Contributed Commentary by Eric Langlois
January 10, 2020 | Every day counts when it comes to saving lives and generating revenue, especially when you’re trying to bring a drug, treatment, or diagnostic tool to market. Unfortunately, these processes often take a lot longer and cost a lot more than initially expected.
The development lifecycle can go awry from the very start as researchers design preclinical studies. Especially in smaller, earlier-stage companies, brilliant scientists might huddle for weeks or months meticulously designing ground-breaking research projects designed to leapfrog competitors—but then unexpectedly hit a wall. After finalizing their crisp, clean, carefully proofread plan, these researchers may suddenly realize:
- Their deadlines are unrealistic.
- Their budget is too low.
- Or their study isn’t feasible as designed.
At this point, it’s already late in the process to be discovering simple yet key steps that could have easily saved months (maybe years) and thousands (maybe millions) of dollars. Given the time required to restart the process with a new plan and RFP, the researchers may also have unwittingly created an opportunity for their competitors to leapfrog them.
I see this phenomenon more often than I would like from my vantage point as a supplier of human biospecimens—specifically tissue, biofluids or cells—dedicated to helping researchers focus on discoveries that will save lives. As smart as these researchers are, they often make the same mistake: waiting too long to ask for the help and critical insights they need from biospecimen providers who can save them time and money.
What Goes Wrong When You Design Research Projects Without Planning Specimen Collection
One major factor in missing deadlines and blowing research budgets is the assumption that biobanks possess massive inventories of most every conceivable human biospecimen one might need. Although millions of biofluid, cell, and tissue samples do exist, there are pervasive misconceptions around what types of biorepositories are out there, what’s actually stored in those biorepositories, and what types and quantities of samples are readily available.
In many cases, a biorepository may have the class of specimen material you want, but not exactly as you need it. The samples may be too old, in the wrong form, from the wrong patients, or of the wrong quality. In other cases, the samples you need may be hard to store. For example, urine and stool are rarely banked at all since their analytes and biomarkers quickly break down. Then there’s the data. Trying to find samples with the breadth and depth of rich, annotated data you need is yet another challenge to navigate.
In many cases, you’re going to end up commissioning a special “prospective” (i.e., custom) collection. Even when your target samples are banked and ready for withdrawal, there’s often a lot of competition for them. If you’re not at the front of the line, you may need a prospective collection anyway.
A second problem is creating unrealistic RFP requirements. Consider a company working on a liquid biopsy project, and its first RFP to specimen providers calls for 10 ml to 15 ml of plasma from each of hundreds of donors. Unfortunately, finding that amount of plasma biobanked is like hitting the lottery. To get 15 ml from a patient, you need to collect 30 ml to 40 ml of whole blood. If a patient has given that much volume, chances are that a research team has already used it. Another obstacle to obtaining such volumes is that biobanks generally don’t dedicate entire collections to processing plasma. Rather, they prefer to stratify their collection across multiple sample types. So it’s back to the drawing board for the research team, which may have been better prepared had it asked for help regarding specimen feasibility and collection processes in the design stage.
Plan For Obtaining The Right Biospecimens And Data
Here are six other common errors in specimen procurement:
- Insufficient site recruiting: For robust research, it often takes more than one biospecimen provider to come up with the samples you need, especially if you’re requesting special specimens based on carefully selected demographics, blood type, BMI, disease type, medications, procedures or other traits. Someone needs to go out and find the clinics, hospitals, blood centers, or other venues that can produce the samples in an acceptable quantity on an acceptable schedule and create a protocol for the collection. This step can take months.
- Failure to contract: For each specimen collection site, you’ll need IRB approval, consent forms and compliance documents. That can take a lot of time and run up costs. You’ll also need to perform due diligence, especially on unusually low bidders.
- Imprecise kit building: Every prospective collection requires a special kit instructing clinicians how to collect required specimens in proper amounts and how to process them afterward. Detailed specifications can add time and complexity. I once had a client request that plasma samples be centrifuged at a specific speed by a specific brand and model of centrifuge—meaning these particular centrifuges needed to be rented and distributed to providers before specimen collection could begin. Do your samples need to be sequenced at some point in the work? If a third-party is to do it, then executing this step takes added planning, time, and money as well.
- Lack of training: Everyone collecting biospecimens needs to be trained in both the standard of care for collecting specimens and in the specific requirements of the study at hand. Neglecting this step can invalidate years of work.
- Unrealistic collection parameters and timelines: It takes time for the right patients and specimens to come through the process in the right quantities. If you’re looking for specific tumor tissue from a specific demographic, these patients appear in hospitals, award their consent, and undergo the surgeries on their schedules, not those of the researchers.
- Failure to account for special requirements: Twists like longitudinal studies and matched specimen pairs add further complications for which more time and budget need to be built in.
To make deadlines and stay within budget, avoid huddling up too much at the front end and wasting time designing preclinical research that won’t fly. Bring someone into the process who can help you determine the feasibility of your study with respect to sample collection and data requirements and identify and solve for the pitfalls before you send out your RFP. Find someone who can help you with timelines, feasibility assessment, and good cost estimates. Look for a partner who can orchestrate even the most complex prospective biospecimen collections through established networks of providers, and who have protocols and consent processes in place.
While specimens are just one of several tools in your research, they are essential for getting your work done. Not accounting for specimen collection at the outset of a project is like conducting an in vitro diagnostic project without test tubes, a cell therapy project without cells, or a cross-country road trip without a gas card.
To save time and money, seek help with biospecimen planning from the beginning. You’ll likely cross the finish line sooner. And every day counts.
Eric Langlois is Senior Vice President of Sales & Business Development for iSpecimen. He can be reached at [email protected].
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