Tip:
Highlight text to annotate it
X
Jeffery Schloss: Okay, so we'll bring the slides back up -- thank
you -- and just run through a few more details about the program and then open it up for
discussion. Oh -- okay.
Okay, so, the history of the solicitation. We started this in 2002. This was on the advice
of the Advisory Council; particularly, Maynard Olson was very strong about the idea of having
investigator-initiated ideas, and so that's carried through.
We refined the program announcement after a couple of years of experience because we
were -- sort of a broad description of what we're looking for because we're not trying
to constrain it too much but -- so, we were able to refine the way we describe what the
program is about and also, at that point, NIMH joined the solicitation. I don't think
Andrea and Thomas are here. They weren't able to make it, but -- and then every -- it's
actually every three years we renewed the program announcement after discussions like
this with the council. So we -- and we renewed it with high enthusiasm.
We did have a sort of pilot project, a P20, for a while. We never -- we had very few applications
and we never made an award so we just decided to take that out of the program. We couldn't
actually articulate what that would look like very effectively. On the 2010, we're off the
three-year cycle just because the stuff about the application changed and so we had to issue
a new program announcement, and now we're at the end of the previous one and need to
get some input from you.
So these next few slides are just -- I have here in the set in case we need to come back
to them quickly, but they're the same ones that you saw before, and the only thing I'm
going to add here is to stress that whereas originally the Minority Action Plan was integrated
with the CEGS program announcement, now we've split that off and it's a separate application,
but when you apply for a CEGS application -- for a CEGS grant, you must also put in
the R25 for the Diversity Action Plan grant, and you cannot be awarded a CEGS grant until
we've worked with you in case your regional application for the DAP wasn't of appropriate
quality, we'll work with people to improve it so that they can run an effective Diversity
Action Plan program. So these must go together. I should say, if we have two grants in one
city, then they'll work together -- not get two separate DAPs.
A CEGS is not -- sometimes it is useful to say what something isn't -- so a CEGS is not
just an -- it's not supposed to be just 10 years out of somebody's lab of what they usually
do. It's not a program project. That is, it's not a bunch of projects operating pretty much
independently that have a little bit of complementarity. It should not be a resource or an infrastructure
for an existing department. And actually, all of the things that are listed here were
examples of applications that we got in the first few years, and so it helps to say what
they're not.
It's not primarily for the collection of a set of data in the absence of some novel concept
or methodology, though we understand that in order to demonstrate that something is
working, you may have to collect some data. And it's not just outstanding science that
fails to meet CEGS criteria. And this is the hardest one, because we talk with lots of
people who have a lot of fantastic ideas, really outstanding investigators. And then
the question is just does it meet the other criteria of the CEGS? So it's not that some
of these other things are bad science, but a lot of the ideas that we hear about don't
rise to the level that the staff believes will meet the criteria of this, and the staff's
assessment is pretty strongly reinforced by the review process.
Okay, so these are, again, they're interdisciplinary, integrated, and synergistic. So by synergistic,
one of the things I mean that we tell people when they're coming to us with their ideas,
if you have a component that is not absolutely necessary for the other parts of the project
to work, don't put it in the application. It should not have stuff hanging out there
on the edge because, you know, it's the department chair, and the department chair wants you
to put his project in there. Sorry for department chairs.
These can include an ethical, legal, and societal component. It's not required. As you know,
there is a separate program for the seers for centers, but if it fits well with the
project, there can be LC component. We have a -- we require a management plan for the
team, but we also require a very strong -- require very strong direction from a PI. We require
a PI to be at 30 percent effort for this project. And so that's why I asked the question to
reinforce Deedee's [spelled phonetically] statement because somebody -- if you got a
whole bunch of PIs at 5 percent, you know, it's gonna be particularly hard to make the
decision. We have to drive in this direction. We have to now narrow the project and do the
things that are going to get us to our goal, hopefully in 10 years. So, that's why we require
a PI at 30 percent effort. So all these are features that we're essentially asking you
about, should these continue to be in the program.
