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 5th year. In September
I’ll be giving a talk with a colleague at IIR’s 7th 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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