 Well, thank you, Rudy. Let me reiterate the fact that we do have these open sessions webcast live, and that includes my director's report, and all of these videotapes that we're making of the open session. And all those recordings and associated documents are made part of our permanent institute's record through our website, genome.gov, for the purposes of people being able to access them, not only in real time, but also after the fact and for many years to come. Now for those of you who are new to council meetings, I want to make you aware of an electronic resource that we established for each of my director's reports analogous to a supplemental materials of a published paper. You can access this at the URL shown on this slide. And the slides that I'm going to show during my director's report are also downloadable either as the original PowerPoint file or also as a PDF. When there are associated documents relevant to a particular slide or a topic, though on that slide will be an indication of a document number in the bottom right hand corner that you could then access through the URL that's shown. In addition to the video of the open session, this particular website and all of its linked documents and websites will go into the archive on genome.gov as sort of a historic record of my director's report. Now, there's going to be several other presentations during the open session. My director's report is going to be tailored around these presentations, so I'm not going to discuss in great detail topics that others are going to cover. Immediately following my director's report, Gary Gibbons, director of the National Heart Lung and Blood Institute will give a presentation entitled Seizing on Presented Opportunities, NHLBI, Trans-OMIX, and Precision Medicine, also known as TopMed. Following that, Adam Felsenfeld from NHGRI will give a presentation on Opportunities for Synergy between NHGRI genome sequencing program and the TopMed program that Gary Gibbons is going to discuss. And then after lunch, we're going to hear two reports. One is going to be from the Genomic Medicine Working Group of this council. That'll be given by NHGRI's Terry Monolio. And then one will be about the recent Genomic Medicine 9 meeting, and that'll be presented by Councilmember Carol Bolt. Next, we will hear from Eric Dishman, the recently-arrived director of the Precision Medicine Initiative cohort program, and he will talk about the U.S. Precision Medicine Initiative. And then the last component of the Open Session will be a special presentation given by NHGRI's Jeff Schloss. His talk is entitled 23 pairs plus one lessons learned, and I expect he will explain the title when he has the opportunity to give the talk near the end of the Open Session. So with that as a general outline of the Open Session, let me now go through each of these seven areas to cover the topics that I wanted to cover as part of my director's report, starting with at least one general NHGRI update. Now as I think I've previously mentioned, NHGRI is partnering with the National Institute on Minority Health and Health Disparities, also the National Heart, Lung, and Blood Institute, also the National Institute of Diabetes and Digestive and Kidney Diseases, and finally the Office of Minority Health at the Food and Drug Administration, to hold a Genomics and Health Disparities Lecture Series. These lectures focus on the role that genomics research can have in addressing health disparities and understanding health inequities. Previous speakers have included former council member Carlos Bustamante, also Neil Powell, Geraldo Jimenez-Sanchez, and Fumi Olapade. The series will continue with three more outstanding speakers in the coming months. This includes Sarah Tishkoff from the University of Pennsylvania, Herman Taylor from Morehouse School of Medicine, and Mark Cullen from Stanford University. I will note that all the lectures in the series are being recorded and are being archived in NHGRI's Genome TV channel of YouTube for people to view. So that was a singular general NHGRI update, but now let me move to general NIH updates with a flurry of quite impressive recruitments to report on at the leadership levels of NIH. Starting with the National Institute of Mental Health, Joshua Gordon has been named the new director of the National Institute of Mental Health, or NIMH, Dr. Gordon is a psychiatrist and neuroscientist with extensive experience in mental health research and practice. He comes to NIH from New York City, where he is currently associate professor of psychiatry at Columbia University Medical Center and research psychiatrist at the New York State Psychiatric Institute. His research focus on the analysis of neural activity and mice carrying mutations of relevance to psychiatric disease. He earned his MD and his PhD degrees from the University of California, San Francisco, and Dr. Gordon is expected to join NIH this month. Moving to another institute director ship, Deanna Bianchi has been named the new director of the National Institute of Child Health and Human Development, or NICHD. Dr. Bianchi is a prenatal geneticist with clinical and research experience in both pediatrics and obstetrics. She comes to NIH from Boston, where she is the founding executive director of the Mother Infant Research Institute and vice chair for pediatric research at Tufts University. Her research focuses on prenatal genomics, specifically noninvasive prenatal DNA screening methods, and the development of new therapies for genetic disorders that can be administered prenatally. She earned her MD from Stanford University School of Medicine. Now actually as an added bonus for us, Dr. Bianchi's research laboratory will be housed with an NHGRI's intramural research program, adding another outstanding investigator to that part of our institute. Dr. Bianchi is expected to assume the role as the new NICHD director next month with her laboratory arriving and being established within NHGRI's intramural research program in early 2017. Yet another external recruitment, Maureen Goodenot has been appointed the NIH Associate Director for AIDS Research and Director of the Office of AIDS Research, or OAR. Dr. Goodenot joined NIH in July, bringing nearly 30 years of experience in HIV AIDS research and advocacy to the position. She was previously at the University of Florida, where she was a professor of pathology, immunology and laboratory medicine, leading a research program in molecular epidemiology, pathogenesis, and vaccines for HIV-1 and related viruses, including viruses that cause cancer. She received her PhD in molecular genetics from the Albert Einstein College of Medicine. Dealing with a former institute director, many of you probably heard that Jeremy Burr, previously the director of the National Institute of General Medical Sciences, or NIGMS, and good friend of NHGRI's, recently assumed the role as editor of Science magazine. Dr. Burr is currently also a member of the research faculty at the University of Pittsburgh School of Medicine. So congratulations to Jeremy. Moving on, on June 21, NIH released a new policy on the use of a single institutional review board, or IRB, for multi-site research, research in which more than one site conducts the same protocol involving human participants. This final rule follows a notice of proposed rulemaking released in December of 2014, which received 167 comments that were mostly supportive of the idea. According to the policy, all domestic sites of NIH-funded multi-site work must use a single IRB for the ethical review of research involving human participants. This policy is intended to streamline the process of IRB review and promote efficiency while maintaining adequate human subjects protection. Exceptions will only be granted if the designated IRB is unable to meet the needs of specific populations or if local IRB review is required by any federal, tribal, or state laws. The policy will be effective on May 25, 2017. Both the House and the Senate introduced bills that would reauthorize the small business innovation research, or SBIR, and small business technology transfer, or STTR, programs. The bills would increase the proportion of federal research dollars going to small businesses across 11 participating federal agencies, including NIH. Both programs are financed through a set-aside for each agency's research budget. The Senate reauthorization bill would increase the set-aside from the current 3 percent to 6 percent over the next several years and make the program permanent, rather than requiring reauthorization every five to six years. Meanwhile, the House version includes smaller increases and fewer program changes. Biomedical research advocates and several congressmen have expressed concerns about how increasing SBIR and STTR budgets under the proposed legislation might erode the budgets of other extramural research programs. Opponents of the bill proposed increasing or proposing to increase the overall research budgets of federal agencies so that all programs, including SBIR and STTR programs, would benefit. So stay tuned to see what develops in this area. After holding a series of public workshops last year to discuss next-generation sequencing, or NGS, analytical and clinical validity, FDA released two draft guidances in July. One guidance, entitled Use of Standards in FDA Regulatory Oversight of Next-Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germ Line Diseases, proposes analytical validity standards for NGS tests used to detect germ line diseases. The second guidance, entitled Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next-Generation Sequencing-Based In Vitro Diagnostics, proposes a voluntary