iSpecimen Creates Marketplace for Clinical Discards

iSpecimen (Lexington, Mass.) can be thought of as a cross between a dating site and an online marketplace for human biospecimens. The company has built a turnkey solution that connects providers, such as hospital systems, commercial labs, and biobanks, to researchers looking to gain access to these specimens and associated data from electronic medical records and other sources. It's a win-win situation, with providers having a new market for both soon-to-be discarded and banked specimens, researchers more efficiently accessing needed specimens and rich clinical data, and patients getting a chance to make a contribution to research.

DTET recently spoke to Christopher Ianelli, M.D., Ph.D., iSpecimen's founder and CEO, to learn about the company's business model, patient preferences for sample donations, and how biobanking is anticipated to evolve in the coming years.

iSpecimen's goal is to reduce research costs and procurement time, while ultimately hastening clinically relevant discoveries. What is the business case for iSpecimen? How do you deliver value to your partners and investors?

"Instead of throwing it away, allow iSpecimen to identify researchers across the world who are asking for access to that material because it is perfectly useful for research endeavors."

—Christopher Ianelli, M.D., Ph.D.
Founder & CEO, iSpecimen

What I tell investors is that there is real value to the bookends on our business model—the bookends being the health care provider system and the life science research community. We create value on both sides. On the health care provider side we focus on hospitals as the prototypical partner we work with. If you walk into the laboratories of those hospitals, they have very well organized workflows that take in samples and conduct clinical testing to deliver results to the clinicians and patients. Then, those samples are almost always thrown away. In the clinical laboratory it is a matter of days before they throw away a sample that was tested. In pathology labs it is anywhere from days to a decade later that tissue that doesn't get used is thrown away. You can walk into 99.9 percent of hospitals across the country and you can point to the garbage cans and say that there is tremendous value in that garbage can, especially if you can link the material in that garbage can to data.

We give them an opportunity to work with us, before they throw anything away, to help us identify what in their workflow can be utilized beyond the clinical lifespan. Instead of throwing it away, allow iSpecimen to identify researchers across the world who are asking for access to that material because it is perfectly useful for research endeavors. This gives hospitals the choice. Instead of discarding the material, they can take it, pack it, and ship it off to the researcher.

That sample can yield research results that will ultimately come back and help their patients or patients like them. We will provide all of the tools in the form of technology and processes to make it a very efficient process so that the laboratory does not need to worry about distractions to their core workflow.

If you go out and talk to life science researchers, in industry or academia, they have long complained about the bottleneck in going from discovery through validation, which can slow getting their product— a diagnostic test or therapeutic—to market. The bottleneck is they can't proceed because they do not have the number of samples they need, or adequate quality of samples. We solve that for them. Instead of calling the 5,000 hospitals across the country to cobble together samples, they can work with just us and we will deploy their request across our partner network to make it more efficient. For researchers, it is a huge defragmentation exercise that helps them get material.

"Overwhelmingly, more than 80 percent of patients, for no compensation, say 'channel my sample into research."

—Christopher Ianelli, M.D., Ph.D.
Founder & CEO, iSpecimen

We are compensated by the research community for the matching service when we are successful in identifying samples for them. We share that revenue back with provider partners that sourced the material, and they put this back into their day-to-day operations, including patient care. Our investors like it because from the money we take in from researchers and the money we share with our partners, there is something left over as profit. We are not yet profitable, but we are on our way.

When researchers can't use remnants we have a whole other track where they can make requests of us that they need collection under certain conditions or a specific volume or collected in a certain tube you would not ordinarily use clinically. This track is 'research use only,' where we collect non-remnant samples. These are obtained under patient consent to send directly to the researcher.

iSpecimen By the Numbers

iSpecimen's partner network includes:
• ƒƒ250+ hospitals and labs
ƒƒ• ƒƒ10+ biorepositories
ƒƒ• ƒƒ6 clinical research organizations
ƒƒ• ƒƒ1 large blood center With annual access to
• ƒƒƒƒ25 million remnant specimens
ƒƒ• ƒƒ5 million patient encounters
• ƒƒƒƒHundreds of thousands of banked samples

How do patients feel about their specimens being used for research?

