 Okay, this is a concept clearance for a reissue of the request for applications for the Centers of Excellence in LC Research or the SEER program. And I should note I'm doing the concept clearance, but the SEER program is a joint program shared across the LC staff, which it sounds like will be growing in the future, which is great. But Jean McEwen and Nicole Lockhart are also involved in shepherding these grants. And Elizabeth Thompson, who I think is still sitting in the back of the room, is, of course, the godmother of the SEER program. Does this, does the keyboard work for moving things? Do I need to use it? There you go. Okay. Thank you. Thank you. So the SEER program was established in 2003. It was really based on recommendations that came out of the 2002-2003 planning process. Its primary goals are to create transdisciplinary research teams that can integrate a wide spectrum of LC research in the behavioral, social sciences, legal, and humanities with genetic and genomic research. One goal is to actually facilitate the translation of LC research findings into formats that can inform the development of health research and public policies and practices. And finally, a very important goal of the center's program is to train the next generation of LC research researchers with an emphasis on recruiting individuals from underrepresented minority groups. The SEER program uses two mechanisms. One is the P-50 or program center grant mechanism. Its five-year grant mechanism, we limit them to $750,000 direct costs each year. The P-20 exploratory center grant mechanism is a three-year mechanism which is limited to $150,000 direct costs a year each year for three years. The purpose of the P-20 is really to allow institutions who don't yet have the infrastructure to support a full P-50 center grant to develop the transdisciplinary and training infrastructure that will allow them to submit a successful P-50 application. Funding history. So the first SEERS were funded in 2004. We funded four P-50s at Case Western, Duke, Stanford, and University of Washington. And we also funded three P-20s at Harvard University, Howard University, and the University of North Carolina, Chapel Hill. In 2007, we funded two new P-50s, one of which was, I guess, a translation, a graduation of the UNC P-20 to a full P-50. The other was a new P-50 at the University of Pennsylvania. In 2010, we funded renewals of the four original P-50s. This would be Case, Duke, Stanford, and UW. And we also funded two new P-20s, one at Columbia University and one at the Oregon Health Sciences University, which I think Karen referred to this morning, their focus is epigenetics. Today we're supporting six P-50s and two P-20s. And this comes to about $6.4 million, which is 33 percent of the 2011 LC set aside. And I'm not doing that. Thanks. Your call cannot be completed in dial. Please check the number and dial again. I'll call your operator to help you. I should mention that this 33 percent limit was a recommendation that was made by the LC assessment panel back in 2008, and it was subsequently endorsed by council. So we keep the SEER budget to no more than a third of the LC 5 percent set aside. There have been concerns raised about the SEER program over the years in terms of its value and also in terms of its impact on the ability of the LC program to fund a really robust investigator-initiated portfolio of grants. But despite those concerns, it actually has been quite successful in many ways. It has established very productive transdisciplinary research teams that are more and more supporting the integration of LC and genetic genomic research. And I think, as Karen mentioned, in fact, the recently funded clinical sequencing exploratory center grants, a number of SEER investigators are serving either as principal investigators, co-investigators, or consultants on those grants. And there are other instances with the pharmacogenetics network and other projects where SEER investigators actually have stepped up and are fully integrated into genomic and genetic studies. As far as translation goes, they've provided a lot of just basic expertise and other resources for policymakers. They've written policy briefs and white papers at the request of Congress and state legislatures. They've provided expert testimony to Congress and state legislatures, as well as a number of federal advisory groups and also the President's Bioethics Commission. And they also serve on a number of these groups, either as members or as chairs. And most importantly, the SEERS have really been successful at training a diverse cadre of LC researchers. Approximately 80 individuals at the graduate postdoctoral and junior faculty level have received training and mentoring through the centers. Many of these individuals have moved on to tenure-track positions, and I should mention that about 30 percent of these trainees have been from underrepresented minority groups. Many of these individuals have moved on to tenure-track positions, and several now have successfully competed as principal investigators on their own research grants. So we feel that that's kind of a signature success of the SEER program. The other thing that the SEERS have been able to do by reaching across different departments at their institutions, they've really generated a lot of interest and hopefully financial support, though that kind of remains to be seen, for this kind of broadly transdisciplinary research. Okay, the RFA that we're proposing now would be released this spring. It would have a spring 2013 start date. We are, under this RFA, requiring applicants to identify a clearly defined, high-priority issue and a related primary research project that will really serve as the focus for their center activities, and our hope is to avoid defuseness of effort in the centers and really to help them create a strong center core of research. We will be soliciting both P50 and P20 applications. It is open to all applicants. I should note that two of our P50s that we're currently funding are eligible to apply for renewals under this RFA, and the two P20s at Columbia and Oregon Health Sciences University are eligible to apply for their full P50 grants. But again, I want to emphasize that it's open to all applicants. You don't have to have had a P20 grant application, or