 Our first talk is Muin Khoury, who's from the CDC, Office of Public Health Genomics. Good morning, and thank you so much for having me part of this meeting. Can you all hear me? Okay, I'm going to keep my own time here since. All right, so I'm going to start with a big picture, which is the public health perspective. And I'd like to explore three things with you today, is exploring that intersection between implementation or implementation science in particular, genomics and precision medicine and public health. I'd like to second use cancer as a case study, because that intersection has become more and more mature over time, which is outside the traditional newborn screening area, which is the most mature area at the intersection. And I'd like to end up with a new opportunity for collaboration through the National Academies for Science, Engineering and Medicine, so-called the IOM Roundtable on Genomics and Precision Health. We have an action collaborative that hopefully can whet your appetite. So the intersection has kind of been small over time. I live on the left-hand side in this world of public health that's trying to secure as a society what we can do to improve population health. And that world has been not very friendly to genomics, and I can say that without too much misrepresentation. Genomics has come from the world of basic science, bench to bedside, and now that intersection with implementation ignite is actually a first foray into real implementation. That intersection is growing, and I'd like to show you that perhaps more and more over the next decade those circles will not be empty, but there will be a more intersection. I don't have to tell you this. This is the not the right audience for this. This is when I tell public health people about how many genetic tests are there, and so we can skip over that easily. I'd like to sort of revisit this translation cycle because a study manual you showed us earlier, we've arrived to the clinic, which is that green discovery to application a while back, and this is when we say the future is now. It means that the future is ready for doing studies and clinical setting, evaluating what they do, and then developing the kind of evidence for which practice can be shaped, payers would pay, and then implementation science moves it around the circle into both population health and prevention programs and clinical practice, which leads to an ideal world, effectiveness and outcomes and improvement in population health. So where I live on the left-hand side, where you guys live are mostly on the green side trying to move around the circle. The world of public health is trying to pull the genomics world into it, although if you look at where we are with both funding and publications, less than 1% still, in spite of the Ignite Network and others, of genomic research that's published in that T2 and beyond space. Even less than that is in the T3 and beyond space. So a couple of years ago we published this paper of horizon scanning beyond the bench to the bedside, showing that the action is mostly in cancer, as you can see, half of the publications of T2 and beyond are in cancer, and they range the gamut from risk assessment all the way to prognosis, therapeutics and diagnostics. And we're just finalizing a paper that focuses on the T3 component, the implementation science perhaps inspired by this Ignite and other NHGRI funded work trying to move genomics into a real world. I don't have the data here, it's unpublished, but just suffice to say that the state is still very limited in terms of scope, in terms of actually applying principles of implementation science. So moving beyond this sort of where we are in practice and implementation science, I'd like to focus a little bit on cancer. So living in a world of public health, as I said, has been not too friendly to genomics. One of the things we've been trying to do is to show that, wait a minute, there are a lot of things that are actually ready for implementation. So a couple of years ago we devised this three-tiered scheme of genomic applications in practice. The payers would love to see the stuff in the green, which is clinical utility and a base of evidence for which an evidence-based group, such as the U.S. Preventive Service Task Force, or the EGAP, or other evidentiary bodies can actually bless it for years in practice. The stuff on the red is where most genomics is. The stuff in yellow is a growing component of genomic medicine for which more and more evidence of clinical validity is available, but that switch from validity to utility is not there yet. A lot of pharmacogenomic traits are in there, and they are still waiting for that one or more clinical trial to push them over the edge. So having, trying to convince the world of public health to integrate genomics into its world, for the last few years we focused on a few tier one genomic applications. If you go to our website, there are many more, primarily in the field of cancer, as I said. And if you think about it, newborn screening is the largest tier one program. Millions of kids undergo a newborn screening every year, and we don't talk much about it, but it's the prime example of a precision public health program, if you will, screening everyone to find a few that would need extra care. We focused on two generic conditions and one heart disease condition, autosomal dominant, for which there are interventions that can actually save lives, reduce the burden of cancer or heart disease, and a couple of million people are affected, and most of them don't know they have it, and I'm going to focus on cancer, leave FH aside for a minute. We've been collaborating with the Division of Cancer at CDC to try to influence public health practice in states, and each state health department has a cancer registry, a cancer prevention program. There is a one-hour public health grand round, which you can see on the CDC website, that we did back in April, early this year, illustrating what the federal government can do in collaboration with states, in collaboration with health systems, in collaboration with others, to move genomics into practice in the field of cancer. The two genomic applications in cancer are based on evidence-based guidelines, the first by the U.S. Preventive Services Task Force on BRCA counseling and testing, and I don't want to read this just to illustrate that there is a D recommendation. I know that people are pushing for universal BRCA counseling and testing for all women, but the task force is not deemed to be that of a high sufficient evidence to move that into practice, but instead the focus is on a subset of women that have a strong family history of suggestive of BRCA and ethnic background. On the same side, Lynch syndrome screening has been recommended by the EGAP working group, for which we have both the chair and the co-chair here and a few members back in 2009, which is to screen all new cases of colon cancer in the country, about 150,000 of which to find the few thousand that have Lynch syndrome to cascade to their relatives in order to save lives earlier through colonoscopies. So in collaboration with the cancer division at CDC, we've been funding a few states. By the last count, there are five states that are funded now. And what the states would do is provide provider and public education, trying to move the policy and payments within the states, focusing on health disparities and implementation within health systems and taking care of the uninsured. And