An International Perspective on How to Improve Biobanking with Kirstin Goldring

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?

Should Biobanking Come Under CLIA? Shannon McCall, Duke

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.

The Daunting Task of Managing Biospecimens at the World's Largest CRO: Diane Farhi, Quintiles


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.

Biosampling Basics with Scott Jewell, Van Andel Institute


Scott Jewell, Senior Scientific Investigator and Director of Program for Biospecimen Science, Van Andel Institute Bio and Contact Info

Listen (3:30) Do you see more creativity in the sample consent area?

Listen (7:08) Sample collection - the operating room

Listen (6:52) Sample storage - keeping analytes viable

Listen (7:49) Are researchers becoming more discriminating in their choice of samples?

Listen (4:39) A gold mine

Listen (3:21) How did you get into this?

Scott Jewell joins us from the Van Andel Institute today to walk through some of the basic issues involved with the procurement, storage, and processing of biosamples.

This is the second part of our series on biospecimens, and Scott too will leave you wondering if more focus on sampling might just improve your research dramatically. Scott argues that as biomedical research has developed, "we’ve cherry picked the best things potentially out of what we could gain from science that were robust and that didn’t need to have the perfectly preserved samples.” But those days are passing and now there’s “a lot that doesn’t stand up because there are not appropriate measurements.”

It’s an overlooked area that could well offer a gold mine of solutions for biomedical research.

Podcast brought to you by: Quintiles - bringing people and knowledge together for a healthier world.

And by: Fluidigm - Make your biobank a quality research partner. Download the Evolution of Biobanking whitepaper today.

The Open Secret about the HER2 Assay with Jim Vaught


Jim Vaught, Editor-in-Chief, Biopreservation and Biobanking Journal Bio and Contact Info

Listen (6:50) The importance of better biosamples only recognized in the past 10 to 15 years

Listen (2:30) Is there still some convincing to do?

Listen (3:39) A new biospecimen science

Listen (6:55) The HER2 story

Listen (8:46) What can be done ?

Much of biomedical research is carried out on biospecimen samples. Yet the quality of samples used varies a great deal. This directly affects research outcomes for the worse.

Unfortunately, it’s become quite passé to say that a majority of biological research cannot be reproduced. This issue has been addressed recently by the head of the NIH, Francis Collins, and many others, and yet rarely do we hear that much of the problem is actually in the degradation of the samples studied.


Today we begin a new series Back to Basics: Improving Biospecimens, where we’ll look at some of the issues around biosamples. What is involved in sample collection? How do these issues affect drug development? What are we learning from the new science of sampling, and what can we do to raise standards?

To start us off, we’re joined by Jim Vaught, Editor in Chief of the Biopreservation and Biobanking Journal. Jim gives a great introduction to the topic of biosampling and offers a striking example, that of the HER2 assay, that demonstrates why we must bring more attention to improving biospecimens.

Podcast brought to you by: Quintiles - bringing people and knowledge together for a healthier world.

Rare Disease Horizons, Part IV: Biobanking and Disease Registries with Liz Horn


Liz Horn, PhD, Patient Advocate Bio and Contact Info

Listen (8:22) What is biobanking?

Listen (4:05) Sample collection and the diagnostic odyssey

Listen (5:45) Security and privacy concerns

Listen (2:46) The bigger picture

Patients with rare diseases are constantly pestered with sample collection. Blood and tissue samples are required for many different kinds of testing, and often the specialist clinicians or researchers do not connect and share with each other. Biobanks are an emerging solution for aggregating patient samples for research. As Dr. Liz Horn says in this interview, biobanks and disease registries have become an invaluable resource for both patients and those treating and studying them.



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"Rare Disease Horizons: The Hope of New Research and Technology" is underwritten by the Rare Genomics Institute.