Many medical advancements – from life-saving vaccines and treatments to new diagnostic tests like liquid biopsies – are built on research that involves human biospecimens. Biofluids, tissue and cells are indispensable resources for the medical researcher, yet the process of sourcing these biospecimens can be woefully frustrating and inefficient. These challenges can have a direct, negative impact on the pace of discovery, creating urgency for improved access to the biospecimens researchers need to advance their important work.
In fact, as far back as 2008, 4 in 5 researchers said they needed to limit the scope of their work due to difficulties obtaining biospecimens. In our own survey of researchers this year, more than three in four found it somewhat to very difficult to find the type and quantity of specimens they need; seven out of 10 found it somewhat to very difficult to obtain the quality of specimens they need; two in three found it somewhat to very difficult to find sample providers at all.
Who has the specimens a researcher needs?
The specimen-matching market consists of millions of healthcare providers that could potentially offer biospecimens and associated data for research, and possibly hundreds of thousands of life science researchers around the world who need access to them. Unfortunately, this market remains frustratingly fragmented.
Healthcare organizations that already possess (or can quickly acquire) certain biospecimens don’t know exactly which researchers need which of their specimens. Furthermore, researchers, once they’ve decided exactly which specimens they need, don’t know which suppliers can provide those specimens. So how do they discover each other? The parties still commonly use email and phone calls to familiar partners to help find needed specimens from banked inventories or custom collections when existing samples do not match up with the specific sample and data requirements. In other cases, they search the web supplier by supplier, specimen by the specimen. Often, organizations that could help each other don’t realize the other exists.
You might think that modern technology would have brought the suppliers and users closer together, but matching specimen supply to demand is a moving target. That’s because precision medicine requires ever-more-specific biospecimens.
Consider that in the past, a cancer researcher might have been able to complete his or her work using any 50 breast cancer tissue specimens. But today, that researcher is zeroing in on subtypes of disease and might reasonably need 50 samples of tumor tissue from patients with metastatic, HER2-positive breast cancer, with a HER2 L755S mutation, refractory to treatment with Herceptin. Other sorting characteristics are important as well, including patient age, gender, race, condition, severity, blood type, past procedures, test results, outcomes, smoking status, family history and more.
Make specimen matching more like e-commerce
The specimen supply chain is only now just beginning to benefit from some of the efficiencies of consumer commerce, where suppliers of essential products display all their wares online, providing powerful search and easy online ordering tools. Buyers are starting to find good online sources for what they need.
The ultimate solution to precision specimen matching is a technology that streamlines complex procurement much like how Amazon.com makes it easy to buy office equipment, clothes and food in a few clicks, or, say, Kayak.com makes it easy to arrange a flight, rental car and motel. Such an online marketplace paradigm could transform the fragmented landscape into a single online global biobank.
Here are the technology components we will need:
An online marketplace for biospecimens would require the same ease-of-use characteristics that business-to-consumer marketplaces offer. These attributes start with simple guided searches, the ability to refine search criteria with sliders and checkboxes and the ability to add chosen items to a cart in order to purchase them.
Researchers in a high-functioning marketplace would be able to discover not only banked specimens but records of patients who may be able to provide specific biospecimens upon request. The matching technology would need to scour the inventories of a wide range of participating providers, including clinical labs, pathology labs, biorepositories, blood donor centers and clinical research centers worldwide. Researchers could see both banked specimens that exist in inventory as well as the prospective availability of specimens that could be collected when needed.
The marketplace platform would need to easily integrate into researcher and supplier environments to automate key parts of the procurement workflow. The technology would enable suppliers to track and manage all of their specimen requests from feasibility assessment through ordering and fulfillment through a single web dashboard. The workflow would need to be easy and intuitive so that it doesn’t siphon supplier resources from their primary roles of responsibility. It would need to be just as easy for researchers to track their orders from source to arrival. Today, these functions are often managed manually with spreadsheets, which is time-consuming and error-prone.
The biospecimen marketplace would rely on the integration of de-identified medical records of patient populations in supplier networks. The records would supply robust data about patients, specimens, lab results and medical conditions. The data, which would be in different formats and quality levels, would be in accordance with HIPAA and other applicable regulations that protect patient privacy. Integration would be based on commonly used healthcare data formats such as HL7, JSON files and CSV files that would be normalized and harmonized into standard terminology sets.
One of the most important, complex and time-consuming processes in specimen use is compliance: ensuring that specimens are ethically collected and used and that patients are protected. To be truly effective in streamlining biospecimen matching and use, the platform would need to automate, to the extent possible, the tracking and management of unique regulatory and legal requirements across customers and suppliers. The system would need to match such conditions as consent requirements versus patient consents granted; required specimen and data use versus the supplier’s allowed specimen and data use, and resale or distribution requirements versus resale or distribution rights.
Although significant work is needed to improve and streamline the biospecimen procurement process, the industry is starting to make progress. Researchers are getting more tools for specimen procurement, and specimen suppliers are treating their biobanks more than ever as cost-recovery businesses, and researchers as customers. Although medicine isn’t a conventional business, technology can help untangle the vital supply chains that provide required specimens to the researchers who need them. The solution includes a procurement ecosystem that enables technology to bring researchers and specimen suppliers together to efficiently and compliantly fulfill the increase of demand. Medical progress depends on it.
About Christopher Ianelli
Christopher Ianelli, MD, Ph.D., is the founder and chief executive officer of iSpecimen, a global, online marketplace that connects scientists in need of biospecimens for medical research with a network of healthcare providers who have them.