July 11 (UPI) — On the sprawling Mayo Clinic campus in Minnesota, a 60,000-square foot-building houses one of the most important projects of the esteemed 154-year-old medical institution.

Eventually, the climate-controlled, highly secured building in Rochester will hold 34 million samples — blood, urine and saliva — collected from 1 million people. The National Institute of Health’s All of Us project is collecting those samples from volunteers around the nation in a quest for detailed health profiles to advance medical care worldwide.

“If we take a look at medical research, drug discoveries, diagnostic discoveries, how to detect disease, all of this is research,” Dr. Stephen Thibodeau, program director for the Mayo Clinic Biobank, told UPI. “All of the researchers use repositories. You can’t do translation medicine without having a bio repository.”

The biobank is similar to a financial institution’s repository, he said, calling it “a place you take something and deposit it and keep it for future use.”

The Mayo Clinic has had its own biobank, with 50,000 participants from among its patients nationwide — though it actually has been collecting some samples since it opened in the mid-1880s. Mayo’s biobank was started 10 years ago as a way for researchers to collect, process, manage and store samples they were working with.

Creating a national biobank

During his 2015 State of the Union address, President Barack Obama called for the Precision Medicine Initiative to create a massive genetics database. The program was renamed All of Us in 2016, and earlier this year the program’s budget was boosted by $60 million, to more than $290 million.

The Mayo Clinic, which received a $142 million grant to run the biobank, has worked with the NIH to prepare for the program — including doubling the size of the building and starting to collect samples from about 38,000 people who participated in a beta version.

“Part of our business plan was to look at other academic institutions, pharmaceuticals and the NIH in externalizing our work,” Thibodeau said. “When the NIH grant became available, we were in a good position to apply for the grant.”

“We’ve spent a lot of time securing the building,” he said. In redesigning the facility, Thibodeau said the building has significant back-up power to keep samples at -79 degrees Celsius regardless of weather in the area.

Collecting and organizing samples

About seven vials of blood — about 5 tablespoons — are taken from each donor and transported to Minnesota. Several hundred trucks deliver the samples to the biobank each day. The blood samples are broken down into serum, plasma, white blood cells and DNA, and then stored in appropriate parts of the building in an automated system.

Each sample is labeled only by a number, and the names of donor participants are stored at Vanderbilt University — several states away.

While decisions and regulations still need to be made on how the samples will be released to researchers, Thibodeau expects to start generating data from the collection by the end of the year.

“At some point we will have a committee developing policies for accessing data and bio samples,” he said. “How will we use the data, what form to release the data. It will be a controlled process.”

Collecting as many samples as possible

A major goal of the biobank is to come up with samples and medical information that represent a diverse population.

“It’s been essential for us — from the very start — to have diverse voices at the table, weighing in on the best ways to engage and retain diverse communities in this program,” Dr. Dara Richardson-Heron, chief engagement officer of the All of Us Research Program, said during the launch in May.

Thibodeau said it’s important to have a large sample size to reflect this diversity.

“When looking at common disease, look at rare disease or effects, it’s all about numbers,” he said. “With more people, there is a likelihood to find an association for genetics of disease.”

Not all Mayo researchers agree

Dr. Michael Joyner, a professor of anesthesiology at Mayo’s Rochester campus, opposes the All of Us Project — though he says Thibodeau is doing a good job with the biobank and he has no problems with its operation. In fact, at one time he was a vice dean in charge of research at Mayo.

“My biggest concern is with the whole precision medicine initiative,” he said. “The fact that there are already 50 initiatives with 100,000 people — what will we learn with 51?”

Among the efforts he refers to is the UK Biobank, based in Stockport, England, which started in 2006 and has with 500,000 donors. Joyner questions what he sees as a lack of true focus on what to do with all those samples.

“You ask yourself, can the money be spent doing something different,” he said. “There is a tremendous focus on what is described as precision medicine. It changes all the time and is being rebranded. They are going to study 1 million samples from volunteers but there is no hypothesis.”

He also wonders whether a diverse database can be achieved by accepting volunteers. In addition, he questions the reliability of the health records produced by the volunteers.

“This is different than randomly recruiting people,” he said.

Kaiser has a competing biobank

Two health systems — Geisinger Health System, which serves northeastern and central Pennsylvania, and Kaiser Permanente, an integrated managed care consortium based in Oakland, Calif. — pulled out of the program.

“Our original proposal was to enroll 150,000 Kaiser Permanente members in the Precision Medicine Institute Cohort Plan,” now All of Us, Dr. Elizabeth McGlynn, president of Kaiser Permanente Research, told UPI.

“We planned to develop a robust participant engagement infrastructure and conduct research to maximize our understanding of engagement issues, particularly related to return of results. We proposed to provide comprehensive, longitudinal clinical and administrative data on PMI-CP participants. We were excited about engaging scientifically in this important national endeavor,” she said

Kaiser was looking to abide by two key principles as part of All of Us: to develop a significant scientific component that could inform recruitment and other activities and to serve in a scientific leadership role in the national programs.

Instead, the NIH-led program required them to drop the scientific aspects of their proposal and to enroll children, “which we and our bioethics advisers were extremely concerned about in the context of plans for broad return of results.”

Kaiser also was being required to abide by all the All of Us steering committee’s decisions, “including decisions related to return of results that would essentially affect the way in which our delivery system operates.”

“Our research operations simply can’t make promises to do things on behalf of our delivery system without engaging them in the process,” McGlynn said.

Instead, Kaiser is building on its own biobank with more than 310,000 participants, and plans to grow it to 500,000. Kaiser draws from all of its regions and prides itself on its customers’ long-time membership in its health plans.

“Our goal is to create one of the world’s largest and most diverse repositories of genetic, environmental and health data, a resource that will benefit our members and the communities we serve,” McGlynn said. “We believe this work plays a critical role in the pursuit of transforming healthcare by improving our understanding of the genetic and environmental factors involved in complex diseases and may lead to discoveries about the prevention, diagnosis and treatment of these conditions.”

More biobank efforts may be a good thing

The leader of the Minnesota biobank doen’t see the Kaiser center as a competitor, but rather as an additional tool for scientists to perform research, which could be especially beneficial in the United States with its diverse population.

Like the U.K. one, the All of Us biobank is a partnership between government and private institutions.

“We ought to be able to compare our samples with the UK biobank,” Thibodeau said about the overseas repository, which has different demographics than the United States.

Thibodeau sees the collection of blood and urine samples as potential medical breakthroughs.

“The success of how we measure this program is the use of the material,” Thibodeau said, noting that growing pains are part of its development.

“It is a great project,” Thibodeau said. “This is a program that will help with future generations. Recognizing a lot of challenges ahead, we are not blind to them.”



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