 So thanks. I'm sensitive to the fact that I'm one of the few things standing between you guys and going home So I'll try to be officially lunch is standing between you two So there is there is a lunch to which even is a greater imperative perhaps, but Our oversight group has been as you can see talking about the future of these meetings and one topic that has come up a few times is what's happening in the international community and I think The the the context is of course that we are not alone in our efforts to advance genomics into health and society that Probably we cannot afford to be insular and if we wish to we have an opportunity perhaps to take a leadership role on the in the international community so We we address this topic because genomic medicine doesn't have any particular Boundaries as we've talked about it doesn't have a have disease related boundaries, but certainly does not have National boundaries and as we are all aware that there have been significant investments, and I may not have listed them all here creating hubs for genome technologies across The globe and the as as was the case I think with the impetus for these meetings are getting all of you together the opportunity to explore the synergies redundancies and the potential to move the advance the field forward is something that's on our minds when it pertains to the International a community as well So could we perhaps create a more global agenda for genomic medicine as it pertains to the health globally not global health As it's normally thought about but certainly could impact that topic as well I thought I would list here some Initiatives that have come to our attention in our oversight group meetings Some of you are probably aware of many of them Perhaps personally involved in some of them and what I what I hope to do what I'd like to do is just give you a brief snapshot of Of these five over the next few minutes, but I also want to recognize that there are Many other efforts that have not necessarily been topics of conversation in our oversight group and here these are some of the Nationalities that have come to our attention involved in the genomic medicine field and while I'm on the side I'd really like to also extend a welcome and To dr. Milano from Tokyo from the Human Genome Center. So clearly we have had outreach To the international community already and we're grateful for your being here to be participant in this in this meeting So I think one of the things that we're going to be looking for you to do is help us understand What who might be the participants in such a meeting which currently is not scheduled with a definitive date But probably will happen some time in the fall. So first I think in our discussions We've recognized that the Canadians and specifically the genome Canada initiative to advance genomics and personalized medicine into health care through a very large Large project RFA for 2012 called genomic genomics and personalized medicine. It's probably one of the more advanced Countries leading the efforts. You can see the tenor of the RFA here And this probably sounds like something very much like our own Demonstration projects to support projects that will demonstrate how genomic space research can contribute to more evidence-based approach to health and improving cost Effectiveness of the health care system the total funding for this Projects that will initiate this year is around a hundred and thirty million dollars forty million from the government genome Canada Todd 22 and a half million through the Canadian Institute for Health Research and some other small funding agencies and importantly The emphasis of these a requirement of these applications was Co-funding generally through commercial entities to supply up to at least 50% of the funding opportunity The the decisions were made last month. I don't know what they were but about 10 to 12 projects are slated to initiate very shortly I had the opportunity to attend a workshop in Israel this fall Sponsored by the National Institute for Health Research policy the agenda for the workshop as you can see here also has some resonance with Topics that we've discussed here many times how to assess the value proposition for personalized medicine Both from an economic point of view and developing the evidence based through comparative effectiveness research the policy agenda And also what are some of the barriers to implementing implementing personalized medicine the output of that workshop? is a white paper that Has elements that again resonate with our top topics that we've discussed here the knowledge gap in educating health professionals Obviously the topic of this meeting how to create a deris data sharing a framework within Israel collaborative frameworks as well And all of this is going towards to the Ministry of Health as a proposal to Support and provide resources to enable genomic and personalized medicine Within Israel and one of the interesting things about that particular environment is that 100% of the population is covered by four HMOs and the HMOs appear to be very willing to collaborate with each other on really under on gathering data to generating the evidence and also Creating the economic models that support the advancement of genomics in healthcare The we came we last about a year ago the United Kingdom published a strategy document To the best of my knowledge. I don't know that any of this has truly been implemented, but again Many themes in the UK's strategy for genomics in healthcare are similar to our own How do we get it adopted mainstream? What are the translational pathways? What's the