 Okay. Now, my brother. Switching hats. Now, Larry's twin brother. I believe this came up in a council-initiated discussion from a few rounds back that once Larry was identified to fill the position of division director for genomics and society that you would like to hear a presentation about his thoughts for the future research program in that division. And I think among other things, Larry's going to tell you about that. Okay. I think I was here when the query for this came up, but I don't remember who actually asked. It had been you. I'm not sure. Okay. So I don't have a brother, by the way, two sisters. So what I thought I would do, and I know we've been here a long time, is give you kind of a brief flyover of the division, because although some of you have been here long enough to have heard this from the point when Eric started the proposed reorganization to actually happening, I wasn't involved in most of that. So, and I know some of you are not. So I am now the division director for the Division of Genomics and Society. I'll talk a little bit about the mandate for the division and talk to about staff, activities and some of the projections and some of where I see things going. This is going to be a relatively high-level presentation as opposed to getting down into the portfolio and individual grants and things like that. As some of you have been here for Eric's tenure, know that the Institute reorganized itself into several different divisions. And you've just heard from people from the Division of Genomic Sciences, Terry started the Morning Division of Genomic Medicine. This is the Division of Genomics and Society. The vision that I have, and at least that shared with I think most of the people in Genome Institute, is that this division really is wrapping around quite a few of the others and interconnected with the others. And that's what I really, one of the goals I've had since I started is to make that happen. I excluded Division of Management and Extramural Operations because they're more detail-oriented. Really fortunate, the four-leaf clover was because this division was set up and co-run for a year or so by Mark and Karen. And I was really lucky because they basically, all the people on the slide, kind of stocked the kitchen, set the table, and now we're ready to go cooking. Mark and Karen are still around. They faded a little bit more from where I'm sitting than they're still around and still available, and that's actually a major resource to have in case we have questions and Karen still comes to staff meetings. The permanent staff for the division are two long-termers, Jean McEwen is in the back and Joy Boyer, and one relatively newcomer, Nicole, and Dave Kaufman, who's the newest person here. So these are your four program directors for the program, and we've been recently joined by two who you met earlier today, Alex Lee and Annie Nehouse, who are program analysts who split their time between our division and other divisions. So this is a pretty cool team to actually have. We have 40-some years worth of genome experience collected on this slide, or more than 40-some years. There is also the GSWG, which if you're wondering what that is, Genomics and Society Working Group, which is attached to the division, just as some of the other divisions have advisory working groups, and you will hear more in a few minutes from Pamela Sankar, who is chairing the Genomics and Society Working Group. That working group met and was formed before I started in the division. So in fact, my first day in the division was a meeting they had, and it was a very big immersion. You could think about the division from the funding point of view, and if you looked at this kind of view, the dollars in the division, essentially the dollars mostly go into the LC grant portfolio of the total dollars associated to the division. That program, as you know, has about a 5% set aside from the extramural research budget, just a little bit bigger than the small business set aside, and then 2014 was about $18 million that went into extramural grants. This is what the grant portfolio looked like. If you added together for a couple of years' worth, I just want to highlight that this is the cumulative dollar amount. This is the amount that went into R01s, P50s, which I'll get to in a second, and R21s are these green slice of the pie. So we're more than half investigator-initiated activities in this particular division. So it's somewhat the reciprocal of the rest of the institute. If you look at the number of grants, R01s and R21s, which are relatively small grants, and there's a, can't see what color it is, the R03s, those wedges of the pie make up most of the grant numbers for this division. Also note that these numbers are relatively small, we're a small institute, it's a small division. 32 R1s, 12 R21s over this interval. If you, and Terry started with the pies in the bars, I'll stick with the pies in the bars. If you look at the different fiscal years, this is how the grant funds are broken down. SEERS, for those of you who don't know, are the Centers for Excellence in LC Research. They're established about a decade ago, I don't know exactly the exact date. These are infrastructure building, training, and some small pilot projects type of work. So this would be into the RFA kind of category. The investigator-initiated, this gold pie as I mentioned is about 60% of the portfolio. There are other consortium that are RFA-driven, some of which are not funded from the genome and society budget, but are funded from other budgets. So the LC program actually has more funds going into it, mainly through these embedded LC programs, some of which are funded by other divisions. And so you can think of LC as having investigator-initiated grants, this infrastructure and training building that we have, and then as you heard twice, and