 So, let me thank the co-members of our little panel, and Bob Wilden will talk a little bit more about the ISCC after I present a few items, and Wendy Rubenstein has graciously allowed to take some notes, and thanks to Julie also for her input. So, I think one interesting thing, and this is like shamelessly sucking up to Eric Green, but here it goes. I really liked some of these comments that he and Greg made in a piece in JAMA a couple years ago, because I think it makes us think about what is the goal of education and just a few lines from this. Clinicians need not become geneticists to make use of genomic advances any more than they need to become radiologists, to make use of imaging, and that the genomics community has to align our educational priorities with those of the health profession groups we wish to educate, and really act considering the discussion that we just had, all clinicians are going to need informatic support to interpret and act on genomic information relative to patient care, and ensuring that high-quality software tools are available will be more important than forcing them to understand the intricacies of how these tools work. And I put this up here partly to just get discussion going and get us thinking about whether we're all going at this the right way. I am part of this group, which includes many people in this room, that this was a work that was done through one of the ISCC's committees to try to put together a framework for developing physician competencies in genomics, and this is a, I don't know, a six or seven page document with tens and tens of these bullet points of elements of a competency tasks that would need to take place, which I think includes an incredible expectation of expertise on the part of clinicians. So knowing the indications for genomic testing, explaining all the implications of putting the results in the chart, how incidental findings are going to be handled, on and on and on, I do think that it's actually quite a detailed list of tasks that we would expect general clinicians to know in order to be competent in genomics and wonder whether that's realistic. So related to GM8, we've done a great job of putting together how all of the GM-funded focus programs and related programs deal with educational issues and also issues of genomic interpretation, and I've highlighted some of these here in red. And I won't belabor it, but just to say that there are many of the groups that are represented in this room that have taken on different aspects of education and of how to translate and interpret genetic information to try to make it usable by clinicians. And likewise, a lot of barriers have been identified to doing this. From different groups, these include things like harnessing social media and crowdsourcing methods, having concise, comprehensive and interoperable lab reports, which we've just been talking about in panel seven, having use cases for CDS development, and the fact that there's differing education needs across different professional levels. So just a little bit of detail about some of the existing efforts on education of clinicians, and I've just summarized from Cesar's documents some of the items that they have listed, which include high visibility interactions with different scientific and professional exportations, eMERGE has a working group on consent education regulation and consultation, IGNITE has a working group, and then as we'll hear about from a moment, Bob has been very involved. The ISCC is completely devoted to clinician education, and the group that I'm most closely involved with, CPIC, creates these gene drug guidelines and we are trying to get these out widely to the community and get feedback from the community so that they're as useful as possible for those who are actually implementing pharmacogenetic guidelines in the clinic. So at first, I had a little bit of trouble thinking why is reporting results so closely linked to education, but again I think about as we just heard in the last hour and as we heard about a lot yesterday, we all seem to be thinking that by doing a better job of concisely and effectively reporting genetic results to clinicians will obviate the need for didactic education or will at least minimize the need for very specific educational programs, and it also will put the emphasis on the most important elements of genomics that really are going to require clinicians to understand so that they're able to practice in this era of increasing genomic results. But even in this task, I think there's some controversy in the field about whether we're really trying to interpret results so that they can, or report results so that they can be easily interpreted directly by the primary care clinician, or if the assumption is that still these results will need help from experts that needs to be asked for by the primary clinician in order to actually implement those results in their clinical practice. And again, I mean this problem has been recognized by many of our groups, so for example, Emerge has programs to develop, implement, and evaluate the process of clinician patient education from results. There's an app or a website, MyResults.org, that has patient information about genetic results, and my understanding is they're developing a genomic clinical decision support artifact repository, and they can clarify, the Emerge people can clarify as we go along what's really happening with that. And again, I think we've heard several times during this meeting about what kinds of repositories, what kinds of commons can be created by the genomics community, what kinds already exist so that we don't reinvent the wheel too many hundreds of times in order to share information among all of us who are doing clinical implementation of genomics. We've also heard a lot about the IOM Roundtable group working on genomics, and this subgroup