 Good morning. I'm Lieutenant Colonel Cecily Sessions from the Air Force Medical Service. I'm a physician, pediatrician, and preved med by training. I am not a geneticist contrary to popular belief among some of my own leadership, but I want to thank in particular my Surgeon General Tom Travis for extending an invitation on which resulted in so many uniforms being present today. In particular, I'd like to acknowledge Admiral Dahl and Admiral Dollymore for being present. I know you are extremely busy, so thank you for taking this time out of your schedules. I'd also like to acknowledge the literal army of a clinical geneticist who responded to this invitation who are hopefully listening to us or watching us online. Okay, so our program is called Patient-Centered Precision Care, PC2Z. In the Air Force we use the Z ending to indicate that we're doing something that we think is innovative and cool, so genomic medicine research falls into that bucket for us. It's our comprehensive effort to prepare infrastructure for genome-informed personalized medicine and collaborate with academia, industry, and federal partners to achieve those goals. At the top of the slide you see the quadruple aim for the military health system, readiness, better care, better health, and best value, and some of the things that we're doing in the PC2Z program that align with those goals. PC2Z is intended to be a comprehensive approach, and we have four pillars that we're addressing through the program. One of those is bioinformatics. Another is education, research. We're actually doing research projects, and I'll give you a list of those shortly. And then we're also addressing LC and policy issues in the fourth pillar. Our overall long-term goals are to enhance military readiness, improve health care in our system, and to mitigate additional costs, either through reducing duplicative testing or realizing the benefits of genome-informed medicine in our system. Our certain general's vision for personalized medicine is to galvanize research using seed funding, because the Air Force has only a small seed of funding compared to some of our sister services, to model collaboration and create a strategic body of clinical knowledge that can be used throughout our health care system. To demonstrate the translation of omics into clinical practice, and General Travis feels the third one is most important to anticipate the translation that's happening, this rapidly advancing field, and to create evidence-based state-of-the-art care for our entire beneficiary population. Along the way, we hope to develop strategies that complement our current primary care model, which is the Patient-Centered Medical Home, and to work in partnership with sister services and other partners to make sure that we can do this in an effective way across our health system. Just a sidebar comment, and whenever I do my sidebars, as you know, these are my own opinions and do not represent the official position of my department or the DOD. We mentioned that we're moving towards actually integrating those systems, and I think Dr. Cheatham alluded to that earlier. The Defense Health Agency will be standing up on 1 October of this year, and I'm excited to see what kind of transformation we can see with that officially taking place, which is what my recruiter told me when I signed up 20 years ago, that that would already be in place. So it didn't matter which uniform I wore because it would all be purple anyway. So I'm glad to see that I am still alive in an uniform to see that happen. So one of the shared services under that Defense Health Agency model is research and development. So I've been trying to make sure that this topic is on the minds of our leadership so that it's considered as we are standing up that function. In addition, we are trying to utilize our unique capability, which I know Terry was alluding to and trying to get garnered some support for that, because I do think that we have, although we don't have an entirely cohesive system, we do have an electronic health record. We do have a central repository for that data at the Armed Forces Health Surveillance Center, and we do have about nine million or so folks who are enrolled as beneficiaries of our system. So just again, as an aside, my opinion, we have that electronic health record. We have a central repository, but there are plenty of things that fall through the cracks as I realized in preparing for my next assignment. My daughter is seeking care at Bethesda. My husband and son seek care at another facility on the same campus as Walter Reed. Their records, their immunization records are in the system so that when I go into my readiness portal, I can actually download my son's shot records. I can't download my daughters because she's seeking care at a facility that's Navy and Army, and they didn't put it into the Air Force Immunization Record System. So I had to print out a copy from, get a hard copy from Bethesda, and walk that over to an Air Force Immunization Clinic so that that information can be, as we say, that fingered into the Air Force system. So we do have a record. We do have centralized storage, but of course, there are always things that fall through the cracks. So I mentioned that I would get into detail about what we have in our research portfolio. The big one, the one I'm constantly defending is at the top. That's her involvement with the Corial Personalized Medicine Collaborative and our Clinical Utility Study. This one is, we're at about 80% of our enrollment goal right now. We have been exclusively enrolling folks who are part of the healthcare team for the Air Force Medical Service under the assumption that hopefully we're a little bit better educated about what's going on in genomics, and that we will reach out to our colleagues to get those questions answered or educate ourselves rather than pushing the panic button. But this study allows for individualized risk reporting back to the participant only based on SNPs, self-reported family history, and self-reported personal and health lifestyle choices. So that one is supposed to be a longitudinal study. It allows the Air Force Medical Service to be an arm of an existing study since the thing that's been going on since 2008, that has about 6,000 folks enrolled in what we call the