 Well, I'm going to tell you about recent developments in H3Africa. The last time I talked to you about H3Africa was a year ago, this coming May, when you looked at applications, I'll tell you a little bit about what's happened since I last talked to you and about what your role will be in the next council for H3Africa. So for those of you who are new to council and weren't here for the review of the previous applications, H3Africa arose from a discussion at the African Society of Human Genomics, Genetics, meeting in Cairo where Francis Collins and Charles Ortimi were present, and the Welcome Trust was also present as well. Francis and Charles brought the idea back to the NIH and it became part of Francis's global research initiatives. H3Africa is a partnership with the Welcome Trust and the African Society of Human Genetics, and along the timeline of the discussions and securing money for the project, H3Africa became an NIH Common Fund project. Now the goals of the project are to increase the numbers of Africans who are internationally competitive in genomics and population based research, to establish collaborative networks of African investigators pursuing genomic-based disease-oriented projects, and finally to create and expand infrastructure for genomics research including bioinformatics and biorepositories, and you'll see how this works throughout all the applications that we've received, funded, and now are considering. So key aspects of the H3Africa initiatives that make it unique among some of the other NIH programs of global health. The awards for H3Africa are made directly to the institutions and to the African PIs, and this, as you can imagine, is a challenge and an opportunity. We are funding centers and they're all comprised of multiple collaborative projects. They were required to collaborate with at least two or three institutions outside of their own institution. This is something that doesn't happen a lot in Africa and I think it's an important element of the program. All of the NIH grantees must deposit their data in a public repository. They must also deposit specimens in the H3Africa biorepository, which I'll tell you more about, and they must also use the H3Africa Bioinformatics Network. I'll tell you more about that. All the applications must include a training component and the first set of applications may include societal implications LC research. Okay, so this is the results of the RFAs that you saw in May. I mentioned that we're funding centers. We funded two awards, one on metabolic syndrome and one on kidney disease. They each will be getting $1 million a year for five years. In the first year, they got an extra $250,000 for equipment as well. We also had a large number of applications for research projects. These are UO1s, unlike the collaborative centers, which were required to collaborate outside of their institutions. These applications did not have to, but they had to be attached to an ongoing funded grant. This really didn't work very well. We had a large number of applications and ended up really with only one award working on tuberculosis that we funded, and we're hoping that we'll have more applications like this in the next round. So this is what we funded it at, and again it's for five years. Now we also wanted to set up a biorepository program in Africa, and to do that we decided to use a mechanism that would allow us to have two years of pilot biorepositories, after which there would be an administrative review, and up to two of those would be scaled up into an H3 Africa full-scale biorepository. We didn't get enough good applications last time around to fund four pilots, which is what our goal was, but we funded two at $200,000, I'm sorry that's wrong. It's $100,000 a year for FY 12 to 13, so for two years, and this really is for planning and trying to do some logistics in order to put together their full-scale application. And then the Bioinformatics Network, the idea behind this was to have a Bioinformatics Network all over Africa with nodes throughout the entirety of Africa, not just sub-Saharan Africa, and in order to bring the continent together to provide Bioinformatics training, connectivity, and to help the H3 Africa consortium work together and provide them resources, tools, etc. So we funded one award, and it's called the H3A Bionet, you'll see me refer to that. I got $3.1 million in the first year in order to set up a lot of infrastructure, and it'll get $2.2 million for the next five years. This is what the map of Africa looks like. The stars are our primary grantees. You can see we have quite a few down here in South Africa, and then three over here in West Africa, which is an unusual distribution. I think we were all a little bit surprised by that. There are collaborators though all over Africa, even North Africa, and a lot of that is the H3A Bioinformatics Network. If you can distinguish the colors, the greens are the H3A Bionet, and then the biorepositories have some collaborators. The centers in particular have a lot of collaborators throughout Africa, so we really covered quite a bit of Africa in the current funding. So I want to tell you about progress for the project. Eric already showed you this picture. I