it has called Digitize, which many of us are involved in. And this is really highly relevant, again, to the discussion we just had, trying to enable standardized genetic information in the EHR to ensure interoperability and usability of the data in the clinic and for research applications. And so I guess I think that this is where we bring it back a bit to NHGRI, who's in the business of funding research, that to do the kinds of EHR-based research, to do the kind of deep phenotyping we've been talking about, and even to use the clinical genomic information that's in the EHR, we've got to have a way to dig it out of the EHR, and we currently don't have interoperability or standardized terms. In the pharmacogenetic space, CPIC has taken on this problem of standardized terms because it's directly related to our ability to provide advice that can be directly utilized in the EHR by clinicians. And so we've gotten very, very specific about helping to standardize some terms that will result in being able to share information and build CDS to act on the genetic test results. If the CDS that's based on the genetic test results is really the way that we're going to, quote, educate clinicians, then we have to build the terms that can drive the CDS. And right now the EHR vendors are telling us you don't have terms that can drive the CDS. Would your community please get their act together and decide on what terms we can use? So that's part of what we're doing in digitize. Challenges have been identified by, again, by several of the groups. So CSER has identified that these lab reports need to be developed and integrated and optimize interpretation of these given inherent time constraints in the clinic, especially for diseases that may have a poor prognosis and a short window for action. And they're trying to assess and report on common themes across the CSER sites. IGNITE has identified the differing education and training needs for different groups of professionals and identified the issue that there's frequently rotating staff and, again, different kinds of modules for different kinds of clinicians. And CPIC has identified that there's this limited set of use cases for genomic CDS. We are now adding these into every existing CPIC guideline as it is updated and adding this into every new CPIC guideline that's created. And I'll show you some examples of some of the CDS that we provide. So just a little bit of background for those of you who don't know, CPIC was started in 2009. We have members all over the world. The goal is definitely to make each guideline be applicable internationally, not just in this country. And I won't go over in detail, but every guideline, thanks to the Informatics Working Group that Mark and Bob Freimuth are both important parts of, has an algorithm, a clinical implementation workflow that's an example of how it can work in the EHR. As we just mentioned, we recognize that every institution has different clinical workflows, but this is something that somebody can start with about how do you go from the result to the action ability. And it includes very specific example language, interpretive language based on the genetic test result that could be taken verbatim for interpreting that HLA-B test result, in this case, in the EHR of the individuals implementing that gene. And it includes very specific, possible to copy and paste interpretive language or suggested language for the CDS point of care alerts that would fire either pre-test if an individual is ordered a high-risk drug and there's no high-risk gene on file, or post-test if they have a high-risk gene test result that's existing in the medical record, what would be an example of the kind of alert that you would fire, in this case, if the high-risk drugs, Simvastatin, were prescribed to a patient with a high-risk phenotype for SLCO1B1. So this is an example of why the test alert is going to fire off of some kind of trigger or condition based on the gene test result. And this is why CPC and the digitized group have identified that coming up with specific terms to describe the high-risk phenotypes based on the genotypes is a critical aspect of making genetic test results go from the medical record into real clinical action ability is that something has to drive that high-risk status of the patient and it's going to be better if those terms are standardized. So we started back in November or so, this project, the CPC term standardization project with a lot of help from people involved in ClinGen and many other groups as I'll show you. And the goal is very focused, very simple, and it is achievable. We will finish this in the next couple of months. We're trying to come up with standardized terms for allele functional status. And this would be an example of characterizing the allele as low, absent, high or intermediate. So whether you call it a star 2, a G to A at position 233, an amino acid substitution at position 88, you will need an interpretation of the allele's function and you will need to have an interpretation of the diplotype of the patient which is really turned into the phenotype. And in pharmacogenetics those would include terms like ultra-rapid metabolizer, extensive metabolizer, etc. So what we've been doing through this Delphi process that started back in December is to have different phases of evaluating the landscape, clinical labs, literature, preferences, doing multiple surveys of experts, requiring those experts to participate in every survey and coming to a consensus on what sets of terms can be used to describe a allele function and to describe phenotype. And we're close to the end of this process of at least being able to do that. And this is just a screenshot from one of the surveys that we did, which I know is difficult to read, but this asked people to identify the groups with which they're associated, which again