biobanking

For the next episode in our summer series on human tissue sample quality and biobanking, we turn to a veteran biobanker in the U.K. who managed several projects there including the U.K. Parkisons’ Disease Society Brain Bank at Imperial College.

Today we talk to Kirstin Goldring, Principal Scientist at Astra Zeneca where she’s in charge of Human Biological Sample Strategy and Governance. Kirstin is a counselor at the European Society for Biopreservation and Biobanking and also a member of ISBER or the International Society for Biorepositories.

So far, in the U.S. biobanks are not regulated. In the U.K., they have what is called the Human Tissue Authority or HTA. Kirstin explains that the HTA is really some light governance that leaves a lot open to the biobanks as to how they go about maintaining standards. Could the program be a model for us here in the U.S.?

What has been Kirstin's overall take away on the field after managing different projects in various locations? Are we getting any better at sample quality?

When former President Obama’s team released the paperwork for what’s become the All of Us Research Program, in the part about biobanking, the wording specified that the biobanks applying for the grants be “CLIA compliant.”

“They didn’t put quotes around it, but whenever I say it, I put quotes around it. “CLIA compliant”—it's not a thing,” says today’s guest Shannon McCall, one of our country’s leading experts in the field of biobanking and biospecimen science. Shannon leads the Precision Cancer Medicine Initiative with her team at the Biorepository and Precision Pathology Center at Duke University.

What Shannon is getting at is that biobanks are not currently required to be CLIA compliant the way labs are required to be. And they never have. Biobanks are unregulated, and many in the field argue standards, and therefore, biomedical research, is suffering as a result.

This is the second in a series of interviews on the topic of biospecimen quality, and today we focus solely on storage and the biobank.

Shannon is also the Vice Chair of the College of American Pathologists (CAP’s) Biorepository Accreditation Program, the country’s only program of its kind to offer such accreditation. This year CAP is celebrating their 50th anniversary of offering laboratory accreditation. They're widely seen as the leader in lab quality assurance.

Biobanking is a relatively new industry, it's true. Time Magazine made it one of their 10 ideas changing the world in 2009. So is it nigh on time for biobanks to come under one regulatory agency such as CMS and the CLIA program? Some international biobanks, many of which were built in Europe based originally on American models, now serve already as standards of excellence back here across the pond.

Has Shannon heard pushback from the community against coming under CLIA? Why are biobanks going for CAP accreditation in the first place?

What is the biggest issue for storing samples? Why do biobanks struggle with sustainability?

We come in at around 28 minutes.

Guest:

Diane C. Farhi,, MD, Senior Medical Director, Quintiles Laboratories Bio and Contact Info

Listen (6:37) Tracking clinical samples around the world

Listen (5:34) How to measure sample stability

Listen (3:37) New software needed

Listen (5:07) Challenges from the increase in DNA sequencing

As we’ve been uncovering in our special series, Back to Basics: Improving Biospecimens, the issues around biosample collection, storage, and delivery here in the U.S. can be overwhelming. But Diane Farhi and her team have to manage on a global scale at Quintiles, the world's largest CRO. Who better to take us into the practical issues around sampling?

'Harmonization' is the name of the game in dealing with a global laboratory, says Diane, the Senior Medical Director at Quintiles. Diane and her team are dependent on a world wide delivery system, and that can bring with it many variables which impact samples.

“The whole issue of transport--how long it takes, what the temperature variability is within the package, impacts of alterations in flight schedules due to natural disasters and strikes and other event--all impacts the quality of our specimens when they finally arrive at one of our global laboratories,” she says.

In today’s interview, Diane shares some of the ways that the team at Quintiles mitigates the sampling issues that lie beyond their control. She also details some of the new challenges that have come with the dramatic increase in RNA and DNA sequencing.

Podcast brought to you by: Fluidigm - Make your biobank a quality research partner. Download the Evolution of Biobanking whitepaper today.