Human Biospecimen Procurement Should Be More User Friendly
Contributed Commentary by Jill Mullan
May 6, 2021 | In a wonderful case of truth in labeling, COVID-19 vaccines actually did arrive in warp speed. But they are generally the exception. How can we make rapid execution in life science R&D more the rule?
Procurement of the materials needed for research often introduces delay in the development of new treatments, vaccines, and diagnostics because of the many inefficiencies in the buying process and the many stakeholders who need to be involved. The holy grail for procurement teams and researchers alike would be solutions that are as efficient as the mouse click that puts an Amazon purchase on your doorstep in 24 hours. While the vast majority of R&D procurement may never be as easy as point-and-click, we can look to consumer marketplaces for ideas on how to improve the overall life science buying experience.
Wanted: ready access to biospecimens
Pre-clinical research is a particular challenge, and one place to look for new efficiencies is in the procurement of a critical resource—human biospecimens—including biofluids (e.g., blood), viable cells (e.g., immune and stem), and tissue (e.g., tumors). Medical researchers require millions of these biospecimens every year. Demand is only growing for specimens because of the overall expansion of medical research in areas like genomics, precision medicine, and regenerative medicine.
Unfortunately, biospecimen procurement takes a lot of time, often more than anticipated. It can take months of effort for research organizations to cobble together the exact specimen collections they need to conduct their research. Researchers spend valuable time and money dialing the phone and exchanging emails to ask contacts in health care organizations whether they have any of the specific specimens the project requires. These potential specimen holders include hospitals, clinical labs, pathology labs, blood centers, surgical centers, private practices, biobanks, and patient recruitment organizations.
When using the internet, researchers typically must investigate each specimen source separately. After many back-and-forth communications to learn of available specimens, research organizations traditionally then negotiate, draft, and sign a contract with each supplier, which may number in the dozens just to acquire enough specimens for a single project. After contracting, it’s on to tracking and managing compliance at each site to stay within regulatory frameworks before specimens can even start to flow. Then, for each specimen request, researchers much track and manage feasibility assessments and quotes, place purchase orders, create collection kits, train suppliers on custom collection needs, field deliveries across suppliers, wrangle spreadsheet data in different formats, track and manage invoices across suppliers, and juggle myriad other project management tasks involved in multisite biospecimen collections. After waiting weeks or months for all the specimens to arrive, research can finally begin.
Complicating matters is the fact that researchers need more specific specimens than ever, which is driving up the need for even more collection sites to obtain the required number of specimens. For example, in the past, it may have been acceptable for a researcher to obtain any 50 breast cancer tissue specimens, but in this era of precision medicine, a researcher might reasonably need 50 samples of tumor tissue from patients with metastatic, HER2-positive breast cancer, with a HER2 L755S mutation, refractory to Herceptin. Other sorting characteristics are important as well, including patient age, gender, race, condition, severity, blood type, procedures, test results, outcomes, smoking status, family history, and more.
The specimen gap
Bottom line, traditional specimen procurement is arduous, and it carries a steep cost: In 2011, more than 80% of researchers said they had limited the scope of their work because of the difficulty of procuring enough high-quality specimens. We did an informal survey of our own in 2019 and found that the needle hadn’t moved at all, and still, more than 80% of researchers limited their work due to biospecimen availability. Some work gets delayed, some work gets scaled back, and some work gets tabled indefinitely. That’s bad for companies seeking new diagnostics and treatments, and bad for the patients who need them.
The ironic thing is that biospecimens are plentiful and theoretically available, but researchers don’t know where to find them. By our count, more than one billion clinical and pathology lab specimens are discarded every year in the United States, and another 500 million specimens are banked (and too often squirreled away for years) in the country’s 800-plus biorepositories. Of course, not all projects could use these pre-existing specimens if they were more readily available, so research organizations also need a pathway to commission custom prospective specimen collections to accumulate the biospecimens their work requires.
What Bookselling and Travel Can Teach Us
What’s been missing from life sciences research is a way to quickly and efficiently connect researchers with the specimens they need from the types of patients they hope to study. The industry needs to bring specimen suppliers together with researchers in a way that enlists the spectacular efficiencies that the internet can offer.
Researchers need to see a broad array of available, or potentially available, biospecimens in one place the same way that a traveler can see individual flights (and even seats!) across airlines in one place on the internet. Such a framework would not only help researchers; those who possess specimens would have new opportunities to earn revenue for their work collecting and managing these critical resources.
Such a marketplace, however, needs to have unique capabilities. It should automate the tasks previously mentioned, such as contracting, compliance/ethics (IRB) audits, quoting, order management, invoicing, and the like. It should also automate the process of selecting individual patients and specimens for research. That’s analogous to the way a consumer marketplace arranges everything—allowing users to order specific items which are then picked, packed, and delivered—simply with a click on the buy button.
Implementing a consumer-style buying process in the biospecimen space is not as easy as implementing an online travel website, as it requires the ingestion and harmonization of massive and messy data sets about patients, their specimens, their conditions and their medical histories—across hundreds to thousands of suppliers and millions of patients—in order to create that single view into the world of available biospecimens. That’s probably the reason why today, very few biospecimen marketplaces exist and researchers still find biospecimen procurement to be a challenging and frustrating process.
Harnessing the power of healthcare data is key for driving efficiencies in biospecimen procurement and making it a more user-friendly process. Doing so will help to make life sciences research look more like the COVID-19 vaccine development process. Maybe not warp speed, but with all due alacrity.
The benefits of this new era of medical research will accrue to all parties involved, but most importantly to patients. With new efficiency, they will have a far better chance to see medical miracles realized before it’s too late.
Jill Mullan is Chief Operating Officer of iSpecimen. Jill is responsible for ensuring operational excellence throughout the company. In this position, she oversees iSpecimen’s supply partner programs and operations, human resources, marketing, corporate communications, and corporate strategy. She is also responsible for ensuring regulatory compliance, privacy and security across the company’s operations. Jill has over 25 years of experience in operational management, strategy, and marketing. Jill graduated with distinction from Cornell University with a BS in electrical engineering and received her MBA from Stanford University. She can be reached at jmullan@ispecimen.com.