During the -- for the review process -- the peer review process includes an applicant
interview. They come into town for two hours and they get their chance in front of the
review committee for questions to be asked. These are particularly -- it's particularly
important when you have these multi-disciplinary projects, when you have things that are risky;
that means they are not going to be able to explain everything in the application. And
so the reviewers get a chance to, you know, to bounce ideas off and see how people are
thinking about the problem more so than you can in the grant application. And we feel
for this amount of money investment, we want to have that kind of information in the review
process.
There is an administrative site visit after three years. We bring along a team of outside,
you know, of external scientists to help us assess the progress in that project and to
determine whether we would like to invite a competitive renewal. People can submit competitive
renewal. We can't stop them, but I think in every case, people have gotten extremely good
advice from these administrative site visits. And then the renewal itself requires not only
that you're meeting your initial goals, but you've got to be staying at the state of the
art. Obviously, if the field is sort of passing by, there's no point in NHGRI funding another
five years if the rest of the field has caught up.
Again, more details on the budget. Operating costs: people are allowed to request up to
$2 million a year, direct costs. These budgets are big enough that we essentially require
people to figure out over the five years how to reallocate budgets to keep things running.
So we don't adjust for inflation. In addition to the $2 million that we call operating costs,
applicants may request up to $500,000 spread over the five years in specialized equipment.
We've already said the duration of each segment is up to five years, maximum of 10 years.
There have been a few awards that we've made for shorter times for various management -- sort
of, program management purposes. So not all of them are awarded for five years; I should
say, not all of them are awarded at the full requested cost. For various reasons, we've
made some awards at lower levels. And again, this is another important question. For council
consideration, we've always said that we anticipate funding a maximum of about 10 of these. If
we had 10 at $3 million, that's about 8 percent of the extramural budget, which would be a
significant investment.
So here are the investments that we've made over the years since the program started.
We've been up as high, as you see, as about $25 million in one year. What numbers am I
-- and right now, our commitment for FY '14 is $14.5 million; that's commitment coming
from previous years. As you know, we'll be looking at new applications in the closed
session.
What are these numbers? This is the Genome Institute dollars excluding the Diversity
Action Plan. We account for that separately. It's been up as high as $3 million a year.
Of course, the diverse -- actually, up to $3 million in one year of Diversity Action
Plans that were associated with CEGS. There are Diversity Action Plan programs associated
with some other grants programs also, but usually it's a lot lower than that.
We also invested from Genome Institute $2.4 million in the stimulus years of stimulus
funds, and, importantly, we've leveraged our funds and NIMH has leveraged their funds.
They've co-funded particular awards for a total of just over $5.5 million spread out
over the awards and over the years. And they also invested $6 million of stimulus funds
to get started one of the -- one of the projects.
So, this is a very highly selective program. We've received 75 new or amended applications,
out of which there have been 15 awards. We received 12 competing renewals or amended
competing renewals and made five awards out of that. In addition to that, we've talked
with dozens of potential applicants. So we probably talk with three times as many potential
applicants as actually come in as applications. We try to stress over and over again in the
program announcement: talk with us first. These are big, hard, complicated applications
to write. We don't want people to write them if they're very clearly not going to be qualified.
So, quite -- some fair number of people make an inquiry and then they decide not to apply,
but each year we have almost twice as many people who send a letter of intent -- and
these are usually about four pages, very densely written letters of intent -- and then the
team of us here within the Institute and NIMH look at these and provide feedback. And sometimes,
this is just so far off that we don't think you should apply, and other times it's, "Here's
what you would need to do to modify this in order to, in our opinion, submit a successful
application."
So David had a graphic that showed sort of what the awards were. Here is just in a different
format. The awards that have been made over time -- the first four years -- and again,
I've indicated the grants that receive co-funding from NIMH, and then, subsequently, another
set of awards. Three years are missing: 2005, 2008, and 2012. In those years, we didn't
make any awards.
And as you see again here, the renewals. So, one, two, three, four -- it should be five
renewals, right? Are they up there? Yes, one, two, three, four, five. Five renewals. Not
all of these renew.
