GM3: CSER Steering Committee & Return of Results Consortium – Brad Ozenberger

GM3: CSER Steering Committee & Return of Results Consortium – Brad Ozenberger


Brian Ozenberg:
So I had an opportunity to grab the mic, so I thought I’d take advantage of it. [laughs]
So we just had, actually, Tuesday and Wednesday of this week, the first meeting of the Clinical
Sequencing Exploratory Research Consortium. I’ll tell you a little bit more about it
real quick. But we just met Tuesday and Wednesday at a very exciting meeting. We met with the
return of results consortium which consists of the LC programs and the clinical sequencing
programs plus a number of R01 and R21 grants from our LC group. And, obviously, we talk
about a lot of the same issues that are being discussed here. And just, I’m going to steal one of Eric’s
slides and just comment — I’ve got the mic — the week before, a week ago today,
I was at the TCGA steering committee, the Cancer Genome Atlas Steering Committee Meeting,
which is another one of my jobs. And I just have to comment we have — this is, of course,
the large comprehensive analysis of cancer genomes. And that group has three papers in
press, or under review right now, and will put out another five tumor projects probably
by the end of this year. So in the understanding the biology of genome mostly understanding
the biology of disease area we’re still doing lots of work and building the foundations
from which the data can be translated to the clinic, we hope. But now in the clinical sequencing
program is really in the advancing the science of medicine and as Dan and Teri mentioned
we have this, we’ve reissued the RFA. We had a very strong response to this RFA that
was out a year and half ago and these are — this is a call for multidisciplinary teams
that are really looking at the issues around bringing sequencing into the clinical workflow. So each application requires three components:
one, a generation applications — first, a clinical project to drive everything that
follows. We require a clinician to be a PI in the program. Project II is the translation
to sequencing and interpretation and reporting to the physician and patient of the sequencing
data and the variants they’re associated. And then a very important LC component, Project
III, examining the ethical and psychosocial implications of bringing broad genomic data
into the clinic. Variant discovery is actually secondary. We
say that to point out the real aim of this program is to understand some of the mechanisms
involved in bringing broad genomics into the clinic. So this RFA has just been reissued a few weeks
ago HG 12-009 with due date, application due date of July 26. And, just to say, we have
funded — we’ve made six awards from the first RFA. Half are involved in cancer genomics
and half in more complex disease or a variety of diseases. And the ones were successful
in this RFA were those that really built very strong projects in all three areas. You know,
the ones that didn’t take some of the psychosocial implications, the LC issues, seriously didn’t
do as well. This really requires a multidisciplinary effort. There is also a coordination center, I won’t
go into too much, similar to what Teri described for the genomic medicine projects. These are
her slides. And then just real quick, I know a number
of you have U01 awards from either NHGRI or other NIH institutes, many NIH institutes
are participating in this. This is an announcement that just came out recently from the Office
of the Director. They have funds in bioethics at NIH and they’re seeking, basically, competitive
supplements to ongoing U01s that are involved in research related protection of human subjects.
And they’re looking for particular ideas, projects in two areas. One, the effectiveness of current human subject’s
protections and the development of tools and methods to examine evolving evidence-based
approach to improve human subjects protections, and also the feasibility cost benefits and
impacts of requiring consent for research on de-identified human specimens and data
using novel models of consent. This is a very fast timeline. These — the ones that come
to an NHGRI will go to a special meaning of our council the summer for awards before the
end of this fiscal year. So awards in September. The application receipt date is May 25, so
pretty quick. In this you have to have a current U01 to apply for these supplements. Okay,
any questions and I’ll sit down. Okay. Thank you.

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