 All right, we're running about 10 or 15 minutes late. So I will prevent you from eating your lunch for the next 15 minutes. So I'm going to talk about one of NHGRI's newest consortia called Ignite, which this acronym causes a lot of consternation amongst Terry Minolio, who fails to remember what it stands for. So I can take the blame or the credit for that. But it's a really cool logo, and I have to give credit to the University of Pennsylvania Crack Artist Staff for making this acronym for Ignite. The Ignite consortium really emerged out of the need to address issues in the right to domains that you saw from Eric Green's presentation yesterday on NHGRI's strategic plan is how do we really think about taking reasonably well-validated genome technologies and putting them into medical practice and do they actually work in a way that produces desirable outcomes amongst patients and other stakeholders? So coming out of our first and second GM meetings, genomic medicine meetings, of which this is the sixth, as you recall, one of the things that the group came together to discuss is whether there could be some pilot demonstration projects. And I think that meeting, if I recall, was in late 2011. And it was late 2010. An RFA came out in early 2011, which you're seeing here to really propose projects that would develop methodology, feasibility for incorporating genetic and genomic information into the care of a patient and see if that actually translates into outcomes. So the Ignite network was established after, as you'll see, three projects were funded. The goals of the network were to build on existing activities that were taking place at various organizations that we've learned about through this series of meetings and see if we could expand those in meaningful ways, not just in academic medical centers, which have a significant amount of expertise and capabilities, but in other environments where the challenges may be greater, diverse health care environments, underserved populations, rural populations, et cetera, I think is among what this network is trying to address. So it levels the playing field for genomic medicine. And in doing so, to build a better evidence base for the clinical utility of these technologies. And through the network's efforts to articulate some best practices, both in the area of implementation science, but also the area of how to design studies that would actually be best used to generate the kind of evidence that we are striving for, for things that we've heard about today and over the last two days. So this is a snapshot of this consortium. And by the way, I have to tell you, I'm not going to show you any data because this consortium really funding streams began in July of 2013. So we're just about six months old. Like the other consortium you've just heard about, we have a coordinating center, Steve Kimmel, who's in the back. Maybe you want to raise your hand, Steve, is the PI of that coordinating center from the University of Pennsylvania. And one of his colleagues, Reed Pirates, who you just heard ask a question, is also from that coordinating center. And there are three demonstration projects, one led by Julie Johnson, who was here yesterday. Maybe some of you had a chance to meet her. A superb pharmacologist from the University of Florida who's looking at pharmacogenetics. And I'll go into more detail about these projects in a few moments. Irwin Bottinger, who is also in the room. Irwin, maybe you could just say hello, raise your hand, is the PI from Mount Sinai, who is looking at the use of genetic information, genetic risk information to alter behaviors in African-Americans. And again, I'll talk about that in a little bit more detail in myself. Looking at the use of electronic family history information delivered to providers to alter screening behaviors amongst a variety of patients in diverse settings. So as you just heard from Lucia, there is a coordinating center here. This really serves as an integrative hub for the network. It's meant to really facilitate communication and interactions amongst the sites. We have three sites, so it's not particularly challenging right now, I don't think. And we had one of our steering committee meetings just a couple of days ago. And I can say that both the coordinating center did an excellent job, but also the fluidity and communication amongst the sites is really superb. And we're beginning to try to understand where the potential overlap and the Venn diagram of our projects is coming. So we can begin to harmonize across the different projects. Importantly, we want to create a centralized repository of data, both for our own purposes, but also to share with groups like this. And also to begin to think about how do we connect to other implementation programs and networks, particularly within NHGRI that you've heard about, such as CESAR, such as the newborn screening network, which are all implementation science, implementation programs as well as eMERGEN and the PGRM. And we will, for the first time, have our program reviewed by an expert scientific panel later this year. So let me just give you a quick snapshot of the three projects. This is the one from the University of Florida, run by Julie Johnson and colleagues. She's the dean of the School of Pharmacy there. She's had ongoing interest in working with the Pharmacogenetics Research Network and delivering pharmacogenetic information to clinicians and studying how they use the tests and the outcomes as a result. So this is really building on a lot of expertise at that particular site by her group, taking well-validated tests that have information already in FDA labels and that have also been fully vetted and analyzed by the Clinical Pharmacogenetics Implementation Consortium that is spearheaded by Mary Relling, who's in the room, and also Dan Rodin and other colleagues from the Pharmacogenetics Research Network. So in this case, they are implementing in a preemptive fashion, similar to what is happening in the Emerge Network, genetic information into electronic medical records and developing the information systems that are required to deliver that information just in time to the clinicians. The goal is to look at outcomes such as process outcomes, just simply how do we actually get this information into the right place at the right time and how is this information utilized by the patients and by the providers and what actions are taken and to also develop the understanding of, in this case, with the CIP-2C-19 program to look at things that are safety and efficacy outcomes. This is just a snapshot of the overall organization of the program, so extending their reach into other practices outside of the university setting to community-based health systems and other cardiology practices throughout the Florida area. They're also going to begin to work on IL-28B for hepatitis C sometime in the near future. Dr. Bottinger's program at the Mount Sinai School of Medicine, Dr. Bottinger is a nephrologist. He's had a longstanding, he and colleagues have a longstanding interest in understanding progressive renal disease and there's been a lot of literature published on the APOL-1 variant and it's associated risk in African Americans for progression to end-stage renal disease and those that have hypertension. So the overarching hypothesis of his study is that informing patients about their risk of developing renal disease and educating them about renal disease will incur behaviors that will improve their compliance to medications for hypertension and overall reduce in the future their progression to dialysis-dependent kidney disease. So he's conducting this study in