pathway for using public genomic variant databases to support clinical validity claims of NGS tests. Now, the FDA has suggested that it will create further guidance on analytical validity standards for NGS tests used outside of detecting germ line diseases. NHGRI staff is closely monitoring developments in FDA's NGS policy development efforts. In fact, we provided input on the present draft guidances before they were released. Our staff and grantees in the ClinGen consortium have also been in close contact with the FDA to share best practices about genomic variant databases. The public comment period for these draft guidances closes October 6, and this really represents an opportunity for the genomics community to contribute to the development of the regulatory framework that will oversee the implementation of genomic medicine. Meanwhile, in May, the U.S. Equal Employment Opportunity Commission, or EEOC, released its final regulations regarding the Genetic Information Nondiscrimination Act, or GINA, and Workplace Wellness Programs. Now, it turns out that employers offering wellness programs may provide financial and other incentives in exchange for an employee's spouse providing information about their current or past health status, including genetic information. A second EEOC rule was also released to clarify the Americans with Disabilities Act, or ADA, now allowing employers to offer incentives to employees participating in voluntary wellness programs in exchange for providing health information. EEOC has also stated that employers cannot use health information acquired through wellness programs to deny benefits to employees. The American Society of Human Genetics and the Genetic Alliance released statements criticizing EEOC's ruling on the matter, arguing that these decisions weaken anti-discrimination protections. These groups argue that providing financial incentives, or in some cases imposing penalties for not providing health information to wellness programs, make the decision to provide health information less than voluntary. Okay, budget, here we go. Over a year has gone by since the House passed the 21st Century Cures Act, a piece of legislation proposing reforms and extra funding to propel biomedical innovation and healthcare interests forward. Since then, the Senate has been working to advance what is known as the Cures Agenda for their part of the legislative process. Several of the proposed Cures bills would result in funding increases for NIH. Of course, the Cures bills must pass the full Senate and House and then receive the President's signature before becoming law. Both the House and Senate have been pushing hard for this legislation to pass. There remain several ongoing debates regarding NIH funding and FDA issues, so despite vocal support it remains to be seen whether this will actually happen. At the moment, it seems unlikely that the Senate will have time to take up the Cures legislation during the three weeks that they are in session before breaking in October. But the House Energy and Commerce Committee Chairman, Representative Fred Upton, a major proponent of this legislation, is insistent that it will be passed during the lame-duck session of Congress at the end of the year. Well, as the end of fiscal year 2016 approaches, that is, we're looking towards September 6th, when the fiscal year closes, it's again time for Congress to negotiate the federal budget and pass a new appropriations bill for fiscal year 2017. Last year, Congress engaged in deadlock debate and barely made the deadlines to provide funding for fiscal year 2016. However, NIH was fortunate in that the final enacted fiscal 16, 20 of the fiscal 16 budget resulted in a $2 billion increase for NIH for a total of $32.3 billion as reflected by this middle column. Of this amount, $513.2 million was provided to NHGRI. Well, the numbers for fiscal year 2017 are still unknown. President Obama released his proposed budget in February, calling for another increase that would take NIH's total to $33.1 billion as reflected in the far right column, although this did not come with a proposed increase for NHGRI. However, with the impending administration change, Congress is likely to propose an entirely different budget for NIH. Additionally, as of the end of last week, Senate majority and minority leaders were working to pass a continuing resolution, or CR, which is a short-term budget extension through December 9th at fiscal year 2016 spending levels. They hope to bring this to a vote this week, but House conservatives are blocking a longer-term CR that could last, or I'm sorry, are backing a longer-term CR that would last as long as six months. So time will tell exactly how this plays out with respect to how long of a CR we will likely see before Congress goes out on recess. So let's move away from Congress and into genomics. This month, Dr. Elaine Martis and Rick Wilson will be departing Washington University and heading to Nationwide Children's Hospital in Columbus, Ohio, where they will be establishing a new genomics program. Nationwide Children's Hospital is one of the nation's largest not-for-profit freestanding pediatric healthcare networks, providing care for infants, children, and adolescents, as well as adult patients with congenital disease. Both Elaine and Rick are longtime NHGRI grantees and colleagues, and Dr. Wilson is a former member of this council. Interim co-directors of the McDonnell Genome Institute at Washington University will be Dr. Susan Dutcher, Ira Hall, and Nathan Stizio. NHGRI staff are working with them to develop a permanent transition plan for that institute in particular for the grants they receive from NHGRI. The Global Alliance for Genomics and Health, or GA4GH, recently published a perspective in science entitled a Federated Ecosystem for Sharing Genomics Clinical Data. This perspective represents an important major publication from GA4GH, articulating the need for a common framework of principles, protocols, and interoperable technical systems to enable responsible and effective data sharing. Finally, in our usual Genomes in the News feature to round out our genomics updates, there have been a number of recently generated genome sequences reported since the last council meeting, including the carrot, more ancient horses, the giraffe, now by note, the giraffe is on the left, and a random institute director is on the right, not to be named. Moving on, the rubber tree, orca, the olive tree, ancient barley, the manx cat, calligo, a gliding mammal, the sumatra rhino, the tobacco hornworm sphinx moth, and last but not least, the snub-nosed monkey. So genome sequencing marches on. Moving on, speaking of genome sequencing, let's talk about major programs in our extramural research program, starting with our genome sequencing program, or GSP, which aims to understand general principles and features of disease genomics and the genomic variants that influence disease risk. Now, as many of you know, the program has multiple components. The Centers for Mendelian Genomics, or CMGs, investigate rare and Mendelian diseases, while the Centers for Common Disease Genomics, or CCDGs, look at common and complex diseases. The CCDGs have recently released their project plans online at the website maintained by the Genome Sequencing Program's Coordinating Center, and that Coordinating Center provides logistical and scientific support for the GSP. But we recently announced awards for the fourth component of the genome sequencing program, the analysis centers. These latest centers aim to conduct novel analyses of the genome sequence data produced by the entire program, rather than data from individual projects. Three analysis center awards were made with the associated institutions and PIs listed here. The work proposed by these groups includes multiple approaches to interpret non-coding genomic variants and to use admixture information for improving genomic analyses. The analysis centers will be funded at roughly $11 million over four years. We also recently announced that awards have been made to produce additional very high-quality reference genome sequences for human and non-human primates. This additional component of the genome sequencing program aims to address the need for high-quality reference sequences as a resource for the human genomics community. Such improved references would aid efforts to interpret human genome sequences in both basic research and clinical implementation of genomics. In the end, two awards were made. The first award to Dr. Ed Green will use new methods for long-range scaffolding in conjunction with short-read sequence data to assemble 50 human and non-human primate genome sequences. While the second award to Drs. Rick Wilson and Evan Eichler will use a multi-tiered approach that includes long-read sequence data, innovative scaffolding technologies, and back-end sequence data to close remaining gaps. And they aim to apply this to the generation of about 14 genome sequences split between human and non-human primates. These groups will be funded at roughly $8 million over four years. Our genome sequencing program has also been extensively involved in the Cancer Genome Atlas, or TCGA, which is a coordinated effort, by NHGRI and the National Cancer Institute to better understand the molecular basis of cancer. Genomic data production on over 10,000 tumor normal pairs has been now has been completed. And TCGA is currently focused on manuscript writing as the project comes to a close later this year. For each of over 30 cancer types, the TCGA network has published a comprehensive integrated account of sequence mutation analysis, copy number variation gene, and microRNA