 And I have to, I want to go on record and saying Eric specifically and Terry and Caroline Hutter have been fantastic at both trying to get me at least a little less stupid about what an HGRI does as well as just helping me settle as we move across the country from Portland to the area. So that's which grocery stores to go to, which traffic to avoid. All of those are very important codes for how to live here successfully. So I called this Precision Health for All and what I'm going to do, Eric tell me how long we have so I can because I could go for days or weeks or months you know. I was going to be a Dickens scholar at one point paid by the word so you know it's like I've never seen a word I can't use. So at this point I would say I mean I've read your strategic plan, it's certainly the part of the strategic plan around genomics and society is particularly near and dear to my heart as a social scientist and as somebody who has spent a whole lot of my career focused on the legal policy and social implications of capabilities. Back in the early days of telehealth I built very successful telehealth equipment and and even workflows with clinical teams when I worked for Paul Allen the co-founder of Microsoft all those years ago and technically it worked but the payment model the entire sort of reimbursement scheme all of the legal and social implications and the development of workflow were not ready and in many ways we've taken 25 years to catch up with the technology and start to incorporate those. So I am very sensitive to those and the need to work on those early on when you're trying to do bold new innovation. I know enough about emerge to be dangerous and I'm excited what we can already learn from the work that you're doing on EMRs and biorepositories and and certainly on ClinGen as well in terms of you know I don't mean it in a negative way but how do we make meaningful use of variant data and clinical practice part of the discussion that you were just having and not not only do I think a lot of the experts and a lot of the people that are frankly in our awardee community are part of we're already parts of the awardee communities at NHGRI so you've helped fund both training wheel what wheels and sort of moving into sort of the 10 speed and now we'll eventually get to 27 speed bicycle racing on this as we go forward in time. I'm a very appreciative of your work as as Eric mentioned I won't go through the whole story here but the long story short is this is me the first week of a very imprecise chemotherapy regimen the first of about 60 over the next 23 years that I went through that's me in the summer of 1989 Chapel Hill my wife was wise enough to get a dog to help me a sort of puppy to help me survive that first round of Cisplatinum and other nasty things and all the pre pre nausea drug days so I was I was a pretty small guy at that point in my life at age 19 and got a lot smaller really quickly and I did manage to somehow and I have donated my genetic material to two different resilience and survivor studies because you look at my clinical history and say he shouldn't be alive just based on the drugs that we actually put him on and it was a whole genome sequence as I was in my role as an executive Intel years ago four or five years ago going around to different genome companies that needed our highest end computing to be able to even make their research or their business model work and one of these had seen me speak at a nephrology conference years before and you know said well why don't we do a whole genome sequence and we'll help you understand our technology that tries to take that and start to visualize that data I didn't think much of it I mean I did we arranged to have tissue and blood and all of that sort of done I signed forms that said they could share it with my clinical team at that point it took three months of processing on Intel's highest end equipment and the top sequencers that were out there to compare me to the not me and and then I didn't know but my clinical team took another four months trying to get people from help from startups from clinical research to actually is the first time they had ever done it make sense and they basically came to a lucky well educated guess they were very precise when they told me that 92% of everything they had ever put me wrong was Dustin never to have worked I now understand that they couldn't actually know that but it was a good guess but they got enough data and understanding to say it looks more like the mechanisms that cause pancreatic cancer are what are causing your cancer we're going to put you on a pancreatic cancer drug and they did and I became cancer free really quickly full kidney failure Intel employee donated a kidney to me because my old ones were failed and suddenly I'm healthier now at age 48 than I was at age 28 or even age 20 so I came out of that my wife will tell you in the ICU that I can't remember it but she took notes because we knew that I wouldn't remember at all she said I've got to figure out how to make this kind of stuff available to everybody else and that's been my mission when I came back to Intel and and ever since then so this fits in I've kept a journal since third grade and yesterday I was actually looking back at what I wrote on 9-11 15 years ago and it was kind of interesting you can start to see some of the mindset that I wrote in here I saw what horrors that I wish I could unsee I wonder if more will hit tonight meaning attacks and then I said Ash and I can't sleep we're talking mostly about fear and in a way I'm glad this whole ride this whole cancer ride has meant we never brought kids into this insane world I'm not afraid of dying in a terror attack though I do worry bombings are now in our daily lives as in many parts of the world cancer will certainly save me from an explosion there's one benefit I could never have imagined me each year they would say well you've got about nine to 14 months to live and after about 10 years I said stop doing that and I now recognize that what was happening was sort of two things a complete lack of data and understanding to know how to come up with the definitive diagnosis with me that stuck but also it's pretty clear I was morphing my tumors were morphing in response to the various things that were happening so it's true that I didn't probably have one diagnosis that made sense during that period of time so as we think about that I've been talking to a lot of folks within NHGRI and people that you fund even back when I was on the working group and we were hearing from people around the country so there's been some good consistent advice from many leaders in genomics which I thought was summed up well in the bio IT world piece that