think this is our first meeting, and we held it in Addis Ababa, Ethiopia. We had really great attendance from the PIs. Eric already told you the agenda. I don't need to go through this very fast, but as usual at these meetings, there were grantee presentations, and then a lot of discussions about major policy issues. Eric also told you about the outcome that we had established, a steering committee, working groups. We prioritized among these working groups drafting a marker paper and policies for obtaining consent, data, and sample sharing. And then the NIH and the Wellcome Trust also agreed to let the PIs put in an application to the two funding agencies to put together a coordinating center at the bioinformatics site, the H3A Bionet site. For the progress on the organization, we have agreed to fund this coordinating center, so that will be helping us a lot with the 10 conference call, 10 working groups and conference calls we have every two weeks helping us organize the meetings, et cetera, the kinds of things coordinating centers do. And so far, the steering committee of the PIs and the funders meet every two weeks. It sounds like your typical NHGRI consortium. We meet with the Wellcome Trust staff every two weeks, and then these are the working groups that are active, and you can see we have six that are ongoing now, and we have four more that will be starting in the next few months. So we've been very busy talking about first what the working groups need to do, because this is really a new concept for the African PIs that we're dealing with. And they've really gotten into it and very interested in coming up with policies that then they will bring forward to the May 2013 consortium meeting in Accra, Ghana. So what have individual grants been doing? These are the PIs from both the Wellcome Trust and the NIH, and Eric and Pat Goodwin from the Wellcome Trust. So the H3A pilot biorepositories meet every two weeks to discuss their protocols, and they've begun to survey the consortium about anticipated biobank needs. They're trying to put in place protocols and SOPs so that when whichever groups scale up, we'll be able to have some standardization of samples so that when they come in, it can be more automatic and more efficient. The Bionet, as I showed you, is setting up all their nodes. They're preparing for—they're going to help everyone with data submission, and they're preparing for that by, again, putting out a survey to find out more about what types of data are going to be prepared, be generated. They're also starting to work on their training components, and I said the coordinating center earlier. Most of the research projects are still in the phase of writing their consents, and several of these, at least for the NIH projects—I don't know as much about the Wellcome Trust projects—will be going to their ethics committees or IRBs. And then their first progress reports, which are a progress report that the H3Africa program has put together, will be due in mid-February, so we'll be seeing those very soon. All right, so now for the future, where we're going in May. As I said, we want to fund a few more collaborative centers. We could have made four awards last time, last round, and we would like to make at least two more, if we can, if we get the quality applications. And I should say, those of you who are on council know what a great job the Review Committee did a year ago, and we're looking forward to a similarly terrific review. We did not. We only funded the very, very best applications. We felt that there was another round, and we're hoping that these applicants will come in and have better applications, and we'll be able to fund even more. So we really do want to be sure that we are funding quality, and we won't fund all of these awards if we don't get quality. The research projects, again, I told you that we had a lot last time and only funded one. We could still fund two or three more. We've increased the size of these, and we've dropped the requirement that they be allied with an ongoing grant. And I think that probably, that may help in the review. The reviewers didn't like that part of the RFA last time. Again, we want to fund at least two more pilot biorepositories. They will be out of synchrony with the other pilots, and they will be judged for scaling up a year later. But this part, the biorepositories, if we can successfully scale some up, have a seven-year term. So they'll miss one year of the seven years. Again, that number's wrong. It's $100,000 per year. And then new to this upcoming round are some ELSI projects. Ebony Bookman is in charge of this part of the project, and she wrote an RFA that we published, and this will be reissued two more times. We anticipate making three to four awards of $54,000 each for FY13 to 16. Okay, and this is what the applications look like, the spread of them across the African continent. You can see that there are 12 countries that we actually get applications from. The pool represents collaborations among 20 African countries and 98 African institutions. And this is very similar to last time. It's truly incredible the number of institutions that are participating. And then, as I said, the review meeting will be held