How To Run A Biobank

September 23, 2019

September 23, 2019 | When Zuanel Diaz moved to Miami, the idea of a cancer center in that area was just that, an idea. With her expertise as a PhD earned in Experimental Medicine at McGill University and a postdoctoral fellowship in Clinical Research, as well as playing a critical role in establishing the first metastatic cancer biobank for the Quebec Clinical Research Organization in Cancer, Dr. Diaz helped translate that idea into the services offered at Miami Cancer Institute, a state-of-the-art facility that brings outpatient cancer services and research together under one roof, including the Protocol Support Laboratory and the Biospecimen Repository Facility, of which she is the founding Director.

On behalf of Bio-IT World, Mary Ann Brown spoke with Dr. Diaz about her role at the Miami Cancer Institute and what's next for the biobanking industry.

Editor's Note: Brown, Executive Directors of Conferences at Cambridge Healthtech Institute, is producing the upcoming 11th International Leaders in Biobanking Congress, in Miami, FL, October 30-November 1. Diaz will be the chairperson for the event. Their conversation has been edited for length and clarity.

Bio-IT World: Could you just tell me a bit about the background of Baptist Health and the Miami Cancer Institute and your brand new laboratory there?

Zuanel Diaz: Baptist Health South Florida has been a one of the main networks in Miami and South Florida during the last 50 years.

With the creation of the Miami Cancer Institute, a hybrid academic-community cancer center, we established the Protocol Support Laboratory and the Biospecimen Repository Facility to position the Institute at the forefront of biomedical research.

In this facility, we manage biospecimens. That's what we do on a day-to-day basis. The infrastructure, the team, and the operational set-up is designed to collect, process, store and distribute unique biospecimens that can be used by researchers in a variety of translational and clinical research projects.

The biospecimens arrive to the Protocol Support Laboratory from patients that are enrolled in clinical trials. These patients are treated with innovative, promising therapies that, in order to make them available to all the patients, need to be fully studied, have minimal toxicity, prove to be effective, and all that is determined by studying measurable signals in those biospecimens that will reflect a particular disease state. These signals are called biomarkers and we need to characterize those biomarkers at different time points of the patient’s treatment to determine the right dose, understand the drug metabolism, and identify some patterns that can be associated to the patient’s response to that particular treatment.

The biospecimens can also arrive to the Lab from patients that are enrolled in the Biospecimen Repository Facility Program. These patients donate blood, bone marrow, other fluids, and allow us to obtain excess tissue removed during surgical procedures that are considered left over after the diagnosis has been established. We collect, preserve and store those biospecimens, and make them available to the scientific community. Through an in-depth analysis of these biospecimens, researchers, either within the Miami Cancer Institute or anywhere in the world, are able to further understand biological factors that contribute to cancer and develop prevention strategies, early detection tools, and more effective therapies.

We manage these biospecimen following strict standard operating procedures, which allows us to control pre-analytical variables. If the specimens are not properly collected, processed within a very tight range, following standards and preserved in a manner that is compatible with the downstream molecular analyses, then the biomarker integrity is compromised and therefore the research project, using low quality samples, will result in low validity and reliability.

How are you able to accomplish all this? Could you describe the facility, the processes, and the team?

We have automated the blood processing for banking purposes. With the blood donated from patients enrolled in the Biospecimen Repository Facility program, we isolate plasma and serum, which can be used to identify and validate safety, predictive and prognostic biomarkers. From the same tube of blood we extract the buffy coats, which contains peripheral blood mononuclear cells, whose DNA can be analyzed to identify germline mutations, or whose proteins levels can be determined. We also prepare double centrifuged plasma from which circulating tumor DNA can be isolated and further characterized; this provides a snapshot of metastatic processes and can be used to describe how and which cancer cells are leaving the tumor areas to reach distant organs and spread the disease. The automated blood isolator can process four samples at the same time and is connected to our Laboratory Information Management System to capture sample processing details and storage location. All cases are subjected to our quality control process and aliquots are stored in ultra-low temperature freezers, until requested by researchers.

We process tissue shortly after its removal from the patient by surgical procedures and immediately freeze the tissue in liquid nitrogen to preserve its molecular status. This provides a true representation of the biological processes that are activated at that particular moment in the patient's life. All tissues are subjected to quality control; a Pathologist performs a comprehensive histological characterization and determines the percentage of tumor cells, the extent of necrosis, the fibrotic areas, etc.

