Biobanking: A Thing Of The Past?

June 13, 2019 | Ten years ago, Andrew Brooks, COO at RUCDR Infinite Biologics and Professor of Genetics at Rutgers University, spoke with Mary Ann Brown, Executive Director of Conferences at Cambridge Healthtech Institute, about the real need for biobanks to continuously adapt if they want to fulfill both the science and business of their enterprise.

"As technology continues to evolve, the samples that are being utilized in the biobanks are continuing to evolve as well," Brooks said at the time. "Transitioning a biobank from an entity that will simply collect a sample, be able to process that sample, and do a single test, is very different than being able to proactively collect a sample, store it, distribute it over time, and also manage the quality of the distribution of those samples."

A decade later, Brooks sees improvements in the sheer volume of samples, though a lack of harmonization across biobanks remains an issue.

On behalf of Bio-IT World, Brown followed up with Brooks, discussing the differences between biobanks and biorepositories, the rapid changes direct to consumer applications are bringing to research biobanks, and whether or not traditional biobanks are a thing of the past.

Bio-IT World: What's your working definition of "biobank" and "biorepository"? Frequently, these terms are used interchangeably.

Andrew Brooks: I think that there are a number of terms that are used in the biobanking world that have been muddled together over the years.

An example is when you look at samples that are considered storage samples versus biobank samples, which I think relates to the definition of a biobank versus a biorepository.

There are still two real defined segments people that store samples for analytical use. Those are the ones that people store for their own use or for their own circle of collaborators, which are not collected with the idea of future use, and for the development of more global discovery. Those are more biobank samples that are for storage.

Biorepositories have evolved into global resources that are designed for the future, for the sharing of samples. That also involves the data and the use of the data, as well as samples; prospective or proactive quality control of samples so they can be shared across sites; and also, for a biorepository, the forethought of collecting samples that may not be of use right now or analyzed, but would be in the future.

When I think about the working definition of a biobank, I look at that as a focused program that has defined end points in mind for a defined community, whereas a biorepository is a program that is looking at a more global, collaborative standpoint with a wider variety of biomaterials, with an eye on collaboration now and in the future.

You and I recorded a podcast on biobanking 10 years ago. What have been the biggest changes you have seen during these past 10 years?

A lot has changed. Some of the biggest changes in the past 10 years, certainly, is the number of samples. I think that more samples have been collected than anyone has ever imagined.

Unfortunately, one of the biggest changes, or the lack of change, is the lack of harmonization across biorepositories and biobanks. I think we've always talked about it, that there's still a desire, and an urge, and a requirement for us to do that, to maximally use all of these samples that are collected. Even with meetings like CHI's biobank meeting, the ISBER Society, and all of these other international groups that are working together, I don't think we've achieved the harmonization across biobanks and sample quality that we're still looking to do. It's not from a lack of anyone's effort, it's a huge undertaking.

The landscape of biorepositories and the banking of samples has also changed in that there are many new players. 10 years ago, we didn't have direct to consumer biobanks, which have grown faster than some research-based biobanks, making samples and data available to the community, but also directly to the consumer.

I think the single biggest change in the last 10 years is the role of the biobank, which has evolved from, "we'll take care of your samples in these freezers at these controlled environments, and make sure nothing happens to them," to a critical and pivotal role in the advice and engagement on the collection of samples, the processing of samples, the quality control of those samples, the management of that data, and actually managing that kind of shared resource that's being developed versus just a central area for where you keep and how we manage the samples.

I think that's continuing to evolve. As biobanking makes a transition into healthcare and clinical care, that role will also continue to evolve, where the lines between the collection, testing, and then storage of those samples will ultimately all become part of a biorepository framework.

You commented that there's a rapid change with direct to consumer applications eclipsing research biobanks. Could you please elaborate on that just a bit?

I think that the direct to consumer market for people that want to understand their own wellness, their own genetics, and a lot of great technologies that are out there that have been developed around the interpretation of data that we get from genomic, and proteomic, and other applications has really developed into new types of biobanks that are being created.

So, if you look at the Ancestry.com's of the world, the 23andMe's of the world, and all of these other large direct to consumer companies, they are creating biobanks that are similar to what was created for what we would consider future research, or future use.

The numbers of samples have grown, but the way to engage, and data security and privacy are changing the landscape of how you would access samples in these different biobanks, and also the rights that people have, certainly, to their data and to their samples, even in an anonymized form.

I think that these companies and these entities are taking into consideration the best practices for how to process samples, how to store them, and are taking advantage of the newest technologies. However, the approach that's being used to access those samples and/or the data associated with them is something that, from a biobank perspective, is different.

It's led to a tremendous increase in the overall numbers of samples being collected.

What about the sample quality and integrity with this avalanche of samples being collected?