expression, and promoter methylation. TCGA papers focused on diffuse glioma and adrenal cortical carcinoma were published in January and May in cell and cancer cell respectively. The TCGA network is also coordinated analysis on follow-up papers to the original marker papers. This includes an ongoing pan-cancer analysis of all 10,000 tumors, as well as more focus papers on topics such as comparisons of lung adenocarcinomas and squamous cell carcinoma, and investigation of genomic alterations in tumor-adjacent breast cancer tissue. As an important update for users of TCGA data, NCI recently altered the location for accessing DNA and RNA sequence data from the TCGA project. Rather than being available at CG Hub, the data are now centralized, standardized, and made accessible through the Genomic Data Commons, or GDC. The GDC contains over two petabytes of data, including data from TCGA and its pediatric equivalent, called therapeutically applicable research to generate effective treatments or target. In addition, the GDC will accept submissions of cancer genomic and clinical data from researchers around the world who wish to share their data more broadly. Now, shown here is Vice President Joe Biden exploring the TCGA data online as part of the GDC launch at the American Society for Clinical Oncology meeting in June. As noted, TCGA is officially wrapping up this fall. Our NCI colleagues will continue to lead projects in the large-scale genomic and molecular characterization of cancer. Of note, we actually planned to give a more formal update about the TCGA project at the February Council meeting. NHGRI's Technology Development Program continues to move forward and has several active funding opportunities that deserve highlighting. There are active requests for application for novel nucleic acid sequencing technology development that involve DNA and direct RNA sequencing. We are in the process of making awards from the first round of applications. The second set of applications have been received and will be coming to the February Council meeting after they're reviewed. And there is also an upcoming application due date in June of 2017. Program announcements for novel genomic technology development yield to the first round of applications that will be considered later at this Council meeting. There are also upcoming application due dates in October of 2016 and then of 2017. The goal of the Encyclopedia of DNA Elements or ENCODE project is to create catalogs of all functional elements in the human and mouse genomes and to make those catalogs available as a resource to the biomedical research community. ENCODE regularly engages in outreach activities to help a broad range of scientists use ENCODE resources. For example, the second ENCODE users meeting took place in June, modeled after the highly successful 2015 meeting. Over 200 participants from the research community attended. Consortium members led interactive tutorials demonstrating how to access ENCODE data and tools and resources. They also ran ENCODE pipelines that uniformly processed data and also performed integrative analyses of ENCODE data. In addition, a panel of distinguished researchers not involved in ENCODE explained how ENCODE resources are enabling their own work. ENCODE consortium members will also lead two tutorials at the upcoming ASHG meeting. These will focus on enabling attendees to utilize 3D genomic data generated by ENCODE and other projects and how to use ENCODE data processing pipelines and tools to assess experimentally reproducible reproducibility. Well, as a result of outreach and collaboration, ENCODE data continue to be heavily used. There are now more than 1,500 community publications, the pink line, from groups outside of ENCODE, do not have ENCODE funding, but who use ENCODE data for their published work. And meanwhile, ENCODE consortium members have produced more than 550 publications to date shown by the green line. Now, as we described at the May Council meeting, NHGRI released five funding opportunity announcements or FOAs in functional genomics, all of which will be organized under the general ENCODE umbrella. Applications for these RFAs have now been received and reviewed. These RFAs will support genomic projects with a variety of goals, including expanding the catalog of candidate functional elements in the human and mouse genomes, developing generalizable approaches for characterizing candidate functional elements in specific biological contexts, developing new computational approaches for analyzing ENCODE data, making ENCODE data readily available to the research community through coordinated data management activities and supporting the centralized data analysis needs of the next phase of ENCODE, including developing updated and refined versions of the ENCODE encyclopedia. The key dates associated with these FOAs are shown here. Applications were received in March and reviewed for scientific and technical merit over the summer. And council will discuss these applications in the closed session of this meeting. And the anticipated project start date is in February of 2017. Now, as the number of sequence human genomes increases, a major bottleneck in using these data is the challenge of knowing which variants influence phenotypes, especially those variants that sit out in non-coding regions. Well, the non-coding variants or NOVA program supports the development of computational approaches that integrate functional data sets to implicate non-coding variants with phenotypes and disease risk. The resulting computational predictions will then be tested using experimental data. All of the data and methods will be released publicly to allow other researchers to use them and to compare methods. Five new NOVA awards were made this year, including one funded by NCI, joining the six awards that were made last year. These new awards use several diseases as model systems, including autoimmune disorders, cancer, schizophrenia, arthritis, heart disease, and chemotherapy response. The awards use diverse approaches that integrate many types of data and information to address this challenging problem. Moving on to the Electronic Medical Records and Genomics or Emerge Network, which conducts genomic discovery and clinical implementation research by leveraging data from large biorepositories linked to electronic medical records. Now, last June, Emerge Investigators developed an e-book called The Foundation of Precision Medicine, Integration of Electronic Health Records with Genomics through basic clinical and translational research that was published online. Now, this e-book contains 19 articles presenting topics in basic clinical and translational research that are relevant to the integration of electronic health records with genomics. The authors describe the Emerge Network and its contributions to genomics, the results of genetic studies, investigating various diseases, complex analyses of genome copy number variants and epistasis, and the return of genomics results to patients and clinicians for clinical care. The release of this e-book is timely since several countries are now launching major initiatives in precision medicine research. The e-book has been viewed by people in more than 30 countries, as shown by this map on the upper right, with over 70,000 views in total and over 12,000 downloads to date. The circles on the map represent the number of total views in each country or region with the number of views per region displayed inside the circle. The large red circles indicate regions with over 10,000 views with the orange circles reflecting regions with one to 10,000 views. Outside of the United States, China and the United Kingdom and France were really the most highly interested in Emerge's research. The small green and yellow circles highlight countries with less than 1,000 views. The clinical genome resource, or CLINGEN, is building a resource that defines the clinical relevance of genomic variants for use in precision medicine and research. There has been significant progress during the third year of this highly collaborative program. As one example, CLINGEN's actionability working group has developed scores for the clinical actionability of the 56 genes on ACMG's secondary findings list. The evidence reports and scores are available on CLINGEN's website and were published in genetics and medicine in this article in May. The three CLINGEN sites have received supplemental funds from the Precision Medicine Initiative cohort program. This funding will help support new bio curators and expanded genomic variants curation interface in efforts to improve the interoperability of CLINGEN resources with electronic health records. CLINGEN has also worked to develop relationships with other international groups doing similar work. So for example, the CLINGEN decipher meeting entitled Curating the Clinical Genome and held at the Welcome Genome Campus in June brought together leaders in clinical genomics to discuss the barriers to sharing relevant data internationally as well as to address a need for common standards and best practices. And finally, CLINGEN will hold a workshop at the 2016 ASHG meeting in Vancouver in October. More information on this workshop and other CLINGEN presentations will be made available on the CLINGEN website prior to the meeting. The Clinical Sequencing Exploratory Research or CSER program focuses on the integration of genome sequencing into the clinical workflow, including the generation interpretation and clinical reporting of genomic information. CSER has now enrolled nearly 5,000 adults and over 1,200 children. For nearly 5,000 of these individuals, germline genome sequence data will be generated and for over 1,000 tumor genome sequence data will be generated. As one measure of overall impact, CSER has now generated 289 publications, including 18 cross-CSER working group publications. As a reminder, the CSER 2 Request for Applications or RFA's were released in May and applications were received in August. A CSER 2 Pre-Application Information webinar was held in June. The webinar included an overview of the CSER 2 RFA's and addressed questions from potential applicants. 