includes CPIC, ClinVar, the PGRN, the IOM, Digitized Group, ClinGen's Working Group, etc., etc., CDC, ACMG and many others listed down here, the HL7 Clinical Genomics Working Group, eMERGE, etc., etc. So we really tried to get as many groups as possible to buy into this process and to participate in the survey so that we'll get as wide a buy-in as possible at the end of this for adoption of these two sets of terms. And I will turn it over to Bob just to say that the Inner Society Coordinating Committee was started in February 2013 after GM4, and it's specifically devoted to educational issues for clinicians, and we'll hear more about that from Bob. Thanks. So I'm going to move on to my... This is from the ISCC website, which is being updated. And I guess I need to do space bar. Okay. All right. So the ISCC is the Inter Society Coordinating Committee for Practitioner Education in Genomics. That's why we call it ISCC. And I want to stay at the output that the ISCC was founded and driven by Terry Monoglio, Mike Murray, as the originating co-chairs until around January when I took over and then Ann Cardi came on as my co-chair. So they deserve a lot of credit for all of the things that were going on. And then G2C2, which I'm also going to talk about, has been driven principally by Jane Jenkins in my branch. So the ISCC was indeed... Grew out of the Genomic Medicine 4 meeting in 2013, and the main goals are to gather and facilitate... I guess there's a mouse here... Facilitate dissemination of best practices and resources in genomics education, promote their translation into evidence-based clinical care. And then there's a part about competencies here, which we'll talk a little bit more about. Okay. So education... This is just my statement. Education is the science and process of disseminating evidence and methods of use. So there are a lot of words and verifying effects. There are a lot of words that are overlapping with what Genomic Medicine does, science, process, disseminating evidence generation and methods of use as well. So just the concept isn't really that foreign when you break it down. All right. So the status summary for ISCC is in your e-book, so I'm not going to describe ISCC in all the different working groups and so forth. I was asked to discuss the gaps, overlaps, and opportunities relating to the Genomic Medicine working groups. And so I'm going to break it down into these three categories for the gaps. So materials are those things that we teach, and they are essential for educators. The Genetics and Genomics Competency Center, easily known as G2C2, is a searchable web-based clearinghouse for peer-reviewed educational materials. It's a product of NHGRI with a lot of help from ISCC members. It has similar goals to the younger MedEd portal, which we do not control. That's a product of the American Association of Medical Colleges. There's some convergence going on there. But G2C2 is Genomic Medicine Specific. G2C2 also uniquely maps submitted and cleared resources to provider discipline-specified competencies. So that's a set of things that allow educators and practitioners a systematic reference by which to judge completeness of their educational program. And these are like specific aims to researchers in a way. The rate of educational resource creation lags behind the emerging translational science. And so there may be a need for incentivizing creation of educational resources. On the consumer side, practitioners and their educators need to recognize the need for such resources and their availability. So marketing could help with that and we're investigating that as well. An interesting educational material is how to communicate genetic and genomic concepts. So there's a lack of consistent widely understood common language to use when communication occurs around genetic and genomic issues in the clinic. Whether it be between the patient and the provider, between one type of provider and another type of provider or between the provider in the laboratory, for example. And there are lots of examples you all know about problems in communication. So we'd like to know if there should be a preferred language or communication mode, including images and if so, how to teach it. So we, Mary already touched on the competency issue and this is just the competencies map link page in G2C2. And establishing those competencies for genomic education is a method and the process of linking up those competencies with the resources. And so each resource gets assigned a handful of competencies that it speaks to and that's an arduous manual process for the site's curators. So that's one of the challenges to using this kind of a setup. So moving on to methods, how do we do it? How and when to make education happen? We can break it into several axes. And I was struck again with some illiteration. So at what stage of a career is the training best done? Is it for done at the academic training when you're in medical school? After that in residency, continuing medical education or during board certification or the maintenance of certifications? There are multiple levels and probably the answer is all of them. On NPR radio this morning driving in, I heard that we should be doing this on Sesame Street in early age. So the next question is who are the targets? Physicians don't operate in a vacuum. Non-physician providers also need to understand something and we need to understand what they need to understand. And there's a mode of education which is gaining some traction called interprofessional education which tends to mimic the kinds of team efforts that happen in the real clinical world. Who are the teachers? Are they all genetic geneticists, genetic counselors? How do you make more teachers who have street cred in their specialty? And how do you know that the test, the educational process that you're going through is