 We're just doing some last-minute work on getting some slides loaded, and then we'll get going. While we're waiting, though, I'm going to take this opportunity, again, to thank everybody for coming and actively participating in the session yesterday. I thought it was excellent. We particularly appreciate those of you from representing professional societies that took time out of your busy schedules to come and work with us. I also wanted to give Nancy Rose an opportunity to put on a different hat. She's here as the official representative of ACOG, but she is also the program chair for the 2014 American College of Medical Genetics and Genomics annual meeting. And she has an announcement that would be of, I think, particular interest to the group. Well, thank you very much. I just told Mark I wanted to make a shameless and transparent solicitation for your platforms, because this is the group that we want to have submit, of course, to a meeting like ours. The American College of Medical Genetics and Genomics meeting is in March this year, and platforms will open, I believe, in a month, about April. Abstracts will be due by December, and, you know, meetings are, of course, only as good as what's submitted. So please be thinking ahead. It's already the end of January, and we would love your ideas for platforms for the meeting. Thank you. Platforms are highly visible. It's a large meeting, and something that particularly is this group, as we move more towards implementation, I think would really be good to get out in front of folks to have an organized session around some of the things that we've been doing. So this is another opportunity that we can sort of advertise and keep us from being a well-kept secret. And so what we'll do is to, when that announcement comes out, I'll have Nancy send that to us, and then we will distribute it to the group so that you'd have the link for the call for the sessions. I'm going to move up front, and we'll hit the recap of day one. All right, hopefully we'll have those up quickly. Yes, I think so. Yeah, even though M Williams did not do anything with it, it was T. Monoglio, who changed her name this morning to Tariq, which I think is really nice. So it's kind of a little bit more exotic, so it's cool. So after day one adjourned, the planning committee went and, as we always do, and kind of reflected on the, actually what we do is we have dinner, we have a lot of fun, and then we spent about five minutes reflecting on what happened the day before. But we did do some reflection. And we never have wine. And we never, no, there was no wine involved. At any rate, we spent some time thinking about what we had heard yesterday, and took that, and Tariq sort of reframed the key points into some action items. And so what we wanted to do this morning was to present those to you. And again, go through and have the opportunity to make sure that you can react and say, yeah, you got it right. No, we need to do this, that or the other thing. And that this will be our stepping off point for what we do next. So the preliminary action items, and this is related specifically to the professional society discussion which took up most of yesterday. Convene society representatives by conference call in about one month as the nascent coordinating committee. So another gnome de plume here that seems to be less objectionable than some of the other ones we came up with on the fly yesterday. And as part of that, we'll use the groups that we'd invited to this who have been engaged and are interested as the NITIS. But we don't want to be exclusive and say we got it right the first time. So we will extend invitations to other societies to be represented on the call. And we'll see if others wish to participate. We want to collect current approaches and develop and disseminate consensus best practices on what's happening with pharmacogenomics. Ideas relating to society reaction to direct to consumer testing. The ideas about when the state of the science is nearing the clinical horizon. In other words, how far are we along that implementation and translation path in competencies versus general knowledge in the education perspective. These are the things we're going to ask the professional societies to send to Gene. Links for available physician education materials for posting in G2C2 so that aggregation function that we talked about yesterday. The individual society's areas of interest. In other words, what in the genetics, genomics, personalized medicine space are you particularly interested in whether it's disease focused or something else. A process, and we'll get rid of the term pseudo guidelines, I promise. But the process for developing guidelines using the IOM definition of what a guideline is versus other types of guidance that we heard about yesterday that have been developed when you don't do a full guideline. There are other opportunities to inform your members about best practices or other things of that nature. We'll try and collect those types of process measures and how that works. And then also try and collect any current publications from the various societies in that range of a guideline and guideline-like substances that relate to genetics, genomics, and personalized medicine. We'd like to produce a white paper from this meeting that would include the compilation of the survey data that we talked about. Now it's not our expectation that we'll take everything in those surveys and somehow smash it into the white paper. But I think what we want to do is identify those areas that we talked about relating to education and to guidelines and that and see where the commonalities across different provider groups. And if people are willing to contribute