99 individuals tuned into the webinar forecasting a robust response to the RFA's. The webinar has been archived and posted on NHGRI's website, genome.gov. The received applications will be reviewed this fall and those reviews will be discussed at the February Council meeting. Meanwhile, the Implementing Genomics in Practice or IGNITE Network aims to enhance the use of genomic medicine by supporting the development and dissemination of methods for incorporating genomic information into clinical care. In August, the IGNITE Network led by Tony Polly from the University of Maryland School of Medicine hosted a workshop that brought together investigators in genomic medicine, clinical genomics consumers, healthcare providers and representatives from the insurance and biotechnology companies. Media attendees discussed the barriers to genomic medicine implementation and strategies to promote genomic medicine sustainability. These issues are important across many NHGRI projects and this meeting was widely attended by members of other NHGRI consortia. Key recommendations from this meeting included creating a process for providing insurance companies with information about the clinical utility of genomic results, also considering reimbursement models to cover provider time in communicating genomic results to patients in addition to supporting the cost of actually doing the testing, considering coverage for the periodic reanalysis of genome sequence data as more information about variants and genes is discovered and patients needs evolve. And finally, ensuring that genome sequence data follow the patient when insurance providers are switched. A manuscript is being drafted based on the discussions at this meeting, including a strategic plan for ongoing efforts to engage stakeholders and address continued challenges in genomic medicine sustainability. Also important to the IGNITE Network was a highly productive meeting that was associated with sort of a program review in general of this initiative. To date, the network's been highly productive, 113 presentations and publications since the initiation of the program in 2013. So in August, our institute hosted a review workshop of this program entitled IGNITE and Beyond the Future of Genomic Medicine Implementation. Several council members, I would note, attended this gathering serving as planning group members, presenters, discussants, and moderators. The workshop evaluated IGNITE's contributions to genomic medicine and identified the future challenges and opportunities for genomic medicine implementation. Needless to say, the discussions were lively and productive with several major recommendations coming out of the meeting. These include providing flexibility in the program to support follow-up single-state studies with larger-scale studies that aim to confirm findings and decrease bias. Also, fostering collaboration with community centers to increase access to genomic medicine in underrepresented and lower socioeconomic populations and partnering with stakeholders, including payers on technology companies throughout study design, conduct, and interpretation phases of the study in order to provide the specific evidence needed for genomic medicine implementation. Of note, we plan to provide a more complete report about this workshop at the February council meeting. Moving on to the Ethical Legal and Social Applications, or LC Research Program, which supports research on the implications of genomics for individuals, families, and communities. The LC Research Program recently launched an online resource facilitating a sample grant applications and summary statements for a variety of grant mechanisms and research methodologies. NHGRI is indebted to the contributing LC investigators for their willingness to share their research applications and summary statements with the broader research community. The LC Research Program will co-sponsor the fourth LC Conference, or Congress, which will be held June 5th through 7th, 2017 on the Jackson Lab Campus in Farmington, Connecticut. This will be a major conference on a wide range of LC issues and is the first such meeting since the 2011 LC Congress at the University of North Carolina. More information, including details on registration and abstract submission, will be available soon. On a related note, the Genomics and Society Working Group of this council is charged with providing advice on short and long-term planning and priority setting for the Genomics and Society activities at the Institute, including our LC Research Program. This working group held its annual in-person meeting in June. Topics of discussion included LC research issues related to precision medicine, the effectiveness of embedded LC research and larger genomics research projects and initiatives, and the boundary between LC research and health services research. The working group chair, Lisa Parker, will provide an update about these discussions at the February council meeting. You can already tell that the February council meeting is going to be a busy one because there's a lot of things we already know we're going to be talking about there. Four Centers of Excellence in LC Research or SEER awards were made in May. The grants totaling approximately $15 million over four years address a range of forward-looking topics that are highly relevant to the use of genomics in public health and medicine today. The new centers were awarded to the following, Gail Geller and Geoffrey Conn at Johns Hopkins on the use of genomics and precision medicine and the prevention and treatment of infectious diseases. Ellen Wright Clayton and Brad Mallon at the Vanderbilt University on Privacy and Practical Rooks associated with the use of genomic data to identify individuals. Incoming council member Jeff Botkin at the University of Utah on better understanding communication among family members regarding prenatal and newborn genomic screening. And Paul Spicer, Amanda Cobb, Grythin, and Cecil Date Lewis at the University of Oklahoma on how communities and academics can collaborate to develop genomics research that will positively affect native communities and health. Now, meanwhile, the next annual SEERS meeting will be held in September in Baltimore. The meeting will include the four new SEERS, the continuing SEERS at UNC Chapel Hill and Columbia University and the transitioning or graduating SEERS at Duke, Stanford, Case Western, University of Washington and UCSF Kaiser. Now, the NSURI Computational Genomics and Data Science program is developing a new organizational model for six large genomic data resources, including the GO consortium, the mouse genome database or MGD, the saccharomyces genome database or SGD, the zebrafish model organism database or ZEFIN along with worm base and fly base. Now, in May 2015, NHRI convened a meeting of these large genomic data resources to discuss the factors that affect their efficiency, cost drivers, impact on genomics research and potential long-term sustainability models. And then in May of this year, 2016, NHRI convened another meeting of these resources to discuss a new organizational structure that aims to integrate common functions and services of the databases, increase interoperability and efficiency and therefore facilitate their sustainability. Well, in response to NHRI's reorganizational goals, the resources submitted a supplemental request in June of 2016 to establish the Alliance of Genomic or Alliance of Genome Resources that aims to provide better support by an integration of shared data, sanitization of data models and interfaces and unified outreach to researchers. This supplemental request is currently under review. NHRI's research training and career development program has a long-term commitment in preparing the next generation of genome scientists and scholars. And as of this summer, NHRI's training program now includes four new institutional training grants in genomic medicine and LC research. The new genomic medicine training programs will be led by Lynn Geordi at the University of Utah, Josh Denney at Vanderbilt University and a partnership between Bruce Korf and Greg Barsh at the University of Alabama Birmingham and Hudson Alpha respectively. These two-year programs will train MDs and PhDs together and incorporate a mix of coursework, clinical laboratory rotations and mentoring. Mildred Cho at Stanford University will be leading the new LCT32 program. This program, which is the first of its kind, will use multi-mentorship model drawing on mentors from 10 Stanford University schools and departments to train pre-doctoral and post-doctoral fellows from diverse backgrounds to conduct LC research. These four programs will complement the 11 currently funded genome sciences training grants. Meanwhile, the 2017 research training and career development meeting will take place April 12th through 14th in my hometown, St. Louis. In attendance will be diversity action plan or DAP and T32 PIs and training coordinators, also mentors, NHGRI and coordinating center staff, advisors and valued speakers, and of course the trainees themselves supported by either individual or institutional awards. The main focus of the meeting