Why is there more focus on precision medicine than ever before?
MH: There are record numbers of trials ongoing evaluating novel therapeutics in broad patient populations. In most cases, these novel therapies work in less than 50% of clinical trial participants, further illustrating the heterogeneity of the human population. By deeply interrogating the heterogeneity of each disease, we learn more about those individuals that would respond to a particular therapy over another. This precision approach has the potential to reduce the disease burden and financial burden by reducing the trial and error approach to patient treatment.
What causes the majority of inaccuracies when it comes to samples?
MH: One of the biggest challenges in research and development is acquiring enough samples that provide a true representation of the larger population. Specifically, most investigators acquire samples from an individual clinical site so this limits the ability to extrapolate the data to the general population. In the future, it will be important to identify opportunities with larger sample sizes to get more representative information. Additionally, many samples lack the appropriate clinical information to allow proper analysis. It's important to identify highly qualified and characterized samples to get the most accurate assessment and understanding.
Can you elaborate on the issues less accurate samples can cause?
MH: Generally, investigators collect samples for subsequent analysis to understand the mechanisms behind a particular disease. In the event that insufficient information is collected by the clinical site, this can limit the investigators ability to fully interpret the analysis. Ultimately, this can limit the overall study and prevent further advancement of our understanding.
Are people still relying on ineffective methods?
TC: Yes, many are still relying on ineffective and disjointed methods, especially when it comes to obtaining samples. For example, we see confusion when it comes to repetitive customer email requests for samples and most of these actions are still done through spreadsheets and inventory reports.
How can this be changed and how urgent is it that it changes?
TC: Much like the way Amazon has made buying very simple for consumers, we think there is still room and a desire from our industry to create this type of marketplace for researchers and vendors. Everyone on either side of the industry acknowledges that there needs to be a new system in place that will improve this process, especially for those still utilizing / tracking CSV files, tracking orders manually, relabeling orders, dealing with non-consolidated data sets, etc. All of these efforts lead to bottlenecks and inefficiencies. As such, there is an appetite for better solutions. There is definitely a motivation from those in the industry to focus on the client and make their lives better, by making this process easier, faster and more trustworthy.
Can you give some examples of the valuable types of information researchers are missing out on?
MH: Overall, it’s important to gather as much information from participants as possible. As technology continues to improve, so does the complexity by which we are able to analyze clinical samples. Specifically, it is important to identify key clinical information for each participant including information about the family medical history, disease history (onset of the disease, past treatments, co-morbid conditions, etc), and laboratory assessments. All of this can be pulled together in more complex data analytics to provide innovative assessments of the data.
Tracy and Eric Langlois, who is chief revenue officer at iSpecimen highlighted the differential in the types of biobanks and how clinical/institutional biobanks work through their research administration offices to process requests, approvals, and distributions.
"These institutions may be run by a very small team and do not have the resources for large operational support, including a sales force or business development team. Oftentimes, with the lack of operational support, when researchers are requesting specialized data packages, it is very difficult and time consuming to fulfill. There may even be lost opportunities due to the lack of resources. Such circumstances have resulted in an opportunity for iSpecimen to assist these organizations and is the reason why we have created our embedded coordinator program. This program provides sites with the needed resources to help manage complex requests."
They also explained that from the commercial biobank side, these biobanks are currently working very much with rudimentary spreadsheets and are not US-based. This, they say, creates roadblocks in terms of higher shipping costs and logistical issues, especially following the COVID-19 pandemic and other world issues.
They added that researchers these days have broader needs that sometimes cannot be fulfilled by one biobank. "As a result, they have to send out their requests to many different providers. iSpecimen helps to alleviate this disjointed process to allow researchers to place one order with us. The company then collects the specimens from multiple biobanks and collates and harmonizes the data. The specimens are consolidated and provided to the researcher along with one collated data sheet."
What prompted iSpecimen to be different?
TC: iSpecimen hopes to transform the way people access biospecimens. The goal has been to aggregate a much larger network that is not solely reliant on one healthcare system/hospital/biobank/protocol.
Today, many biospecimen samples are still being underutilized. The system is fragmented and it creates obstacles for researchers to access and gather everything they need, not to mention, put in the time to canvas each system. To be able to achieve this through efficient and innovative technology - especially when the focus is on advancing clinical research - is the goal for iSpecimen.
We’ve built out a robust provider network so that researchers who approach iSpecimen with complicated requests can feel confident that we can help and make a difference, where other vendors may not be able to.