that data share, I think that would be an interesting paper because most of that type of information either comes from other countries where they survey their physicians or it's specialty-based. So I think that would be somewhat novel. Develop a working group to address liability issues that are presented by the GM implementation. As we discussed this, the idea had been would we want to take time at an upcoming Genomic Medicine meeting to discuss the liability issues. We ultimately decided that there it probably wasn't an issue that would be of a great interest or would consume a lot of time of the group at large. And so we thought a working group would probably be the best way to deal with that and there hasn't been as much attention paid to the implications for professional liability that were raised by some of the societies yesterday. We'd like to be able to convene society's guideline producers to outline process and evidence needs. Maybe this would be at a Genomic Medicine meeting down the road that we would focus solely on guidelines. We'd also like to engage disease-specific institutes and see if we can get them to collaborate with society. So those are the items that we took away from yesterday's meeting and the floor is now open for any comments, questions, errors, omissions. Yes, Mark first? My only reservation is on pharmacogenomics. I'm not sure there's a society that has thoughtfully considered this for all of medicine. I mean, the theory American Society for Clinical Pharmacology and Therapy was could do that, but to my knowledge hasn't. And I'm just worried that by relying on the disease-specific societies, the one really won't get the best practices and a real consensus. So that's my reservation on pharmacogenomics. I don't know if Mary or anybody else has some thoughts. Yeah, I'll just reflect my thoughts and then we'll go to Mary. My view is that I think you could be right, but we'd have a better shot if we had different perspectives around the table in the sense that you might be able to identify some general principles that are common across the different disease-based entities, even though they may be considering different use cases. And if that was in fact the case, then that might be of some use and could then perhaps provide direction to another group. As you say, the ownership of that is somewhat up in the air. Yeah, I mean, you know, I've been active in ASCO as an oncologist. I mean, and ASCO's view of genomic medicine is completely related to the tumor genome. And so it's, you know, and even though there's plenty of good examples in oncology, the associations between germline variation and outcomes, the society certainly hasn't thought about this at the society board level. Mary? Well, I agree with what Mark is saying, but I think that would be the value of getting these people talking to each other. And I do think that CPIC deals with pharmacogenomics across all diseases, and we can provide some perspective to all of those groups that will be at least a common perspective, maybe people may not agree with it, but it has buy-in from the Pharmacogenomics Research Network, 12 countries, I don't know how many institutions, 80 or 90 members that work in pharmacogenomics. So I think it would be a way of bringing a common approach, make it available to all those different professional societies. Yeah, I think, you know, a lot of the things here when we talk about particular some of the policies around guideline development, the different societies have the opportunity to be very contentious, and possibly things where you're just going to say, you know what, this is just not something that we can work on or that we think we can bring much value. And so I think in some sense the function of a group like this would be to sort out all the different things that you could do and say, these are the things where, you know, we have a lot of energy to actually accomplish and then perhaps as assuming that there is some good output that you could then maybe begin to, with the good will that's been developed on the easy stuff, begin to approach some of the harder things. But, you know, these are all, I think the whole idea here is that we to some degree don't know what's going to happen until we actually pull things, pull groups together and the hope would be is that they would take some ownership and in some ways define what it is that they think is most important. John. Mark, can you go back to your first slide? Can you say a little more about what exactly you mean by best practices? Are you talking about best practices around clinical practice areas, around educating providers around these areas, around, you talk about guidelines later. So I'm assuming it's not best practices. Well, I think that the best practices refers to this as at least a nominal initial list of things that can we identify are there best practices relating to these four items. Now I don't think this should be looked at as the exclusive list. I think there are other things that could potentially be added to this list. But I think the way that this is constructed, it's really meant to refer to the list underneath there. Maybe I could just comment that, John, this is not the best clinical practice. This is almost the best societies practice. So, you know, what kind of advice should or could societies be giving to their members rather than what physicians should be doing? Thanks. Mike. For the white paper, I wonder if a survey could be sent out to all the professional societies, asking them just two or three questions. Like, one, how many hours of time would the practicing clinicians in your membership be willing to spend on genomics education? And two, what's your membership's