for which tools like no BRCA tool, which has been developed by CDC, both for providers and the general public. The state of Michigan has been more or less the gold standard over the last few years because they've been doing this for the longest period of time. They've had the champions and the extension beyond newborn screening programs. They even had a genomics goal for the whole state, which is to increase the availability of cancer-related generic information and decrease the barriers for risk-appropriate services. So that's what the Michigan strategic plan has had over the last few years, and they're trying to implement that. And partnerships with their health care providers within the slide is from W. Kett, who's a state genetics coordinator from Michigan, trying to figure out how to work with across the various state and academic partners as well as the private sector and the payers. And for that state, there has been quite a bit of success because they've been able to increase the number of referrals, counseling, access, and testing over time over the last few years. And I don't have the data here, but it still shows disparities in utilization. Black women still are slightly than other women to use cancer generic services in the state of Michigan, which tells you we need much more work to do ahead of us. Lynch syndrome is a little bit more lagging behind because of the newness of it, the more complication. These are two recent papers that show that, yeah, we've made recommendations about how to implement it in practice, ready set how, or room for improvement. A couple of years ago, we had a clinical public health meeting to discuss how we can actually move this recommendation to practice. In a way, it's similar to newborn screening, but you have to screen 150,000 coronal cancer cases every year to find the few that have Lynch syndrome. And that has not been easy, but each state has a cancer registry, and a few of them are experimenting with bi-directional reporting from the state back to the health system. And last but not least, Lynch syndrome screening network was formed with more than 100 institutions that are part of it that does reflexive Lynch syndrome screening to find the three to five percent of coronal cancer cases that have Lynch syndrome. And this group has been meeting for the last few years and numbers are growing, and more is to be done. I'd like to close with sort of this opportunity for moving ahead through the IOM Roundtable on Genomics and Precision Health, the co-chair of the Roundtable. Jeff Ginsburg is here. This Roundtable has been around for the last 10 years. We recently changed the name. It used to be the Roundtable for translating genomics into health, and now we jumped on the Precision Bandwagon, like a lot of people have. We've been exploring the intersection of implementation science with Genomic Medicine through a workshop that we did last year. The report came out this year that actually calls for a number of things to be done. The first and foremost is these hybrid studies that combine T2 and T3 at the same time, in a way exploring effectiveness within the construct of implementation, because it takes a long time to implement. I think we can learn a lot by evaluating and implementing at the same time. There are case studies that could be learned, what we call exceptional implementators or implementers. These exceptional groups, of course, they have to have champions, they have to have funding. The constructs for early adopters needs to be explored a bit more and, in a way, ignite as an example of early adopter as a network. Leveraging existing health systems and networks, such as at the state level, could be very useful to implementation. I was very pleased to hear that Indiana is engaging the whole state as well, so this kind of dialogue between public and private institutions as well as clinical and public health systems is really important for implementation. One of the outcomes of the IOM roundtable was paper that David Chambers and Greg Fier and I collaborated on earlier this year in JAMA on the convergence of implementation science, precision medicine and early learning health care system. I don't have time to explore this, but in a way I already said the content of this because we've reached a point where the dialogue around implementation is not if we should implement but how to implement and when to implement and how do we get maximum data on effectiveness and utility from the early adopters as well as making sure that the tier one at least applications get implemented and at the same time take care of the health disparities issues. I'd like to close with sort of my own view of this. There is still a public health reluctance in the space of precision medicine and genomics and I'm not going to refer to my last week's paper with Sandro Galea that we kind of debated each other. Sandro Galea is the dean of the Boston University School of Public Health and there is a lot of people in public health that don't think that genomics will improve population health. I happen to disagree with that but we teamed up and eventually wrote the paper. But this refers to the paper we published last year with Jim Evans on balancing long-term knowledge generation like what will happen with the one million person cohort with early health benefit that will accrue from actual implementation of what we currently know. So as long as we're sequencing a million people why not learn how to implement at least the 56 genes from the ACMG list if not more. I think maybe that list is now up to 200 or 300. And by the way BRCA and Lynch syndrome and FH and others are on that list and I think we should be able to get new knowledge while we learn how to implement on a population-wide basis. So in closing I'd like to share with you that last year we formed a genomics and population health action collaborative of this round table and Ned Calonge, one of the co-leaders of this action collaborative, we're trying to develop an online guide or toolkit for states that are interested in integrating genomics into population health programs. So the way this works is that we work across the continuum from evidence to implementation sort of using the case study formats figuring out what you need to get to that tier one level then explore the potential population health impact if you implement them i.e. how many lives can you save, how many diseases can you prevent and then looking at the factors that will determine readiness in public health systems and then using principles of implementation science, develop tools and metrics for success. And I just want to leave you with the bottom line here because I added this the last minute, we just recently got funding from NCI to go through this round table. Hopefully we'll be working with Ignite and NHGRI in the next year to add to this population health perspective additional toolkit for health systems. And I know Ignite has its own toolkit, you've been working on it for the last few years but it's time for public health and health systems to work together to try to reap the benefits of genomic medicine in the next few years. So in summary, I think there is an increasing intersection between genomic medicine, implementation science and public health. Cancer continues to be the main driver for public health genomics beyond newborn screening and the current field is still limited and what we need is more robust collaboration at the interface between public health and healthcare. Thank you.