Our CEO, Chris Ianelli, MD, PhD, was recently interviewed by Precision Medicine World Conference (PMWC), where he will be speaking in January 2018, about the power of the iSpecimen Marketplace in redefining the way human biospecimens are procured. PMWC attracts recognized authorities and experts across healthcare and biotechnology sectors, and we are very excited for the conference and our panel early next year in Silicon Valley. Below is a quick recap of Chris’ discussion with conference organizers. This is the iSpecimen Marketplace in his own words.
Q: iSpecimen recently announced the launch of the iSpecimen Marketplace for human biospecimens. Can you tell us more about this marketplace?
A: The iSpecimen Marketplace is the first-of-its-kind, self-service platform for researchers to search for and obtain human biospecimens. Through the Marketplace, researchers across the globe gain instant access to millions of specimens anytime, anywhere, while participating provider organizations gain an opportunity to contribute compliantly to medical research as well as their bottom line. To date, there has never been a technology platform like this to connect researchers who need human biospecimens with the healthcare providers that have them.
The full potential of this platform is tremendous. Whether researchers need banked samples or prospectively collected samples, the efficiencies and scalability of a self-service platform that can search across thousands of hospitals, practices, biorepositories, clinical labs, pathology labs, and other healthcare organizations is unprecedented and game-changing. At the same time, it gives provider sites a broad-reaching, streamlined opportunity to move specimens into research programs.
Q: What problem is this Marketplace solving and who is the audience / the customer for it? What is the technology behind it?
A: The iSpecimen Marketplace solves one of the life science industry’s biggest challenges – how to more efficiently find and obtain annotated human biospecimens required for diagnostic and therapeutic discovery research. It’s the only platform that allows researchers and scientists to search a truly federated network of healthcare providers and biobanks to find the specific specimens and data sets required for their research. It was initially developed to address the growing need for biospecimen access by scientists across the biopharmaceutical and in vitro diagnostic (IVD) industries, as well as those with government and academic institutions, driving biomarker discovery and validation efforts. Coincidentally, it also provides a tremendous service to the healthcare provider organizations that take part – such as hospital systems, commercial laboratories, biobanks, and private practice groups – that desire to contribute more broadly to biomedical research and offer research participation opportunities to their patients/donors.
Regarding the technology, the iSpecimen Marketplace has been developed on a proprietary, cloud-based platform. At the heart of the platform is technology that securely and compliantly receives de-identified data from electronic medical records, laboratory information systems, and other data sources about available specimens and patients and harmonizes the data across all participating organizations for one standardized view into the federated specimen pool.
This data is then easily searchable by researchers using our intuitive, web-based user interface, which bears similar ease-of-use and faceted-search functionality found in other marketplace/search platforms. Additionally, the iSpecimen Marketplace simplifies administrative tasks associated with specimen procurement and handles all compliance management and financial transactions on behalf of both provider partners and researchers.
Q: What biospecimens are made available via the Marketplace?
A: iSpecimen’s Marketplace provides access to a wide range of biofluids (blood, plasma, serum, urine, etc.), solid tissues, and viable hematopoietic cells (PBMCs, bone marrow, cord blood, etc.) collected for research use under approved IRB protocols with the informed consent of the patients and donors. The Marketplace also provides near real-time access to tens of millions of remnant biofluids and solid tissues that are flowing through the clinical labs and pathology labs of the healthcare provider organizations in our network. These are biofluids and solid tissues that were collected and tested for clinical purposes, have exhausted their “clinical lifespan,” and are scheduled to be discarded. Many of these samples are useful to a variety of research endeavors.
Q: What makes the iSpecimen Marketplace different from a regular biobank? What are some of the advantages?
A: Two things primarily – our technology and our business model, both of which allow us to minimize internal inventory and rely on the distributed inventories across the globe. iSpecimen runs the only true technology-driven marketplace for biospecimen procurement, which makes it possible for us to source samples and data sets without the need to build internal inventory (i.e., bank samples). We are the only company using technology to essentially watch the healthcare grid and biobanking world in near real time to provide access to the samples. We do not need to house any specimens ourselves to satisfy researcher needs. Individual healthcare providers and biobanks in our network each maintain their own inventory from which samples are provided – inventory that we monitor virtually in near real-time to broadcast availability.
Q: How do you ensure the protection of patient/donor privacy and compliance with regulations that govern the use of healthcare data and biospecimens for research?
A: iSpecimen has made numerous and substantial investments into the security and compliance features of the platform. First, all of our processes, whether manual or technology-enabled, have been designed in accordance with the appropriate section of the Department of Health & Human Services (HHS) Common Rule and HIPAA. As a rule, iSpecimen does not ever take in Protected Health Information (PHI) from its healthcare provider’s sites. All data transmitted to iSpecimen have had any PHI removed by our proprietary software, iSpecimen Guardian®, for secure storage behind the firewall of the institution from which the data came. Only non-identifying data elements are sent to iSpecimen to provide a general description of the specimens and patients that are available (specimen type, test results, diagnoses, medications, etc.). When a specimen within the Marketplace is selected by a researcher, a secure message is sent back to the source institution where it is reunited with the respective PHI to allow staff there to select that specimen and send it to the researcher in an anonymized format.
As an added level of protection, iSpecimen restricts any researcher from ordering specimens until they have executed iSpecimen’s Material & Data Use Agreement. This Agreement prohibits the researcher from ever using de-identified data sets that iSpecimen provides, or any data sets that the researcher may generate from analysis of the specimen, to attempt to re-identify a sample or patient/donor.
Q: What are some of the key applications and studies that will benefit from the Marketplace?
A: There are many applications across both basic and translational research that benefit from the Marketplace – applications ranging from biomarker discovery/validation to IVD analytical/clinical validation to assay development/refinement to correlation studies to instrument calibration. A sampling of the projects we’ve helped accelerate can be found here: https://www.ispecimen.com/blog/category/specimen-spotlight/
Q: If we understand this right, access to samples is free. Who pays for the Marketplace or in other words how do you create revenue?
A: Access to the iSpecimen Marketplace is free, meaning that there is no charge for researchers/scientists to create an account and search for the samples that they need. There is a modest charge for the service of procuring the samples, should the researcher wish to obtain them following their search, with pricing determined by each sourcing institution. iSpecimen derives its revenue through a variety of revenue-sharing agreements that we manage with the numerous healthcare providers and biobanks in our partner network.