top needs as far as clinical guideline-ish kind of things? But, I mean, you could probably put together a short list that goes out to the societies. And I think that would be powerful to put in a white paper rather than sort of the general ideas to actually have some things there to report. So there'd be a couple of things I would say about that. One is that if we were to do that, it could be done in conjunction with the invitation letter. The second thing, though, and I'll let Laura speak to this specifically because you and I have had discussions before about surveys that would arise from NIH. And there are fairly significant issues in terms of permissions that need to be obtained to actually do something like that. So I don't know if you have anything you want to add to that or? I would just say that it would be something that we can look at. And there may be limitations to what we can do, but there also may be ways to work around the rules we have. Okay. Did you have something specific to the survey question, Bruce? Okay. Then David, I think, oh, I'm sorry. Okay, Katie does. I was just going to say that that similar survey to what you're talking about was part of the data that informed the Secretary's Advisory Committee, the Genetics Health and Society Report on Education and Training, which just came out a couple of years ago. So actually, there's quite a lot of data in that report, and perhaps it could stand to be updated now. But I think some of that, of what could benefit this group, is actually in that survey. Yeah, that's a really good reminder. And I think that the other thing would be incumbent, as we synthesize this, is to look at the SACGHS and the SACDNC reports on education that both came out about two years ago. Both of them collected some of this information. So we could use that to enhance. David? Yeah, I guess I'm a little surprised to see liability singled out here in bullet two as something at that level as opposed to a much broader, it was on that slide, bullet two, address liability issues, as opposed to a much broader economic sort of consideration of positive and potential negative impacts of genomic medicine implementation. Reflecting on yesterday's discussion, which is mainly around education, is we didn't have a discussion around the economics business plan for sustainable models of education, training, how to get people. The only comment that I remember that stood out to me was Debra Leonard's talk representing CAP, where they have a bullet at the top on CAP pathologist transformation strategy. Number one, will it enable our members to control their professional economic destinies? And that's something the American College of Medical Genetics could learn from because we've failed to develop a healthy, sustainable business model that will attract young people into the field. And so I think if we're going to talk about educational needs, which are vast, we need to have some broader economic discussion about how to align incentives around implementation in an appropriate way in the economic impact of genomic medicine implementation. Yeah, and I think that to some degree that we'll hear about that from the payers work group meeting that occurred last fall that Derek is going to have a report out, and that was something that actually came out of discussions that we had here one or two meetings ago where we did raise the issues more in the context of how can we encourage payers to move some of the technologies into practice, but the scope of that could presumably be widened. So I think this group has led to some things that have been touching on the economic area, but that doesn't mean that we couldn't be looking at that more broadly. The other thing that relates to that was the whole discussion about societies working together and finding some efficiencies in work around collecting evidence data, et cetera, so that at least has a potential positive economic and sustainability component to it. Yeah. Bruce. Could you go back to the other slide for a second? This one or that one? That one. So with regard to approaches and consensus, I didn't see on there anything about genomic sequencing, whether wholly or otherwise, where I think you're inevitably going to bump into the areas of interest of different societies just because genes relevant to their interest will be encountered no matter what the original reason for doing the sequencing is. So it seemed a kind of obvious place for discussion about standards in terms of reporting and actions taken based on finding. Yeah, I think you're right. And I think it gets back to what Mary had said yesterday that, you know, if we frame the discussions around the perspective that the information will be there, how will you use it as opposed to should I do a gene test or not do a gene test that, you know, if we could frame the conversation from that perspective, then that might yield a different set of conclusions than the sort of the way business is running currently. Yeah, I agree with that. Yes. I don't know if this is consensual or was my personal obsession with data products. But for the budding new data scientists that are emerging out there in graduate programs and even in residences to some extent, there is this lack of a data resource where these issues can be investigated. And maybe this is something where the societies could together pull and develop something. Yeah, I think that that was something that we did spend some time talking about, although I'm not sure that we actually got to the point of an action item that would be, you know, what is the role of professional societies in terms of doing data aggregation or outcomes. But we did talk about concepts of safe harbors and some policy