grant before submitting a P50 application. We're setting aside 2.75 million in 2013, and we hope to fund two P50s and two P20s. We are limiting the number of grants that we're funding this round to keep the program within the one-third cap of the LC program budget, and also to allow some future year flexibility given the current budgetary concerns. We don't want to make some commitments right now that are going to tie our hands in the future. And that's it, and I'm happy to answer any questions that you might have. Oh, length of funding. Well, the P50s would be funded for five years. The P20s are funded for three years. If the P50s are renewals, they cannot request a third five years of funding. We limit them to just 10 years of funding overall. So if you have a P50, you get your original five years. You can put in for a renewal for five years, and then your funding ends at that point. Okay. Any questions? Thanks. If you get one of the P20s at the end of that three-year period, what options do you have? You can apply for a P50. We try to time our RFA so that they're eligible, the RFA is open when the P20s are ready to apply for a P50. If you don't get a P50, you cannot come in with a renewal of your P20. That's a one-shot deal. Pamela? One just informational question because I'm not sure I understood, and then another question. So you dropped the funding to $2.75 million for the coming year because to keep it in line with only being 30% of the LC budget, a third, and previously it was $6.4 million. Did the budget drop that precipitously? No. I should say, I mean we're, and I'm going to show you another slide, but this is going to be confusing and I'm not sure I want to explain it. Okay, this is the Sears funding timeline. So if you look... Hey Joy, why don't you, because they're going to lose you on the web if you're not here on mic and that way you can point. So they continue, so yeah, yeah, yeah. All right, I'm going to get that slide off of there because it's confusing. No, no, no, I get it. All right, so my other question really is a comment and that is that I am fairly familiar with the training activities at Stanford and at University of Washington and I just want to comment that I'm extremely impressed at the work that those two centers have done and well perhaps the other two, I just don't know them as well. I'm amazed at the people they've turned out, they're all excellent, they've gone on to amazing jobs, they've got incredible publication records. This is an effort that is very, very exciting to look at and it has taken them the amount of time, you know, it's coming to fruition now in the seventh year and I understand why they're not being funded again. I understand the principle behind that, I don't have a problem. Not that it would matter if I had a problem, but the point is that I would hate to see that training organization lost. So much effort went into building that and they have been so successful that I would just put that out there if there's any way to discuss something different going forward that would be important because it is a pity to lose and they will lose it and I understand they're supposed to pick up their own funding and I understand all of the concepts that go along with this but what they're doing in both of those places is really, really impressive. Yeah, something that we have talked about is doing a T-15 program for LC research, which is something we've never done in the past because there was never really an infrastructure, a cohort of strong enough research centers that could support something like that. So that's something that we will be exploring. And Karen, did you want to add something? I just wanted to add and maybe, Jo, you want to talk a little bit more about what we've now put in place in order to continue to track the over generations and some sort of an infrastructure also that they can collaborate and support one another both in their trainings and post training. So did you want to just say, Laura? We've actually are instituting a series, well each of the centers has a web pages and has a web page and we're standardizing the information on the trainees and the alumni trainees across the center web pages to encourage them to get in touch with each other and to maintain contact with each other and we'll be tracking them as they move forward in their careers. And I should say that's been one of the really nice things about the trainees every year associated with the annual investigators meeting. We have a trainee workshop and the trainees really do network. And if one trainee is successful getting a K99, they share their application with the other trainees and there's just a lot of exchange and interaction. Amy. Thanks, Joy. Can you say a little something about the P20s? Because it seems like this is a three-year grant. The purpose of it is to then build to a P50, although as we've seen one of the P20s has turned into a P50, it's a relatively small amount of money per year. So can you say a little something about what the P20 centers are supposed to be doing during that P20 time and how successful they've been and sort of the pros and cons of going forward with that mechanism of easing people in? Right. I should say one thing. As far as the original three P20s, only two of them applied for P50s. The Howard University Center did not. The successful P20s, I think what they do is they really start to bring together the people across the various departments at their institutions to build trust across the disciplinary borders. A lot of them hold seminars. They do use a number of different mechanisms to kind of create that. And they also have done some pilot projects, some pilot research work that really sets the stage for the work that they'll do when they come in with a P50. I don't know if Elizabeth or Jean want to say anything more about that. I can't hear you, Elizabeth. Well, I think that I was involved in both the P20 and the P50. I think that the P20 did help us basically form a community that was nascent at the outset, but was really formalized and enhanced by that. So it is a relatively small amount of money, but the upside of that is it's a fairly small amount to spend. All right. The other thing I should say is that the UNC P50 center, when it got its P50, boy, it was out of the blocks