Show me the (“Fit-for-purpose”) Biospecimen Evidence Based Practices (BEBP’s) Data

By Lisa B Miranda

The term Biospecimen Evidence Based Practices or BEBP’s appears to have been recently coined by colleagues from the United States National Institutes of Health National Cancer Institute Biorepositories and Biospecimen Research Branch.  Last month, Engel et al published an article in Biopreservation and Biobanking titled “National Cancer Institute Evidence Based Practices: A Novel Approach to Pre-Analytical Variability Standardization”. As many in the biobanking field are aware variance in sample management practices can affect biospecimen integrity and often alters quality.   Biobanks typically aim to address this issue via adherence to standard operating procedures and protocols, documentation of any inter-specimen variability for reference during analysis downstream, as well as implementation of automated sample processing technologies, which some believe may reduce technical inconsistencies often found in manual practice.  In Kelly et al’s article the cogent point is made that while internal standardization of biobanking sample management practices aides in optimizing pre-analytical variability of specimens at one’s own site, this does not address the equally important issue of managing variability across biobank sites.   Optimizing and understanding pre-analytical variability across sites is a common issue for an abounding number of biospecimen research collaborations (i.e. multi-center clinical trials) and network based biobanking activities (i.e. aggregation of and analysis samples across sites), etc.  

Looking back in retrospect from last year’s conference while looking prospectively to the 2014 conference, it is clear that quality-driven-collaboration is an ongoing theme echoed again this year by the theme of optimizing quality control and sample integrity.  In my opinion the one thing that ties these two themes together and addresses the issue of cross-site inter-variability is “fit for purpose” evidence based biobanking.   This approach advocates prospective development of BEBP’s, which regardless of site of origin should provide reproducible validated results.  Navigating “fit for purpose” evidence based protocol requirements requires a certain level of precision. Planning of which should be driven by the specimen, molecule and analyte of interest otherwise referred to as an SMA-approach. To increase the likelihood that a biospecimen collection is managed in a fit-for-purpose fashion, it is essential that biobanks and biospecimen resources prospectively define their procedures using an evidence based focus.  What isn’t so apparent is how to get there so that this idea can become a common reality. 

In 2012 I developed a fit-for-purpose evidence based protocol framework which was distributed in its early stages at when IIR’s conference was its 5^th year.  In September I’ll be giving a talk with a colleague at IIR’s 7^th Biorepositories and Sample Management Conference.  The talk will offer insight from a recent collaboration amongst pharmaceutical, academic and biotech colleagues with whom the fit- for- purpose evidence based protocol development framework has been vetted.  In this talk we plan to present a brief overview along with relevant lessons learned, feedback and take homes from presentation and peer based discussion amongst the broader biobanking community.  The technical and scientific framework is meant to function as a quality control instrument, consists of nine sections and is designed to offer utility in a two ways.  Firstly, it can be used as a guidance document (checklist and worksheet) and fit-for-purpose (FFP) planning exercise (to assist biobanks in understanding evidence based biobanking requirements) so that BEBP’s can be established in real time. Secondly, it can be utilized retrospectively as an internal audit tool (to ensure your biobank protocols, operations and equipment can support FFP sample management.)  The comprehensive document factors in best practices as well as relevant reporting guidelines (e.g. BRISQ).  With the advent of biospecimen science leading the way for evidence based biobanking practices, Biobankers have an amazing opportunity to impact both the biomedical research and clinical realms in a significant capacity.  This instrument if implemented across biobank sites could accelerate real time practice of evidence based biobanking and remedy the issue Engel et al raise regarding variability between multiple sites.  If all sites in an organization or collaboration incorporate this framework, they’d be more apt to increase proficiency of biospecimen collection quality and be more adept at ruling out variability between collections across sites.  If this topic and information interests you, we hope to see you at the conference September 8-10, 2014 in Boston.  Check out what we’ve got lined up.

Save your seat now and you could SAVE 15%. Use discount code XP1998BLOG. Register here.

About the Author:  Lisa Miranda is President and Chief Executive Officer of Biobusiness Consulting Incorporated, a biobanking and biotechnology commercialization advisory based in the Greater Boston Area.  She is known worldwide as a biobanking and clinical research subject matter expert.  Much of her work focuses on biobank strategic planning and/or development of biospecimen research applications and biotechnology commercialization.  She may be reached at: lisabmiranda@biobusinessconsulting.com

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Biorepositories 2013 Conference Preview: An Interview with Philip Branton, M.D., FCAP

About the author: My name is Alex Gelman and I’m deeply interested in the biorepository industry. I’m the Managing Partner of Poplar Partners, an investment firm looking to acquire a company in the biorepository space. Before founding Poplar Partners, I worked at KKR Capstone and before that at McKinsey &Co. I have an MBA from the Stanford Graduate School of Business and a BA from Dartmouth College.