infrastructure bioinformatics as a is and training our clear themes and the policy agenda? As well, so, you know, it's it's interesting to see how Many international communities are working in parallel As was mentioned earlier Today or yesterday Dan Rodin is on is on loan to the European Science Foundation at a meeting in which they're discussing these very Similar types of initiatives This was a report that came to our attention just several months ago personalized medicine in the European citizen so again again illustrative also some of some of the fragmentation the UK has its own strategy the rest of Europe has has theirs and although the words are slightly different on on the focal points for the ESF initiative I think if you look at them carefully, they are a very synonymous with what the UK and what we're doing here in the US Are really thinking about doing again. We'll hear back from Dan Hopefully about his experience there, but the early reports from his presentation about what we're doing indicated There was a lot of interest in in partnering I also wanted to Give you a sense of what the world economic form is thinking about this topic Lord our Darcy was chair of a genetics and medicine committee for a year or so At the WEF and they published a white paper result in the New England Journal of Medicine about 12 or 14 months ago that Articulated the output of that sort of primordial committee on this topic Again several that several of the themes that you see are things that we've discussed And certainly touched on in many of these meetings that committee has been reassembled or actually disbanded and then Reassembled this summer To a global agenda committee on personalize and precision health as you can see it has Somewhat global representation. There's a high. There's a strong footprint from the United States Francis Collins And Peggy hamburger on this committee and Victor Zau Chairs it and the the the WEF met last week in Davos as some of you know and these Were some of the outputs of that meeting on this topic. So there were three initiatives that were provisionally approved for resources from the Board of Governors from the World Economic Forum the first one was to address the global to understand how personalized medicine and genomic medicine Technologies might be helpful in addressing the global economic burden of disease this relates to another initiative at the WEF which is called sustainable health systems in which a A model of of Healthcare economics and the disease drivers of the economic burden in several countries was articulated over the last year That report has been presented and the question is are there approaches that can synergize with alleviating that health economic burden of disease in various global economies so a number of committee members from our global agenda council will be Creating a white paper on the value proposition of personalized health care approaches in various world economies That's obviously sounds quite synonymous or quite Synergistic with what the World Economic Forum might want to do the second Area that is also Was widely discussed in at the global agenda council was a big data data sharing data sharing frameworks Charles Sawyer's is a member of the committee. He chaired the Iowan panel on Toward precision medicine in which this topic was very much a thread through the entire through its entirety and Francis Collins I think has had a significant impact on Helping us think through this so the idea essentially which seems to have been approved is to With a knowledge partner and that's a that's WEF terminology for the likes of McKinsey Deloitte or Price Waterhouse to Really understand the landscape and the gaps That would exist to try to create a global data commons that would Accumulate a lot of genomic and health care related information. So again, this sounds very much similar Synodistic with big data and other topics that we've we've talked about here and then the last topic that was discussed and Again provisionally approved was was trying to begin to understand The what is needed to achieve greater? Harmonization and alignment in both regulatory approval strategies as well as reimbursement strategies for genome-based Technologies and I'm sure that Peggy Hamburg also had a strong hand in Putting this agenda item forward so the the output which we Anticipate seeing over the next year is a workshop of the global community to address some of these policy issues and perhaps a White paper that will articulate what those policy alignment strategies would be So I think I've given you in the in the last few minutes a snapshot of some of the gears that are turning on the international Scene that are very much related to our agenda here. So We've we we haven't fleshed this out in any great detail That was one of the things we realized last night at dinner Why we couldn't really conceive of putting on a meeting of the international community in May without having Engaged all of you as well as even ourselves and trying to think about what that agenda would look like I think the answer to this question about should we is probably answered yes And Eric may want to comment, but he certainly has told us that he's been The subject of a lot of inquiries on the international from the international community about how to really engage with NHGRI and the activities of this group Why should we do this? I think Identifying as I said earlier the Commonalities and addressing barriers and solutions synergies and eliminating redundancy The kinds of things we've talked about in terms of standardization of of data standardization of CDS