2014 CPMC Research Institute Annual Report RESEARCH FOR BETTER MEDICINE 1 2 TABLE OF CONTENTS Message from Leadership................................................. 5 Highlights............................................................................. 7 CPMCRI Investigator Achievements............................... 8 Recent Hires and Investigator News............................. 10 Research for Better Medicine.......................................... 11 Sutter Pacific Epilepsy Program................................... 12 Center for Melanoma Research and Treatment............ 14 Ray Dolby Brain Health Center..................................... 16 Sutter Research Consortia........................................... 17 Sutter Cancer Research Consortium............................ 19 Sutter Neuroscience Research Consortium.................. 22 Key Investigators and Team Members........................... 27 Liliana Soroceanu......................................................... 28 Greg Tranah................................................................. 29 Kevin Kim.................................................................... 30 Arshia Sadreddin......................................................... 31 ALS Research Team..................................................... 32 CPMCRI Team Members.................................................. 35 Lynne Day.................................................................... 36 Jamey Schmidt............................................................ 37 Joy Becker................................................................... 38 Martin Wu.................................................................... 39 Grants Team................................................................ 40 Featured Studies............................................................... 41 Lung-Map.................................................................... 42 RReACT Repository..................................................... 44 MrOS Study................................................................. 46 Media Activity and Exposure........................................... 49 Financials........................................................................... 52 Compendium..................................................................... 53 3 4 California Pacific Medical Center Research Institute 2014 Annual Report California Pacific Medical Center Research Institute (CPMCRI) is a division of CPMC and an important part of Sutter Health’s transformation of healthcare to enhance well-being in our communities. CPMCRI has played a vital role in the creation and growth of the Sutter Research Enterprise. In 2014, we continued to demonstrate the value of research in reaching the highest levels of patient-centered quality care, access and affordability. Within this report, we’ve profiled the achievements of some of our investigators, highlight critically important clinical trials, summarize the breadth of our research, and showcase how CPMCRI investigators have had a profound influence on the lives of our patients. Attached to this report is the 2014 annual CPMCRI Scientific Activities Compendium of Peer-Reviewed Publications. Research at CPMCRI can be divided into three large groups: basic science, primarily focused on cancer; clinical research, with a portfolio of innovative and important clinical trials, investigator-initiated studies, and translational research, and; the San Francisco Coordinating Center, a national leader in epidemiology and cohort-based research in many disease areas. Recognizing the many centers of research expertise in oncology and neuroscience and an outstanding investigator base, CPMCRI played a key role in the creation of the Sutter Cancer Research Consortium in late 2013 and the Sutter Neuroscience Research Consortium in 2014. Both facilitate communication between investigators and are already leading to initiation of new system-wide studies. Through newer trials initiated at CPMC and disseminated throughout the Sutter system, such as Lung-MAP—the first of many system-wide studies—the entire clinical trial infrastructure will be made more efficient and reduce recruitment roadblocks for patients and physicians. As the transformation of research at Sutter Health continues, CPMCRI will remain a foundation for the scientific discoveries and clinical advances that catalyze Sutter’s excellence in healthcare delivery. Michael Rowbotham, M.D. Scientific Director California Pacific Medical Center Research Institute 5 6 HIGHLIGHTS Greg Tranah, Ph.D. Senior Scientist 7 CPMCRI Investigator Achievements Findings by scientists Liliana Soroceanu, M.D., Ph.D., and co-author Sean McAllister, Ph.D., shed new light on the mechanisms of resistance to brain cancer therapy, focusing on intracellular levels of reactive oxygen species. As published in the Nature