actually Phil also mentioned it, that the field is mature enough and LC is well known as a brand and as a discipline that they get embedded and built into these other programs as they go forward. Sometimes the division contributes to that. Sometimes the original person or the original group doing it funds those parts. This was to highlight where we stand. I'm sure you've seen this slide before. There's genome. And I highlighted in blue the CIDR member institutes that my brother just talked about, only to remind me to talk about trans-institute efforts. And so one of the things that we're pushing and that I'd like to push even further is trans-institute efforts in the LC realm. We already have several different institutes that have signed on to our program announcement, and you can find exactly their specific questions on our website. The individuals in these blue institutes who oversee the CIDR program, a lot of them are the same ones who oversee the LC portfolio. So we already have a known end to most of these individuals. Part of the goal for the next couple of years is to work with other institutes to have this be done in a more coherent fashion. One example that we are doing right now is, and I'll leave the details out, is there's a big institute doing a very large clinical trial that involves genomic testing, very, very obviously expensive clinical trial. We are now teaming up with them to build an LC component, a smaller LC component directly into that clinical trial so we can find out, asking questions about what do people think about, what's the best way to deliver this information, and that's going to go off with that other institute in a partnership. The other way to think of it is the funding view of the entire NIH. This is obviously not to scale, but I couldn't fit the type set in here if I made the Genome Society budget to scale with the NIH budget, but we really hope to be able to spread this wealth by taking the kind of questions we can help the investigator background and the staff here to help the other institutes explore the areas when they either recognize it or when we point it out to them that they really ought to take a look at some of these LC issues in their grant portfolios, obviously neither of these are to scale. The other way to look at the division is staff time. So this is roughly to scale, but estimate that the staff probably spends about 60% of their time, or going forward once we're at full strength, about 60% of their time on grants, management, and the other is in these mandates that came with, is written in the charter of the division that I strongly support, is to do other services. And I'll give you an example of what we've done just in the last couple of years, some of it in the last couple of months. This is part of the mandate. We collaborate with other extramural research divisions. That's not been a problem, not been a problem to collaborate with other divisions, especially the division of genomic medicine and the policy communications and education branch. I would say that between Laura and Derek and Vince, if you still hear, in that branch, if we were any closer, we'd be sharing toothbrushes because we really spend a lot of time talking about what each other's division. So there's no siloing when it comes to these divisions. We also do collaborations, consults, and consulting with other institutes. And I'll just give you an end national and international agency. I'll give you an example of those. Oh, this is within NIH, within NHGRI, fair bit of connection, weekly meetings and joint meetings once a month with the policy communication and education division. A fair bit of interaction. We have embedded programs that are part of genomic medicine. And even genome science, as you've heard a little bit, is starting to dip into LC to a certain extent. On the NIH as a whole, we spend time talking with the Office of the Director, Office of Science and Policy. We do work with individuals in the intramural research program. And NIH has a bioethics department, which is an intramural program, but also has international and national outreach. And we actually, in our own institute, we have a bioethics core, and we interact with all the people in each of these elements. These are just the committees and consults that have been done in the last couple of some of them six months. So Office of the Director, I find myself in building one a lot, where Francis's office has in various capacities asked us to help out. And the NCI was doing stuff jointly with us. These are consults that various people in the division were asked to weigh in. So you get a call from Mental Health. We're doing this program. We need some advice on what to do in this particular LC component. And the people in the division have also done consults for AIDS research and Fogarty. Other agencies, this is a fair bit of time, to my surprise. There's a lot of need out there for getting at least some primer on LC issues. So a couple HHS Secretaries' committees, the FDA, the CDC, those are all within HHS. I've spent some time with the FBI, Homeland Security, Air Force, Army, doing consults. And we've also had some other people from policy go to some of those. Went to one meeting that had no name tags and no attendee list. And it didn't strike me until afterwards that that was probably on purpose. I do have an email list. And it's surprising having spent time with those. They're interested in both the technology and the ethical and legal issues related to genetics. And so if you think genetics is just medicine, it's not. These people are all wondering what to do with it. We've consulted with the Presidential Commission on Bioethics, which weighs in on a lot of these topics. And Thursday, I'm going to talk to staffers at the Senate building. And later in the fall, we've been asked to participate in a