New York City across a diverse set of practices. There are academic setting practices as well as a strong partnership with the community family medicine practice also in the New York metropolitan area. Importantly, this is a cluster randomized prospective study so there are control practices and there are practices that are going to have the active intervention and again the end points that are being measured are having process measures about the way that recommendations are delivered, the understanding of those recommendations both at particularly at the patient level certainly whether this translates into better control of blood pressure and also at the provider level whether the appropriate monitoring tests are being used and there's this whole series of qualitative assessments that are being done through questionnaires that you see at the bottom of this slide. The last study that my own study is that is building on a project that we've been running for several years to develop a patient facing electronic family history tool meaning that the patients enter the information it's not done necessarily in the physician's office the information is captured and put through a series of clinical decision support rules that deliver guideline specific recommendations about genetic counseling and screening tests to the patient and to the provider so two reports are generated and putting this into a number of diverse care settings that I'll show you in a second so our goals that you see on the left hand side is to optimize how this process occurs to facilitate the integration of the clinical decision support rules as well as the reports themselves into the electronic medical record and also through a cluster randomized prospective study with a number of control practices and intervention practices show both demonstrate both the clinical utility as well as the personal utility of an adequately collected family history. This gives a sense of the sites where in 34 clinics across the United States you see their geographic locations they're very diverse ranging from academic health centers to rural and underserved clinics particularly in the Northwestern United States and we have a number of process measures that in implementation science methodology measures that we're using across this study. I think you're not intended to read what's in the cells here but the point is the kinds of outcomes that we're looking at are at the patient provider and at the system level and as you can see we're trying to capture data and I think this is true for most of the studies in this consortium at the behavioral, biological, clinical and financial levels and we're looking for ways to do this as part of usual care so in some cases we'll administer questionnaires but for the most part the data that we're capturing is in electronic medical records or in administrative databases. Like the other consortia we have a number of working groups these are cross cutting there's one on implementation science another one on dissemination, outreach, education, economics and sustainability and then a third that's on process and effectiveness measures and our goals are not only to begin to standardize these aspects of how we do implementation of genomic medicine but also to be a vehicle to communicate this information across other consortia that is that a part of the NIH genomic medicine working space. I think this is my last slide which is just coming out of our last steering committee meeting on Tuesday we know that there's a another RFA was another call was made there are other proposals that have been that are under a review so the network we hope will expand to other sites and other initiatives we also are thinking very carefully about how we share data how we put data sharing plans into place, communicating best practices as I mentioned and also as we discussed a little bit yesterday and as Anna Colby had mentioned that we really want to also engage payers into our community so we begin to understand what they're looking for in terms of clinical utility because ultimately sustainability is going to be dependent upon reimbursement as we've acknowledged in several of the discussions we've had over the last two days. So I don't have a final slide which is the acknowledgement slide but clearly I want to acknowledge NHGRI and Terry Minolio and her team Ebony Madden who is our project officer and Heather Junkins as well as Irwin, Steve, Julie and their teams for making this a really exciting series of projects that I hope to report back to you on with data going forward. Thank you. So I have time to ask myself a few questions. No. Okay, so I'm gonna ask you a question. What does IGNITE stand for? No, just good. No, please. So this is open for everybody to join? I mean, or only for the US? Well, that's a question I think we're gonna discuss this afternoon. I mean, to the fact, I think we would want to see perhaps opportunities to take pilot projects. We've heard about a number of pilot projects, not just these over the last couple of days and decide whether they are ones that might be amenable, feasible and desirable to do on an international scale of some type. I would just say that I think, and Terry or Eric, you can correct me if I'm wrong, that these consortia, while they have the funded groups, I think there is a way to participate in them as a visitor or an outsider, just so you can learn, pardon, okay, I'll let Terry comment on that. So actually, NHGRI, as you've probably heard and NIH in general, really tries to encourage these kinds of collaborations, recognizing that it does take some time away and focus away from the parent group, but the ENCODE consortium, which is a functional genomics consortium, did a very nice job in encouraging what they called, I believe, ancillary auxiliary members. There's maybe a better term than that, but at any rate, they had a whole policy for doing that. We then took that and moved it into eMERGE and have that opportunity. So actually the Air Force has a personalized genomics project that is participating now as an auxiliary member of eMERGE and they sit on our steering, affiliated, thank you, thank you so much. One of those A words, yeah. But at any rate, we could do the same sort of thing and ignite and we would encourage that to some, at some point, it becomes a little bit unwieldy and difficult to manage. The policies are not terribly odious. It's mainly that you're willing to share your data and willing to maintain the privacy of the data that are available. I know, Tim, you have done these kinds of things in ENCODE, yeah, so do you want to comment on how that's worked? I think it's worked really well in terms of essentially signing up to the common data sharing platform within the consortium and adopting those policies and turning up at the consortium meeting, but generally people are keen to do that because that's information exchange. I see my colleague Jeff Schloss in the audience. Jeff, could you comment, are there other programs in addition to ENCODE that do this sort of affiliate membership? That's the main one I'm aware of. Oh, 1,000 genomes, so that's another, another, yeah. They may have their own, right, yeah. All right, I think we've arrived, thank you very much for that discussion. We've arrived at lunchtime, which I think is the same drill as it was yesterday. We have an hour, also breakout groups. You should have received an email from Rita Chambers last night that was with the list of breakout sessions, and it's also out on the reception table outside the room with the room assignments and the breakout leaders, so enjoy lunch, and we'll see you all back here at 2.45.