Civilian Cohort, and our goal is to enroll 2,000 Air Force Medical Service Providers. The next few studies all started in FY12 as part of our broad agency announcement. Epigenetic biomarkers of stress at high altitude conditions is a mouse study. I always smile when I say that, Dr. Miller. But this one looks at a validated model for post-traumatic stress disorder in mice and then is evaluating how hypoxia can impact that in looking for epigenetic biomarkers that predict that outcome. The next two studies generating change and genetic risk testing and health coaching and genetically-guided statin therapy both are in partnership with Duke University. Thank you, Dr. Ginsburg, and some of our researchers at Travis Air Force Base, and those will be doing just what they say. So one is looking at type 2 diabetes and coronary artery disease and looking at genetic risk factors and then using certified health coaches to guide participants through what that information means and how that informs their treatment plans, and then genetically-guided statin therapy is looking at using pharmacogenomics around statins. The cellular sentinels toxicity platform is using stem cells to model toxicity response and looking for biomarkers that are predictive of that. The next study is not in my portfolio, but part of the autism research that we have ongoing through the Air Force Medical Support Agency that began as a congressional funded project and is now something that we're funding. But this one is looking at modifiers, genetic modifiers that are predictive of asthma and obesity. And then the next one is building on the registry of children with autism and their parents that was created through an earlier project and then going and doing triage genotyping of the parents and children who are in that registry. Pending because of sequestration and lack of FY13 funds are the last two studies, a rapid learning system for delivery of personalized health care also in partnership with Dr. Ginsburg and his Center for Personalized Medicine at Duke and implementation adoption and utility of family history in diverse care settings, which would be another collaborative between Duke University and Travis Air Force Base, which was something that we pursued through an NHGRI grant. Obstacles that I think are unique to our system So we do have, as I said, we have a centralized electronic health record. We do have biorepositories, but we also have regulatory constraints around, in particular, the inability to use tests in our systems that are not FDA approved. So laboratory developed tests are not something that we are able to order when we specifically indicate that we are ordering those tests outside of FDA guidance about how those should be implemented. National security concerns about biobanking and data sharing. My geneticists tell me that even if we try to strip identifiers from the data and if we publish a sequence in its entirety that there are ways of reverse engineering someone's identity based on existing publicly available data about mapping people's DNA to their area code and their surname. So because of that, every time that we talk about doing one of these collaborative partnerships where we're sharing data or talk about storing our sequence data in dbGaP this is something that we need to make sure that we're mindful of. Information assurance. This is something that we've been dealing with in a very substantive way as part of the Coriel project. We've enrolled about 1,600 people into the Coriel study. We're supposed to be marrying up their genomic sequence data and electronic health record data from our system, but we can't do that until we have met information assurance guidance about the IT system where that data will be stored, which has translated into us needing to purchase and configure that IT system and then export it to Coriel for them to plug in so that we can transfer the data to them. We already mentioned I'll just pass over the financial stuff because I don't want to get myself in trouble. The more important one is operational versus clinical omics. Now I will give the caveat that I've been a uniform for a little while, but I'm relatively naive when it comes to practicing medicine in a state-side military facility. Also, as a pediatrician, I tend to be somewhat of an idealist. So in my function in this job for the last couple of years, I have tried to draw a line in the sand between what I call operational genomics and clinical genomics. So I like to, I like very much Dr. Manolio's narrow definition of what clinical genomic medicine is, which is that we're using that genomic information in the course of clinical care. There are many other research groups and people who would like to use that type of data for more operationally relevant concerns, and I do not wish them any ill will. I just don't want that to be part of my portfolio in this program. Excuse me. Therefore, I have tried to draw that line in the sand. However, as Admiral Dahl rightly pointed out, for this, for genomic medicine or personalized medicine to be something that's truly embraced by the military health care system, we have to do it in such a way that it is operationally relevant. So walking that fine line between, sorry, that fine line between something that is operationally relevant and something that is of operational significance, that's, that's really, that's an obstacle to me. Trying to find out, trying to figure out where we can implement personalized medicine and genomic medicine in a way that's clinically responsible in a system where, and this gets to the last one down there, privacy concerns, where it's a standard practice in our health care system that if something in someone's medical care could impact their ability to perform their job or could impact the mission, we don't have that privacy, that doctor-patient privilege that normally exists outside of military treatment facilities. So that's something that I'm not senior enough to navigate. I've only been in the position of saying that in the patient-centered precision care program so far, we've only addressed the clinical genomics aspect and tried to distance ourselves from people who were trying to use genomics for human performance enhancement as an example. So privacy concerns, I mentioned, and lack of coverage under