will be to provide an opportunity for trainees to present their research through posters and plenary talks to network with other trainees and scientists and to listen to professional development and scientific presentations. Our DAP program seeks to expose underrepresented minority students to genomic research experiences at the undergraduate, post-baccalaureate and graduate levels. The DAP's funding opportunity announcement was reissued in June. The previous announcement accepted applications from a limited number of NHGRI high-profile genome sciences programs. The major difference with this reissued announcement is that it is no longer limited to such groups. Since the DAP program started in 1992, many academics and research institutions have emerged with strong research programs in the three broad areas of interest to NHGRI, genome sciences, genomic medicine and ELSI. And so the reissued announcement aims to broaden DAP participation, including an expansion into genomic medicine and ELSI research. Now, genomic medicine is advancing not just in the United States, but also abroad and thus the education of healthcare providers in practice and in training is a goal shared by other countries as well. And so in August, the Division of Genomic Medicine and the Division of Policy Communications and Education organized a meeting of domestic and international experts who are actively developing and implementing programs designed to fill the gaps in provider genomic literacy. The 22 participants came from the United States, Australia, Canada, England and Wales with many attending via remote conferencing. Participants learned about the United Kingdom's interprofessional certificate and master's degree programs designed for providers in practice and also a master's program at the University of Florida that is pursued in parallel with residencies. Education programs that are integrated into and dictated by the health systems in the United Kingdom and Australia were discussed as well as coordinated educational resource development in Canada, including point of care education options. Opportunities for synergy sharing and overcoming shared challenges were considered and the participants discussed evaluating effectiveness of these various educational methods. So moving then to NIH, beyond NHRI, to Common Fund and Trans-NIH initiatives, particular Common Fund programs that we play a major role in starting with the Knockout Mouse Phenotyping Project or COMP2, which was launched in 2011 with the goal of making and phenotyping 2,500 mouse knockout strains over five years. The project is on track to meet its goals in the fall of 2016. The project is now entering its second and final phase of support by the NIH Common Fund. For this phase, the NIH Common Fund is matching the funds provided by other NIH Institute Centers and Offices. In total, there will be 18 Institute Centers and Offices contributing funds for a total of roughly $100 million of funding over the next five years. The funding plan for this phase of COMP2 was discussed with Council in May, and the awards were issued in August. Meanwhile, the annual COMP2 meeting will be held in October in Bethesda. Now, of note, COMP2 manuscript describing the characterization of embryo lethal strains is in press in nature. And finally, the program is planning to continue its broad-based phenotyping of knockout mice in collaboration with our international partners through the International Mouse Phenotyping Consortium. Another Common Fund project is H3Africa, our human heredity in health in Africa. This has, as its central goal, the development of a sustainable and collaborative African genetics and genomics research enterprise. This coming October, H3Africa has the honor of welcoming President Amani Gureb to speak at the opening of the ninth consortium meeting in her country, Amaricious. The president has been an outspoken supporter of research in Africa. In fact, she wrote a piece in The Guardian last fall entitled, African Governments Bus Urgently Invest in Science and Research. And her excellence leaves interest in H3Africa as encouraging as the consortium continues to work on plans for its long-term sustainability and ability beyond common fund support. Also of interest, the ninth consortium meeting will feature both an ethics and a special topic science workshop. The ethics workshop will tackle the complex issues surrounding the provision of research findings to individuals in an African context, while the special topic science workshop will focus on HIV co-morbidities. The latter workshop will kickstart the newest H3Africa working group, which brings together common interests and HIVAs research from projects throughout the consortium. Now, as announced at the last council meeting, H3Africa has been renewed for a second five-year phase of NIH common fund support. And so this past August, seven new RFAs were published. In addition to renewing the RFAs from the first phase for individual research projects and collaborative centers and H3Africa Informatics Network, the second phase adds RFAs aiming to fund four additional components for the future H3Africa consortium. First, an administrative coordinating center. Second, a global health bioinformatics training program. And third, a dedicated ethical, legal and social applications projects as either individual research grants or fourth as collaborative centers. So those are the four new components. All the RFAs are open to both previous H3Africa grantees and also to new applicants. All the applications are due November 15th. The NIH Common Funds Undiagnosed Diseases Network, or UDN, aims to improve the level of diagnosis and care for patients with undiagnosed diseases, facilitate research into the etiology of these diseases and create an integrated and collaborative research community to identify and share improved options for optimal patient management. To date, the UDN has received almost 800 applications and accepted 281 patients for evaluation at one of the seven UDN clinical sites across the nation. To apply, one simply need to access the UDN gateway by clicking on the Apply button on any of the UDN webpages or by going to the dedicated website hosted by Harvard University. On July 4th, the first UDN patient case study was published by Baylor College of Medicine's clinical site. And information about other UDN genes of interest and participant pages can also be found on the UDN website. And such information really aids gene function research and also important patient matching. Now, as I've discussed at previous Council meetings, NIH has been heavily involved in implementing the U.S. Precision Medicine Initiative, PMI, which was first announced by President Obama in January 2015. The fiscal year 2016 NIH budget includes $70 million to the National Cancer Institute to lead efforts in cancer genomics as part of PMI for oncology, as well as $130 million to the broader NIH to build a national longitudinal research cohort of one million or more volunteers through the PMI cohort program. Information about the PMI cohort program in particular is available on this program's main landing page shown here. And Eric Dishman, as I mentioned earlier, directly of the PMI cohort program will be giving a more detailed update about this program later in the open session of this Council meeting this afternoon. I will just now provide some very quick PMI highlights that have unfolded over the last few months. For starters, the PMI cohort program transitioned from its pilot planning phase to its full startup phase with the awarding of a series of cooperative agreements. These awards, totally $55 million in direct costs for the first year were announced in July. The awardees, along with previous awardees that I mentioned at the May Council meeting will be collaborating to bring together the major components needed to launch the PMI cohort program later this year. This announcement of these awards in July was accompanied by an op-ed piece by President Obama in the Boston Globe where he noted, among other things, that precision medicine is one of the greatest opportunities we've ever seen for new medical breakthroughs, but it only works if we collect enough information first. Well, the initial set of awards aimed at jumpstart getting the information as quickly as possible. Specifically, the awards include enlisting the first set of regional academic medical centers at the sites shown in red. These groups will build program protocols engage and enroll participants and collect health information and biospecimens. A pilot program involving six federally qualified health centers or FQHCs at the sites shown in blue will determine infrastructure needs for FQHCs in the PMI cohort program. FQHCs will be critical for reaching underserved participants, families, and communities. Additional enrollment centers will be added over time. Now, recruitment will also take place at Veterans Administration or VA hospitals via direct volunteer recruitments nationwide. Meanwhile, the Mayo Clinic, Biobank will collect store and distribute biospecimens while the Data and Research Support Center awarded to Vanderbilt University of the Broad Institute in Verily Life Sciences will be the central hub for collecting and organizing the data and making it securely available. The latter groups will also provide analysis tools to enable interested researchers and citizen scientists to use the data. And finally, for the final, the Scripps Research Institute in Vibrant Health will develop and maintain mobile and web platforms for enrollment consent in the collection of data from and communication with participants. They will also support the enrollment