 Great. Thanks for inviting me to talk about this. Thanks particularly for putting me before Matt rather than afterwards because his talk is going to be that much more interesting than mine that I would hate to have to follow it. I'm going to be talking about the title is Patient-Centered Research from Consent to Outcomes. And actually, I just want to start by saying that the session before this one, the one on clinical utility, was really also about patient-centered research and patient-centered outcomes. The whole day has been about that. Question was asked at the very beginning. How does what we're talking about here differ from what PCORI, for example, talks about with respect to patient-centered outcomes? In some sense, patient-centered outcomes are those outcomes that matter to patients, at least that's PCORI's definition. Here we're going to be talking about that, but we're also going to be going a bit more broad to talk about outcomes that don't just overlap with that, but talk about things that matter to populations and also to health systems. Now, I want to suggest that we could take two different paths to responsibly integrating sequencing into clinical practice. There's lots of irresponsible paths that you could take, but there's at least two responsible paths. One would be, I think, a traditional sort of clinical development path where we demonstrate utility, clinical utility, and here probably one of Robert Green's or Muir and Curry's more narrow centers, and then later go back retrospectively to evaluate the impact of sequencing on psychosocial outcomes, economic outcomes, and health system outcomes. The approach that CSER has taken is a more integrated approach, I think. First of all, it's to find utility more broadly in terms of the outcomes that matter, but I think importantly, and that's going to be the focus of this session, it has from the start sought to integrate psychosocial economic and health system outcomes into the evaluation of sequencing from the get-go, and if sequencing is a potentially transformative technology in health care, and I think that it is, then CSER's approach is, in my view, the more responsible way to proceed, especially because the technology is not going to wait for all of these outcomes to be studied and evaluated and their impact to be known. So, let me say a word about what I think CSER has taught us so far about LC, ethical, legal, and psychosocial outcomes, with apologies to the investigators whose work I don't mention, and also with a note that some of this is stuff that you've seen before from some of the presentations earlier today, but just some highlights. So, one of the areas, and many of the outcomes are yet to come, that CSER projects are, in general, not complete and are still collecting and analyzing data, so many of the outcomes that are, many of the data that we have are really some of the early data. I think we've learned a lot, though, about informed consent and preference settings and some of the things that go on in the pretest space. So, in a project led by Gail Henderson, looking at heterogeneity and best practices in consent forms. So, for example, some of the recommendations and best practices that came out of that work, quoting from the paper, clarity about the limitations of whole exome and whole genome sequencing as part of the consent, description of the processes that will be used to determine which results to return, and the meaning of positive, negative, and uncertain results. Very important piece of information for counseling and consent up front with sequencing. Paul Applebaum's work, this one of the R01s that's part of the CSER LC consortium, conceptual models for how we might approach consent incidental findings or return of incidental findings. So, Paul makes a very careful distinction between up front consent to return of incidental or secondary findings versus a more staged or just-in-time approach to consent and works through the advantages and disadvantages of those two approaches. And then in work led by Barbara Bernhardt, lessons from genetic counselors about consent to genomic sequencing. So, for example, the importance of dispelling unrealistic expectations that patients might have about what they're going to get back and avoiding some of the disappointments that you might have if you don't get what you were expecting to get. We've learned something about patients' preferences for incidental and secondary results. It was a lot of work went on prior to CSER on hypothetical preferences. What do you think you might do if you were ever in this situation? But CSER actually did this with real patients, real research subjects making real decisions with real consequences. So, we learned this from the clinic that most patients, or in this case, probably you might say research subject, actually do prefer to learn sequencing results and that the factors that drive that are an interest in prevention for themselves and their families and just a general philosophy or desire to know results. We learned from the Baylor project that most families of children with cancer, despite the focus on the cancer and the tumor sequencing to inform treatment, agree, most agree to tumor and germline sequencing. Almost nobody says no when offered the opportunity to have tumor and germline sequencing. And then when given one choice within that project, which is would you like to know carrier results related to any carrier status that your child has? Again, despite the fact that the focus is on the child cancer, most families are saying yes. We've learned something about