So, I think that sample quality and integrity is more important than ever before, simply because the data that's being generated, and the way it's being shared with individuals, and with more and more samples that are being managed by biobanks with data from studies, and/or trials, and/or direct to consumer that are being reported back to subjects, patients, clients if you will, is really driving a unification of the highest sample quality and integrity that's required.

Sample quality and integrity is a function of the sample type, certainly. Not all samples are created equally, so all analytes and data is not going to be created equally. However, the annotation of what happens at the time of the collection of that sample and throughout its life cycle is critical. Again, because of how samples are being used now for data reporting, quality integrity is really on the top of everyone's list that's building a quality program.

With this emergence of the digital age, are traditional biobanks a thing of the past?

No, I don't think traditional biobanks are a thing of the past.

I think, as a scientific field and as a business, biobanks are a hybrid of those two entities. We just need to evolve and go with the trends and the ideas that make us relevant and that also make the samples relevant.

If you think about it, if a biobank that focuses on the quality of the sample, but doesn't manage the quality or the digital chain of custody, or the quality of data associated with the sample, it leads to a huge decrease in the value of those samples. Vice versa, if you have high quality, clinical data, that's curated and annotated, very well managed, but the quality of the sample is not up to the standards of the community or those that want to use it for analysis, well, then, all of that clinical data is not useless, but has a very different impact.

So, I think what's evolved is the integration of health data and other data associated with biological samples other than just disease, or whether you're part of a trial or you're not, has led to really the advancement of a model that biological banks are as much about data as they are about samples.

Fortunately, there is technology, there are the people that are driving the collection of those samples understand the importance of data, and there are defined quality metrics for annotation and getting high quality data. We need to combine the traditional bricks and mortar, physical sample handling, and physical sample chain of custody methodology to the digital age, making sure that we have the same rigors, the same quality assurance and quality control around the digital chain of custody of each sample, which includes a lot more data now than it has in the past.

You mentioned a hybrid model. Is this the new business model for today's biobanks?

I think it is. I think that in order for biobanks to be successful, they need to have a very good technology infrastructure, and be a service-based facility.

They also need to think and act like a business, largely because the ongoing maintenance and cost of samples is not free. When a lot of people think about biobanks, or building biobanks, their focus is on the infrastructure and the technology for getting the samples into the biobank, quality controlling them, or what have you. Unfortunately, a lot of biobanks don't think about the other half of the equation.

A biobank is not unlike a bank where you keep your money. Imagine if you went to your ATM, and you put your card in and you asked for $100, and you got a little slip of paper that said, "In eight weeks, we will bring the $100 to your house." You would immediately go and find another bank. You need access to your assets.

Biobanks are not any different. The problem with biobanks, and the sign that a biobank is a good biobank is that people are using it. Access to samples in addition to that high quality data and physical sample are really critical.

In order to support that back end part of a biobank, you need to be fiscally sustainable to be able to continue to store and access the samples that you have. When you think about a biobank from a business perspective, you need to think about how you're going to collaborate and share those samples.

A model where you can recover the cost, or part of the cost, associated with the storage and the ongoing maintenance of those samples helps drive that business forward, making it more fiscally sustainable. This requires the appropriate consenting of subjects, and all of these pieces, that allow you to run a biobank as a business.

I think that 10 years ago, the business of biobanks was, how do we recover the cost for sample collection and/or what are the funding mechanisms for building that biobank? Now, we have to look at the value of the data and that sample, and how we can use that collaboratively to help cover the ongoing costs and expansion of a bank.

I do think the model has evolved a bit to include those business components, and not just the scientific and technological components.

You mentioned our interview 10 years ago. We closed that discussion with my asking, what new technologies or protocols should a biobank invest in so as not to bankrupt your biobank? Can I ask that question again?

I wouldn't be surprised if my answer is somewhat similar to what I said back then.

I think that biobanks and biorepositories are becoming integrated programs, a lot like precision medicine programs that don't necessarily gravitate around one component.

Precision medicine are programs that are built about understanding the genetic makeup, the environmental makeup of individual people, and how medicines are created to help them specifically for that disease and them.

Biobanks and biorepositories have evolved, not just to collect and store one analyte at one temperature for one purpose, but to prospectively collect samples that can not only help development of therapeutics and diagnostics, and understanding of wellness, and ancestry, and all of these things today, but what they can be used for in the future.

I think the technologies and protocols around maximally using every sample, getting the most out of every sample that you can, is what's really critical not to bankrupt your biobank.

If you're collecting blood, for an example, and you're just now looking at genomic DNA, think about collecting cell free DNA from that blood sample, think about cryo-preserving a cell from that blood sample so you can create a cell line later one, or do some kind of mechanistic development.

The approach and the technologies that are required to maximize the use of every sample, thinking about applications and analysis for today, need to evolve to create biobanks of the future so that you have biomaterials to be able to expand this discovery process.