Allison Prophet wrote and says one thing rain would definitely not recommend spending all the precision medicine and initiative budget President Obama proposed 215 million to start on sequencing I would argue you need to spend more time focusing on the effective collection of phenotypes something that we're exploring and in trying to execute towards and towards the bottom and we should use the questions that we come up with an expected answers to drive the building of the infrastructure as we go that theme of learning and iterating as we go is one that I certainly bring from industry and it's one that I'm going to describe to you here in terms of the mindset and the processes that we're setting up to be able to go for the long run of building out this program so I'm going to give you a quick review I'm Eric shared with me previous slide so I think most of you know the basics I'm going to run through this part quickly but then I'll dive then a little bit more deeply on the sort of status of things right now so I believe you know that the precision medicine initiative cohort program is part of the broader precision medicine initiative our piece is to you know one million or more volunteers reflecting the broad diversity of the US opportunities for volunteers to provide data on an ongoing basis and data shared freely and rapidly to inform a variety of research studies right that's that's the sort of it in a nutshell the what the mission and this is not a formal mission but as I came I arrived on a Monday and they said oh you need to do some White House prep and briefings because we're about to announce the first 33 awards or it's really eight huge awards but to 33 organizations and you need to lead a three-day workshop starting Wednesday because they're all coming to town so I said okay all right I can do this I know where the bathroom is that's a start and how to park and then we'll do this and I I wrote on that first day when we all came together a co-present for the first time the initial awardees I said really this mission is to accelerate the science and breakthroughs that drive precision health for all and using the broader word health because medicine is a key part of it but it's not the only part of it and if you think about sort of you know all the different you can go back and read all the different models of how science works or how inquiry works right but you know there's different versions of it but it all comes down to three or four stages of questions problems hypotheses how do we capture data and and our kinds of data secure and clean it and share it because it's a very complicated thing to do how do we unleash science and diverse scientists on top of that data and how do we then translate that into action practice and meaning as you've just been discussing the challenges of getting people to accept anything that's non-human data as they're informed and if you think about that knowledge turn a turn that comes from economics that used to be the way they would evaluate the potential growth of a company country was based on its knowledge turns its ability to ask questions and have its workforce walk through the cycle that takes a certain period of time and when we succeed we're trying to shrink the period of time it takes to move through those and let lots more people actually move through those cycles by building the baseline infrastructure of both a million people who are going to trust us to engage with us and provide different kinds of data over time as well as different kinds of data types so how do we accelerate that we certainly are trying to you know make this a very signature piece of the platform or of the of the philosophy is a very transformational approach to diversity I call it often quadruple diversity so a diversity of people in the American melting pot is going to be able to generate a wide range of cultures and ethnicities and making sure that we over sample and over recruit the understudied with regards to a wide range of people wide range of health status it's not a disease specific cohort program many of the people will be well at start and understand the unfolding of their various health aspects over time a diversity of geography and in that we mean meteorological diversity because people's experiences in different parts of the country very different different times of year rural urban and all points in between and you'll see as we're making it more and more awards you know we're working on building out networks of health provider organizations that can help us do that as well as a diversity of data types right it'll start with things like surveys and EHR data pulling in but you know we will be doing things with wearables both the existing that people that people already have and eventually you know pieces of technology that we might want to put out into the cohort program of course the challenges everything times a million gets very expensive so anticipating the cost curves and everything from omics to mHealth or some of the challenges that we've got to figure out what's the right time to go do these things and then also a transformational approach to participation we're not just changing the word subject to participant and being done with it we're it doesn't also mean that we know how to do all of this yet but participants involved in every aspect of it from governance to in the invention of questions of what we're going to be doing I've just come from and we'll return to some of the reviews of our current round of health provider organizations where there are many of them are already experimenting with you know what are the questions that our participants want to know and what's the kind of science that they want done out of these particular kinds of studies and then a transformational approach to data access you know one of my goals is to make sure that we don't just use taxpayer money to you know let the tier ones who already have this infrastructure might even be able to do a million person cohort on their own and just advance them what is it going to take for us to enable citizen scientist industry community colleges in high schools to meaningfully participate in using the data and generating science on top of that you know came in on the sort of tail end of the discussion many of you are having about education and your challenges in that regard it was something I spent a lot of time on in my Intel career of how do we anticipate having a workforce both to do the science and deliver the precision medicine so that technology and then science don't get there but it can't scale because we just don't have a workforce to do that and I think that's part of our investments and part of our thinking here as well two primary methods of engagement