 Thank you for coming to our 8AM meeting. I am Christina Caposti, Chief of the Policy and Program Analysis Branch at the National Human Genome Research Institute, and we'd like to welcome you to today's National Human Genome Research Institute Investigational Device Exemption and Genomics Workshop. And to frame the day, we're happy to have Dr. Eric Green, Director of NHGRI, to give a brief introduction. Thank you. Thank you, Christina. Good morning, everyone. It's great to see you, and we also welcome what I understand are an equal, if not more number of people who are joining us remote through our video cast, so it's nice that we can bring people into a meeting like this in multiple ways. So I want to thank all of you for joining us for this workshop on Investigational Device Exemptions, or IDEs. This workshop was designed to have this topic discussed specifically within the context of genomics, and it really reflects what is a significant collaboration now between NHGRI's Policy and Program Analysis Branch and then our colleagues at the Center for Devices and Radiological Health at the Food and Drug Administration, FDA. Now as all of you are aware, genomic knowledge and technologies are advancing at a breakneck speed. Genomic technologies are already in use medically and hold great promise in areas such as rare disease diagnostics, cancer, genomics, pharmacogenomics, and others. Now as our understanding of the genomic underpinnings of disease continued to grow and genomic tools become more affordable, the need and demand for genomic medicine will only increase. Well to meet this need, research must pursue strategies and approaches to ensure the safe implementation of genomic medicine. Research is critical not only for generating the knowledge and the innovations that will bring genomics to medicine, but also for the informed development of regulatory policies to usher genomic medicine into broad clinical use. Well NHGRI funds a number of test drive programs, as I often refer to them, that are really relevant in this context, for example our Clinical Sequence and Exploratory Research or CSER program. Another example is our Clinical Genome Resource or ClinGen program. These efforts collectively aim to push forward genomic medicine applications and to define the strategies best suited to ensure the responsible integration of genomic information into medicine. Well in light of these transitions, investigational device exemptions or IDEs while not new have become relevant to genomics research community much more recently. And so as such, our goal today is to provide practical information for those who wish to learn about FDA's IDE regulations when they apply to genomics research and how to fulfill them when carrying out genomics research studies. I can tell you that this is again part of a broader context and interactions we have with the FDA. We're going to continue to work with the FDA in order to seek the twin needs of enabling innovation but also promoting patient safety. Or our two organizations ongoing collaborations are necessary to continue advancing the field of genomics at this critical juncture. Now of course researchers and IRBs and all of us in the research community have to play a role in this transition as we move from bench to bedside so we need to be aware of the regulations that might impact our work and learn how to navigate the requirements. We look forward to hearing throughout the day from a diverse set of perspectives representing both research and regulatory bodies. That's the way the agenda was formulated so that we can learn from one another, identify best practices and address knowledge gaps that exist between our communities. And HR anticipates an informative and productive workshop over the next eight hours or so. Thanks again for joining, whether you're in person or remote and I hope this proves to be a fruitful and productive set of discussions. So with that I'm going to turn this back over to Christina. She's going to tell us a little bit more about the charge for the day and also describe some of the logistics. So Christina.