6th Annual BioRepository and Sample Management Conference Preview:

An Interview with Philip Branton, M.D., FCAP

By: Alex Gelman
September 10, 2013

Ahead of the 6th Annual Biorepository and Sample Management Conference in Boston in two weeks, I sat down with some of the leading minds in the industry to get their take on this fast-moving field. Below are edited excerpts from our interview with Dr. Philip Branton, a consulting pathologist at the National Cancer Institute’s Office of Biorepositories and Biospecimen Research and Fellow of the College of American Pathologist (CAP). Dr. Branton is currently Vice Chair of the CAP Biorepository Accreditation Committee and Chair of its Surgical Pathology Committee. Dr. Branton told us his views on the changing industry, gave us a preview of his talk on CAP’s accreditation program for biorepositories, and walked us through the challenges that all biorepositories will face in the coming years.

Us: Dr. Branton, the College for American Pathologists has recently launched its biorepository accreditation program. However, not all biorepositories are created equally. What counts as a biorepository for the CAP’s accreditation program?

Dr. Branton: A biorepository is defined as an entity that receives, stores, processes, and/or disseminates biospecimens, their derivatives, and relevant data, as needed. For purposes of CAP accreditation, a biorepository encompasses the physical location as well as the full range of activities associated with its operation. Biospecimens are tissue, blood, or serum samples that are taken from a living creature. In isolation, it is simply a specimen bank - it can be genetic material or breast cancer tissues. There are different types of biorepositories. Some are simply repositories – they check a sample in, hold it, and check it out. There are some that are much more complex that may collect and preserve specimens fresh from the operating room. There are lots of combinations and permutations in between. There is no “one size fits all” definition for biorepository.

Us: Does CAP’s accreditation program focus on a certain type of biorepository?
Dr. Branton: The program is applicable to those facilities that store biospecimens for research. The program is not applicable to tissues being stored for transplant purposes; however, the CAP Laboratory Accreditation Program does inspect the storage of transplant tissues when they are under the purview of the laboratory director. Before the CAP accredits any biorepository, they need to fill out questionnaire that has questions like, “what kind of specimens they receive”, “how they process them”, “do they do histology on site”, and “do they have a pathologist on site”. These are all things we need to know before we send an inspection team.

Us: So how would you compare a for profit cord blood bank to a university affiliated cancer cell bank?
Dr. Branton: We don’t compare or rank them. The CAP, in conjunction with other entities, has drawn up lists of standards. We evaluate biobanks against what they represent themselves as doing. We operate on a checklist model. We’ve been accrediting hospital medical laboratories for more than 50 years. For the biorepository accreditation program, we are utilizing a similar model. There are agreed upon standards of care for a given service and we test to see if they meet those standards. Depending on the level of services the biorepository provides, the check list can be very long or it can be relatively short.

Us: So you’ve seen dozens if not hundreds of biorepositories. What are the biggest challenges facing the biorepository industry today?
Dr. Branton: That is a complex question with a somewhat complex answer. Not all biospecimens are the same. Learning how to collect biospecimens under the right conditions at the right time is the biggest problem. The rise of molecular testing and personalized medicine has changed the rules of game. Bioscientists need to figure out the optimal times when a specific biospecimen needs to be collected. This is biggest challenge facing biospecimen collection, and by extension biorepositories. Even though biorepositories may not remove a specimen, they need to annotate it and they need to know when the specimen was removed from the patient and did the specimen sit out on counter for 30 minutes.

Us: Conversely, what is the biggest opportunity for the biorepository industry?
Dr. Branton: Thousands of biorepositories exist, varying in size, nature of collections, specimen types, purpose, quality, and age.

We can develop easy-to-use information technology (IT) interfaces that can reliably provide annotated specimens to the research community. One thing that’s become evident to me is that robust IT is critical.

Further, recently there has been a realization that some biorepositories do not fulfill research requirements (most importantly personalized medicine); a high degree of heterogeneity exists in the methods used to collect, process, and store biospecimens. Excellence and quality measures in biorepositories are interrelated concerns that have a direct bearing on research that can help advance health care.

Us: There will be a lot of folks at the conference that are debating whether they should outsource or build a biorepository. How should a biorepository make the buy/build decision?
Dr. Branton: They need to figure out where they need to be in 5-10 years. The decision is so incredibly complex. There are very few institutions that can do it all on their own. Public/private partnerships can often be very helpful. One model going forward can be large hospitals partnering with large laboratory organizations. The industry can provide the infrastructure and IT support and the universities can supply professional expertise.

Us: Thank you so much for your time, Doctor!
Dr. Branton: Thank you and see you in Boston.

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