you've probably heard this before is through the what we call the HPO path to health provider organizations as well as DV direct volunteer so we are working on developing the capacity to get the quality biosamples and physical evaluations that we actually need from anybody that calls a 1-800 number or pops onto the website or approaches through their church or through their health provider organization that's what we've got to be able to scale out and do over time with a kind of wide range of data going into that so the DV path and the HPO path so what's going on I just want to give you sort of a snapshot of what it looks and feels like to be part of this startup team we are that one of the challenges is to get everybody to act as one interdisciplinary platform team when I said the word platform and we basically are a platform company stitched together from a mix of technology and academic grants as well as staff that we're hiring into the NIH you know more than three-quarters of the room and there didn't even really know what I meant by the word platform right it's one of the first things I said at the first work group meetings I hardly knew Francis Collins or anybody and I was happened to be sitting next to him and I whispered to him and said you do realize this is kind of NIH basically trying to act like a platform company right and I guess he thought about it for a while because somehow I ended up here be careful what you say in those opening working group meetings you never know where you're gonna end up so getting those 33 initial awardees as well as the more than 14 or 15 government agencies who are part of the PMI umbrella to act as one team right so we can deliver this million person engaged volunteers in these diverse datasets is no small feat and it's the most important thing that I do out of the gate because if we don't build the culture we don't build the processes then we will not be sustained for 10 20 50 100 years for what we want to do here 33 awardee partners so far really divided up into 11 working groups I will eventually I can't do it today because it's too complex and I can't make PowerPoint do it I will eventually come in and share with you our departments and these departments will look like what it would be like if a company was actually going out and building this infrastructure and it will be made up of people from NIH from corporate entities from from academic research centers as we go through so 11 working groups the steering and executive committees are actually set up and actually moving forward and you can see some of the working groups actually listed there I'm still working to build the core team I will probably send out to you soon some additional senior leadership positions that we actually need there's sort of about seven or eight people and then another about 20 that are holding all of this up right now because we part of the challenge is they're so busy working on the working groups or the protocols that they're the same people that need to be writing the position descriptions and doing the searches as we go out here so a lot happening hiring that core NIH leadership team part of what we're also doing as you can imagine this being the President's Precision Medicine Initiative all of those government agencies and partnerships and I have to tell you is somebody new coming in to be a Fed I this has been unprecedented collaboration that I've ever witnessed or seen in terms of you know the different parts of the Health and Human Services family being brought together by the secretary to work towards this common effort right and everything like what challenges are going to have with HIPAA going forward went to you know what are the policy changes that we're going to need in place we want to make sure that that support continues regardless of what happens in the election so we're working on transition plans and making sure that we have not you know federal employees as the mesh network keeping this alive regardless of what happens politically above us this takes time and energy to do right and it's a key thing that we're working on right now and then we were building a robust community partners network there's a top 50 lifts of community partners that we're working our way through who are national but also have local chapters to help us with everything from recruiting to educating providers educating community members who will be on the front lines to help us hold this together as well as a workshop next week with help with health and human services on all the different community partners they've used coming together to say okay what can we do to work together towards this effort and then also we're using known industry methods I am teaching people and we are instituting and we are higher competencies so that we do user-centered design and platform development process and I'll talk a little bit about that in a minute because I'm assuming this is the first discussion that we'll have for probably years to come so I want to get you right into the mindset out of out of out of the gate so that it doesn't become alien to you as I give you these updates and these discussions going forward the other pieces thanks to the great work that NIH had already done the working sessions and listening sessions some of the pilot grants awards that were actually funded at Vanderbilt and elsewhere as well as what we did were these implementation papers where we said okay well we can anticipate these are the kinds of problems everybody's going to have as soon as you bring all these awardees together here's what's going on right now we're actually rolling out and it will soon be fully public there's an image of one of them we've developed based on focus groups and ethnographic studies of people in their home with a wide range of what the kinds of participants that we expect to come in here what we call the ecology model and it's a it's a basically a segmentation model that cuts across ethnicity and race and age to help us identify these are going to be the challenges but not for me persona segment cuts across lots of difference and are we going to what would we need to do to convince the not for me is that this is something that they can trust and what are their concerns so there's about nine or ten segments that you'll hear about and for years we will come to talk about of our different success of trying to pull them in we have a five thousand person community of beta testers already and we're actually recruiting additional to increase the diversity of that five thousand initial test bed we're testing consent language in the first five survey model modules with great progress on the next twelve we're iterating a website the smartphone application that