We explored this question with patients directly. It turns out most patients don't understand what happens to that tube of blood after they give it. They know it goes to a laboratory and test results will be generated, but they don't realize that several days after the results are generated, the sample will be thrown away. More often than not, there is an adequate volume left that is perfectly useful and sought for research. We educated patients about the process and then asked them, assuming that your privacy and confidentiality are protected, would you rather we throw away the sample or channel it into a research effort. Overwhelmingly, more than 80 percent of patients, for no compensation, say "channel my sample into research."

What legal mandates govern the re-use of clinical samples for research?

In mid-January a ruling was made on proposed changes to the law that governs the use of clinical discards. Under the Common Rule, patient specimens may be used for research without consent as long as they are left over from a clinical process and are de-identified. In September 2015, a Notice of Proposed Rule Making was issued that would have changed this process and mandate consent for de-identified discards. But, President Obama's administration decided to keep the process as is and consent will not be required for these samples.

"The first barrier is getting them comfortable that as a company we are compliant with all of the regulations that exist."

—Christopher Ianelli, M.D., Ph.D.
Founder & CEO, iSpecimen

Having said that, iSpecimen has always offered consent support for partners who want to implement consent. So, whether or not the law changed we were ready for what ensued. We will continue to operationalize consent for our partners who opt to implement it for discards, as many of our partners feel good about informing and asking their patients.

While the proposed changes did not go into effect, the rationale behind the proposal was that with progress in genetic technology came a little less confidence that de-identification of samples and datasets was really enough to protect each patient's identity because gene sequences and mutations may someday be able to re-identify the patient. Because of that, some believed that we needed to revisit the issue and respect patient autonomy a little bit more than in the original version of the Common Rule. The general sentiment of industry has been that requiring consent for de-identified discards would slow things down and stifle research. Now we know that, at least for now, nothing will change.

2016 appeared to be a year of tremendous growth for the company. What challenges does iSpecimen face as it continues to expand its partner network?

When we go into meetings, the providers bring in their chief of compliance or privacy officer. There are lots of questions around privacy and security, but is not a strict barrier. It is more of a picket fence. They want to understand to what extent we are taking measures to adequately protect patient privacy. They want to understand what we are doing to de-identify patients and what we are doing to protect against re-identification. The first barrier is getting them comfortable that as a company we are compliant with all of the regulations that exist.

We also let them know about the rules and regulations around the use of remnant specimens and that they can, but do not need to, obtain patient consent.

We are set up to give hospitals support for operationalizing consent, so they can decide how they want to handle it.

"Biobanks have collected so much material with the promise of directing it into research, but they don't have the tools and systems in place to share."

—Christopher Ianelli, M.D., Ph.D.
Founder & CEO, iSpecimen

The next obstacle we face in growing our provider network is information technology (IT). Electronic medical records are being aggressively adopted and implemented across the health care workflow. IT departments are so busy, and since we need to have data transmitted, we need the time and attention from the IT group of the hospital, laboratory, or practice group to implement our solution. We have to wait in line for that to happen. Understandably, they are focused on the systems that are in place for patient care, and then they can get to us.

How will biobanking and specimen sharing evolve in the next few years?

You hear a lot about the challenge of interoperability in the health care system with electronic medical records. Biobanks are even further behind. In the shortterm I see standards being applied for what information is collected and how it is collected. It has to change and as biobanks move towards interoperability for sharing, we can play a central role in impacting interoperability discussions.

Biobanks have collected so much material with the promise of directing it into research, but they don't have the tools and systems in place to share. We refer to them as biomuseums because most of the material never finds its way out to researchers. Biobanks are filling up. I think in the coming years, biobanks will be forced to specialize in a way that will align with their center's clinical expertise. General inventory will transition to specialized neuroscience or hematology collections and sharing across systems will be needed to get material into these specialized banks. I see iSpecimen playing a dominant role as a channel partner in helping get samples quickly and efficiently to researchers, which will help biobanks with their long-term sustainability.