Many medical advances – from life-saving vaccines and treatments to new diagnostic tests like liquid biopsies – rely on research involving human biospecimens. Biofluids, tissues and cells are indispensable resources for the medical researcher, but the process of sourcing these biospecimens can be terribly frustrating and inefficient. These challenges can have a direct negative impact on the pace of discovery, creating an urgency for better access to the biospecimens researchers need to advance their important work.
In fact, as early as 2008, 4 in 5 researchers said they had to limit the scope of their work due to difficulties obtaining biological samples. 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 specimens they needed; two out of three found it somewhat to very difficult to find sample suppliers.
Who has the specimens a researcher needs?
The sample matching market consists of millions of healthcare providers who could potentially offer biological samples and associated data for research, and possibly hundreds of thousands of life science researchers worldwide. world who need access to it. Unfortunately, this market remains frustrating and fragmented.
Health organizations that already possess (or can quickly acquire) certain biological samples do not know exactly which researchers need which samples. Additionally, researchers, once they have decided exactly what specimens they need, do not know which vendors can supply those specimens. So how do they find each other? Parties still commonly use e-mails and phone calls with familiar partners to help source needed specimens from banked inventories or custom collections when existing specimens do not match specific specimen requirements and data. In other cases, they search web provider by provider, specimen by specimen. Often the organizations that could help each other do not realize that the other exists.
You might think that modern technology would have brought suppliers and users closer together, but matching sample supply to demand is a moving target. It’s because precision medicine requires increasingly specific biospecimens.
Consider that in the past, a cancer researcher could have completed their work using 50 breast cancer tissue samples. But today, this researcher is focusing on disease subtypes and could reasonably need 50 tumor tissue samples from patients with metastatic, HER2-positive breast cancer with a HER2 L755S mutation, refractory to Herceptin therapy. Other triage characteristics are also important including age, sex, race, condition, severity, blood type, previous procedures, test results, smoking status, family history and more Again.
Turn sample matching into an e-commerce
The specimen supply chain is just beginning to benefit from some of the efficiencies of the consumer trade, where suppliers of essential commodities post all of their wares online, offering powerful search tools and easy online ordering. Buyers are starting to find good sources online for what they need.
The ultimate solution for precision specimen matching is technology that streamlines complex purchases, much like Amazon.com makes it easy to buy office supplies, clothing, and food with just a few clicks, or, say, Kayak.com facilitates the organization of a flight. , rental car and motel. Such an online marketplace paradigm could transform the fragmented landscape into a single global online biobank.
Here are the technology components we will need:
An online marketplace for biological samples would require the same ease-of-use features as business-to-consumer marketplaces. These attributes start with simple guided searches, the ability to refine search criteria with sliders and checkboxes, and the ability to add selected items to a cart in order to purchase them.
Researchers in a successful market would be able to uncover not only banked samples, but also patient records that could provide specific biological samples upon request. The matching technology is expected to run through inventories from a wide range of participating vendors, including clinical labs, pathology labs, biodepots, blood donor centers and clinical research centers around the world. Researchers were able to see both the banked specimens that exist in the inventory as well as the potential availability of specimens that could be collected should the need arise.
The marketplace platform should easily integrate into researcher and vendor environments to automate key elements of the procurement workflow. The technology would allow vendors to track and manage all of their sample requests, from feasibility assessment to ordering and fulfillment through a single web-based dashboard. The workflow should be simple and intuitive so as not to divert vendor resources from their primary accountability roles. It should be just as easy for researchers to track their orders from source to arrival. Today, these functions are often handled manually with spreadsheets, which is time-consuming and error-prone.
The market for biological samples would be based on the integration of anonymized medical records of patient populations into supplier networks. Records would provide solid data on patients, samples, lab results, and medical conditions. The data, which would be in various formats and quality levels, would comply with HIPAA and other applicable regulations that protect patient privacy. The integration would be based on commonly used health data formats such as HL7, JSON files and CSV files which would be standardized and harmonized into standard terminology sets.
One of the most important, complex and time-consuming processes in the use of samples is compliance: ensuring that samples are collected and used ethically and that patients are protected. To be truly effective in streamlining the matching and use of biological samples, the platform should automate, where possible, the tracking and management of unique regulatory and legal requirements between customers and vendors. The system should match conditions such as consent requirements versus patient consents; required use of samples and data versus vendor’s permitted use of samples and data; 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 beginning to make progress. Researchers have more tools for sample procurement, and sample providers are treating their biobanks more like cost recovery companies and researchers like customers than ever before. Although medicine is not a conventional business, technology can help unravel the vital supply chains that deliver the required samples to the researchers who need them. The solution includes a supply ecosystem that enables technology to bring researchers and sample providers together to respond efficiently and compliantly to increased demand. Medical progress depends on it.
About Christopher Ianelli
Christopher Ianelli, MD, Ph.D., is the founder and CEO of iSpecimena global online marketplace that connects scientists in need of biological samples for medical research with a network of healthcare providers who have them.