people will be able to come through a one eight hundred number and all of the data center infrastructure going through security and stress testing you know if the president and the national media stand up and say we want millions of people then we have to have a way of catching that incidentally we expect to have three tiers those who are just interested click here this exists on our website now there's a lot more content that's going to fill that website very soon those who may want to participate in the surveys and could do it for years to come we could potentially take millions and millions of people for that effort and then those who will have full you know biosample physical evaluation as we go forward in time so we want to be able to set up for people to have different levels of engagement and by if you have millions and millions of people that sign up to be sort of members and fill out surveys and consent it helps you figure out you know okay who from those do we want to invite to move to the third tier so you can help achieve some of the diversity challenges that you have we're getting feedback on content on the name brand and look and feel will announce the name of the whole program soon it won't be called the PMI cohort program doesn't mean very much the word cohort to real people when you go out and actually talk to them and it doesn't sound or feel very good to a lot of them we're experimenting with different recruitment methods amongst our recipients have different strategies of pulling in from buses and vans that pull up into you know parking lots to church based to you know other online tools and we're drafting a full protocol for the v1 version one launch it's coming along nicely in terms of the physical evaluation the survey data and the biospecimen and then also doing cybersecurity testing right no better way than to lose the trust of the country than coming out of the gate and so certainly doing and partnering with the different parts of government and industry to make sure that we're using the best methods so a lot is happening and all these pieces are coming together i'll close with the section here that just says what do i mean by platform approach so this is a classic diagram from innovation literature almost every company in silicon valley or every company that does innovation around the country has some version of what's called the innovation funnel and there's usually three or four different phases or steps to it you know out here at the edge of the funnel it's like you're trying to understand human challenges scientific discoveries that are happening that may change the game what are researchers needs what are the research questions what are the new technologies what are the crazy ideas right and that funnel is always open and we'll have a part of our function that's always sort of trying to keep that funnel open but then you come through all of that and say okay well with all of these kinds of inputs we're in the exploration r&d mode of what are the measures that we're going to do what are the questions that we're going to ask what are the recruitment methodologies that we're going to use at some point you got to stop in time and say we're going to finding this platform and by platform i mean everything from what the communications and media plan is and who it's targeting of those particular persona segments to the technology platforms that are in place both to take participant input as well as researchers use that you move that into advanced development and the reason it gets smaller is you're starting to throw and focus you're starting to throw features and capabilities that you thought were ready but aren't ready for prime time out of the boat and eventually you move into production and launch and this is a repeatable process it's a phase gate process where you say look this particular program we're not moving from here to here until it meets these phases we're not even going to spend the money on the rest of the pieces eventually we will have three teams we're not there right now right we're kind of right here with the one of the launch where all those pieces i just described a moment ago are in advanced development and we're moving towards production but since this process it wasn't used we have to go back and do some platform definition because each awardee and NIH all had slightly different assumptions about what they thought the users might do and you will not launch a product or a platform until you're really clear this is the definition this is the minimum and so forth so this is kind of where we are we will ultimately have teams the operational team that's moving from advanced development to production will always be the largest it's the most difficult somebody back in here in platform definition is a smaller team and then further back in R&D is an even smaller team so your resources resources are usually almost in an inverse proportion to the way the funnel works so each release and the mindset that you should be in is this is not a one time we're taking data one time right this is every 12 to 18 months we're releasing a new release of the PMI cohort program platform and in any one of those releases somewhere between two and four of these things may be true we have new features for participants about ways that they can engage with one another or provide data to us we have new features for the researchers and we're not going to have a lot of features for researchers out of the gate but we have a plan to build those out over time by the way we will borrow heavily and reuse things from emerge or whatever programs we very much believe in you know borrow and license and use what's already out there and build only when we absolutely have to scientific focus areas and measures will change over periods of time even though it's a general population study and then the data capture capabilities oh we're now ready to take in data from anybody's wearable oh we're now ready actually to have a set of neurological games that we want people to play and can actually take that kind of data in as well so just a little bit more on that you're going to hear me over time use the word landing zones this is an industry term that just means the targets for what you're trying to do for a launch so part of what i'm trying to get the teams right now to do and a little bit of this is retroactive is define for all the swim lanes or all the departments of what we've got to deliver from knowing what the user experience is down to the policy and legal things that we need to have in place before that particular launch what's the minimum that we would need to have in place to launch very crisply defined what's the goal and then what's the stretch goal you cannot solve