THANKS TO 10 YEARS OF EXPERIENCE, an existing infrastructure for banking patient specimens, and the unique capabilities of its clinical laboratory organization, Mayo Clinic has been awarded a five-year, $142 million grant from the National Institutes of Health.
Last month, NIH announced this grant to Mayo Clinic. It will establish the world’s largest research-cohort biobank for the Precision Medicine Initiative (PMI) Cohort Program. To further this longitudinal research study, Mayo will enroll at least 1 million Americans. Mayo will collect and store specimens and clinical data from the participants for researchers pursuing PMI projects.
This grant is part of the Precision Medicine Initiative that President Obama announced earlier this year.
“From each participant, Mayo will collect 35 samples and then store those samples in automated freezers in Rochester, Minn., and Jacksonville, Fla.,” stated Mayo’s Stephen N. Thibodeau, PhD, in an interview with THE DARK REPORT. “The collection of 35 million samples of blood and urine from 1 million patients will make it the largest biobank project anywhere in the world.”
Thibodeau is Co-director of the Mayo Clinic Center for Individualized Medicine Biorepositories Program and a professor of laboratory medicine and pathology in Mayo’s College of Medicine.
What helped Mayo win the grant funding is that the facilities in both locations have already been built and are now being prepared to store the specimens. “The facility in Rochester has already been in use for five years,” noted Thibodeau. “In fact, Mayo has biobanked samples in one form or another for well over 100 years.
“Our different investigators are continually involved in a variety of projects,” he said. “Thus, over time we’ve become increasingly sophisticated with our laboratory and biobanking ability. In addition to Rochester, we have existing biobank repositories in Arizona and Florida.
Labs and Biobanking
“About five years ago, Mayo started a major effort to consolidate the labs that were involved in biobanking,” stated Thibodeau. “The goal was to centralize and automate the lab involved with biobanking and processing samples. At that time, Mayo constructed this new facility.
“At the start of this project, the idea was to create a state-of-the-art laboratory for specimens that Mayo clinicians would collect and use for research,” he explained. “We knew that eventually we would be able to offer these biobanking capabilities to another organization as a commercial venture.
“In fact, at about the time that work on the biobanking facility was completed and the automation work had commenced, the NIH sent out an RFP,” said Thibodeau. “With the building done and the automation ready, Mayo fulfilled the requirements of this NIH grant.”
This summer, NIH will announce grants for a PMI Cohort Program Coordinating Center, a Participant Technologies Center, and a Healthcare Provider Organization Enrollment Center. To reach the goal of processing 1 million samples by 2021, Mayo needs to begin collecting specimens quickly.
To collect the specimens for the PMI Biobank, Mayo Clinic will harness the resources of Mayo Medical Laboratories (MML), which receives 35,000 to 40,000 specimens a day and performs 23 million tests annually. MML’s nationwide network covers all 50 states and includes more than 300 couriers and logistics providers.
“We expect to be processing roughly 250,000 patients per year within the next 12 months so that much of the material will be available to investigators within the first couple of years,” he commented.
“In addition to collecting patient samples, the Mayo laboratory organization will analyze the biospecimens with chemical and genetic tests,” continued Thibodeau. “That data will be combined with other information that patients will provide on lifestyle and health questionnaires, medication history, electronic health records, physical exams, and environmental exposures. Also, we will collect physiology data tracked through mobile health technologies.
“Mayo plans to have all the procedures in place this summer,” he predicted. “By October, a pilot process will be ready for some of the collections. At that point, we expect to be fully functional. It means Mayo will be collecting samples from the first 250,000 patients, certainly by about this time next year, which is the end of the first year of the grant.
“From each patient, we will derive 35 aliquots of different components from his or her blood and urine,” added Thibodeau. “That will give us a total of 35 million tubes to store. We plan to store about 75% of the specimens in Rochester and the rest in Florida. To handle this work, we’ll hire 20 to 30 individuals in the next 24 months.
“Another reason NIH looked favorably on our proposal is that Mayo has an existing automated freezer process in Rochester, along with multiple layers of redundancy,” he continued. “For example, one requirement of the grant is to have off-site storage. That’s why we will store about 25% of the specimens in the Florida biobank facility. In case something happens at one site, back-up samples will exist at the other site.”
Contact Stephen Thibodeau, PhD, at 507- 284-2511 or firstname.lastname@example.org.
Pharmacogenomic Work Was a Boost for Mayo
ONE BIOBANK PROJECT AT MAYO CLINIC that is similar to the work Mayo will do for NIH involves pharmacogenomics testing for patients. In the first phase of that project, John Logan Black, III, MD, Mayo’s Co-Director, Personalized Genomics Laboratory in the Department of Laboratory Medicine and Pathology, is testing 1,000 patients. In phase two, Black and colleagues plan to test 10,000 patients. (See TDR, June 22, 2015.)
“The patient population from which Dr. Black is recruiting is in the Mayo Clinic Biobank, one of the biobanks our group manages,” said Stephen Thibodeau, PhD, Co-director of the Mayo Clinic Center for Individualized Medicine Biorepositories. “In the Mayo Clinic Biobank, we have collected samples and created a repository from more than 50,000 Mayo patients.
“That Mayo patient repository of samples from 50,000 patients is analogous to the federal government’s Precision Medicine Initiative,” he said. “The national repository of 1 million patients is similar to what we’ve done for 50,000 Mayo Clinic patients, and we have those samples in hand right now.”