workshop that NASA is holding because they're doing genomic sequencing on astronauts who are obviously hard to be anonymous. And they're interested in what some of the issues are. We also work with non-governmental organizations. Fair number of US and foreign academic institutions call the program and say, we need help with this particular grant or this particular informed consent style. So this is the consult kind of activity. These are a couple of other organizations that the staff have worked with. We've worked with ASHG, the Genetic Alliance, National Congress of America, and now with Global Alliance for Genomics and Health. So we're starting to have the LC is clearly has an established brand, has an established discipline. The division is starting to have the same kind of thing in a slightly different way. So that will lead us to trying to work on the balance, balance within the grant portfolio. I personally think it's pretty close to where it should be, but this is not my decision alone. I think it would be hard to answer some of these LC questions on the time scale it takes to do concept clearance, RFAs, reviews, and cycle through all of that. There is a discussion as how much LC research should be embedded versus freestanding. And there's advocates of both sides. I really like the free, really like the embedded model. And there's other people who say that may lead to a conflict. Obviously, if we do both, we don't have to worry about choosing sides, how much in each realm. And then one of the other goals is how much time do we spend on LC research done by other research institutes, who in theory will be the people who get all of the credit. I'm not worried about credit. I'm worried about getting the answers right. And you could imagine if the FBI gets something terribly wrong about genetics, the whole field is going to pay. So we want to make sure that we get all of that done correctly. Some of the goals that I mentioned that I will be pushing over the next couple of years is expand the base via what I call magnetism. People just either are attracted to it or they realize they need it. I think that's different from going out and saying, you do this. And that's just not my style. And it's probably not the best way to get things done. So far, there's been a lot of traction in people saying, yes, we'd really like to get together and talk about what the issues are in the LC area. We, as Pam will briefly mention this, we probably need to increase the volume of investigators initiated grants that go through the study section. Like to widen the trainee pipeline as the amount of LC research that gets done is expanding, we're suddenly realized that the trainees that we built 10, 15 years ago, there's not enough of them to deal with the new research. We probably have to slowly open up the spigot a little bit on the training pipeline. Clearly, with strategic plan, there's a lot of issues related to genomic medicine that fall into the belly wick of this division. And this is a difficult one to do in a really tactical way or strategic way, but we hope that the division itself can increase international cooperation and either find out what's going on elsewhere or at least let them know what we're doing here. So those would be the goals that I have for the next couple of years. That's all I prepared. I don't know if I address the issues that you guys wanted to hear about, but I'm still here and willing to do that. Questions for Larry. Bob. Larry, I'm wondering if you could cut. You had a long list of all the various agencies that you've interacted with, including the Anonymous. And I'm wondering about OHRP and the extent to which your office is involved in informing OHRP, which then, perhaps or not, disseminates out to all the individual IRBs about genomics in particular. Yeah, it's a good question, I have to say, since. So I've been doing this for about 10 months now, and I have not personally interacted with OHRP. And maybe I don't know if any of the staff want to talk about past interactions with them. It looks like she wants to stand up, but. The only way I bring it up is I've heard from a number of different IRBs that they feel a lack of guidance and educational material from OHRP central to help them deal with the approval of, or I should say, the valuation of human experimentation applications involving genomics. In genomics in general, not even really high end stuff. I can address one thing that came up when I started this, which was asked within the first month or so, do we have a database of good protocols or examples? And this division doesn't do that, but the Division of Policy, Coordination, Communication, and Education does it. And that website's almost revamped, and I don't think it's ready to launch. We'll be launching shortly. So that's tomorrow. That's what I was going to say, too, is that we do have a lot of interactions with OHRP, but most of them are indirect because a lot of it goes through the policy office. But because we work closely with them, we do have input. But I take that suggestion pretty seriously. It's a good one that we could look at. We are helping so the office, the director, has a bioethics grant portfolio, and we are helping chip into that. And one of their focus is, can we have central IRBs, which I know for anyone who's done a multi-center study would really like. I wonder if you had any interaction with the VA? We have not, but is Terry still here? Over there. Oh, there she is. So the Institute has, and one of the things we try not to do is that there is a lot of overlap. And so when we have one person dealing with the VA, we don't have another. So I don't know if you want to address. We've had a number of interactions with the VA, mainly around a number of studies that we're planning and discussing. Nothing in regard to this in particular, but I don't know what