 And I think we're ready to resume with Lucia now talking about the Genomic Medicine Pilot Demonstration Project. Oh, no? Oh, sorry. Clinical, right. Exploratory Coordinating Center. Okay. Let's get my slide set back up here. Okay. So this is the concept clearance for the clinical sequencing exploratory research program Coordinating Center. And I am presenting this on behalf of my colleagues, Brad Ozenberger and Jean McEwen. So just to give you a little bit of context, late last year, NHGRI funded this clinical sequencing exploratory research program, which I'm going to abbreviate as CESAR, as an extension of the NHGRI sequencing portfolio. So the goals of CESAR are three-fold. First, to establish the infrastructure methods and issues that are necessary to integrate genomic sequence into clinical care. Second, to address the ethical, legal, and psychosocial challenges inherent to this integration. And third, to disseminate methodology and breast practices coming out of the consortium. So Eric showed a variant of this slide earlier. This is the six funded sites. So as you can see from the third column, there are a range of disease focuses from cancer to heart disease, pediatrics, and so forth. Two of the awards that are focused on cancer are co-funded by NCI. As you know, if you've read the concept clearance, we are planning to reissue the RFA funds permitting at a potentially another two to three sites. So for that and other reasons, we feel that adding a coordinating center at the same time would be helpful. The goals of the coordinating center would be as follows. First, to facilitate the work of the consortium through scientific coordination of its many moving parts, as well as logistical and administrative coordination. A second goal would be to accelerate the generation and dissemination of findings and best practices from the consortium. And that would be through identifying key consortium challenges and opportunities as well as accelerating the resolution of those issues. A third goal would be to support the interactions of potential collaborative activities with related efforts, especially this return of results consortium that was alluded to earlier. This is a consortium comprising the LC investigators from this program, as well as nine other grants. And they're focused on developing consensus and policy development around the area of return of results. All right, so why is the coordinating center needed? Well, if you look at the individual grants, they're each individually multifaceted, so they comprise three projects, the first of which is a clinical study, the second of which is a component that deals with sequencing, analysis, and interpretation of sequence data, and the third addresses ethical and psychosocial research issues. And it's really important that the different grants talk across the consortium as well to learn from each other and to build on lessons learned. So in terms of the consortium-wide activities, there are a few key issues that we've identified so far. The first is to develop and share technical standards for doing sequencing in a clinical context, sharing genotype phenotype analysis strategies, as well as harmonizing outcomes where necessary, sharing standards for storing sequence information in the electronic medical record, as well as discussing implementation and tools related to clinical decision support, coordinating approaches to defining and bending variants that may be useful for clinical care. Harmonizing psychosocial measures, identifying emerging issues, and developing new approaches related to informed consent. And then finally, focusing on policy and practice guidelines around this return of results consortium that I mentioned earlier. There will also be synergy with other NHGRI efforts, such as Emerge, which is the NHGRI program on electronic medical records and biorepositories, as well as the ClinAction and Genomic Medicine initiatives, which you'll hear about shortly this afternoon. So as I mentioned, one of the key goals of the coordinating center would be scientific coordination. What does that involve? It involves a variety of roles, potentially. Everything related to, from genomic sequence analysis to quality control of sequencing, genotype phenotype analysis, phenotype harmonization return of results, harmonization of psychosocial measures, as well as electronic health record integration. So this is quite a range of areas that are applicable to the consortium. And we anticipate that some aspects are going to be more needed than others in response to the consortium needs, which will certainly also evolve over the project period, excuse me. Which is why the most important thing probably is for the coordinating center to be flexible in response to the consortium needs. So the applicants will be asked to describe why they are uniquely qualified to be flexible and responsive in anticipating the evolving needs of the consortium. So the coordinating center will also take on a number of logistical and administrative roles. They'll coordinate, synthesize, and disseminate the lessons learned from the consortium track release of data and tools, organize working groups, serve as a repository for consortium documents and practices, plan meetings for the whole consortium, as well as the joint return of results in the consortium, harmonize data formats in preparation for data dissemination, and then facilitate communication between the studies and the data repositories. So to give you some other examples that coordinating centers have served for other NHGRI cooperative agreements, I wanted to list these. For example, the Geneva Garnet and Page Coordinating Centers have developed data cleaning and QC pipelines for large-scale GWAS and other association data. The Emerge Coordinating Center has been crucial in taking on lead in identifying and addressing privacy concerns inherent to incorporating genomic data into clinical care. The Geneva Garnet and Page Coordinating Centers have developed or released tools to make the consortium data more accessible and more user-friendly to the scientific community. And then finally, the Geneva and Emerge Coordinating Centers have provided recommendations to the study investigators regarding chromosomal anomaly findings that may have been discovered through data cleaning. The proposed mechanism is a U01 cooperative agreement, which is the same mechanism that the other investigators through. The RFA will be open to all applicants, not just those who are current or future members of the CSER consortium. Of course, there'll be one award. We suggest a maximum of $800,000 in total cost per year for four years. And as I mentioned, this RFA will be concurrently issued with the release of the CSER RFA. So CSER is a key flagship effort of NHGRI in moving towards the reality of personalized medicine. So we're not just studying, but rather implementing genomic-based clinical care during this project period. And the vision is that such integration will become routine eventually, so that the work from this consortium can extend from impacting individual patients to solving some of the critical challenges that will be necessary to integrate genomic sequence information into the broader health care arena. So with that, I'm happy to take any questions. Gents, comments? Pretty straightforward, it sounds like. Rex. I was just gonna say, I think it's straightforward and given the experience everybody else has and the value that the coordinating centers bring. I think this is a no-brainer. Wonderful, thanks. Other comments? Anything to add, Brad or Jane? Okay. All? All right. Sorry, can I just say one thing? I'm sorry, did I miss something? Yeah, only because I'm tardy. The one thing I would just encourage you guys to do is to make sure that some of the cross-cutting focuses, right, don't end up being separate efforts. So what I'm getting at is, for example, you've listed actionable variants and return of results kind of as separate things. In reality, those become one big problem, right? And so I would just ask that as you roll out this RFA, you emphasize that the coordinating center has to really coordinate without adding new complexities, right? Cause it's already a big job for the various consortium members to kind of get together, which you want is something that'll really facilitate and maybe roll some of those consortium concerns into a more tractable type of thing. Does that make sense? Yes, it does. I think that's a great point. In our experience, coordinating centers have often been a very good kind of focal point to initiate those discussions, and they also can help make the conversations and work more efficient. It might even take the place of some of the other extraneous kinds of consortium consortia, right? See what I'm saying? I just would hate to see a proliferation of issues when it might be able to be simplified by bringing everything together under that mechanism. I think that's a great point, yeah. Thanks. That raises one other thing that I thought of during the presentation, and that is there's a lot of commonality between a lot of the coordinating centers, and has there been any thought about how the coordinating centers should interact with each other? I think there was some interaction between merge and Geneva coordinating centers, but just to throw out the idea that if there, I'm sure everybody else has thought about this as well, but there might be some real benefit gained to some very significant interaction between the coordinating centers. Not to suggest we need a coordinating center for the coordinating centers, but to suggest the coordinating centers need to coordinate with each other. I think that's an excellent point. And I'm sure we have started to have those discussions. I think until grantees are actually funded and you can see who's going to do the work, the exercise is mostly kind of planning on our ends, but we have thought about those things and we will be kind of sitting down and evaluating how all these efforts can harmonize. Okay, all in favor? Any abstentions? More opposed? Okay. Thank you very much.