ethical and regulatory guidelines?
First, all specimens collected specifically for research are done so under the oversight of an IRB/IEC or other appropriate ethics committee and with informed consent. We audit our suppliers to ensure that their protocols and consent forms are up to date and approved. We also track contractual, IRB, and consent terms – such as allowable specimen uses – and match them up to the researchers’ needs. Meanwhile, we are also very careful to protect the privacy of research subjects. We do not transmit or store their personal identifiers in our iSpecimen Marketplace, and we use contractual terms with our research clients that forbid them from trying to re-identify patients, ever.
How has COVID-19 impacted your priorities and your operations?
From the very onset of the pandemic, we were inundated with requests for specimens of patients who had contracted COVID-19. Fortunately, because of the breadth of our network, we were able to quickly respond and maintain a steady supply as infection abated in some areas of the country and spiked in others. As early as April, researchers were procuring remnant nasopharyngeal swabs from both positive and negative patients as well as blood, serum, and plasma through iSpecimen.
Additionally, as requests came in for custom collections of specimens from COVID-19 patients, we were in a position to help. In May, we began supplying the U.S. Centers for Disease Control and Prevention with serum samples from patients who had tested positive for the SARS-CoV-2 virus. We also partnered with a company called myOnsite Healthcare to deploy mobile phlebotomy, bringing convenient at-home sample collections to patients who were practicing social distancing but still wanted to help support the fight against the deadly virus.
How do you envision the future of the biobanking industry in the next 5-10 years?
Sustainability has been a hot topic for biobanks over the past several years, and I think they are undergoing a couple of major shifts that will help them reach it.
The first is around the biobank’s mission. In the future, biobanking success will be focused less on the quantity of specimens in the biobank and more on the utilization rate of the biobank’s specimens. This is, after all, why biobanks exist and why patients donate to them – to provide specimens for research that ultimately helps advance healthcare.
The second shift is around business planning. Biobanks of the future will increasingly focus on creating self-sustaining business models that allow them to fully recover their costs. This will likely require institutions to open up their inventories to external organizations which will, in turn, drive biobank managers to make more informed decisions about the types of specimens they bank based upon broader industry demands. Together, these actions will help increase specimen utilization rates and bring in financial resources needed to sustain the biobank.
Organizations like iSpecimen that bring researchers and biospecimen providers together in one place will make it easier for biobanks to distribute their specimens to a larger researcher base. Additionally, technology like ours that can automatically aggregate and synthesize specimen requests to look for trends in the data – to understand what’s in high demand, what’s emerging as a demand, or what’s difficult for researchers to obtain – can provide the needed intelligence to help biobanks better plan their collections. By linking and syncing broader biobank supply to a greater set of research demands, more research and breakthroughs are possible.