 Hi, everyone. Welcome. Thank you so much for joining us today for this webinar entitled Introducing the NIH Inter-Society Coordinating Committee for Practitioner Education and Genomics Pharmacogenomics Learning Series. These are new peer reviewed online education modules for healthcare professionals. My name is Roseanne Gamble, and I am one of the co-chairs of the Pharmacogenomics Project Group of ISCC PEG. I'm also an associate professor in the Department of Pharmacy Practice at Massachusetts College of Pharmacy and Health Sciences. I'm joined here today with my colleague Dr. Phillip Empy, who is the other co-chair of the Pharmacogenomics Project Group, and he is an associate professor in the Department of Pharmacy and Therapeutics at the University of Pittsburgh School of Pharmacy. And again, both very excited to share with you about this new educational series that we have developed with our colleagues in the Pharmacogenomics Project Group of ISCC PEG. Please. So for our learning objectives for the next 30 minutes or so, we'd like to review first the importance of pharmacogenomics education for healthcare professionals and review the existing competency standards. And then secondly, to describe the new pharmacogenomics learning series for healthcare professionals. Next slide, please. So first by way of background, just to give a high level overview of the topic today, a little bit about what is pharmacogenomics. So pharmacogenomics is the field of study that lies at the intersection of pharmacology and genomics. It's the study of how our genes impact medication response. And what we're trying to do essentially is to personalize medication prescribing based on an individual's genetic profile. So we hope to optimize medication outcomes for our patients. Next slide, please. So by using genetic information essentially to guide our drug selection and dosing the real goal here again is to maximize the likelihood of drug efficacy and minimize the likelihood of adverse drug reactions. We know that one size does not fit all in medicine and there are many factors that influence medication response and genetics may be an important factor in that equation to take into consideration. So by using pharmacogenomic data and clinical practice, we're really hoping to cut down on that trial and error process of finding the right medication at the right dose for a patient. Next slide, please. It's important to note that pharmacogenomic variation is very, very common. So we've seen in study after study, looking at cohorts of patients and doing this type of testing that 99% of people carry at least one medically actionable pharmacogenomic variant. And so it really speaks to the relevance of this topic and the real potential for it to have an impact, a really big impact on patient care by using this in our clinical practice. Next slide, please. There are several evidence-based pharmacogenomics resources for clinicians that are available that really help clinicians understand how to interpret these results and as well as how to apply them to patient care. I'm going to briefly highlight three resources here. But there was a really great session this morning at 11 a.m. Eastern. And if you did miss that session, know that there will be a recording posted soon to the genome.gov website for the healthcare professionals, Genomics Education Week. So you can catch more details there. But just for a brief overview of some of the evidence-based pharmacogenomics resources that are available. First, we have the U.S. Food and Drug Administration Drug Labeling. So currently there are over 350 medications where the FDA includes pharmacogenomic information in the labeling for the drug and that prescribing information. And not all of that information is clinically actionable. It doesn't all associate with medication changes necessarily or dosage adjustments, but some do. And so there are some very important gene drug associations that are highlighted in some drug labels. In the middle here we have CPIC or the Clinical Pharmacogenetics Implementation Consortium. This is a global consortium that essentially its mission is to create evidence-based peer reviewed, freely available clinical practice guidelines for gene drug associations. These guidelines are used worldwide to translate pharmacogenomics into clinical practice. And they really do a great job of really breaking down how do you interpret a genotype result, you know, pharmacogenomic result that you would get back from a laboratory. And then how does that translate into very specific prescribing actions, whether that's a dosage adjustment or specific medication selection recommendations. And then on the third panel there we have FarmGKB or the Pharmacogenomics Knowledge Base. This is a resource that essentially provides a searchable database of genes of drugs. You can also search for gene drug combinations and it's going to pull in a lot of very nice curated information about the gene or drug of interest. It's going to show you primary data, summaries of the primary data. It's going to pull in prescribing information from the FDA and other regulatory agencies worldwide, as well as provide summaries and links to available guidelines from CPIC as well as other guideline writing groups. Next slide please. So in terms of the current pharmacogenomics landscape and some I want to highlight a couple of factors that are really driving us towards needing more education and pharmacogenomics for healthcare professionals. The first is limited implementation. So in the current, you know, medical practice today, pharmacogenomics is not yet standard of care for many gene drug associations. So in spite of having available clinical pharmacogenomic tests and evidence based guidelines, we are seeing a lag in terms of the implementation of this information into clinical practice. And a big reason for that is really we don't have enough, you know, education for healthcare professionals yet in this space. So it makes sense that if clinicians don't know about pharmacogenomics, haven't had sufficient education, they're not going to be comfortable ordering these tests or interpreting and applying the results to patient care. So in order to bridge that gap between the science of pharmacogenomics and its clinical application, education really is key in helping us to do that. Secondly, here we do see increasing patient access to pharmacogenomic information, oftentimes outside the traditional healthcare paradigm. So yes, we do have