 So I had a question for Sarah, which is, it's a technical question, but I think it probably has some bearing on the outcomes, the social and behavioral outcomes of babyceak, probably too. And that is, how did you guys decide what conditions to put on this sequencing panel? Because I guess that's such a controversial issue generally, and depending on what results people are going to get back for what conditions, that will probably affect just everything downstream, right? Was that controversial at all? Yeah, it definitely was. And given the research group that I'm working with, there were advocates of including everything. But we ultimately decided to include pathogenic variants associated with childhood onset conditions because there's potential for more imminent manifestations and use of that information. And because parent, not only for the infant, him or herself, but for the parents who may still be making reproductive decisions, those results could more directly impact their reproductive decisions. So we have one PhD postdoc who has been curating the literature for months and months and the existing databases and identifying, starting with a medical exome, going through all of the genes and identifying those that have solid evidence for childhood onset and strong associations with disease. So that's, it was a process, but that's how we settled on it. So just to respond to what you were saying, Laurie, and Danielle can jump in whenever. I think that, so the, I think in terms of collaboration, what I found most helpful is looking really close to home. So I haven't collaborated with lots of big outside groups, but obviously Danielle and I collaborated because we knew we were familiar with each other's research training from being in the program together. And I think we've also had some really fruitful collaborations, as Layla knows, with students involved in the program as well. So I think that that's been really fruitful for us. Yeah, and I would say I'm going to go to the practical side of things, that my day job has nothing to do with exome sequencing. So I work in industry. I have a very different job. So the hat that I get to wear doing this collaboration serves the purpose of keeping my fire lit about what matters in genetics. So I think that the way that I can do this is that Julie has a 100% research job. I have a 100% not research job and we can find the middle where I can find pieces of this to be a part of the team. So that was very, like from a logistical standpoint, that's important. Although one of the things you guys haven't talked about is why you needed a collaborator, which I think is a central issue to Lori's question. Yeah, absolutely. I think that it would be entirely too close to home for me to conduct the interviews because I interact with our participants in every other way. So I'm trying to divorce myself from that process intentionally. And then coding the transcripts was another area that we introduced. We're having research assistants and summer students do that as well. Also just because there's so much that I could impose upon participants' responses just because I interact with them in so many different ways. While my mic is on, though, I had a question for you, Sarah. I think that the project is super interesting. I'm curious if there is a mechanism. I feel like there's as much to be learned about the declineers as from people who choose to participate. And I'm curious if there's been any discussion of trying to ascertain some reasons for declining at all. And also then I guess a practical question that I'm just curious about is what's the blood volume here and how is it obtained, especially from the healthy newborns. I think that's so interesting. I know you're doing consent. I was so curious. That's right after they've given birth and how long is that process? Because your consent is pretty long, right? OK, remind me if I missed some of these questions. So declineers. So we plan to ask for basic demographics and a reason for declining. We haven't yet come up with, are we going to provide them with some structured reasons and then give them some option for free text? But we will try to gather those reasons. What was your second question, Julie? Blood volume. Oh, blood volume. I'm just so interested in that. Yeah, so we're going to, for the NICU babies, we're going to try to time it with a clinical stick. But there are, I'm forgetting exact volume, so unfortunately I won't be able to give you that. But I know there are regulations in how much blood can be drawn within a certain time period. And that could get, we may have to really think carefully about that because for the NICU babies over the course of their NICU stay, it could exceed that with the addition of our research draw. So there have been, this is a bit tangential, but there have been discussions about how closely should this model newborn screening and should we try to gather on the Guthrie card, you know, and then. But I think what we've ultimately just, I think we're at a decision at this point is that that's not really the intent or the goal of our study is to, it's not to model newborn screening, but it's to look at the use of this information. So we're probably, we're probably talking at capillary too, but I don't know exact volume. Yeah, I would think that's possible. Yeah, and I'm sorry Trisha, what was your other question? My other question was just about the consent, how you envision how much time when, I