for features of a platform schedule and resources all at the same time and when you define things in this ways it lets you make some trade-offs of saying well we could be ready earlier or spend less money if we just went ahead and launched minimum nope it's really important we've got the money and we can actually you know expand out in time to do stretch goal and then lastly what i want to talk about here is because this is going to and it's going to come into the fore very quickly now this is a framework i made up this is not the final framework but i'm just using this as a conceptual framework for you if you think about a bunches of areas of scientific medical knowledge right infectious diseases neurocognitive heart and lung metabolic conditions cancer chronic pain right and we have a scientific working group actually working on this right now about what's the right framework over time as we do releases there's a bunch of horizontal capabilities that you're going to that apply across this prevention and wellness is something that you would want to consider in a lot of these buckets right what do we know disparities and and reducing improving access what research what science do we know within these buckets care giving genomics the m health capabilities from smartphones and wearables you know environmental exposure so there's a bunch of things that are horizontal capabilities here's a way to think about the versions over time right i mentioned v1 v2 v3 if you take these these areas of of thought right our v1 launch may only you know get in terms of what these different areas need this much progress and the way that we're going to be doing this is basically going through a bunch of these areas of thoughts and defining requirements and looking for capabilities that can cut across many three four five of these particular areas so v1 might get us this far you know v2 might you know we we might have called this the heart and lung release even though there were capabilities that were a lot about more than heart and lung but we're ready to add some capabilities that are going to be a game changer for heart and lung or v you know v3 right might really boost up where we've been on neuro and cognitive i'm getting you into this mindset because with as we engage with you and as you engage with other bodies of thought and other institutes trying to understand what's ready when and and you know that though we want to get the public and the researchers excited about these different releases over time you know we could look at a framework around you know ultimately focusing where the human need is you know a daily's approach i don't know what this framework will ultimately be but you want to make sure that you're getting requirements from it so what's next in terms of the spirit of this is what i'm calling research question workshops and we started we did this back in the working groups but they were very high level and what we need is to convene areas around this bodies of thought and then basically the premise of these workshops is this imagine the entire pmi cohort program of a million people is focused on just accelerating scientific knowledge and breakthroughs in your particular domain near term what are the low hanging fruit questions and measures for which the scale of something as large as this would be useful medium term what kinds of questions might this the platform the cohort program answer where additional work is needed to select amongst measures to answer those kinds of questions and long term what kinds of questions are ripe for the cohort program of the size but which need fundamental science and technology development to know the instruments to go answer those the kinds of attendees that we will want to come to these workshops or research experts in that particular field co funders i don't have the money to pay for all the research on this we have the money to build the foundation if we're not building something that's advancing in hgri's agenda and the various agendas of funders around those domains then we will fail we will have built a field of dreams problem where we build it and nobody comes so we want other co funders participant advocacy groups and providers and then what we'll do this is just classic product development you look across for common capabilities across those needs and put it into those releases and the negotiation that i will get into over periods of time is hey is that really something that needs a million people if the thing is unique only to your body of knowledge then we're going to have to work together to get a co investment to be able to carry that forward because it just doesn't apply to enough other domains it doesn't require a sub study or does it require all million people so that's the mindset and what i would just close is i mean and i you know again as i said i know at the beginning i know enough to be dangerous about all the scope of hgri i kind of know a little bit about cesar in here was that was that was what we called you were just talking about cesar but i don't really know what it is and i'd be in trouble it have to use a lifeline to carolin or to eric or somebody but defining our genomics read roadmap and plan in detail it's not done and the reason we haven't asked your input into it yet is because we are trying to get the basic infrastructure up and running and that one of the pieces of advice that i shared with the quote from bio it world at the beginning eric gave it to me again last week is get the basics up and running you know the the longer you can wait to do the genome piece you'll get more bang for your buck and it's a complicated issue given the kinds of return of results issues that we've got so you know we've got a great sort of 60 percent draft based on all the public comments and all the input previous but over the next few weeks as i get more senior people involved we'll start a process and build a work group around helping us build our actual genomics plans and the timelines for that research question workshops right so as we think about the genomic strategies in each of those domains find ways to drive more ethical legal and social implications research as we go and as we grow i i appreciated the lc memo i you know i i saw it more recently i think actually saw it back in may when i was on the work group those kinds of issues i worry more about than actual technology than cost because i've been burned so many times of having everything ready except for the oh it has to get sutured into the fabric of society yeah that that's a little bit of a challenge and then you know i think we also should explore what clingent becomes over time as our as our capacity kicks in right i think understanding what the roadmap