So you have these in front of you. I just wanted to make the point that you've heard
from two of the CEGS, and just the kinds of projects that people are doing are addressing,
I would say, deep, important problems in genomics, contemporary problems in genomics. So here
we have not only single cell transcriptome, but very high -- very large numbers of single
cell transcriptomes is one of the goals here. And then being able to engineer human genomes
so that, for example, you would take fibroblast from an individual, differentiate those down
different differentiated pathways, in those cells modify specific nucleotides in promoter
regions that are not random but that are the variations that you find in patients, and
test the transcriptome against other outcomes of those particular variants in different
tissue types. Those are pretty hard experiments to do in real people.
So, I think I -- just for time, I'm not going to go through these. You have these in front
of you if you'd like to look at them, and these are all -- I just extracted some key
sentences from the websites of each of these. You can get to these websites from our website.
So I'm going to move on. Sorry those three groups and the other ones who I didn't include.
As was mentioned, we have an annual grantee meeting with this program. These are pretty
interesting meetings because we're really getting people together who don't necessarily
talk to each other otherwise. They don't necessarily go to the same meetings. They're running the
same kinds of big grants and there's quite a -- quite interesting intersections that
are revealed as people give their talks. It's also been a great opportunity for students
to find good post docs and so forth, and people to move around amongst the CEGS, including
the Diversity Action Plan participants.
So the team of program directors who are involved here is significant across the Institute.
Lisa, Elise, Adam, Colin, Tina, Peter, Brad, Ajay, Erin, Jeff, and the other Jeff -- I'm
the other Jeff -- Lou, and Andrea and Thomas from NIMH, and, of course, Keith, Ken, and
Rudy keep us all honest by running fantastic reviews. These are hard to review, and it's
an important component of the program.
So, the questions for you -- some of the questions for you are the ones that I've listed here.
Do you support that we continue the program? We -- is the scope about right we've described
in some of the earlier slides what we're trying to achieve here? We're working on broadening
the language to apply across the new strategic plan. Some of that's relatively easy. I think
we wanted to maintain the level of innovation, forward lookingness. Do you think the budget
level is okay, the number of awards, and anything I've told you about the program management
that you have questions about, or from your own experience that you would suggest that
we change?
I'd just like to open it up. Rudy, do you want to run the --
Rudy Pozzatti: Or other questions, obviously, about the program.
Arti, start us, please.
Arti Rai: I was wondering whether you have any special
guidance you give -- it seems like a lot of these programs do involve multiple institutions.
Do you give any particular guidance with respect to intellectual property across institutions?
Jeffery Schloss: I'm trying to remember if this is one. In
some program announcements that we have written that we suggest that people work that out
before they get the grant. That's the main advice, because it's really messy [laughs]
if you're trying to work it out after you get the grant. Other than that, no. If you
have suggestions about language you think we could include, that would be great.
Robert Nussbaum: At the risk of speaking out here since I'm
new on the council, I think it's a fantastic program, and if what I heard correctly --
Jeffery Schloss: Stop there -- okay.
[laughter]
Robert Nussbaum: And I like it for many reasons. One is the
fact that it is doing things that are risky and are hard to get done otherwise. I like
very much that it is investigator-initiated, and that, in some sense, it counterbalances,
I think, an NHGRI tendency to be a little heavy-handed on the management side of pushing
particular programs. And so I think it's a good counterbalance to that. The third thing
is, if I heard correctly, that there were about half of the CEGS are renewed? Is that
right?
Jeffery Schloss: Yeah.
Robert Nussbaum: Yeah, I mean, for something that's supposed
to be high risk, I think having a 50 percent success rate for renewal is actually too high,
which, to me, would suggest that the program is actually too small.
Jeffery Schloss: You want to see more failure.
Deirdre Meldrum: Just something on that. I think that's probably
some element of it, but I think also some of these things just take -- they're so challenging
it takes a certain amount of time to get -- to make the progress that's needed so it's probably
a balance of that. And I would like to see more CEGS funded as well. I think it's a great
program, and looking around NIH, I don't see any other programs like the CEGS.
Rudy Pozzatti: Ross, go ahead.
Male Speaker: Yeah, so I'd also like to thank David and
Deedee for these presentations. They really exemplify how well the program can work. I
mean, clearly, high risk initially -- I mean, who would've thought sticklebacks [spelled
phonetically], right? You know, and it's informed us so much and gotten to the point where,
you know, these technologies, these approaches, are accepted. So, they're not high risk anymore.