just think practically speaking, newborn postpartum period is, people barely remember they had newborn screen, you know, the long genome sequencing. Yeah, and that's part of why we did the pilot survey in that period, but again, that was so different than actually offering parents participation in the study. So our goal is to do consent in the hospital, before moms and babies are discharged, but we'll do it any time up until 30 days of life. It's easier, easier of course, if they're in the hospital and they're the captive audience, but we also don't want to put time pressure on parents when that's obviously not the ideal time for some to be making a decision like this. So, but we would ask them to come back for, at least for the blood draw, but we'd ask them to come back and that adds that that logistic difficulty and, 60 to 90 minutes? 60 to 90 minutes? If you consider the pre-enrollment counseling piece, which I really think is more just consent, it's just a thorough consent. So that's probably in itself like an hour and then the actual formal consent, signing the paperwork, blood draw and family history, I would say that would add another half hour. You're anticipating getting declineers for that? Or people who opt out halfway through. I mean, it's very onerous. I need to breathe, I need to breastfeed, I need to. Can you tell Trisha just had a baby? Yeah. I mean, the study as a whole, it is quite onerous for them to come back for the results, come back again a year later for the exam, yep. I had a question too for, I think it was Katie. For your side, do you, or anybody, do you know if anyone's ever looked at, I find it so interesting what people are more surprised about with their genetic test results and I'm not surprised, well, somewhat that they're more nervous about the things that are already in their family. Just thinking of people in my own counseling for direct consumer, people who have a history of Alzheimer's, that's the one that they freak out about, right? You could tell them they'd be at the same mutation, they would, whatever, it's not in my family, I don't care. Has anyone asked, are you guys asking if people are an opt out of things that are in their family, like presented that way, you know, you can opt out of Parkinson's results or you can opt out of heart disease? I don't know about anybody asking about it in that way. I think it's an interesting way to think about it, but I think you're exactly right that when you break it up into categories of like preventable or unpreventable, the examples that are gonna come to their mind and that they're pulling out for you do tend to be these things that either are in their families or that they have some sort of experience with in the community through friends or things like that. But I don't think anybody that I know of is asking about that as a specific sort of type of result or a way of categorizing, so it's a good thought. What about the one, you'll know about this and I don't, the one result where the woman's family history was so burning to her they made a special exception and looked for the mutation. So it's the opposite of what you're saying. It was actually turned out to be essential to her motivation to participating in ClinSeq to begin with. Yeah, so we have people all the time who actually are calling about this and really want this. I actually just, it's too bad Nina's not here. Nina's one of the counseling students and she just consented somebody on Friday and that was exactly what she wanted was will you take my family history and then adjust my risk profile for the things that are specifically in my family history based on what you see genetically. And I think it was so instructive for us because I didn't, I don't think about it that way. I think about a genome first approach but so many people look at this as a way of modifying existing risk. And so it really does make sense and a lot of people that is absolutely what they're after so it may be a really helpful way to talk about risk in the consent process and I think when we're returning results, yeah. Well, and Trisha probably the people who don't want to know about the thing in their family aren't gonna enroll in this or tell you about it, right? So which again gets back to the thing I had asked Katie about which is like to what extent should we even be thinking about this as predictive genetic testing for something that's in your family because it's totally different from that. So I had a question for you guys and for Sarah as well just thinking about the fact that the most impactful results are rare events and you have a great sample size but it's still a rare event particularly for the healthy cohort. How we go about getting that data and really understanding what that's like for people. Questions slash comments slash concerns slash challenge. Clint Seek I think is, I mean, yeah, that's never, it's our sample size is really too small but it's a really great consideration and we talk about this all the time that for many people this is really, it's not a big deal until it is, right? And so it's like one in a thousand people for whom it's gonna be a big deal but it's a lot of people you have to, it's just interesting I think, yeah, it's a big consideration. Partly out of concern that we would have boring results, we would have nothing to say to people that's probably the reason why we decided to include carrier status and to include a limited number of pharmacogenomic