of direct volunteers. Together, these efforts put the PMI cohort program on a trajectory to begin recruiting individuals in the near future as I'm sure Eric Dishman will discuss in greater detail later today. So moving away from trans-NIH efforts back to NHGRI and just a series of updates from the Division of Policy Communication and Education. So NHGRI's Division of Policy Communications and Education, as you may recall, partners with the American Society of Human Genetics in sponsoring two fellowships. The Genetics and Public Policy Fellowship Programs provides fellows with an opportunity to work in NHGRI's Policy and Program Analysis Branch, also at ASHG and also in Congress. This year's fellow is Krista Wagner. Dr. Wagner earned her PhD in Cellular and Molecular Medicine from Johns Hopkins University School of Medicine. Meanwhile, the Genetics and Education Fellowship Program provides fellows with an opportunity to work with NHGRI's Education and Community Involvement Branch and also at ASHG in developing educational programs for a wide range of audiences. The fellow may also rotate to a public or private organization involved in genetics and genomics education. This year's fellow is Teresa Ramirez. Dr. Ramirez earned her PhD in Molecular Pharmacology and Physiology from Brown University and then completed a post-doctoral research fellowship at the National Institute of Alcohol Abuse and Alcoholism. Well, in June, NHGRI's Policy and Program Analysis Branch held a public education workshop on Investigational Device Exemptions, or IDEs, and Genomics to help investigators and institutional review board members learn more about the Food and Drug Administration's IDE regulations and to understand how these regulations apply to genomics research. As a reminder, the FDA may require researchers to apply for an IDE before beginning a clinical research study that involves the use of investigational devices. The FDA considers tests performed using next-generation sequencing platforms to be investigational devices. If an investigational device study poses a significant level of risk to participants, investigators must apply for and receive an IDE before enrolling participants. Well, speakers at this workshop represented the Research Institutional Review Board and FDA perspectives providing advice on how to determine whether an IDE is necessary, how best to communicate with the FDA about possible IDE submissions. Meanwhile, a meeting report and a video of the meeting are available on genome.gov. In order to provide additional resources about IDEs to the research community, branch staff are now drafting a white paper offering points for investigators to consider based on what was learned at the workshop. In another workshop this past May, NHGRI convened a two-day meeting to initiate a renewed dialogue about the risks and benefits of sharing aggregate level information from genomic research studies. Under the current NIH Genomic Data Sharing Policy, this aggregate level information is only available through controlled access, although it has long been acknowledged that the privacy risk posed by the information is very small. It became clear during the discussion at the workshop that there were different understandings among the participants. Workshop participants recommended using the term genomic summary statistics to clarify that the information is the statistical results from a study based on many individual participants' genotypes and that it does not include individual-level data. Participants also recommended that NHGRI work to pursue policy changes that enable genomic summary statistics to be made available through unrestricted access in DBGAP with appropriate exceptions for studies associated with particular sensitivities. It was also recommended that NHGRI work with the research community and public stakeholders inform research participants more effectively about the benefits of sharing genomic summary statistics and to articulate the privacy risk and mitigation steps taken. And I would point out that a report from this workshop is now available on Genome.gov. And speaking of Genome.gov, the NHGRI's website was recently upgraded to a new mobile-friendly design, which means the site is now easier to browse on a variety of mobile devices like iPhones, androids, and tablets. It's notable that roughly one-third of Genome.gov's total traffic comes from mobile devices, and that number is expected to increase as mobile devices become more prevalent. So this update will ensure that people can readily and quickly access important information about NHGRI's research, its programs, and other activities from a more diverse set of electronic devices. The NHGRI History of Genomics program recently completed a lecture series that I've been telling you about at various council meetings that commemorated the 25th anniversary of the launch of the Human Genome Project, the series entitled A Quarter Century After the Human Genome Projects Launched, Lessons Beyond Base Pairs. It actually began last December, 2015, and then concluded in May with the last talk given by Dr. David Bentley from Illumina. And you can now find video recordings for all six of the lectures on NHGRI's Genome.tv channel of YouTube. Meanwhile, the Genome Unlocking Lives Code exhibition will make several more stops across North America as it continues its road show over the next two years. The exhibition closed last week, actually, the National History Museum of Utah in Salt Lake City, and it will then open at the Exploration Place in Wichita, Kansas on September 30th. It will then travel to Peoria Riverfront Museum in early 2017. In August, I gave actually an evening lecture to about 600 people at the Natural History Museum of Utah on human genomics, precision medicine, enhancing human health, and then the following day, I met with medical students, faculty, and researchers from the University of Utah and their healthcare partners. We encourage you to please continue to check the exhibition's website, which is URL's easy to remember, unlockinglifescode.org, and follow it on social media for the most up-to-date program information as it continues to tour North America. And then, meanwhile, in partnership with the Smithsonian Associates, NHGRI has co-developed a public lecture series that features NIH Institute directors and scientific and medical experts discussing with the public what is currently hot in biomedical research and what it means for our health and medical treatment today and in the future. The series is entitled The Pulse on Modern Medicine, insights from NIH experts. To prime the attendees for each session, each lecture is preceded by a brief introductory talk that offers fundamental background science and information for the evening's general topic. Now, last week, I actually kicked off this series, giving a talk entitled From the Human Genome Project to Precision Medicine, A Journey to Advanced Human Health, and Larry Brody, one of my division directors provided the introductory talk reviewing some general basics of genetics and genomics. Also speaking in the series, from NHGRI, Dr. Bill Gaul and Undiagnosed and Rare Diseases and Dr. Julie Segre, and meanwhile we have two other institute directors joining this series, Dr. Gary Gibbons who you'll hear from shortly who just joined us and also Dr. Tony Fauci and that will round out this series. NHGRI's partnership for community outreach and engagement in genomics held its annual in-person meeting in August in Salt Lake City at the same exact time I was there. The night before the meeting, many of the participants actually attended my talk at the Natural History Museum of Utah. NHGRI has established the partnership for community outreach and engagement in genomics in 2014 as a way to bring together community liaisons, health advocates and health practitioners representing diverse populations to discuss efforts to increase genomic literacy in their communities and as a forum for NHGRI to gain a better understanding of community needs and concerns related to genomics. The partnership's dedication to promoting public understanding of genomics has been steadfast and the group used this meeting to invite new voices into the discussion as well as to articulate their vision and priorities for the next two years. Now in addition to the nation outreach programs, NHGRI's education and community involvement branch regularly organized activities for students and teachers and organizations visiting the NIH campus. This summer was a particularly busy one with many of these visits extending over several days and involving extensive programming. So for example, in July the branch hosted a group of 10th and 11th grade students from Prince George's County Youth County Connect program for a week. The students heard presentations from NHGRI staff, they toured various NIH facilities and participated in several hands-on activities. Then in late July the branch hosted five students from the Smithsonian's National Museum of Natural History's Youth Engagement in Science or Yes program. The students toured a zebrafish laboratory, conducted their careers in genomics and attended the NIH summer... Your conference contains less than three participants at this time. If you would like to continue, press star one now or the conference will be terminated. Hopefully someone will... Okay. And they also, when they were here, attended the NIH summer internships programs poster session. Finally, NHGRI staff also had the opportunity to meet with National Congress of American Indians Health Scholars during the week-long visit to the Washington, D.C. area. The scholars heard about training opportunities and