They're hard still, but it's working beautifully, so -- and with the investigator ideas as Bob
said, investigator-initiated is so important.
The other thing I think is really important is those years where there weren't any that
were funded. You don't have -- it's investigator-initiated. If there aren't really sterling, challenging
ideas coming forward, you don't put the money out. So it seems to be working very, very
well.
Rudy Pozzatti: Howard.
Howard Jacob: So I also think it's a great program, and
although I'd like to see it expanded, I just wonder on the budget constraints but towards
that end, this does seem to me because of the success of this program of a potential
partnership opportunity with some of the other institutes. I mean, I think this is a really
unique program that brings together resources, and I really like the time window. You know,
you have 10 years. You have to get renewed. It really keeps the pressure on innovation.
Eric Green: So, Jeff, can you expand on that? Jeff Schloss?
Jeffery Schloss: Yeah, I'm listening --
Eric Green: I mean, in terms of -- I mean, NIMH has been
a good partner but over the years, have we shopped for other institutes and not had interest?
Or have we not done significant shopping?
Jeffery Schloss: I don't I'm thinking vaguely NINDS one year,
but I'm not sure. Does anybody remember?
Male Speaker: [inaudible]
Jeffery Schloss: I think -- I mean, I think, in part, we haven't
had applicants come to us with something that sounded relevant. I should say, on a program
announcement, another institute doesn't have to join it for us to go to them if we get
an interesting application. They could co-fund. Again, it's not a set-aside. It's just a program
announcement, which is an expression of interest. So, mechanistically at NIH, that's completely
possible to do.
Male Speaker: Is that what happened originally with NIMS
[spelled phonetically]? Is that the one institute that you had partnered with?
Jeffery Schloss: I don't think so. I think they saw the program
announcement and just liked it.
We have a couple questions in back. Rudy, do you want to decide the order?
Rudy Pozzatti: Lis [spelled phonetically] -- Lis, you're
up first.
Female Speaker: Okay, I just wanted to make a comment about
Bob's question about whether 50 percent was a good or bad success rate. And Jeff had mentioned
that there is an administrator review between the first grant period and a potential second
grant period, and those are pretty rigorous reviews. We provide a lot of -- we bring in
outside people and provide a fair amount of feedback and I think people -- applicants
have found that really useful. And I think that has not always made a difference in terms
of whether someone succeeded or not but I think -- I think it actually does help in
terms of providing really a good -- a good preliminary view of how the project is going
and the direction that they're thinking about moving in.
Jeffery Schloss: And really there's been some correction in
those. When there was -- there was good stuff that the PIs may not even have identified
but outsiders could find it. And so that might be part of the reason that we have a higher
success rate.
Rudy Pozzatti: Lisa, go ahead.
Female Speaker: Hello? Yes, to address the question about
other ICs, certainly we can go to any IC. If something comes in with something we think
is appropriate for another institute, we absolutely can go there, but I think what happens is
that the PI sees that it is genome and mental health. Okay, I can do any disease for this
process but, you know, I'm going to choose a mental health one. And so I think mental
health is really benefited because lots of grants specifically focus on mental health
topics, so, you know, that may be a selling point to other institutes. If you're on it,
there may be focus there.
Robert Nussbaum: Does NIBIB have any involvement in this because
I think -- I mean, Deedee's project, for example, might be something they'd be really interested
in.
Jeffery Schloss: [inaudible] -- probably started by predated
Robert Nussbaum: Yeah --
Jeffery Schloss: -- before their creation, right? I mean, they
haven't been around 10 years, have they? I don't think. Yeah.
So, I mean, really the only mechanism we have other than to knock on doors, which we could
do -- these program announcements all go into something we call the early notification system
so that all the other institutes have an opportunity to see -- every institute has an opportunity
to see every announcement that every other institute posts. So there's that opportunity
but we haven't done the door knocking on thing.
Deirdre Meldrum: Can I just make a comment? If you do get like
NIBIB or any of that -- I'm not talking about them specifically but there really is no other
mechanism like the CEGS. And I've looked at all the ones of -- that are possible across
the other institutes, which you would know well, but they have very complex mechanisms
and requirements, and I just hope that you wouldn't lose any unique features of the CEGS
in partnering like that, so just make sure you don't lose that.