and where clingent is going that's something that we've supported and i would expect us to continue to support over time i think that'll be important for us so last slide you know if you think about my own experience this is in the transplant experience four years ago that was never supposed to happen that's the tracy from intel who donated to me having never met me before you know it was luck and pluck right that got me then and my personalized health or my precision health experience took 23 years to get there right that's not a very scalable model for a global global population so how do we make that happen routine care and infinitely more quickly than we could otherwise and i just i look forward to making this dream possible with an hgri and your extended communities happy to take your questions i had two one quick and one maybe a little more extended the quick one is the vertical bars you had of the different disease areas were those just examples or was that meant to be yeah comprehensive no those were those were those were erics examples i mean we're actually i think there's a meeting coming up with the ic directors and a scientific working group that's helping us figure out what those were be i don't want them to all be organ body parts or diseases i mean there's a certain level and i think the way that we'll have to set it up and talk about it with the scientific community might be slightly different so you can imagine us doing a breathing campaign right that makes it creates for all of our participants the number of conditions and the number of institutes that that would cross over would be enormous so it's not like a real one-to-one mapping with all the institutes but that's partly why we need the framework in place okay i was just going to say that i i think you might you might garner a lot of interest if you had a nutrition and diet bar in that list the other comment i want to add i i just joined a genetic startup company about a year ago and so a lot of what you're saying is resonating with my learning experience over the last year and i'm just wondering but the government is wonderful for doing certain things in terms of stability competence of the staff i mean it's just that there are great things the government can do but there are also some incredibly irritating and difficult around i'm learning that more and more each day around particularly around software and around contracting there's not a wonderful track record of software development and maintenance in many of the agencies in the government i'm wondering whether you do you occupy a somewhat special or privileged position in the government workings that would allow you to if i've been given a magic if i've been given a magic ring yet i haven't been told it my assumption is is you know we'll use the right partner to do the right thing i mean we're already looking there's a lot of companies large and small that are saying how can we donate capacity and capability to you there there is one aspect of the program a particular kind of authority called other transactional authority which does and if we didn't have it we could not have attracted some of the companies and others that we've already brought into it because a lot of these folks have never even even this particular round of health provider organizations that we're doing the the benefit of the other transactional award authority is there's several but one of it is it really allows in kinds of players who wouldn't normally normally participate integrated delivery networks and others you know who like i've never applied for an NIH program in my life and it also allows us flexibility on the other side of the award to say oh wow we didn't think this part through as we've iterated and learned as we've gone we need to add an additional capability onto that so it's a it's a legitimate government capability that's been used in other other places and HH or NIH has started using it for common fund and others more recently yeah and not everybody has that authority there's no any Shari dollars associated with OT authority it's called other transactional authority but the way the the PMI money was sort of flowed through into NIH it was put into a place that has that authority so so the program does have OT authority yes yeah but we i mean i but i very much you believe in use the right tool for the job and we you know if we have to make software you know and even with our DRC which stands for the data and research support center the award is to Vanderbilt and Verily Google Verily and the Broad right who who have had experience doing those tools in the case of the PTC which is the participant technology center so focusing on that direct volunteer capacity you know they have a partnership with Walgreens to help with the national capacity as well as a software company called Vibrant Health and in many cases we're using off-the-shelf commercial software that's re-skinned or added to and going through a fisma you know security process and that's you know important to do but it's much easier when you're doing it with you know fundamental google layer components that are in thousands and thousands of secure commercial products i'm interested in the biospecimens in biobanking you know it seems that this is going to be a tremendous resource over time and technology changes over time and so what you can measure today is not necessarily what you can measure 10 years from now or 25 years from now so what what's being done with respect to the kinds of samples that are being collected and you know the ability to you know keep keep enough of those available so that they become even more valuable in the future yeah but it's i now this is why these things where it's like wow if i really felt stupid it was in the meetings where mayo mayo won the award for our biobanking and steve tibodeau there is just fantastic and they and the working group and then in the very near term the protocol is not completely done but in the very near term it will be blood and urine and they're going through all the trade-off analyses of how much do we want to hold how much do we want to put out for awards what's the range of kinds of things that we want to do but we're also looking at the pros and cons of storage around you know daily drinking water brought in with the participants and from from different sites hair fingernail clipping so there's a wide you know that trade-off list is being done and the other thing is we're trying to anticipate what kind of what kind of metadata and other kinds of things do we need to capture anticipating when we run out of those capabilities and you know the blood draws three four four years from now and then three or four years there after you know or sort