standardization of Genomic variants and a number of other Technologies could certainly be brought to the to another level and the global community is probably also addressing that the notion of international pilot projects of which genome Canada has already taken a First step is something that we could also perhaps leverage some of the activities that we've talked about here and bring in international resources to To help enable those public-private partnerships understanding the economic models the policy issues and Also the ability to work in And perhaps environments that might make it even easier to capture the data single-state single-payer types of countries or Environments where that data is read up more readily available than perhaps in the fragmented system in which we currently operate Here so I think you can appreciate the you know the litany of potential ideas that might Emerge from such a meeting. I'm sure you could think of many of your own We've certainly thought about Who should we invite? I think there's a on on one hand We would probably want to attract the leaders of the ministries of health that are making the policy decisions to fund these types of things But they may be not well connected enough to the science to Speak cogently about what the scientific agenda should be so we thought about actually trying to perhaps bring both flavors to a meeting like This that's not etched in stone and also we would Also choose to have this meeting also in Washington DC for obvious reasons So I'll I'll stop there and open it up for discussions questions or comments Okay, thanks Jeff Howard Thanks Jeff what I would add that the Emerging countries as they're called We should also be thinking about it the the development countries have problems way beyond genomics But at least with pharmacogenomics, which I know is only a small part of it I've been shocked at the level of implementation. That's already gone on in terms of routine use of pharmacogenomics in Thailand and in China and You know, you think about it as something you know, we're not doing it here. No one's doing it They're doing it routinely and it's paid for for things like avoiding Stevens-Johnson syndrome with Noverapine carbamazepine alpyrinol in Thailand and then in China there are both commercial and Government funded, I guess you they're all the same over there that it is Now in major hospitals, so there they're There really is a lot more going on out there than I I realized And we can really try to pull that in because I think we could actually learn from what they're doing as opposed to The assumption that they will be learning from us Yeah, well, that's a that's a fantastic point And I would mention, you know that I think on one of my earlier slides I didn't I didn't mention specifically but the H3 Africa initiative is one of those Initiatives to bring genomics into develop the developing world in a sense I think would be Resident you know constant with what you just said We know that YT Chen in Taiwan has been highly successful in executing on Genomic genetic guided clinical trials for things like carbamazepine and has Changed the way that practice medicine in some of those countries And maybe you'd like to just mention a couple of words on PG any your initiative in this in this area I think I had the first slide So what We've been using pharmacogenomics in a kind of a weird way we've been working with developing countries So not the emerging ones as much but the developing countries that may not have clean water or electricity But they're one of their major decisions is choosing their national formulary. And so They rely predominantly on white data for because With our recent FDA analysis 87% of the pivotal FDA data comes from white patients. And so if you're in Ghana or In Myanmar, you're relying on white data to try to make your national formula decision So we take pharmacogenetic risk risk data from local populations Merge that with the the white data from Geneva to come up with a national formulary recommendation for each individual country And so it's population or public health genomics not individual patient genomics But it's been a great experience and it's caused the ministries of health to think of genomics in a different way because they're scared of Braca and Alzheimer's or whatever, but they're not scared of safe medicine. And so it's been kind of a way of introducing that as well Thanks Howard. Great John. I Think the our international colleagues face very different Implementation barriers than we do and in some situations There are fairly large databases already put together of clinical material that I hope those are those scientists will be In part of this and invited like 500 whole exomes that have been for a specific phenotype those kinds of Studies could provide huge insights for us Yeah, I well first of all, thank you I would I would say that one of the things of we would encourage all of you to do is to Send us your ideas of what we might want to highlight at such a such a venue. So if you know of specific projects or specific, you know collaborators of yours or people that Could make a significant contribution in illuminating the commonalities as well as the diversity and heterogeneity of the challenges that we face We'd like to hear from you because we've just you know We're just we're very myopic in some ways of our own But I think we can leverage the crowd here in terms of your I know you a lot of you have frequent flower miles that Justify that so that you've you've traveled to a lot of these places you collaborate with a lot of international Groups and we want to make