Jeffery Schloss: And that's a very important point actually.
When NIMH decided to join us, they said, "We like this program. All we want to do is add
a couple sentences about stuff we're interested in. We do not want to change the way you manage
this program."
Rudy Pozzatti: Yeah, Lon?
Lon Cardon: Yeah, so, I'll jump on the bandwagon. I think
it sounds like a terrific program and the examples we heard were great. I guess my question
is, you started out and you hit this number of about 2 million per program. It seems about
right. Was that a fortuitous sweet spot? Have you had to turn away any that are just too
big, of those that you reject? I'm curious about the level.
Jeffery Schloss: So we don't let them come in bigger. Some
of the people around the table may tell you that when they were applicants, they said,
"Oh my god, you know, we've put this thing together. We've got so many people excited
about this program. We can't possibly do this for just $2 million." Other advice that we
got at the beginning of the program was that we should do it for $1 million of operating
costs. So we just sort of did a seat of the pants and put it out there for $2 million.
And, I mean, you know, it's bouncing against other parts of the portfolio.
The other thing that I should say is that we started it in 2000 and it was $2 million.
We have had some inflation since then. So the value of the grant has actually gone down,
but we're just trying to balance all the factors and $2 million's a nice round number. If you
have -- we haven't come up with a strong rationale for changing from that.
Male Speaker: Just so everyone's on the same page, that's
$2 million in direct cost.
Jeffery Schloss: Direct cost.
Male Speaker: So, the typical grant size is more like $3
million in total.
Jeffery Schloss: Right. And that $2 million, by the way, we,
specifically to not discourage partnerships, that, in our calculation of the $2 million
in direct costs, it does not include the indirect costs from a collaboration at another institution
because we want to, if anything, encourage rather than discourage. So, actually, I -- now,
the NIH rules say that, but when we started this, the NIH rules did not say that.
Rudy Pozzatti: Jill.
Female Speaker: I was just wondering about that because when
Deedee described her CEGS, it -- you know, there were a huge number of names there, and
I'm just wondering to what -- you know, what's the average size in terms of people that are
funded versus leveraging other sources of funding to sort of grow out the efforts or
something?
Female Speaker: [inaudible] over the time period so people
come and go. So, it would average around 50 counting everyone, students --
Female Speaker: 5-0?
Female Speaker: -- yeah.
Jeffery Schloss: At -- right now? Well, in the last year, the
grant is 50?
Female Speaker: [inaudible] $2 million direct.
Jeffery Schloss: Okay, and probably yours is a little smaller
than that?
Male Speaker: It is smaller, so we would tend to probably
have maybe a total of 20 people including graduate students, post docs, and PIs over
the four or five labs that would be participating at any one time.
Again, if you integrated overtime, you could add quite a few names but...
Jeffery Schloss: So, this was a big question that came up when
one of -- I won't mention the name, but one of labs that had one of these and did apply
for a renewal, which ultimately wasn't awarded -- the renewal of that particular grant. People
were kind of astounded by the amount of progress that had been made and said, "Well, you know,
how much of this progress that you're telling about is from the CEGS grant versus others?"
And he said, "Oh, it's almost all from the CEGS." He said, "I do have another grant but
that is another big grant from another agency, but that has a completely separate set of
aims. And there's some synergy but --"
So, I think most of these -- at probably at least the beginning probably don't have a
lot of leverage. You have to find ways to, you know, to keep some of the activity focused
-- parts of the activity going toward the end.
Arti Rai: Just at the risk of stepping into something
that you may have thought about a great deal already, I know -- one thing I did study way
back when I was looking at collaborations among institutions that were funded by NIH
was the glue grants that were done by NIGMS. I assume that you guys studied that closely,
that whole experience closely, to kind of make sure that you avoided those mistakes?
Male Speaker: We know they're a nightmare to review.
Arti Rai: [laughs] Well, in addition, there was a report
that was done on kind of what went wrong and why, you know, they decided not to continue
-- NIGMS decided not to continue with those glue grants, and it sounds like --
Male Speaker: Yeah, that's a good suggestion.