clinical testing there are a number of sites across the US for instance that are really leading in the clinical implementation of pharmacogenomics and they have really robust implementation services, where many patients are getting this type of testing but again that's not routine in all healthcare settings as of yet. But outside of the clinical setting patients increasingly are getting access to this information often on their own accord. So for example, there is such a thing as consumer initiated provider mediated testing. It's kind of a semi direct to consumer model in that patients can go online essentially to a pharmacogenomic testing companies website, order a pharmacogenomic test, and a physician who's employed by the patient can then sign off on the order, and then the patient can submit their sample and get back clinical pharmacogenomic results that can be used to guide their medication therapy. So in this particular instance there's no direct patient provider relationship there but the patient's really taking the initiative to get, get this data on their own and then they may bring it to their primary care provider or other healthcare professionals. We also have true direct to consumer pharmacogenomic testing that's available as well. And so this is a model where there is no healthcare professional involvement at all. And the consumer can again, you know, buy a direct to consumer genetic testing kits submit their sample to the company and get the results directly. And then it's up to the consumer then to determine you know when and how they want to share those results with other healthcare professionals. Now for most direct to consumer genetic tests they do need clinical confirmation before use in, you know, guiding medical care. However, pharmacogenomics in pharmacogenomics there are a couple of exceptions to that currently and so some direct to consumer pharmacogenomic test results may be able to be used directly to guide prescribing. And lastly here we have research so there are ongoing research initiatives in pharmacogenomics whereby research participants may receive a pharmacogenomic test results and a really great example of that that's ongoing right now is the NIH is all of us research program. And so their goal is to enroll a million participants from across the United States in a large precision medicine kind of research program. And as part of that program they are returning genetic results directly back to research participants. This includes genetic test genetic results for disease risk but also pharmacogenomic results. The caveat here is that these are research results so they do require clinical confirmation, but you can imagine that many people who will receiving this information will then turn around and bring it to their healthcare professionals and ask them about you know, getting confirmatory testing and asking them to explain those results and what they mean for their care. So again in summary here all of this kind of pointing to the need for more education pharmacogenomics for healthcare professionals. So when it comes to genomics education for healthcare professional there are competency standards competencies that have been published for a number of different healthcare professional disciplines. You can find links to these different healthcare professional competencies on the genome ed resource it's part of the genome.gov website and the link is down there below. Genome ed is a resource that kind of pulls in it's a website that pulls in a lot of different educational resources in genomics, and there is a link there as well to these disciplines specific genomic competencies. So we currently have published competencies for physicians pharmacists nurses, PAs and genetic counselors in genomics, and there may be varying levels of pharmacogenomics competencies across these different disciplines. We do see the most competency standards in pharmacogenomics for pharmacists but certainly is relevant for other healthcare professionals, particularly those who prescribe medications. A really key point here that I'd like to emphasize is that pharmacogenomics education is important for all healthcare professionals, and not just a select group of specialists who are really focused in this space. Next slide please. And with that I'm going to hand it over to my colleague Dr empty for the second half of the presentation. Thank you. Thank you, and welcome everyone. I want to reinforce one of the information elements that Dr Kamala just emphasized regarding availability of education. That's out in the marketplace, and you're looking at data from one of the ISCC peg scholars from the last couple years that conducted a survey of professional societies and organizations about they're thinking about whether they had enough education to be available for their members. So this was a couple hundred organizations that were surveyed, and you can see the majority of them came back asking and stating that they needed major addition to the current education materials. You can imagine these may be professional societies who are serving their members by offering continued education, or are serving their membership and providing education of all forms to try to keep practice standards current in all purchase all providers these 57% cited maintaining an up to date curriculum was a significant barrier to being able to provide this resource to their membership. So this ISCC peg come in. So as was mentioned previously the inner society, coordinating committee for practitioner education in genomics is an NHG or I organization that brings together volunteers who are passionate about educating healthcare practitioners. There are 200 individuals organizations and industry members who seek to either contribute education specifically, or connecting collaborate with others who have a passion for educating and for thinking about how to disseminate genomics into practice through education. So this group is led by doctors measure Smith and Haspel, and has a number of individual domain expert area subgroups I mentioned in a moment, but the main goals are to identify these educational needs and potential solutions to share best practices and educational approaches into develop educational resources as was mentioned and if you were to go to genome.co.gov, you can find a very prominent banner that emphasizes the organization and I, I'd urge everyone to click on the link below or go to the ISCC peg website to be able to learn more and consider