in March. Actually, February, I think. But anyway, the end of February, beginning of March. And at that point, we will go into overdrive, figuring out what we're going to do as far as presenting this outcome to you for counsel. So, one thing I wanted to tell you about that has been an ongoing problem with electronic submission of applications from low and middle-income countries, and our experience, of course, is with Africa, is that there's a huge problem with the electronic submission at the NIH with applications coming in from these countries. For the first RFA and the second RFWA, we lost about 40 percent of the applications at the early stages of the electronic submission process. Either they didn't get in, or a large number of them got stalled at the error correction time. So, several of us from H3Africa went to the Office of Extramural Research to ask, with a bunch of suggestions, I should say, most of which didn't work for one reason or another. But one thing we did agree on is that we could put in more language into the RFA template to help applications from low and middle-income countries. It explains the registration, which is the biggest problem, because it takes so long, and the electronic submission process better. So, we're hoping this will really help. We also have the... So, we're experimenting with this on the LCRFA that was just recently released. It's going to be out for four months. The letters of intent will come in after one month, so we have more time to work with the applicants, and that's still enough time for them to complete the registrations, which is usually one of the big hang-ups. And we made a couple of other tweaks. We recommended that applicants submit... applicants begin their submission a week before the deadline. So, we're going to follow this story more closely, and the LCRFAs that remain to be released in the coming years will be watched carefully, and we'll tweak... Every time we can, we'll go to the office and try to improve the process. Okay, our next steps. The review, as I said, will be in March. We will be site-visiting the highest-scoring applicants, hopefully before council. It depends on the outcome of the review, where the sites are going to be, and how we can fit that around the consortium meeting, which is in Accra in May. And then it's adjacent to the African Society of Human Genetics May 20th and 21st. Those happen to be the same days you're going to be considering these applications here at council. So, lucky for us, Mark Geyer, I think, is going to be in town, and he will be presenting those applications to you. And the rest of the H3Africa team will be trying to Skype into the meeting next May. So, we'll see how that goes. And then the new awards will be made by August 2013. This is the NIH working group members, many collaborators from all the institutes, and I'm happy to take questions. Jane, can I get a little clarification? The biorepository projects are separate from the other projects, or they're meant to support the other projects? They support the other projects. And so, the ascertainment and the collection of those samples is all driven by the questions being asked. Yes. Yes, I'm sorry if I didn't make that clear. In fact, no samples will get to the biorepositories until we have a scaled up biorepository. So, it's going to be years before they get to the biorepository. And what do you think most people are going to be banking? They all are banking. They have to. And they're going to be banking what? Sorry? Blood, primarily. Blood. Okay. Whole blood. Primarily. There are other things in some of the applications, or microbiome, for example. Okay. Thanks. Can you say a little bit about the financial oversight that the GRI is planning on doing? It's an area of the world where there's a lot of variety of financial oversight, we'll say. So, I wonder what you're doing there? Well, our grand Spanish team goes with us on our site visits. And I forgot to also mention that we have an independent expert committee advisors that are joint with the Welcome Trust. And so, we are meeting twice a year. So, we don't have any special program for financial oversight, but our and grants management people are quite in tune with what's going on. So, that's what we're doing. And the second part is, are you engaging some of the funding bodies in Africa? Obviously, the South Africans have been around, but several of the West African countries are now starting to get a little bit more focused with their research funding. So, we are trying to talk to research ministers or national ministers for research in the different countries. Given that we've just gotten started, we haven't done much yet. We certainly, we invited, I don't know if you know about NEPAD. It's the new, somebody has to help me with that. It is an African organization that is trying to get African governments to spend more on science. And it's relatively new. And it came to our first consortium meeting. So, we're trying to encourage the countries as much as we can. I'll talk to you a lot about it, but you're going to be in a crawl. And there's no better place to start, both because of what they're doing with their oil money. And also, with their, they've been a major