We recently spoke with Michael Clare-Salzler, MD, chair of the department of pathology, immunology and laboratory medicine at the University of Florida Health, as well as Amer Abouhamze, MHA, assistant director at the University of Florida Clinical & Translational Science Institute Biorepository, about the evolution of their state-of-the-art biobank. We discussed how data needs and improvements have changed the way the bank operates and what they deem critical for sustainability in meeting researchers’ needs in the age of personalized medicine.
The biorepository at the University of Florida (UF) Clinical Translational Science Institute (CTSI) provides high-quality biospecimens, biospecimen processing services and an extensively monitored storage facility to meet the needs of researchers both inside and outside of the University. As we discussed during the conversation, this concept of extending biorepository reach to include serving and sourcing from external parties has been critical to the biobank’s success. iSpecimen is one of several channel partners they use to help ensure their specimens are making it into the hands of researchers who need them.
Approximately 18,200 samples are currently available at the CTSI biorepository, including solid tissues, such as fresh-frozen samples; formalin-fixed, paraffin-embedded (FFPE) blocks and slides; and biofluids, such as blood and blood derivatives. All samples are annotated with as much data as possible, including pathology report data and de-identified electronic medical record (EMR) data. Additionally, all specimens are de-identified in accordance with HIPAA guidelines.
The following conversation sheds great light into the processes and considerations of a modern biobank:
When was the CTSI Biorepository created? Can you describe the driving force behind its development?
We started off with a small collection of specimens, more of a rudimentary biobank, many years ago, but began growing the collection in earnest in 2008. The University was applying for a Clinical and Translational Science Award (CTSA) grant from the NIH and building out a biorepository to accelerate research was an essential part of that process. In 2009, UF received an award of $26 million over 5 years to develop a clinical and translational research capability, which included a state-of-the-art biorepository. These funds were supplemented with contributions from the University and the College of Medicine.
What changed after receiving the grant?
After presenting a business and operational plan, a suitable space of 2,000 sq. ft. was identified and allocated funds were used to expand sample collection capabilities, outfit the laboratories with equipment needed for processing and analytics, implement quality control and specimen monitoring measures and recruit dedicated personnel.
We created an IRB-approved collection of tissues and biospecimens open to all investigators at the University of Florida. We also offered the option of collecting specimens under study-specific research protocols and storing investigator-collected specimens procured under their own IRB-approved protocols.
At first, the biobank was not making specimens available to researchers or biobanks outside of the University. However, we realized that internal utilization was not meeting the rapidly growing number of collected specimens. Aspiring to make use of procured specimens as quickly as possible and recognizing that cooperation among multiple organizations advances resources for all, the decision was made to provide biomaterials to outside groups.
By working together, biobanks enhance research through sustainability and scope of offerings to a greater number of individuals in the scientific community. In the end, opening up our offerings to outside organizations will accelerate important scientific investigations into human disease processes. That’s always been our main goal-to further research.
How has the sophistication of your biobank, including technology and data management improvements, changed the way the biorepository is viewed and operates?
As we put more and more focus on expanding our biospecimen library, we realized there had been decades of lost opportunities to collect samples from patients passing through the UF system. Moreover, the leftover samples or parts of samples that were not used for testing or diagnosis were routinely discarded.
Now, we consent patients, asking permission to use their residual tissue or blood for research. Overwhelmingly, they agree to this use and welcome the chance to become involved in research and see themselves as partners in this process. Because of this form of patient philanthropy, we now have a better chance to enhance researchers’ abilities to directly study human disease.
Importantly, we have enhanced the value of the specimens by collecting data associated with the samples collected under an IRB-approved process. Many researchers want to know important details that will document the quality of the specimen, such as time of ischemia or how long a sample has been frozen. Other data, available with IRB approval from the EMR, will also provide valuable information about the patients’ medical history, medications, treatments, etc.
The more information on how a specimen was collected and stored and the more information about the patient donor; the more valuable the specimen is. While properly collected and processed specimens with these extensive, associated data sets cost more to collect, researchers increasingly recognize just how valuable a quality specimen is to the quality of their research.
What else have you learned that is extremely important over the last several years?
The closer each biobank can move towards assembling big data sets, in which all information in the EMR, lab reports, pathology reports, etc. can be searched and linked to the respective specimens, the closer we will all be to optimal biobanking.