joining us. I mentioned those project groups earlier. Today we'll mention the pharmacogenomics one specifically, but there's a large number of specific project groups that have a variety of different interest areas within genomics. There really does offer tons of opportunities to connect with other like minded professionals who are interested in education. And I have the pleasure of co chairing this group with Dr. Kamal, as was mentioned earlier in pharmacogenomics specifically. As we recognize very early on as was mentioned earlier, as if you look at the adoption curve that may be familiar to many of you. As we have innovations that need to disseminate into practice we go through phases where there's innovators, early adopters, and then we begin to rise to the early majority, the late majority and then finally the laggards. I think that's accepted that this chasm that happens early in the expansion of adoption is a challenge. It's a challenge to overcome. And so focus of education and dissemination. So this is where I think the pharmacogenomic project group and ICC peg as a whole, and really fill the gap. Our goals and our project group are to create and repurpose pharmacogenomics education content and resources targeted to clinicians to prepare presentations and clinician professional meetings to tailor pharmacogenomic education for content for all healthcare professionals. And finally to educate the public and pharmacogenomics to improve health care. So again really focus at overcoming that chasm to accelerate pharmacogenomic implementation. So I'm really excited to announce and really bring to conclusion, really what's been a multi year effort among our membership and announced the release of the ICC peg pharmacogenomic learning series. This was our group's effort to develop expert content on highly contemporary topics and pharmacogenomics that could be broadly shared and be highly accessible, and would meet the need in this evidence gap we mentioned for needing to disseminate education to all healthcare professionals, and particularly to make it broadly accessible and could be disseminated for to a variety of sources to those organizations and to within memberships of those groups sought education specifically. So these are the modules that have been developed to date again this is a multi year effort on the left hand side you see the module titles, and it starts off with nomenclature moves into pharmacogenomic resources, practical aspects of pharmacogenomic education, genetic testing, direct to consumer pharmacogenomic testing, economics of testing, how to navigate pharmacogenomic test coverage and Medicare populations, and then specific focus areas on gene type guided clop integral treatment, as well as optimization of psychiatric treatment with pharmacogenomics. And I want to call everyone's attention to the authors again these are volunteers that are providing their time within ISCC peg to really draft excellent peer reviewed education materials that can be disseminated. So these modules are created that go through internal review within our project subgroup, and then our shared to external peer reviewers that are in broad practice areas or broader practice areas for comment and then finally approved at an HDRI level for further dissemination. And I mentioned our goal was to make sure they were accessible. So the models that we've created our tech space to start off with their self paced meaning you can access them on your own busy schedules, anytime during the day, and on demand. So if there's an interest area you could simply click enroll in the course and step through it. And these modules are about an hour long and for most of them, and provide again expert content that are quite engaging and interactive as the way they are developed. So this is an example of a screenshot of the pharmacogenomic resources one. And this is how it starts off explaining about one of the resources that was mentioned previously that clinical probably go to next implementation consortium. So this is into introducing cases and how to use this particular resource as you walk through engaging interactions with questions with immediate feedback as to how you may use in particular resources in this example, and even interacting exercises where you can sort and try to link concepts together that you were just taught through the education materials. And then finally, additional on to the higher level beyond multiple choice matching exercises and other type of interactive ways of engaging the learner around this expert content. It also links out to the external resources that may be useful that are all freely accessible and made available within the program that may be on resources you're familiar with or resources that you need to learn more about that are connected to the education materials. So really excited to be able to say that these are freely offered. They're hosted online you just need to do a free registration. And then they're also we made them available broadly for continue education with a small fee due to collaboration that we've organized with the University of Pittsburgh School of Pharmacy. And then we've got these education approved for a broad number of health care practitioner professions. You can see them listed here and working to continue to expand those for all health care professionals to be able to see continue education as their professional licensure may require it. But again, and if you're not seeking see they're also free to learn and freely accessible. They're available now. If you go to the website that's linked at the bottom there on the genome.gov website, you can find a link within our project group within ICC peg to click on the individual references you'll be transferred directly to the University of Pittsburgh where they're housed. We have a very quick registration to create an account so you're able to submit your continuing education if you'd like to do that, and we'll be increasingly adding more modules as they're completed in production, and we'll be seeking additional interest areas with our pgx group to see if there's other areas of interest within pharmacogenomics as we continue to expand the series. So I just want to conclude here today to again offer membership in the pharmacogenomics subgroup with an ICC peg really easy to join just click on the website there and go and visit. We're seeking new members I know that ICC peg as well but also our project group so if you're interested in education genomic