issues related to that. Terry? Yeah, and I think we, and Jonas, it's a good point that you make. Let's be sure that we focus the societies on the things that are relevant to the society. So a data resource is a big, big issue that NIH is pursuing on a kind of a grander scale. But what would be probably very helpful is for the professional societies to tell its members, boy, it would be really wonderful if you guys would put your data into this. And here's how we can help you, you know, avoid HIPAA issues or avoid other kinds of things. Does that make some sense? Martin? Yeah, I just was, I'm just thinking about what you presented. Thank you so much. With regards to the guidelines, could you maybe move it to the slide, because I couldn't really see, but what, is there something specific that, so convened societies' guideline producers to outline process and evidence needs? So is the goal, I'm just trying to understand what the goal is for this. Is it to identify how to use exome genome sequencing to diagnose, predict, or is it just much broader? I think this is really at a much more of a level of understanding how the different societies, what their process is to actually produce a guideline and to say, you know, everybody right now kind of has their own way of doing things. If there are some commonalities, could a group like this, you know, provide feedback to the individual society, say if we modified our process, then we could have perhaps a number of societies that had a process that looked relatively similar, which might then facilitate actually trying, you know, to do joint guidelines. I think, Terry, is that a fair statement? Exactly, yes. So I think we're far too early in the process to define what exactly these things are, and really we're talking about the process for doing it, since that consumed a fair amount of the discussion yesterday. Yeah, so that's what I was thinking of as, you know, this, I was at Rand for a while in this modified Delphi approach to when you don't have evidence, which is what I think we're grappling with, is to convene a bunch of experts, different stakeholders, to, you know, try and reach a certain level of agreement or disagreement on very specific items, and it's, so if it seems to me this would be a good place to try and do that. No, agreed, and I think where we're trying to figure out is how the various societies would take the output of that, and make guidelines out of it, so that we can have that process serve them best. Yes. Apologize for not having been here yesterday to hear this discussion, but it does sound like here you have come back around to talking about clinical practice guidelines. Is that, is that right, or are you still talking about the kind of guidelines on the previous page for what society's best practices would be? Yeah, so I think, again, we got into a little bit of a semantic discussion yesterday about, you know, what that term means, and what we ultimately decided was there are guidelines, which the IOM has just issued a white paper on. This is what constitutes what should be involved in producing a guideline, but we also heard in a number of the society's presentations yesterday that they produce other types of documents that guide their members' practice that do not reach the level of this systematic evidence review-based guideline, and they're, you know, called practice alerts or best practices, or these types of things. And so we're interested in exploring that whole range of things that kind of fall under the broad rubric of guidelines. Yes, Bob? I agree with you, and I think, you know, yesterday, the other, I think that you're saying as well, we recognize that at this stage in the game, for some of the genetic screening or what have you, even if we can get that number one A evidence, we probably would have to wait much longer. What do we do in the meantime? I think speaking from a cardiology point of view, if we had statements across several societies saying, you know, this is the level of consensus about this without true hard RCT evidence, I think it has meaning for all of us that we could refer to. Thank you. Terry? I might just know, Rose makes a good point that we have a bit conflated clinical best practices and society's best practices. And so we'll try to tease that out. That could be one of the things to talk about on the first conference call. Yeah. Good. Ned almost had a question, but friend in Colorado that always talks about being the skunk of the church picnic, I just say that Delphi techniques, expert consensus to an evidence-based person is a little grating. And it's OK. I mean, I understand. But recognize it's not an evidence-based guideline. And inherent in that are the risks of being wrong. That's why I keep coming back to a balanced approach more than just expert consensus of considering the risks of being wrong, the potential harms, and the potential benefits always have to be at the base. Or we end up with consensus guidelines, which we already have. Thank you. But that could be exactly what is discussed is what is OK to not so much about a specific test or condition, but more about the approach. Yeah. Great. Derek, why don't you go ahead and work your way up here, because we're just about done. I think we're, I didn't see any other hands, so unless there's any other, good. So we have it, I think, the takeaway we will refine these action items based on the discussion we had. And Terry, are you thinking that we'll send these around one more time? That would probably be a useful thing to do to everyone. So keep an eye out over the next few days for an email. And again, if you have any other thoughts that occur, we'll continue to refine this until we get it close to right.