Group publication, Cell Death & Disease, they investigated the response of glioma stem cells, to cannabidiol (CBD), a non-toxic, non-psychoactive cannabinoid compound. Results suggest that combining small-molecule reactive oxygen modulators represents a promising treatment for glioblastoma, especially since these agents may also enhance the efficacy of chemotherapy. Mohammed Kashani-Sabet, M.D., a physician with Sutter Pacific Medical Foundation, CPMCRI Senior Scientist, and Medical Director of the Center for Melanoma Research and Treatment at CPMC, was honored with a Humanitarian Award from the Melanoma Research Foundation. The award is presented to individuals who have committed to fighting melanoma through exemplary patient care, cuttingedge research and scientific leadership. Dr. Kashani leads CPMCRI’s largest basic science laboratory. Global findings from the Repository of Registered Migraine Trials (RReMiT) database were published in a September issue of Neurology. To capture a snapshot of registered clinical trials related to migraine and a scorecard of the availability of trial results, Michael Rowbotham, M.D.—Scientific Director of CPMCRI and senior study author—and colleagues created RReMiT. The initiative follows their earlier work in creating a similar database for registered analgesic trials (RReACT) of common pain disorders. Research by scientists Sean McAllister, Ph.D., and Pierre-Yves Desprez, Ph.D. led to FDA orphan drug designation for cannabidiol to treat aggressive brain tumors. Orphan drug approval of the compound represents the first time in the U.S. that a cannabinoid compound has been recognized by the FDA as a potential potent anti-cancer agent in treating this aggressive form of brain cancer. The leadership of Stanley Leong, M.D. and Mohammed Kashani-Sabet, M.D. in melanoma research was recognized earlier this year when their research on predictors of sentinel lymph node metastasis in thin melanoma —in collaboration with the Sentinel Lymph Node Working Group—was highlighted by the American Society of Clinical Oncology (ASCO), published in the high-impact Journal of Clinical Oncology, and summarized in a daily news summary for all ASCO members as the lead story. 8 H I G H L I G H TS Cawthon Cummings Desprez Kashani-Sabet Leong McAllister Rowbotham Soroceanu Stone Tranah Research by scientists Katie Stone, Ph.D., and Terri Blackwell, as part of the MrOS Study, linked poor sleep quality to cognitive decline in older men. Results published in April in the journal Sleep showed that higher levels of fragmented sleep and lower sleep efficiency were associated with a 40 to 50 per cent increase in the risk of clinically significant decline in cognitive function over three to four years. Greg Tranah, Ph.D., developed new means to investigate the mechanisms underlying peripheral neuropathy. Dr. Tranah studies mitochondrial dysfunction in age-related illnesses, and has focused recent investigations on understanding sensory deficits and neuropathic impairments. His latest study, published in the Journals of Gerontology, expanded upon this work and examined the influence of inherited and acquired mitochondrial DNA (mtDNA) mutations, on peripheral neuropathies in the elderly. Research by senior scientists Steven Cummings, M.D. and Peggy Cawthon, Ph.D., M.P.H., led to a clinical diagnosis of ‘dismobility’, which arises from two decades of studies on the consequences of slow walking speed from the collaborative Mobility Working Group and other scientists, as published in The Journal of the American Medical Association in April. 9 Recent Hires and Investigator News Atri Chan Kim De Semir Dar Stone Sadreddin Alireza Atri, M.D., Ph.D., joined the Ray Dolby Brain Health Center as Endowed Chair in Brain Health Research. Dr. Atri is an internationally renowned Alzheimer’s disease clinician-scientist and educator, who will lead the Center’s clinical and discovery research into healthy brain aging, Alzheimer’s disease and dementia. Dr. Atri will work closely with the Center’s Founder and Director, Catherine Madison, M.D., and with CPMCRI Scientific Director Michael Rowbotham, M.D. Gynecologic oncologist John Chan, M.D., joined Sutter Health and spearheads CPMC’s gynecologic oncology research. He serves as Gynecologic Oncology Lead for the Sutter Cancer Research Consortium. Dr. Chan specializes in the surgical and medical treatment of ovarian and pelvic cancers. He is the first scientist at Sutter who spans two of Sutter’s research institutes – CPMCRI and the Palo Alto Medical Foundation Research Institute. Kevin Kim, M.D., joined CPMC’s melanoma program as Director of Clinical Research. Dr. Kim was previously appointed as physician and professor at the University of Texas MD Anderson Cancer Center in Houston. A prominent medical oncologist who is board-certified in internal medicine and medical oncology, Dr. Kim’s research