education of any kind, please do join us. We're seeking new members, either individuals professional organizations representatives from those organizations industry as well to really advance and try to fill that chasm and that gap in getting pharmacogenomics to be implemented in a greater fashion. Also want to call your attention we mentioned one of the earlier sessions that was 11 o'clock Eastern time. And of course this one just finished up is finishing up now, but there's also another great webinar that is scheduled for 3pm from Dr. Hadar at St. Jude talking about clinical pearls and pharmacogenomic implementation. So if you go to genome dot gov right now and click on the banner image, it'll take you right to the med gene at 23 page and all the registration links for zoom or right there just as you registered for the presentation here today. Thank you very much for your attendance today, or do you want to consider this questions. We're certainly here to answer them and you can take advantage of the question and answer period. That's, that's going on now, and I'll invite Dr come out to join me as well if there's any open questions from our audience members. Please feel free to add questions to the Q amp a feature. I don't see any questions yet. My colleague Dr. Gamal you're in the spot. Can you share a little bit about your participation is CC pegged in the pharmacogenomics group. So maybe how long been a part of it and what you enjoy participating in. Sure, absolutely. Yeah, I believe I joined back in 2017 so I've been a part of it for quite a while. It's really a great forum to meet others in the field who are also passionate about pharmacogenomics education. So I've really enjoyed getting to know others in the field and again collaborating on efforts such as our, our new learning series, because that's something that as someone in the field I hear all the time when I give presentations is like how can I learn more what are what are available resources or anything that's freely available for me to learn more about this so it's really great I feel really honored to be a part of this to be able to put something like that out there and be and be a part of this group that's doing that. So yes, I really enjoyed it and recently became co chair with with Dr. MB, not too long ago Dr. MP is is provided really great leadership for this group for the last several years. I don't know if Dr. MP you want to talk a little bit more specifically about your experience as well. Yeah, thank you. So, yeah, one of the things I enjoy the most is actually the inner professional nature of it. It's really nice from all disciplines on and really passionate and it's really nice to see, especially a volunteer led organization able to contribute and get such a important deliverable across the finish line. So we're proud of the model that we developed and the partnerships and the ability to disseminate that. Absolutely. We have some questions as well. So the first one is from Tina Butler. These modules are great how do you envision health system is using these. Maybe I can tackle that one. First. So they're, they're accessible. So between anyone really can access them from anywhere and they're, you know, geared to be for learners at all levels so they're not expecting anyone to have significant foundational knowledge to start. So there's an interest group within a health system that would like additional training. Individuals can sign up certainly healthcare professions can direct folks to it. Again there's no additional requirements for any partnerships or, you know, payment for to be able to access and they're designed to be a freely distributed resources. They can be short and sort of focused in that way so they can be bite sized you can select the ones that are of the most interest to you. The next question is about will the recordings of these lectures be available and how to access them so yes they will. I believe there was a link that was pasted in the chat at the beginning of the session. So the healthcare professionals to know makes education week through the genome.gov website where you kind of registered for all of this so they'll be links to recording some soon for for these different sessions this week. And then I think the next two questions are maybe somewhat similar. The membership is wide open, we do have members in our project group that are from Europe. So you certainly welcome to join. But not only for folks working in health care specifically we have patients in some situations we have, you know, the lay public we have folks that really the interest is that you have an education an interest in education in genomics. And those multiple different perspectives I think are really an asset, as we developed education that meets the needs of a variety of learners. The last question here, how concurrent genetics undergrad students become more involved in pharmacogenomics within their coursework is it possible to aid in the ISC peg effort at this level. There isn't an ISCC peg scholars program, whereby trainees can apply and it's a two year commitment, and basically you'd be paired with a mentor in a project group and work on a project related to genomics education. And so on the ISCC peg webpage there's I think there's a link there information there about the scholars program and that kind of application process. Is there empty job anything else to add around that. Yeah, I'd be happy to so it is mentored. So the goal is that we will partner a scholar with a mentor within the organization where the projects make sense and line up and there's typically a admissions process in the fall so I'd encourage folks to look at it as it approaches in the summer and early fall, but we've had several rounds of scholars and really it's it is competitive to be able to be selected. But it's a wonderful opportunity to get connected with educators who are excited about disseminating genomics education in whatever area of genomics you're interested in. And just to reiterate and maybe in closing the this recording will be available on genomes.gov. It'll take us a little bit of time to get it up, but we'll be sure to make sure it's disseminated there. And with that, on behalf of Dr. Kamala Kamala and I, we certainly appreciate everyone's attendance today and hope you enjoy the education materials that are available and again would encourage you to join ISCC peg. If you're interested all in genomics education and we'd love to have you. Thanks so much. Thanks.