Arti Rai: -- you're avoiding those problems. I mean,
that's great but, you know, there is a nice report by NIGMS actually evaluating what went
wrong.
Jeffery Schloss: So, I don't want to cut the discussion off,
but I also don't want to drag it out unnecessarily. I'm hearing pretty strong enthusiasm that
the program should continue -- that, barring deep insights into reasons to change the costs,
we are probably about in the right range, and that also that the idea of having about
-- probably not more than about 10 of them but having up to 10 of them at any time, budget
allowing, sounds like a good overall plan. Is that correct? Is that a reasonable summary?
Deirdre Meldrum: Can the number be something that's -- I mean,
you say about 10, but when we looked at the budget overall and the priorities, it seems
like it's -- and it's not every year. Maybe one year you'll have three stellar grants.
I mean, the flexibility to vary around the 10?
Jeffery Schloss: Yeah, I think --
Deirdre Meldrum: -- minus two or three?
Jeffery Schloss: -- I think that the 10 is more of a way to
send a message to the community that these are really going to be highly competitive
and that if they see that we have seven of them, it's not like we're going to award five
or six or seven more this year. So, it's been useful that way to say this is really competitive,
but yes, there have been years when we've funded multiple, and so people are hearing
the suggestion that we might go over 10. Do I see sort of nodding, or it depends on availability
of funds and whatever? And what we discuss in a discussion like we're going to have tomorrow
about priorities, and that's something that we revisit.
Male Speaker: Could you tell us, without divulging anything,
what you see? Do you find yourself just pulling your hair out because you've got three really
good ones and you only feel like you can fund one?
Jeffery Schloss: I would say generally, no. There was one year
when we wanted to fund a couple and we were really constrained for budget, and what we
did was we got them both started on lower budgets. And it turned out they were doing
fine on those budgets. They would've liked to have more money, there was no question
about that, but they were doing acceptably, and then we were able to add some supplements
here and there. But we try to manage it as best we can.
But I would say no. There have not been cases where, you know, where we really, really wanted
to fund two more and couldn't do it if I remember correctly. Again, people back there, remind
me.
Male Speaker: I do think one of the strengths of the program
is this bottom-up aspect, and that is going to mean flexibility in what looks like a great
set of proposals or not.
Jeffery Schloss: Yeah.
Male Speaker: And over time, that average of 10 has worked
out to less than 10 because it's been seen sort of as a maximum against which sometimes
you're less, right? So I think right now, if you counted them up, there'd be six with
the current round then currently under review, but there'd probably be less than 10 in the
coming year.
Jeffery Schloss: Yeah.
Male Speaker: I would say that I think it's appropriate
that the size of the program depends upon the quality, and the novelty, and the innovations
of the ideas, but I think that also means you should be prepared for the possibility
that some years would bounce above 10 --
Jeffery Schloss: Yeah.
Male Speaker: -- instead of below.
Jeffery Schloss: Yeah, I mean, partially, it's -- you know,
PIs, or potential applicants, are doing a calculation. Well, they have six of these.
You know, I'm going to be competing. I don't know how many more applications will come
in. They make a calculation of how they want to invest their grant writing time.
Howard Jacob: I'm just wondering if there's any way you
could partner this program with your SBIR portfolio so you could maybe add something
on top of that since there's discussion of IP and spinouts.
Jeffery Schloss: Hmm, boy, that's -- it really is separate
money. I guess there's nothing to stop applicants from coming in with a small business; though,
it would be, you know, center's dollars not SBIR dollars. That gets -- that gets really
complicated. I guess the only other comment I'd make there is we actually fund companies.
At NHGRI, again, we're kind of unusual, we fund companies under RPGs when they're the
right place to do that particular kind of research. And a lot of our technology development
portfolio does involve IP, and licensing, and spinning out to companies, some of which
then become small businesses and are eligible for SBIR money. It's an interesting idea.
I think it's -- mechanistically, it's pretty hard.
Rudy Pozzatti: Okay, I think we're finished here.
Jeffery Schloss: All right, thank you.
Rudy Pozzatti: Thank you, Jeff. Thank you, council.