the challenges that clinicians and health systems face. And it's worth noting that there's a big focus in many of the CSER projects and perhaps all of them on the clinicians as an important actor in this process. So Junho Yu from Seattle has taught us that genetic professionals beliefs about the return of incidental findings vary by patient populations. So much more positive when we're talking about an adult patient, somewhat less so when we're talking about a healthy adult and more controversial when we're talking about children. The issues of the age of onset of the condition, more favorable responses to return of results when we're talking about a childhood onset condition versus an adult onset condition for a child's patient. And a great deal of controversy about whether actionability should matter, something like a 5050 split and whether actionability should matter in terms of driving decisions about return. And then from the MedSeq project and also from our Dana-Farber-CanSeq project, a real sense that primary care physicians, cardiologists and medical oncologists report being quite unprepared for the challenges of sequencing that they see coming towards them. And finally, a note about electronic health record integration. This has been a topic of discussion this morning so far. We know from various folks within the electronic health record group within CSER that there's not a lot of consistency about how genomic data find their way into the electronic health record or which section of the electronic health record they are found. So if you're looking for a result, you don't know as a clinician where to go find it or as a patient where to go find it. The most common format is a PDF type format, obviously not very interactive. There's an acute need for clinical decision support that's integrated into the electronic health record. And we know from the folks at the University of Washington that it's possible to develop alert systems based upon pharmacogenomic results, but it's research intensive, particularly given the fact that the knowledge base is evolving in the way that it is. Stacey Gray and others from the Outcomes and Measures Working Group has given us a very nice conceptual model of the kinds of outcomes that we might be looking for if we want to understand the psychosocial and societal implications of sequencing. And they have suggested that we focus on preferences for disclosure of sequencing findings of patients or research participants understanding in various dimensions, the psychosocial impact, the behavioral impact, the behaviors that patients and families actually take, healthcare utilization downstream from sequencing results, and then satisfaction and regret about decisions. And then identified particular measures that can help us to get to these outcomes and areas where we don't have good enough measures and we really need to develop better ones. So these are some of the things that we have learned. There's a lot more that we need to learn. And some of this we will learn as we get more data from the latter stages of CSER. So the impact of return on patients and families, we're just starting to get those data now. And particularly beginning to define patient and family-centered measures of value of information, and this will be something that I think Matt will speak to. Economic and health utilization outcomes of CSER, what are the impacts in terms of economics and utilization? Extending sequencing to and understanding the outcomes in community settings, obviously the CSER projects are primarily tertiary care kinds of academic settings and in diverse populations. So it will be the topic of the next session and I think a major challenge. And many places where we need better measures of the key outcomes, particularly with longitudinal follow-up rather than just one time cross-sectional follow-up. A couple of you may have seen this diagram previously, Eric Green earlier suggested that CSER really focus on advancing the science of medicine. I want to suggest that it also focuses on improving the effectiveness of health care, some of the longer term goals that were set out even for 2020 and beyond. How is it doing this? Well, in terms of advancing the science of medicine, CSER is actually delivering genomic information to patients and clinicians, one of the goals that was set out in that strategic plan. And I don't want to over-claim what it's accomplishing in this arena because it's really in very early days. It's beginning to shed some light in helping us to address the impact of genomics on health disparities. And in terms of improving the effectiveness of health care, CSER is facing in real-world clinical settings the challenges of integrating genomics into electronic health records. It is beginning to demonstrate the effectiveness and also helping to define the metrics for effectiveness, something that is not an entirely empirical task. And all of this will lead to shaping of the regulatory questions that sort of regulate how sequencing works its way into practice. And you've already seen some of the papers, for example, from Barbara Evans, that have begun to address some of the regulatory challenges that we face. CSER is developing methods for educating health care professionals, patients and the public about genomic sequencing. And ultimately, the insights from CSER, I think, are going to help us increase access to genomic medicine, although, again, this remains one of the major and long-term challenges that we have. So I will stop there, turn it over to Matt, and then look forward to the discussion. Thank you.