working? How do we share our materials, methods and effectiveness measures across medical specialties and other disciplines? And there are questions, these are all questions that have limited scientific answers. So this is just an example of something that gained some exposure at the November 2014 ISCC in person meeting. And that's a promising teaching approach that was developed for training pathology residents and it was presented by Rich Haspel and involves using flip classrooms, problem solving in groups and real time use of online databases. So from that presentation, a new innovative approaches working group was founded with NISCC to explore how to make this approach apply to training other residents and other types of providers. And several training events including a training session have or will happen this year as a result of that. So point of care education is a large subject. It's another innovative approach that EHRs and the electronic world has begun to make possible. And it's kind of embolized by the info button which has a much richer possibility space and has some real science behind it, which is great. A persistent problem with clinical decision support is as people have mentioned alert fatigue, a phrase which conjures strange looks from people who don't understand the background, alert fatigue, you know. So we really need to solve the alert fatigue problem because well, I have alert fatigue, alert fatigue. So I'm sick and tired of having it brought to my attention so you need to solve it. All right, so one of the big problems is motivation and relevance. And I think this has been spoken to a couple of times excuse me, already. So what motivates practitioners to learn about genomic medicine? Is it that they have to do it to continue practicing? They have to do it for their board certification or maintenance certification. Right now, they don't really have to do it except for geneticists. Does it bring value to them? Does it bring coverage and reimbursement for what they wanna do? There are providers who really are involved in the patient outcomes. Does it improve patient outcomes? What's the evidence for that? Is it in the peer reviewed literature? Is it supported by professional practice guidelines? And are there system priorities? Are there healthcare system administrators saying this is something that they need to do? So I'm bearing all here. ISCC has some challenges. It's made up of diverse members of professional societies kind of the guilds in a way as well as representatives from several NIH institutes and centers as well and a few health systems. And some of the challenges are inherent but can also be strengths and others are addressable. So members are varied. There are differences in governance, especially for focus of what they're trying to do. There are differences in roles and responsibilities as part of the team. The mission, each member society has its own mission and they don't necessarily overlap but in general they're abstractly aligned on the same goals. The mission interestingly is not a research mission. The money is an issue. It's a volunteer organization, no dues, no purse. It's not a research organization so really doesn't pursue research grants. We are trying to get approval to seek donor funding through the foundation for NIH. Just for perspective, last week of year at the ClinGen meeting you heard that in the UK, the National Health Service is planning on spending 20 million pounds on provider education for genomic medicine. Then the additional problem is metrics. How do we know if we're having any effect and when a specific, when do we know when specific education and genomics is no longer needed? So I'll close with an opportunity slide. So in the context of this meeting, there are a few opportunities that are intertwined with the ISCC, G2C2 resource and this group. And the grid provided by Terry and reviewed by Mary shows significant overlap and Mary went over those. And I think we should consider exploring having some joint activities around those shared areas. One strength for ISCC is the opportunity to become the leader in facilitating provider education across discipline and specialty boundaries, not just through resource serving, but also by helping advance the motivators that I talked about. For this group, one of the greatest opportunities potentially is connecting researchers with organizations whose members can facilitate research activities, particularly with respect to education, communication and implementation. And I added a little note here and utility utilization of the learning healthcare system. Yesterday there was also a discussion about the emerging need for learning to do re-phenotyping and could that be a skill that's disseminated through the most multiple specialties by ISCC? And it's kind of a two-way street too. Can there be a crowdsourcing effort for finding out what are the needs in the community? And the societies are often populated by people who are the local champions for their specialty. And so if you want to try to reach those local champions, that may be a way to do it. And I'll stop there. So obviously there's lots of groups working on education, so some discussion points, I think are to go back to do we know what we want when we say education of clinicians? And are there, given that, are all the gaps and barriers that exist being addressed and is the coordination of educational endeavors across projects adequate? And likewise, there are lots of groups working on how to report genetic results to clinicians. So again, I think I left off, but I think one important thing is what's the goal of reporting the results? Is there a need or desire to catalog approaches, to harmonize approaches, and also maybe to evaluate how are all of these approaches to reporting results being shared? And I'd like to open up the floor for discussion.