about the institute's engagement with and outreach to American Indians and Alaska Natives. Again, part of the busy summer in August, the Education and Community Involvement Branch held its annual short course in genomics. This year's course welcomed 24... Your conference contains less than three participants at this time. If you would like to continue, press star one now or the conference will be terminated. Don't you love technology? This year's course welcomed 24 faculty members who teach at middle schools, high schools, community colleges, and tribal colleges from places as far away as Puerto Rico, California, and rural North Dakota. These educators came to NIH for three days to hear lectures and receive teaching resources from leading NHGRI and NIH researchers, clinicians, and staff. Discuss ways to incorporate genomic content into their classrooms and also to participate in tours of NIH facilities. Topics discussed during the course range from undiagnosed and rare diseases to bioinformatics, to CRISPR-Cas9, to cancer genomics, also ethical issues in genomics research and health disparities among many others. Now, meanwhile, several years ago, the Genomic Healthcare Branch began hosting a second track for the NHGRI short course that was focused on nurses and nurse educators providing them a similar opportunity to learn about cutting-edge genomic advances from NHGRI experts. The aim of this track is to enhance genomics education of health professionals so as to facilitate the integration of genomics into practice. This year, the program was expanded to include an interdisciplinary focus and participants included 21 nurses and nine physician-assistant educators. Over the three days of the course, enlisted experts presented lectures, participated in panel discussions, and performed one-on-one mentoring with attendees. Topics included a genomics primer, a genomics competencies, educational resources, and strategies for integration of genomics into health provider curricula and into clinical practice. Best practices were shared by nationally-recognized nurse and physician-assistant genomic educators and panel discussions exemplified this on cross-disciplinary interaction. Well, to extend the reach and impact of this track of the short course, the slide presentations have been made available on a public course website and a community of practice listserv has been created to facilitate further communications among these genomics educators. Meanwhile, to address the growing need of medical staff in the insurance industry to understand genetic testing, the Genomic Healthcare Branch and the Blue Cross Blue Shield Association to produce an educational webinar series on genomic medicine topics. The specific goal was to prepare insurers to understand genetic testing strategies, interpretations, outcomes, and patient care needs so that they are able to better understand what they need to know in making decisions regarding the healthcare activities of their companies insured. Starting in June of 2015, there will be 13 live monthly webinars that will be produced by voluntary experts in genetic and genomic medicine and all have had 70 or more online participants to date. I can tell you that each session was recorded and is now publicly available on NHGRI's website for continuing education. I can tell you that this effort arose from the Insurer Education Working Group of NHGRI's Inner Society Coordinating Committee on Genomic Education in Genomics or ISCC. Meanwhile, Family Health History is often called the cheapest genetic test yet its usage in clinical practice is far lower than its potential. Today's Family Health History tools are computer programs that help collect and organize the health histories of individual family members and in some cases estimate inherited risk for diseases like breast cancer, diabetes, and colon cancer. So this past June, the Genomic Healthcare Branch convened a meeting to explore the Family Health History Tool Field and to identify opportunities at this dynamic period in its development. The conference provided 14 tool developers and vendors, four of which are NHGRI funded to a forum to demonstrate their tools and to highlight their approaches to enhancing clinical workflows to address gaps in most current electronic health records. Discussions on data format standards, electronic health record integration, and the use of clinical decision support provided evidence of progress. Some surprising lessons were learned including key clarifications relating to federal privacy laws. The meeting resulted in a strong interest for collaboration to solve remaining barriers to optimal use of Family Health History and Healthcare and the branch is working to sustain and build on the meeting's momentum. And finally, just a few things about NHGRI's Intramural Research Program starting with a few highlights that I always like to give. Once again, been highly productive since the last council meeting. I thought I would highlight three things. In a perspective published in the New England Journal of Medicine in May, Mr. Vence Bonham and colleagues discuss whether a precision medicine approach will reduce or eliminate the role that race plays in prescribing drugs and in healthcare overall. The paper highlighted the importance of economic knowledge and a precision medicine approach in moving us beyond the use of crude, racial, and ethnic categories in the care of individual patients. Research by NHGRI senior investigator that you may have heard of, a guy named Francis Collins, and an international team of more than 300 scientists conducted a comprehensive investigation of the underlying genetic architecture of type 2 diabetes. Their findings published in Nature in July suggest that most of the genetic risk for type 2 diabetes can be attributed to common shared genomic variants, each contributing a small amount to an individual's overall risk for the disease. In third, Dr. Ellen Sedransky and her colleagues identified and tested a molecule that show promise as a potential treatment for Gauchat disease and the more common Parkinson's disease. The findings demonstrate how insight from a rare disorder can have direct relevance to the treatment of common disorders. Their findings were published in the Journal of Neuroscience in July. Finally, I thought it was probably time for me to say a few things about a set of issues that are affecting the broader NIH intramural research program specifically related to the NIH Clinical Center. Now, as many of you or some of you might have heard in the news, there have been several unfortunate developments within the NIH Clinical Center in recent months, and these then prompted NIH Director Francis Collins to establish a working group of his advisory committee to the director. The working group, which has also been referred to as the red team, was charged with examining the organization financing and management of the NIH Clinical Center. Well, in April, the red team released its report and recommendations which grouped into three very broad themes, culture and safety, the culture of safety and quality, leadership for care oversight and compliance aiming to align authority with responsibility and to enhance accountability, and finally, steril processing procedures and facilities, this last theme being particularly relevant to the events underlying the red team's creation. I can tell you that Dr. Collins accepted these recommendations and announced immediate action to begin addressing them, including the formation of a hospital board constituted with external experts and communications, also the creation of a central compliance office within the NIH Clinical Center and finally a change in the leadership structure for the NIH Clinical Center. Now, in an effort to provide more accountability and consistency in the operation of the NIH Clinical Center, a number of specific measures are being aggressively implemented. A new clinical center research hospital board was created and held its first meeting this year. The board is charged with advising NIH leadership about the clinical center's performance, including management, finances and quality, requirements for hospital leadership and gaps in expertise, and also policies and organizational approaches that promote quality and patient safety. The board is expected to meet four times a year and will operate under the same open committee procedures as this council to ensure transparency of their work. The practice committee is being formed to review standards for patient care and further enhance patient safety and quality. This group will carry out continuous surveillance of all clinical activities in the clinical center, providing real-time input to leadership on patient care and safety issues. Performance metrics will also be created or enhanced for the clinical programs of individual institutes and also the clinical center departments so as to enhance accountability. Next forward with these efforts, a series of town meetings and focus groups are being conducted to engage with institutes and the clinical center communities on next steps and opportunities going forward. The red team also called for changes in the leadership structure for the NIH clinical center and various of these changes are also being implemented. To begin with, a new position of clinical center CEO has been created and that recruitment is now in place. This individual will have authority over everyone working within the NIH clinical center and all aspects of the center's facilities. In late August, the current clinical center director, Dr. John Gallin, was appointed the NIH associate director for clinical research and the clinical center's