For clinical trials, we have a completely customized approach. Each Sponsor, provide us with details on what samples they would like to collect, based on the particular therapeutic agent they are studying, how they want us to process that sample, what data elements we need to capture, where those samples need to be sent… We have to follow strictly those directions so they can receive high-quality and fully annotated biospecimens. They rely on us! And this is our commitment to the patients! We also support the Miami Cancer Institute investigators and help them design the correlative science portions of their studies. We are then responsible for all I have mentioned, but also for performing the biospecimen molecular characterization or partnering with basic scientists and commercial analytical platforms to study mutational status, cellular functions and signaling pathways that are activated in response to the therapies used.

Our team is our most important asset! We have technicians specialized in tissue management who personally bring tissue from the OR to the Pathology Department. The diagnostic workflow is performed immediately, and the excess tissue is preserved within a short period of time. We also have technicians specialized in biofluids management. They process blood, urine, saliva for clinical trials and for biobanking purposes. Our supervisors oversee the day to day operations, the clinical trials laboratory specialists set up all the research projects that we manage, including the kit collection plans. Our Laboratory Information Management System administrator is on the back-end optimizing processes and maximizing use of the technology available. In this manner, we ensure that biospecimens are managed within a tight chain of custody and using strict standard operating procedures to control pre-analytical variables.

That's what we're here for, and that's what all the attendees will see when they come to our facility.

They'll get the opportunity to see the biospecimen continuum: from the Precision Medicine Unit, where patients enrolled in clinical trials are seen by their physician and biospecimens are collected by our technicians, to the Protocol Support Laboratory where we process the biofluids and tissue, to the Biospecimen Repository Facility, where we store them and finally to the Molecular Diagnostic Laboratory where those biospecimens are molecularly characterized.

Approximately how many patient's samples do you process per day?

We see an average of 15 patients per day, some of them are enrolled in Phase I/II clinical trials and have multiple collection time points for pharmacokinetics, pharmacodynamics or biomarker analysis. On a daily basis, an average of 20 patients donate biofluids and 5 patients undergoing surgery donate excess tissue.

Sounds like you're busy. What does a typical day at the office look like for you?

I work in a very dynamic environment. In the morning, I pass by the Laboratory before arriving to my office to connect with the staff and the Supervisors. The assignments are already distributed, the plan for the patients scheduled is ready and one of our pharmacokinetic technicians might be already preparing kits for the next day. At the office, a good Cuban coffee is awaiting... and the calendar with the schedule of meetings, which can be operational, scientific, 1:1, team meetings, etc. is set. The operational meetings ensure that we have the resources in place, the applicable workflows, the necessary funds allocated and our efforts remain focused on our strategic goals. The scientific meetings are usually with physicians that are developing new research projects; we design together the correlative science: which biospecimens need to be collected, at what time points, what molecular profiling can be performed to test the study hypothesis and how we can design the study in a way that maximizes the use of the Miami Cancer Institute programs and teams. Frequently, we connect our physicians with external laboratories, such as those at Florida International University, to capitalize on their expertise in specific fields. The 1:1 meetings serve a variety of purposes: mentoring, direct reports development, reporting to executives, coordinating the next service line and expansion, working on an Institute priority, etc. The team meetings focus on quality management, strategic alignment, communication, and reporting as well. I make sure that we take a pause, from time to time, and look at how much we have accomplished, recognize our wins and give thanks, again and again, for our collective efforts.

What's next for biobanking?

The biobanking community is multidisciplinary and I am happy to see that the current focus is biospecimen science and data management. I believe this paints a beautiful canvas to remain at the forefront of cancer treatment, prevention, and research. The biobanking experts close the specimen gap between researchers who need high-quality human biospecimens, and the patients, who want to contribute and help advance scientific knowledge, develop new drugs, diagnostic tools and screening strategies that will help future cancer patients. In this era of precision medicine and genomic research, the complexity and the amount of histological, clinical and molecular data that needs to be linked to the biospecimens has increased substantially. The preservation strategies have also become more demanding and will continue to evolve. Only by operating a robust and concerted infrastructure capable of adapting collection and annotation strategies to meet the biospecimen supply needs of the future, will we continue to support the advancement of science and the creation of new medical and scientific knowledge to enhance patient care.