of set in stone partly is that that innovation process i described is making sure that we've got people in the bio banking world that are looking out at the edge of that funnel of what's starting to move through diffusion of innovation and then wrap that into our five-year strategic plans that's the best answer i can give you well and i would recommend that you know microbiome stool samples too yeah all of those things are considered and i think we'll get to over time that was that was a really inspirational talk that i just want to ask a question about managing expectations so there's a lot of money going into this there are going to be people within the NIH and outside in the outside community who say well you know all that's just taking stuff away from me and and so the question is one of early wins do you have a sense of how you're going to manage that and i will say that that senator alexander visited us last week the week before and as far as he's concerned this is a genomics project that's sort of you know that eric as far as senator alexander who is one of the biggest advocates in the senate for this you know he it's it's all about human genomes so so there's a whole bunch of expectations that you have to manage and nobody's going to expect an early win in the next two months but how are you what are your thoughts about that yeah i think the i mean i there's a manager i had at intel and and he had an equation s equals r minus e success equals results minus expectations and so colin's law is with me uh full on i mean to be honest with you i think some of the expectations where that major science would start being done by the end of this year and you know people had hey we'll have a half a million people by the end of the year and i came in and said no no no no no no um you will hurt us if we try to drive towards crazy expectations like that and we'll we'll never be able to get off the ground or we'll do something that's a flash in the pan but doesn't have the infrastructure the process for the long haul and can potentially violate our trust the scientific working group and it's part of the protocol that we're considering right i mean the early wins are going to be you know just understanding characterization of survey data linked to geo data you know the clinic the even the e h r data we are certainly the health provider organizations who have won the awards have demonstrated and we've done pilots with them to show that they can get the e h r data to us relatively quickly though they're still slogging with each one to make sure that those interoperability there even for being able to get the e h r data for those coming into the direct volunteer path i mean that's just an enormous challenge right they come in from they may not even have one and if they do it could it's probably you know they can be completely uninsured have no access to healthcare and they're going to be invited into our study so trying to figure out that over time is going to be part of the key but part of the um the expectations management has been to try to get everybody to understand the principles and there are a lot of people that think this was a genomic study i think and think in some ways candidly it's partly why francis and others said look there's the practical cost issues and it's not even supposed to cost of sequencing but the cost of wrapping the human beings that help make this a responsible giving back of information and and so because of that expectation that precision medicine equals genomics it's another reason why we've actually not just started out of the gate doing that i think we will pilot things early next year at some of the sites where we can just start to learn what it's like if you get whole exome or whole genome or systems ready for that but in terms of scaling those out there's a set of criteria and phase gates that we're trying to do to make sure that we wouldn't actually do this until all of these things were in place and some of we have not communicated a lot about the program yet as we as you can imagine a program this visible has lots of masters so but there's a whole set of communication materials and branding and educational material for different audiences including the provider community that we're building the capacity to go do but i'm just waiting for the right timing it's just back to you know i don't want to if we're going to go out and talk to providers i want to make sure that we've got the content and the understanding of the kinds of providers that we're going to go do in the support organizations in place but we will i believe pilot elements i'm trying to get off of the notion of one big all singing all dancing lunch you know if you're you're going to start in regions and then scale out you're going to start with some particular health provider organizations who are more ready and scale out and you're going to start with four or five different approaches to enrollment of especially diverse populations and then save the other 12 to 15 and until you start to learn from those so you know this is this is partly why and the other thing that we're going to be doing is when we're setting up the infrastructure to do it i will we will be talking to the the cohort to the participants in a very regular way saying hey we think we're going to do this about then but telling them you know what we think there's going to be a two-month delay and here's why i mean that level of transparency i think is just going to be required out of the gate in terms of expectations management okay i see many hands jeff and then mark and then gal and then Sharon yeah thank you for this presentation i'm a little uncertain still about the role of children in the the PMI and in particular you know given the potential influence of prenatal influences and environment on future health are you going to be recruiting pregnant women and collecting samples relevant to pregnancies as part of the PMI even now or down down the road yeah we will and and the particularly the children piece is something that we're not going to start out of the gate with nor will we do those with cognitive impairment or incarcerated populations and so forth but we have a roadmap and a plan for tackling all of those things with work groups are going to be working on those you know the variability of state law in some of these particular areas is going to be particularly challenging for us so an analysis of all the state laws that that add another layer to it but we will take children we will take pregnant women and we will get to the point where we figure out how to take those with different developmental disabilities some of the some of the players that we have on the network in the hpo network have experience with