I fully agree with Nadine's comments on being able to assess the
performance expectations for a given methodology, may it be for regulatory
purpose or for self evaluation. When is no bench mark to compare the
performance of certain methodology, i.e., MW determination by Laser light
scattering. It is very difficult to gauge the capability and the robustness
of method.
Ed Cheung, Ph.D.
Manager, Analytical Development
Biomira Inc.
e-mail: echeung@biomira.com <mailto:echeung@biomira.com>
Phone: 780 450-3761 ext. 148
Fax: 780 463-0871
-----Original Message-----
From: Ritter, Nadine [SMTP:NRitter@bioreliance.com]
Sent: Monday, November 06, 2000 3:53 PM
To: Recipients of ABRF List
Subject: RE: why publish studies?
There is another value to be gained from publishing the results of
these
interlaboratory proficiency trials for the selected methods:
regulatory
agencies can assess the field performance expectations for a given
methodology. With the proliferation of biomolecular drug
candidates,
regulatory reviewers must assess the methodology used in their
analysis.
When a sponsor submits a set of methods with their product
information -
especially for pre-clinical approval - the reviewers must judge each
method's performance against a fairly limited data set.
By having access to published performance results for many of the
key
biotech methods, the reviewer can assess if the overall method
performance
is meaningful. There is no other forum of which I am aware where
this kind
of field data is available. If it is collected periodically enough
to
monitor instrument capabilities as they age, it provides a snapshot
in time
for the field. Moreover, if it is updated to reflect new
technologies as
they become routinely established (eg as carbohydrate analysis is
becoming
now, and ligand binding methods may be soon), it remains the
benchmark
assessment of the state of the art (or science, actually). It can
also show
when a technology needs more work to be robust (as with carbohydate
analysis
and mass spec, in their early days).
I have been told by FDA and USP reviewers and scientists that they
use ABRF
information in this way, especially because there are very few
pharmacopeal
monographs that utilize biomolecular methods such as sequencing,
AAA, and
mass spec. As such, ABRF studies become their 'guideposts' for
these
technologies. When chosing methods to be used in product
characterization
and testing, the limitations of these technologies must be
considered. ABRF
field studies often serve as the proof of the methodology's
capabilities. I
also know that I use this information in assessing method
capabilities and,
in some cases, to set preliminary specifications on methods in early
development.
I strongly urge that ABRF continue these studies for both old and
new
technologies, and continue to publish them. They are a unique and
valuable
part of this organization's contributions to the field of
biomolecular
science.
Nadine Ritter, Ph.D.
Director, Analytical Services
BioReliance
> -----Original Message-----
> From: Ruth Hogue Angeletti [SMTP:angelett@aecom.yu.edu]
> Sent: Friday, November 03, 2000 8:43 PM
> To: Recipients of ABRF List
> Subject: why publish studies?
>
> There has been at least one suggestion that publication of the
ABRF
> studies
> serves primarily to pump up the CVs of our (presumably faculty)
ABRF
> members
> for career advancement. Besides being a very divisive statement
with some
> underlying resentment, this is very far from the truth. I can't
think of
> one among us whose career has been boosted by running a resource
> laboratory
> (often the contrary) or being an ABRF study coauthor. Planning,
> performing,
> analyzing and writing up these studies is a lot of work, but we
have all
> found these studies immensely valuable, reason enough to do all of
this --
> and to continue them. We usually have had fun, too.
>
> What is the value of publishing our studies, by whatever technical
> mechanism, print or electronic? Just to think of a couple... (not
a
> complete list)
>
> --If the study is one which defines the practical limits of a
particular
> technique for resource labs, the publication is a document which
we can
> use
> in our daily operations. For example, if a local immunologist
hears Don
> Hunt talk about low femtomoles and attomoles for MS or MS/MS
analysis as
> routine (without him mentioning the enormous work and talent that
is
> required for that stretch), a publication can place some
perspective on
> what is possible, when our say-so just isn't convincing enough.
>
> --If the study is one which tests relatively new or improved set
of
> methods,
> there is a document that can be shared within our entire research
> environment.
>
> --If the study is one which really helps us evaluate our functions
and
> --if we do well, we can justify further investment from our
> institutions
> in terms of staff salaries and instruments, etc.
> --if we do poorly because our instrumentation or other is
inadequate,
> we
> can provide documentation that will help in gaining investment
from our
> institutions, with help from our colleagues and user groups
>
> --peer review is good
>
>
> On the rest of the controversy, I can't say much, because a member
of our
> group whom I value is closely involved. However, if a scientist
whom I
> respect as much as I do Len Packman should tell me in some detail
that my
> study was poorly designed or inadequately tested and why, I would
sit up
> and
> pay attention.
>
>
> Ruth
>
This archive was generated by hypermail 2b29 : Thu Nov 09 2000 - 09:18:08 EST