chief scientific officer. In this role, Dr. Gallin will oversee all research activities within the clinical center being responsible for contributing to the systematic research, helping to prioritize clinical research conducted in the center and overseeing the scientific review of all clinical protocols. Meanwhile, Dr. Andy Griffith, the scientific director of the National Institute of Deafness and other communication disorders, has agreed to be the acting director of the office of research and support and compliance which was created last spring as part of the initial response to the red team report. I will aim to keep council updated on the changes at the clinical center that are anticipated in the coming months. And that is the end of the main topics in my director's report. Before ending, I would just like to as always put in a plug and say that anyone wishing one extra email a month can get my monthly update, the genomics landscape, can simply go to this site indicated here and sign up for this. I will note that our external subscription base for the genomics landscape will be 1,000 mark. I want to end, of course, by thinking all the NHRI staff members that worked very hard, the latter part of August in particular, and the first couple weeks of September to put together everything I just presented to you. A group effort is always needed to compile all the information from across the institute that I could then communicate to council. A particular thanks to the NHRI communications group and web team for getting all this stuff up in my video and then posting that for the broader community to see. And then, of course, special thanks to my usual ringleader, Chris Wetterstrand for directly compiling all this and being responsible for coordinating the director report. And shown here as Chris at a DC bar's nerd night in the summer where she presented a talk at nerd night on the Human Genome Project, which I heard was very well received into the wee hours of the morning, I am told. And and happily take any questions that you have. Thank you. Carol So for the new hospital board for the clinical center, are there patient advocates or patient representatives on that board? That is a great question. Gary's not in yet. My assumption was absolutely yes and Gary just confirmed it. So yes. I do remember the composition was extremely broad in terms of lots of different types of expertise, including patients. Any other immediate questions, lots of other time over the next day or so? Yeah. Gail. Yeah, I wondered if you could comment on the overlaps between the CESAR program and the INSIGHT program because especially the second CESAR and IGNITE? Sorry. Yeah. Especially the second CESAR CESAR 2.0, which it feels like it is getting quite a bit of overlap and it feels that there could be a lot of synergy. I bet that the sites are different. I am not positive of that. When I read through the program descriptions, I just said I would really like to know a little more about it, especially with CESAR 2.0. So for the second CESAR we really can't see much more than what is in the RFA because the applications are in review. It is our expectation and has been the reality that all of these programs will interact amongst each other. But each of them has tended to address different things and it can give you another presentation on how they do that. What we have found is that each of them, when it comes up for a four-year renewal, sort of moves into a new area of science that often is based on what the others have been doing as well. So when Emerge got renewed it was building on what CESAR and Ignite and EnSite and others had done. When CESAR was proposed it too was building on what Emerge and other things had done. And the same will be true for the Ignite renewal and from the workshop that we had there. What that is going to look like we don't exactly know because we are still in the formulating processes of it and we will be bringing that to you in February for to just say the same thing and yet to say the same thing. It would be really great to have really specific examples of the synergies because there are really important topics that are being investigated and I guess the other thing I was thinking and of course I don't have the slides in front of me I was going to try and write it down but the issue about education for non-geneticist practitioners which is something that is it's being focused on in a couple of different consortia and I just really hope that they take advantage of the program that they are launching. Thanks. Point well taken. I was actually going to make exactly the same comment. As a member of CESAR 1 it sounded like that once we know the CESAR 2 consortia because we've done a lot of efforts to have overlap for example working groups with Emerge and with the return of results consortia. I think looking at whether some of the working groups might overlap between Ignite and CESAR 2 or have some visitors to the meetings I do think it sounds like there could be a lot of information for that. The other thing I was going to ask about the course or the meeting or the workshop that you had for the payers and that that's actually something, it sounds like that's available online that might be something you want to share with the American College of Medical Genetics and Genomics because that comes up very often do we have resources for payers and I was wondering what types of things were generated out of that. Was it Mike there? Mike Watson? I don't remember Ebony might come but I think he was. I thought he was to my right. I think he was just to my right when I was there. That one was not webcast but we will be preparing a summary from it and it also will be considered in going forward with the Ignite future but it's really something that we need to address broadly with payers and something we've been trying to do for years so we'll keep at it. Ebony do you want to make a comment? You may have to turn that microphone on or it might be on. Yeah it's on go ahead. Yes we the decision to not webcast was so that it would be open discussion at the meeting so we are going to do a workshop report and in the workshop for discussing the future of Ignite it was really stressed that we incorporate payers along the entire process so that's something we're really thinking about actually how to do that through the whole process so and that workshop was webcast and we'll be online soon. And at the payers meeting ACMG was there wasn't Mike Watson there? Yes. So we have that connection. Yeah Bob. I just wanted to say it's a great idea but in addition to the payers who are in some cases driving the evidence review process there are other groups that are not payers that the payers depend upon a lot for their evidence review. I can give you some additional names but I think involving them as well because in general and I'm speaking very generically the non-payer based evidence review groups are less sophisticated and knowledgeable than the payers driven ones and yet there are many payers who don't have their own and rely on these non-payer groups and they could use some additional education. Yes that would be helpful and they actually at the workshop it was some acronyms that was thrown out that the payers use and that will be in our workshop report but if you have any more information that would be wonderful. Thank you. Jeff. Yeah perhaps I missed it with your presentation. Did you give us an update on the NSITE program the newborn screening sequencing initiative? There was not an NSITE and I'm looking at the stage there's not an NSITE update this council that was not out of disrespect to the program there was just I assume NSITE there was nothing we thought was to report I'm sure it's not because of a lack of remarkable progress and exciting findings. Yeah we just didn't have Yeah so we just didn't have any big public meetings or anything like that that we wanted to be able to report out this council session but if you have any specific questions I'd be happy to answer them. In general Jeff what we don't we don't want to we don't want to use directors report to touch on every one of our programs every time there's nothing to update so we I think staff does show good judgment of there's nothing worth reporting don't add to it what already is a pretty long set of summaries we want to give so this was an exam I'm sure there'll be most of the time we do have something to report this was it wasn't. Okay well in that case I think we'll transition to our next open session speaker it's delightful that Gary Gibb is able to join us director of the National Heart Lung and Blood Institute some council members probably remember Gary came and gave a presentation to this council shortly after he arrived lots going on with the Heart Lung and Blood Institute in the genomics area I think in many ways when we talk about seeing genomics sort of spread across the NIH campus all the institutes and centers this is a good thing I think it's a mark of our success at NHGRI and needless to say Heart Lung and Blood Institute is one of the prototypes of not only uptake of genomics but also terrific partnerships with us and so I think Gary and I have many many things we're doing in common but one of the ones in particular that's quite sizable which he wanted to come talk about we wanted to hear about is this top med program that he's going to introduce you to in part because it has remarkable synergy direct interactions and so forth with our genome sequencing program which is why when Gary is done we will hear from Adam Felseveld to describe a little bit more how these connections are being put together so with that I'll turn this over to Gary.