the specific question was. A million veterans? Oh, yeah, them. So yeah, we interact with them mainly on a consultative basis. Bob actually is still, I believe, on their advisory board. And so we get consultation from Bob as well. But they'll sometimes contact us about what genotyping platforms to use, things like that. Beyond that, they're not looking for a lot of advice, and we're here to help them. But we can't really barge in on their program. Or Bob, if you want to comment on that. There's actually been precious little discussion of LC issues at the Million Veterans Advisory Committee. It's really focused on recruitment, technical issues, consent to some extent. So I take that back. They have talked about consent. But there are a lot of other issues that really not been approached. Yeah, so thank you, Larry. So I feel like a theme for today is sort of this idea of trying to drum up post-sponsorship from other institutes and looking for additional funding sources. And it sounds like the Genomics and Society group is interested in that, too, and thinks that it's important. And we've had a lot of conversations about that in the past. And I know that there's been some difficulty in getting other institutes to dedicate money to this type of research. I mean, is there a plan in place? Or what's the strategy going forward with regard to that? So it's a retail strategy, where you go either by a particular project or go through a contact at a given institute. So there's two ways you can do money. We can add something to a project they already have. Or we can have them put money into grants that come through study section. The staff has spent, Joy and Gene have spent a lot of time cultivating the institutes that like to say, we'll sign on to the announcement. As grants come through, we'll look and see if we'll fund them. So I don't know how much more we can push that because some of the institutes are resistant. When it's in their own self interest to expand this and do it not to reinvent the wheel, that seems like an easier opening. That usually is in the context of existing projects or projects that are on the drawing board. And so those outreach to the ICs, we have a list of every IC and every person who we have this contact and some scores next to them as to how amenable they are to. That's something we'll revisit on a cycling basis. There isn't really a stick that you can do, unless it comes from building one, that you can say you will do this across the campus. So it has to all be done voluntary. And usually it's done by personal relationships or people coming to us because we have the brand and they know that we have the expertise. Don't have a systematic stick to do that. Hey, thanks Larry. Your presentation was really informative to help give us a sense of the extensive amount of consultations that your division does. And I'll just say it's very extensive. What I was wondering about was for your goal slide, and I guess I'll ask it in two different ways, for your goal slide, how would you prioritize those in terms of what you want to achieve for the division? And then relatedly, consultation is, I think, a very important and useful activity, but I was wondering about if within the division you all have articulated a specific set of scientific goals and priorities, like the genomic medicine sequencing, that kind of stuff, sort of genomic and society issues related to those kind of broad areas. So as you heard in the morning, this is a cross-cutting type thing and we do map, we do have that, and I took all those slides out because they're incredibly complicated when you have the strategic plan going this way and the things cross-cutting that way. We are planning, and it's kind of was on a, actually it's bullet point four, is really to try to align it to the strategic plan to a certain degree, but also to retain the flexibility if things emerge that we didn't think about. And I probably, this is my, me speaking, I'm probably more pragmatic about taking on practical issues and I'll give you an example in that if we had a real strong interest from someone in looking at a new pre-implantation diagnosis technique that was gonna cost $50,000 a shot, but could be really technically amazing. We had someone who was gonna look into whether or not non-invasive prenatal testing is going to be offered to every woman of any age regardless of risk status. I think that one with my right hand would have a bigger impact, but when you're running and investigating our initiated programs, they have to come through the study section and they have to be scored. So we can, and part of what I do is go around and talk to people and encourage them to submit applications, but I don't highly, this is not a micromanaged portfolio because we have to be able to fund things as they emerge. So we map the alignment. If we don't get applications in specific areas, we can take some of the budget and carve it off into an RFA to help manage that. If I do that right now, we'll be eating in probably into the investigator initiated a little too much. So Larry, are there specific initiatives directed at bringing in the perspective of patient advocacy groups into the LC discussions around genomic medicine? Initiatives that we funded or just that it's done in a lot of places because it's been thought to be a good idea. You mean, do we fund? I actually don't know if we funded, I know we haven't funded in the last couple of months and I'll look to the folks in the back to know whether we have funded in the past investigation into the role of having patient advocates or representatives present. I can say I've been on review panels when they have been present, it's been very cool. Other questions for Larry? All right, thank you very much, Larry. And let's move along to Pamela Sankar's presentation about the Genomics and Society Working Group.