variants so these aren't necessary, they're not as impactful but at least it's something to talk about, something to study. One of the things that I was taking note of, it seems like a lot of this is cutting edge research based on rolling out new technologies but in our sample today, and I know there's lots of other examples of things we're doing that weren't discussed today, we didn't talk much about effectiveness of genetic counseling, a little bit with Agillian's engagement protocol but effectiveness of genetic counseling in meeting client needs and I wonder what thoughts you had as you were listening to these talks about opportunities to pursue related questions. I don't have an answer but I think it's such an important question and I think it's something that we should, it's so many of us now are getting engaged in these sorts of studies that are being funded because they have the question about the genetic testing itself and is there an opportunity for us to really push what's the role of genetic counseling in the study and are there embedded questions that we can include that either qualitatively allow us to look at the process, those are probably the easiest to put in, look at the process of what the counseling is like and what patients take from it but also are there things that we could do even further than that that can we embed a separate nested randomized trial within the randomized trial to look at different interventions I think the extent to which we can take advantage of these opportunities and do that would be great, it would help Agillian's quest for evidence-based practice and the practice guidelines, I think that's really where we need to be going and we're not gonna get those kinds of studies funded on their own right as easily as these other, the larger studies are getting funded. So I really like the part of, I hope I'm getting this right, I really like the part of Agillian's talk where she said that the ultimate outcome is better health outcomes for patients. So a lot of the things that get measured when we talk about genetic counseling, efficacy and evidence-based are proxies for the ultimate goal which is people not dying from cancer, people having better, and better health outcomes has a component of psychosocial health as well as not getting sick. But that seems to me like we get all caught up in these proxies for what the real goal is and we lose sight of what we're really trying to accomplish. So I mean I tend to now think more in terms about when I think about what I'm trying to accomplish in our reporting and things like that that actually I'm not so much focused on the proxies like people being understanding people, I mean to the extent that understanding your results leads to a better health outcome that's great. But actually if you really had to weigh things it's actually better that they not get cancer than that they understand autosomal dominant inheritance. And so I really very much like the idea of focusing on health outcomes. Katie won't brag so I'll talk about her from the other end of the table. She's spending all of her time now implementing an exquisitely complicated randomized control trial that gets at what we were talking about a few minutes ago which is taking advantage of return of carrier results to clinical participants where Katie's being compared to a web-based platform in terms of returning results, looking at similar outcomes. And each of those two cells is randomized to half of them received genetic counseling and half of them not. So it also looks at the additional question of potential added benefit or not of genetic counseling following the genetics education. So she's very tightly sticking to an education model for the first part that parallels the information that's in the web-based platform and then doing more counseling is a separate endeavor. It's very hard to do because you have to resist all your clinical instincts to do counseling at the same time you do education so it isn't necessarily pleasant. But I think it's a really cool opportunity to tease apart where we need services. And somebody when I presented the original design in our SBRB works in progress, somebody said, you could put your profession to shame and you could put him out of business by doing this study that that was a peculiar, he was being provocative. But the truth is I don't care. I mean, if we find out that people learn information about carrier status in a way that's effective and useful to them and they have a good idea what they wanna do with it, just as well is with Katie, Katie is a lot more expensive than a web-based platform. And it would be really nice to have one at home on your computer that you could have charge of and manage, why would we not want to preserve our time and effort to people who really need it? So I think there is some practical value in just, especially as things roll out into mainstream medicine starting to ask, it's a fairly boring practical research question, but I think it has some real implications for going forward and helping us from a research perspective carve out where are the patients that really need this? A lot of them aren't paying in preliminary data, aren't paying a lot of attention to things that were unexpected, they're not landing on them too much, they're not too worried about them, so there's not a lot of counseling needs there. There may not be a lot of counseling needs around carrier status, obviously, we haven't gotten