GINA. This is not to say that we want GINA amended to include us, simply to say that in its current configuration, it does not apply to members of the U.S. military seeking care in our system through TRICARE. It does not apply to veterans obtaining health care through the VA or through people, for people who were seeking care in the Indian Health Service. So I think everyone's familiar with it. It protects individuals from discrimination by health insurers or employers. It doesn't cover disability or long-term care insurance, but it does not apply to folks in my situation. So Senator Kennedy said it was the first civil rights bill of the new century of the life sciences. There's a lot of confusion and when I talk to my colleagues in uniform about they think sometimes that the N is for non-disclosure, when it's in fact for non-discrimination. There's a big difference there. So in practical terms, it has really contributed to the fear factor around folks who are considering participating in research projects that we're engaging in because they don't want that information to be disclosed to their employer insurer health care team, which for us is all a single entity if you know, when you boil it down. So as I mentioned before, readiness and operational concerns can trump confidentiality and that's another concern that is unique to service members. So partly to address that issue and partly because it was part of the original vision for this program, we have been meeting informally as the precision care advisory panel. At the time, General Travis was the Air Force Deputy Surgeon General. He invited his counterparts to appoint representatives. So we had Air Force Army, Navy, Health and Human Services, VA, and Health Affairs TriCare Medical Authority representation. At the beginning of this year, I had the opportunity to present this information to Dr. Warren Laquette, who is the Deputy Assistant Secretary of Defense for Clinical Programs and Policy, and he invited me to make this presentation to the Clinical Proponency Steering Committee, all that to say, we are being formally chartered as a work group that reports to his office. That is up for a vote virtually, not that I'm advertising, very shortly, and I'm hoping, I'm hopeful that our charter will be formalized in the next couple of weeks. In that charter, the proposed objectives are seen here, gathering evidence about translating genomic-based personalized medicine into the clinical workflow in our system, and then providing policy, scientific, and operational recommendations and approaches to support genetic screening, counseling, and health care services for service members and beneficiaries. Our deliverables, the first one is what I was alluding to earlier with the slides about Gina. We need to draft genetic information, non-discrimination policy for DOD and or the VA if they'd like to partner with us on that. We need to create awareness of genomics within our system, not only for the health care team, but also for beneficiaries, and then review the existing constraints, some of which I outlined in this presentation, and deliver recommendations with respect to genomic-based personalized medicine implementation in our clinical system. So some of the strategic partnerships that this program has initiated, Dr. Minolio and others mentioned the e-merge network, and we're extremely pleased to be affiliates of that organization. We also are on the Institute of Medicine Genomics Roundtable, and thank you, Adam, for your support of that. Integrator for our program has been the Johns Hopkins University Applied Physics Lab. They have facilitated our outreach with academia and industry in their position as a university-affiliated research center. I mentioned our study with the Coriolis Institute for Medical Research and the ongoing study that we have to look at omics and provide kind of a train-the-trainer situation with hands-on access for providers and learning about how to interpret our own genome-informed risk reports. I mentioned several collaborative research projects that we have ongoing with Dr. Ginsburg and the Duke University Center for Personalized Medicine. Also, thank you to Joan for her support of our last two symposia through the National Coalition for Health Professional Education and Genetics, and I mentioned, in great detail, our Precision Care Advisory Panel, and thank you to Dr. Cheatham and others who've been supportive of that effort. Opportunities, we've talked with Dr. Prasgowski and several members of his team about collaborating more closely with the Million Veterans Program. I mentioned to Dr. Coopersmith, when I saw him at the PMC lunch on the other day, that I have initiated a data request to share historic EHR data from the DOD system for a cohort of folks who've enrolled in the Million Veterans Program so that you have some phenotypic data from when they were with us. I also mentioned the standard of the Defense Health Agency and that opportunity for shared services in research and development. The Joint Program Committee sit up at Fort Dietrich, and my understanding, my limited understanding of them is that they are in charge of joint research dollars for the military medical system. We have less of a presence there, but as part of this transition that's been happening over the last few months and that's continuing, the Air Force will be developing a larger presence there and trying to preferentially put our good projects up there rather than funding the projects that we think are really worthwhile with blue money, with Air Force money, and then sending the leftovers up there, which is the way we've done it so far. The barter system, this is my way of annotating the fact that as Dr. Ginsburg and Dr. Monoglio alluded, we have EHR capability. We have a large beneficiary population. We have a relatively standardized system of care. That's what we bring to the table. We're less able to bring large amounts of money to the table to fund research projects, but we do have a community of researchers who are willing and definitely eager to work with partners in terms of leveraging those capabilities. I want to thank NHGRI for welcoming us with open arms over the last couple of years and making a lot of these opportunities that you see on these slides possible. Any questions for me?