sure that we highlight Those that are really helping to drive this agenda. So by all means Before I call on Mike, I might just comment that that we do probably or maybe this is a question. Do we? Want to have an emphasis more on the implementation side than the discovery side and and I think you know To the degree that they're doing implementation in actual patient care I think that would be the kinds of projects that you're talking about But they're both academically oriented and then there are some very obvious businesses that are quite international and their scope that Are making major moves in terms of trying to capture as much of the world's business as possible Yeah, I should well that's a I think that's a good point and we've and many of the themes Topics that we've talked about here the business Opportunities of are not having been on our you know our major focus. So we might Take that as a separate topic altogether but I think as as health care delivery systems struggle with the the ability to put this into their work streams and to Develop the the value proposition on a number of different levels patient provider system economic That's really we want. I think that's the place that we want to focus our Most of our attention so the extent that this that's there that the businesses are enabling of that that would certainly that would be An opportunity I think Okay, Mike you had a comment Briefly that I've been to a couple of these international meetings and there there is a lot of interest in WHO in resourcing some of the developing countries That's all they will put their money towards as the developing countries And then UNESCO has established it's around a particular project Which I won't talk about the viability of that particular project But they've established clinical annotation of the genome as one of their highest priority projects internationally I was at a meeting there last summer in Paris with that UNESCO where there they've been trying to develop this It's going to be exceedingly Useless with the United States at this point in time because we're out of UNESCO for funding purposes because of having brought the Palestinians in the UNESCO and our laws that don't allow us to play in places where they play And they may we may get over that hump But for the rest of the world that UNESCO is likely to be able to resource some of this stuff and is very interested in and working through their connections to other countries to develop genomic annotation and understand the You know the genomic backgrounds in many of these countries as Howard alluded to With his pharmacogenetics project because these that's you know, there's some of the variation is going to be around those backgrounds on which the stuff's operating Thanks. Thanks other comments. I have one As you begin to think about the audience with the implementation as the perspective of the meeting And I know the agenda may be too large for this But also consider the varied health care professionals that are implementing it across those countries We have a very good collaboration with the United Kingdom nursing group, which is extremely active over there So just a thought for future consideration Thank you, and it could be that some of the things that we've talked about even in this meeting yesterday about health professional Education might take on an international flavor at some point. So that might be one of the ways to bring in that Concept thanks for raising it and we may want want to ask up You know a planning group to kind of define what the goals for this meeting would be because because obviously, you know, there's there's an yeah Okay, so so it seems as though we have Reasonable agreement that this is something to go forward with any any objections or concerns that haven't been voiced Great. All right, and I think we can thank Jeff and we're getting close to the end of our of our effort here One thing that was suggested in terms of heading back to the airport I mean, sorry, we're in the airport heading back to your terminal because it's an enormous airport So we're in in terminal C It seems as though you need almost to take the shuttle from the hotel although apparently Howard says there's a walking route That's that's up and downstairs and that really okay So follow Howard if you wanted if you want to do that if you do want to take the shuttle It leaves every 20 minutes on the on the hour But of course there are other 20 minutes at art. So there's nine nine twenty or two two twenty two forty Do be considerate of those who have earlier flights and kind of let them take the first shuttles if they get full I did want to thank Hartley Jean Passimani and Mark Williams for putting together this program and especially Richard Fogli Who did so much work and making it all work. So thank you Richard and Any closing comments from dr. Williams. No, I think just thanks to everyone. I mean the success of these meetings is basically due to the participation in the engagement and we recognize that this is for the most part all being done as volunteerism and We think that it's been because we've been Sensitive to what the group has really wanted to do that we in fact continue to accrue more and more attendees Which in some sense is a metric of the success and we hope that that will continue in the future and a special thanks to all of the presenters those that are still here and those that have already Headed back home and thanks to those of you who have in the course of the meeting Volunteered to participate in some other aspects of the work that we're doing so lunch is available and safe travels to all