that so you know it's one of these things where it's like we want to learn from and and you need the trusted brands of those and relationships of those local organizations and in some places they're doing this quite well and how do we extrapolate and teach the rest of the hpo's to do that but you know all of that isn't the plan to work on and we just you know it's one of these things where it's like focus on a minimum definition get out the door learn and iterate as we go the initiative was announced I don't know seven months ago and you've already awarded eight grants to more than 30 organizations seems remarkably fast how'd you pull it off what was the process partly the I mean the the air cover of the president the secretary and the director of NIH is both a blessing and a curse and the blessing part of it was you were able to pull multiple departments and so many parts of NIH stepped up to help you know we mean I'm based in the director's office it doesn't have a lot of the infrastructure that something like NHGRI does or Gary was here earlier in terms of heart and lung so basically leveraging their expertise to sort of and their capabilities to get it out of the door the other transactional award will be the fastest that we've done we started like for this round of health provider organizations it went out well it's going to be a two-month period from end to end right I mean in fact I have like four minutes and I need to run because I got to get to a review in about ten minutes away from here but that helps us a lot the OT makes a big difference on some of these fast turnaround things and do they have the usual peer review the usual levels of peer review yeah I mean it's it's it's it's it's slightly different but the spirit of what traditional peer review is is in there in terms of the way that it's done yeah well first I'm from Chapel Hill I work at UNC go heels just yeah there's so many Duke people around and I love you but come on I need more time so okay so and so my question it probably should wait till later but it does have to do with the very difficult and contentious debates around how you define race and ethnicity in the context of ancestry populations forgetting about the social factors that are clearly implicated in race and ethnicity and culture and it sounded to me like what you were saying was something that was really quite interesting that you've got proposals that are doing some different things and you're going to see how it works and then you're going to look at it and go forward is that your plan about this really thorny topic that's part of it and each of the awardees had to show us a plan of what their catchment area was what diversity was on a lot of different axes and what their strategies were so and they've signed up to say hey we will deliver certain numbers of these people over this period of time but I think it's one of these things where you're going to want the collective mindset of you know hey this is working really well here here and here should we make that a national you know thing that's available across all all of the folks that are there and there's really thorny IRB issues with this as well right and we have one central IRB for everybody which is I think the way NIH is going for these larger projects but you know we're we're on the cutting edge of figuring out what that means getting all of the locals to be okay with that Sharon so I'll be really quick congratulations I would just say I propose this question of how did you do it so fast I think a lot of the kind of industry terms like I was sitting here taking notes and approaches are things that many of us in academics could really benefit from and many of us running consortia and it would be really nice to see how some of this the work going into this would then translate into other aspects of NIH funding and planning and the iteration phase and things like that I think I've already taken elements of sort of user experience and product development classes that I've talked for years and I finally just said last week to Francis like Francis we got to find more people that know this because I cannot go teach this a thousand times but at some point when I can breathe I would love to teach you know some of these basic infrastructure to both government and academic folks because it works and as a somebody who's been in not-for-profit academic you know large for-profit and now government and so there's some methods in here that are very powerful and really tested for a lot of different things. Can you say something briefly about data release how that's going to work? It's going to work very well see that was very brief. It's like on the Star Trek. Slightly more about that. How do the Heisenberger come to the it will be a it's a risk-based model and certainly you know non-risky data that's de-identified to the degree you know and calculating the risks of different levels you know much of the data will be released to anybody and you know that wants to do a query on top of it and then it's basically just a risk-based model of credentialing for access to increasingly risky data as we go but it's partly not it's partly I mean that's a that's a certain aspect of the answer but as I mentioned there are programs that we want to create and that we have the seeds of for it's like how does how do citizen scientists use this data and what's the education and training that needs to be in place to teach them how to use it not just open up a website and say you can have it and the same thing true for community college as well so it's it's you know full disclosure it's like I mean and Vanderbilt and their colleagues own developing those data and research support tools and they're well down that path and you know many of those same people are involved in Emerge and others so they have experience doing this as well as BD2K projects but we're not we haven't spent a lot of time on it yet because it's going to be a while before we start to have enough meaningful data that that being said you know in the survey data and there's other kinds of things we expect you know to try to release that very quickly and let people mine it and characterize their own geography or their own community right out of the gate as soon as we could as soon as we can before he does or anybody in the phone and we have several council members on the phone did anybody want to get a quick question in no no queries to Rudy okay respectful of your time and your need to get to this review I think we're gonna end there sounds good thank you so much I hope you'll have me back I can't wait to learn more from you absolutely thanks so much okay Rudy are we gonna take a break now how about 22 run upstairs and get your caffeine everyone