any data to analyze yet. So where are the points at which genetic counselors need to be involved? And as this rolls out, it's pretty important for us to identify places where important client needs are being met. And I agree mostly with Eric, I still think that there are a couple of proxy outcomes for which there's evidence they're linked to behaviors that are pretty important and those psychological well-being outcomes I think are important to capture as part of well-being overall, good health, but again, everybody knows forever I didn't care if people understood all the details because that's not necessarily related to what they do with the information and whether or not they're better off for it in the long run. So I think we have to pay a lot of attention to the implications and practical value of the things that we're studying. Not everything we do needs to be about saving genetic counseling in the future and I think it primarily has to be hitched to what clients needs are and whether they're being met but I think a good portion of our effort should be focused in that direction to think a little bit more about as Lori introduced adding this on to other things we're doing where we can look at potential implications for the role of genetic counselors. So I have a question for anybody who's involved in industry and being somebody who's in industry so there's all this really fascinating research going on but is industry playing a role in any of this and do you see it and do you find there is a role for some of this because if you've got 23andMe giving all these exomes, are they doing anything if you've got, where do you add that in and not academia or does it only happen in academia? So I don't know if I can give you a very concrete answer but Neha and I are founding members of a group of genetic counselors who are interested in doing research in industry and our first steps were to tackle things like private IRBs and public private partnerships and just sort of process related things in order to get these studies set up because I think especially as the industry gets bigger and bigger the need for concerted efforts to tie in gets greater and I think genetic counselors present like a really nice space where you can bring people together to do research so long as it stays in the pre-competitive space which is a new term I've learned recently. I think it'd be interesting too because I work in basically industry although in genetic counseling but to have more collaborations with other research groups because I think there is a hesitancy to reach out to industry folks like us but we have a lot of data so I think if there's any interest if you have interested persons from the research or academia side there's a ton of information probably more information about a population with which academic centers don't have access to low income, rural, not usually interested in formal genetic counseling it'd be really great to compare this population so yeah. Yeah I think for me too my company is very actively involved in research and we're constantly coming up with new collaborations that we can do with some of our clients or genetic counselors working at various MFM offices prenatal offices where they're interested in doing something they don't have the funding we have the data they're using our testing so let's use that as a way to see okay what's patients experience of expanded care screening that's not really a question that anyone's really addressed so you know those are like some of the projects but I think very open and it's really great to work because you don't have to worry about money. I think that like bridging the gap in these worlds I think that that's something that I continually think about right academia and nobody's got time, nobody's got money industry we got too much money to do something else with so where you find the middle is where I think could be really fascinating. Is there anybody here who's recently been hired by Gene DX? That's amazing cause they've just hired about 75 genetic counselors in this area that would be a really incredible opportunity with all these genetic counselors that they now have recently hired many of whom I know are interested in research they're gonna be sitting on a lot of data they hire genetic counselors for a reason they're gonna start doing a lot of this genome sequencing that would be an incredible collaboration. I think we should break for lunch a few comments about lunch there is a lot of vegetarian options it's Mediterranean food and there is some chicken on one of the platters so you'll have to figure out the differences. I paid for it which I'm happy to do. I think that Chris put out a hat so if you wanna contribute a little bit don't contribute more than $10 but if you wanna contribute something that would be great you don't have to and just to remind people as they're planning their days I know some people have plans this evening but I am hosting a reception at the house afterwards I need about 20 minutes by myself before you get there but not much time cause it's just gonna be wine and some finger foods so you're welcome to get there soon so I hope you'll plan on coming even if you can only stay for a short time it would be great to have you and I think over lunch while I encourage you to sit with people and have a working lunch we can eat in here just sit wherever you want and talk about whatever you want and then we'll reconvene at 1.30 1.30 no 12.30 sorry.