really fast. They've been extraordinarily productive. And so I think having the P20 really allowed them to kind of jump start their P50. I think that's true. Yeah. Pearl? Thanks so much. I also agree that these are very important programs to keep going. And I realize that it hasn't been going that long and is not that big. But seeing that you're going to fund two P50s and you have two who come in again, some up for renewal, and then if there's a new person or a new entity coming in, are there any lessons learned on how best to select the programs in that I think what Jim just said, you know, you've got a nascent group of people together. If you don't have that nascent group, I mean, what is the institutional commitment? Have you learned enough as to the successful programs? What was there before you went in? What is the degree of institutional requirements even before you plop a P20 or a P50? You know, the thing that we found makes the most difference, and I'll invite Gene and Elizabeth to comment as well, is when the centers are located within an institutional structure, either a bioethics department, a department of history and, you know, ethics, you know, whatever the department might be, I think that's very helpful and it gives them some structure to begin with. The other thing that seems to make a difference is centers that are located at institutions that actually have an active genomic research program of some kind. That seems to make a huge difference in their ability to really function as a center. Yes? My hand was up. Oh, I'm sorry. I'm sorry, David. I've had my light on a couple times. A couple questions. We've talked about the great training we have done and that's wonderful, and you just mentioned there was an infrastructure track-in. Do you know now anything about, you know, how many, what's the long-term sustainability? How many of the trainees have gone on to other types of brands? How many have gone on to R01s? So, I mean, so what markers of success are we really using? Right. Actually, we do know the trainees that have gone on to get their own research grants, and I don't have the number in front of me, but I think it's that six or seven are actually now currently principal investigators on their own grants. And I would hazard a dozen, maybe 20, have gone on to tenure-track positions. A number of them have actually gone into the federal government and are working in related fields in the federal government. You also hinted that there might have been, maybe criticisms might be too strong a word, but, you know, not everyone has been happy with the program and there's been some debate about it. What have been some of the major criticisms and how have you responded to them over time? I think there have been two different kinds of criticisms. One is that it really, the Center's program takes away from our investigator-initiated portfolio and also creates kind of a closed set of elite researchers that is, you know, discourages other researchers from kind of becoming involved in LSE research. It's perceived that they have an advantage in getting R01s and other research grants. So there are those kinds of criticisms and then there are the criticisms about the program itself. And I think the primary criticism has been that the Centers in the past have sometimes been a little bit diffuse. They haven't maintained a tight focus on, you know, the single issue that they've identified as a theme. And there's also been some concern that some of the research, the pilot projects generated haven't gone through, you know, a rigorous review process of some kind. And that's why we're crafting the new RFA in such a way to hopefully address some of those concerns. As far as it taking away from the investigator-initiated budget, I think the thing to keep in mind is that the Centers at this point are limited to $750,000 direct costs, which is about the size of a big R01. So it's not a huge commitment of funds. The time length is longer than most R01s, but the funding itself is not that huge. Thanks. Sure. So if being at a place with a strong genomics emphasis is perhaps a predictor of success, is that something that you talk to potentially interested people about? Is it something you encourage? Is it something you nearly require? What should be the situation there? That's a good question, too. It's something we encourage, but we also leave open the door for people to collaborate with these programs at other institutions, because we don't want to narrow the field such that you have to be at a big institution with a genomic research program. But you do encourage that kind of collaboration across institutions if there isn't a presence there? Absolutely. Good, thank you. Jim. So you had mentioned that you expect the applicants to identify a clear high priority focus, which makes sense. Will you be crafting the RFA in such a way as to define some of those that you're interested in, or is it more to see what bubbles up? I think some of that gets to the issues that Karen brought up about being various tensions, very legitimate tensions about where funding goes. Right. What our plan is, is we will encourage researchers to take a look at the four program areas that were identified in the 2011 strategic plan. And we have on our website a list of high priority research topics associated with each of those four areas. And we will reference the website and encourage them to look there. But we also don't want to prescribe to them. Genomics is changing all the time, and we want to leave the door open for people to come up with creative new ideas or identify an emerging issue that we just haven't seen yet. Pearl. One fast follow-up. You had mentioned that you're looking at the possibility of some T-mechanism for the sustainability of those that are phasing out. Would that impact the budget of new P-50s or P-20s? Would that come out of the same 33% pot or not? No. I mean, that's a good question. I hadn't envisioned it as coming out of that same one third of the budget, but maybe we need to revisit that as well. Any other questions? Great. Thank you very much. As a concept clearance, it is required to have a vote from council. So we'll just do this by show of hands. All in favor of approving the concept clearance. Any opposed? Any abstentions? Okay. Thank you. Thank you.