node for the WHO programs over the last two decades. So, they have a nice reach in West Africa. Yeah, but we're planning to invite a minister of research. Can I add a couple points to Howard's question? Might not have been clear from Jane's answer that when the grants management people go on these site visits, they're meeting with the grants management people in the institution. And they spend a day or two talking to them, learning about their systems, finding out whether, how much they know about NIH systems. So, they've established these face-to-face relationship with the grants management people at the various institutions. There's also a component where, which is linked to a Child Health Institute program, which is to train grants management people from low and middle-income country institutions. So, they bring, they have a two or three-year training program where they bring people here for a while, and then they have various distance learning kinds of opportunities. And Child Health has agreed to include at least one person from each of the H3Africa Institute's institutions in that program. And then with respect to the governmental connection, each of the applications has to have a letter from the appropriate ministry of the government addressing the issue of support for science in that country. Yeah, I wonder if you leverage the medical education program initiative, the MAPI, because they've gone through all these pains of grants management and so on. Yes, we've, they worked with us on this, getting this new template going. They have the same problem with electronic submission we have. We would like, so MAPI is the Medical Education Partnership Initiative. It is at the Fogarty Center, and it is, they are all at PEPFAR institutions. PEPFAR is the President's, it's the Emergency Fund for AIDS Research. And so they don't, they aren't focused on research. They're really focused on medical education. And we would like to meet back to back with them. So far, it's amazing how hard that is to do. So far we've only had one meeting and they've had three or four. So, but so far we haven't managed to do that. On the other hand, what one thing we have managed to do is, when we meet in any city and they meet in another city, we try to invite our grantees who live in those cities to attend our meet, respective meetings. So that actually worked out great in these. We had someone there that was really enthusiastic and it was a great interaction and actually had some research in common with some of our grantees. So I think that will help and we hope to be able to meet jointly with them. Jane, to be very good. Do you want to say anything about individual institutes' efforts and how they might or are synergizing with the broader H3Africa program? Yeah, I hesitate to say anything about this publicly yet. But we do have one institute that is funding a significant size project that's already been funded. So I probably could say what it is, but I think I should be careful. And they are actually going, it's funded completely by the institute. It's going to join H3Africa. And then several other institutes have put funds. So there's some parts of the RFA that specifically ask for specific kinds of applications. And those would be funded by institutes who've promised money if the right application comes in. NIAID, for example, contributed to one of the projects that had AIDS research in it. And the Office of AIDS Research did the same thing. So the other institutes are working with us very well. And we work and talk to each other every two weeks. So I think it's a thing that's growing. There's another institute that is very interested in getting another program going and having it part of H3Africa. So the point I wanted to make, it's an example of leveraging. We talked about leveraging earlier today. In this case, we're not leveraging necessarily an HGRI dollars, although we're putting some of our money in, but mostly leveraging common fund dollars. I'll tell you, the reason I wanted Jane to say a few things about that is, I don't know, maybe it was my year and a half ago or whatever this was, Mark, Guy or Jane Peterson and I, the three of us, I mean, we really went on a tour, just around NIH, where we went and spoke to many institute directors and their senior staff, hoping at the time that they would just be forthcoming with money to add to the common fund because there's a lot of disease work that you would think they'd want to fund, and indeed they are. At the end of the day, they weren't very interested in just writing checks and having to pool in with H3Africa dollars. But no question, we planted some important seeds, and those seeds are starting to germinate now, because now that H3Africa is getting out of the gates, they're seeing opportunities for grants that they're interested in to individually fund them, and then they join the network. So, while at the time it was frustrating, because we got a lot of polite welcome, but not a whole lot of additional funds raised, now it's coming to fruition in that at least they're coming on their terms, they're funding grants in areas they're interested in, and it's being added in a network kind of a fashion with H3Africa. Okay, thank you, Jane.