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The Center for Genomic Health A Whitepaper for the Campaign Steering Committee THE VISION The human genome—the three billion base pairs of our DNA—forms the genetic blueprint that shapes our lives and our health. Unlocking our genome has given us unprecedented access to the genetic factors in human disease, and has suggested groundbreaking methods of treatment and prevention through medicine that is personalized to each individual. Genomic medicine is perhaps one of the most profound quantum leaps forward in human health, yet its full impact has not been realized. A rapidly evolving field that treats individuals across the disease spectrum, genomics combines foundational and translational research, animal modeling and ultimately clinical translation to advance medicine and best practices in patient care. Patients within the UC Davis Health System and throughout the country are currently undergoing sequencing of targeted genes or even all genes (the exome) to assist in the diagnosis of a host of conditions, including multiple congenital anomalies, neurological disorders, cardiovascular disorders and cancer. However, there is much work to be done if we are to fulfill the promise of precision medicine. The Center for Genomic Health will be a comprehensive, multi-site program that will lead the genomics core of the new UC Davis Precision Health Initiative, uniting our Davis and Sacramento campuses with strong basic science that is integrated into transformative clinical practice. The center will spearhead groundbreaking human genomics research in such critical areas as early life development, cancer biology, and cardiovascular and neurological disease. The work of the center will cement UC Davis’ position as a leader in the practice of genomic medicine. The demand is clear for a centralized hub that would organize UC Davis’ human genomics talent and resources. In a recent survey of UC Davis School of Medicine faculty, nearly 80% of respondents felt that UC Davis would benefit from uniting our human genomics efforts under one umbrella. Over 90% of respondents highlighted the importance of gene sequencing and human genomics health care to the research, education and clinical practice mission of UC Davis. The Center for Genomic Health will meet this demand with a vital resource that will serve the UC Davis community, recruit leading faculty and train the next generation of genomics researchers and clinicians. THE RIGHT TIME AND THE RIGHT PLACE Genomic medicine’s personalized and precise approach for prevention, diagnosis and treatment is creating a safer, more effective, and cost-efficient process that is transforming health care for both individuals and populations, and changing the global healthcare economy. Our world-class clinicians and researchers are well positioned to leverage UC Davis’ unrivaled confluence of medical, veterinary, engineering, and agricultural expertise to provide unique perspectives and approaches that will advance genomic medicine worldwide. UC Davis is on an upward trajectory with faculty growth and programs, including several key hires in human genetics and genomics at the foundational science and clinical levels. Our exceptionally collaborative environment is bolstered by top-ranked undergraduate and graduate programs in genetics, our Medical Center and School of Nursing, and our NCI-designated Comprehensive Cancer Center. Our outstanding School of Veterinary Medicine is a world leader in animal modeling of human genetic and genomic disorders that, along with the California National Primate Research Center, constitutes a valuable resource to our ability to innovate in this field. The Center for Genomic Health will be the central resource that harnesses these strengths and puts them to work for the benefit of our patients, faculty, students, researchers and clinicians. As human genomics becomes increasingly commonplace, the center will ensure that UC Davis is able to offer new technologies and cutting-edge medical practices to its patients and researchers. The center’s impact will be immediately felt in clinical practice through its services to the entire Health System. UC Davis’ potential to drive genomic medicine is bolstered by the health system’s large patient catchment area and high patient volume, including a robust system of electronic medical records and an award-winning clinical informatics group. Integrating genomic medicine data with interpretation into the electronic medical record system is critical for transformative patient care, and will be a key resource provided by the center. Clinicians across UC Davis Health System are eager to adopt new technologies for the clinical translation of best practices in medical care. The center will work closely with a number of new and established groups on the UC Davis campus, including the Clinical and Translational Science Center, the Institute for Regenerative Cures, the Genome Center, the MIND Institute, the Division of Clinical Informatics, the Center for Information Technology Research in the Interest of Society, and the Center for Health and Technology. The best practices established at UC Davis will set a new standard of patient care that may be adopted nationally and internationally. THE OPPORTUNITY Currently exome and genome sequencing are being utilized in the clinical arena, and will become easier and more cost-efficient in the near future. This technology is a revolutionary step in medicine which will ultimately translate into new therapeutics for genetic and genomic disorders that were never imagined possible, including the possibility of genome editing for personalized treatment. The Center for Genomic Health will advance these possibilities by working at the core of precision genomics and offering whole genome sequences that will also benefit UC Davis efforts in precision genomics and genomic therapies applied to inherited disorders, oncology and cancer therapeutics, cardiology, immunology and more. In order for precision medicine to reach its full potential in an area like cancer treatment, it is essential that the patient’s full genome context be understood. However, whole genome sequencing of tumor cell lines and samples is not supported in most ongoing research, due to its only recent emergence as a costeffective research and treatment approach. The Center for Genomic Health will provide whole genome sequencing and analysis of essential clinical samples in the UC Davis BioBank for use in basic translational and clinical research. The integration of patient research data into the electronic medical record will allow researchers, under the aegis of the center, to mine genomic data that is linked to robust phenotypes. This level of integration will jumpstart discovery, attract extramural funding and advance clinical best practices for patients with genomic disorders at UC Davis and beyond. The Center for Genomic Health will support foundational science by providing a clearing house for essential research resources, including whole genome sequencing for patient genetic data. The center will also link researchers to additional data on gene expression and regulatory modifications. This support of foundational science will not only aid UC Davis researchers, but will also catalyze translational research and decrease the time to clinical adoption of new treatments and technologies. The characterization of genomic samples as they are used in patient care would encourage basic scientists to utilize clinical samples obtained through the UC Davis Medical Center, connecting these scientists with colleagues and providing a forum for collaborative research and publications. The synergy created by the center will provide a natural path for translation to the clinic and the greatest potential for improved patient outcomes and commercialization opportunities. The center will train the next generation of leaders in human genomics by building a revolutionary residency program for medical geneticists – an area that is not currently taught in medical education. Plans are currently underway for a genetic counseling master’s degree program, which when implemented at UC Davis will be only the second such program in the University of California system. The center 2 would house both the master’s and the residency programs, and would offer training, symposia and seminars for undergraduate and graduate students throughout UC Davis. MOVING FORWARD Creating a state-of-the-art Center for Genomic Health at UC Davis will require investing in the research faculty and staff that are critical to its mission. Translational Genomicists will be hired to integrate the clinical enterprise of genomic medicine across the health system. Staff will be hired to implement a blanket Institutional Review Board process for patient participation and organization of a BioBank registry. A robust informatics pipeline for genomic sequencing will be created to continue cutting-edge analysis of sequence and interpretation of genomic variants along with a pipeline for functional analysis for variants of unknown significance, including utilization of genome editing and animal modeling. The total cost is estimated to be $25 million. 3