interests are in melanoma, mucosal melanoma, and targeted therapies. Arshia Sadreddin, M.D., joined CPMC and its Research Institute as Medical Director of Movement Disorders and Deep Brain Stimulation, for the Sutter Pacific Medical Foundation. A renowned neurologist, Dr. Sadreddin specializes in medical and surgical treatments of movement disorders. She is one of the few neurologists in the U.S. with special training and expertise in deep brain stimulation for the treatment of Parkinson’s disease, essential tremor, and dystonia. David De Semir, Ph.D. and Altaf Dar, Ph.D., were named Associate Scientists. As members of the Kashani lab, their research is aimed at identifying molecular markers of melanoma progression. Katie Stone, Ph.D., was named Senior Scientist, and continued her groundbreaking research into sleep quality and health outcomes including cognitive function and risk of falls or injuries in the elderly. 10 H I G H L I G HTS RESEARCH FOR BETTER MEDICINE Alireza Atri, M.D., Ph.D. Catherine Madison, M.D. 11 Quelling an electrical storm in the brain Research at the Sutter Pacific Epilepsy Program helps lead to FDA approval of new epilepsy pacer for treating epileptic seizures Over one third of patients with epilepsy have persistent seizures despite treatment with medications. New approaches have been critical to reducing the frequency and intensity of these brief periods of abnormal, excessive, or asynchronous neuronal activity in the brain. And while resective surgery is an option for some patients, the procedure increases the risk of post-operative neurological deficits. Last year, research at Sutter Pacific’s Epilepsy Program was key to the Food and Drug Administration’s approval of a new epilepsy pacer—in essence, a brain stimulator—in treating epileptic seizures. The tiny batterypowered device is implanted in the brains of epilepsy patients for whom medications and/ or surgery have been unsuccessful. Its wires are threaded into the brain, tracking electrical activity and preventing or minimizing impending seizures. The effectiveness of the epilepsy pacer was shown in a randomized controlled trial at multiple centers throughout the U.S., with CPMC leading the trials as the largest implanting facility with the most experience worldwide. The epilepsy pacer device is shown (top) implanted into an epilepsy patient’s brain, tracking electrical activity. 12 R E S E A R C H FOR BE TTE R ME DICINE “The device has dramatically reduced seizures in our patients, from dozens daily to just a couple every few months in many cases,” says David King-Stephens, M.D., CPMC’s Director of Neurophysiology, and Co-Director of the Sutter Pacific Epilepsy Program. “It’s truly an evolution: we’re seeing the tangible benefit of this research improving patients’ quality of life and their ability to function at work, as parents, and in leading well-rounded lives free from symptoms.” One of these patients is Gina Smith, a twenty-eight year old mother who experienced devastating seizures since developing epilepsy in her teens. Even after treatment with seven different drug combinations, six weeks was her longest seizure-free period, and surgery wasn’t an option due to a high risk of short-term memory loss. After being implanted with the epilepsy pacer, Smith’s frequency of seizures was reduced by eighty-five per cent. “Before the device, I felt as if my life were falling apart, and with it my ability to care for my kids,” says Smith. “There’s clarity now with months in my life where I feel as if epilepsy were a distant memory.” This year, Dr. King-Stephens and colleagues Peter Weber, M.D. and Kenneth Laxer, M.D. uncovered new findings about the device that may provide evidence supporting its wider use in specific types of epilepsy patients and through stimulation of different areas of the cortex. “The new data reinforce that brain stimulation is an excellent treatment for patients in whom we know where the seizures originate, but who are not candidates for resective surgery,” says Dr. King-Stephens. David King-Stephens, M.D. CPMC’s Director of Neurophysiology, and Co-Director of the Sutter Pacific Epilepsy Program “The device has dramatically reduced seizures in our patients, from dozens daily to just a couple every few months in many cases,” says David King-Stephens, M.D. 13 Investigating the molecular pathways underlying the development and progression of skin cancer Research and clinical trials at CPMC’s Center for Melanoma Research and Treatment were key to FDA approval of nivolumab for the treatment of melanoma, bringing patients one step closer to cure One of the newest classes of agents to treat melanoma and other types of cancer, checkpoint inhibitors have emerged as promising therapies in slowing tumor growth and shrinking cancers. With the Food and Drug Administration (FDA) approval in December of the checkpoint inhibitor nivolumab for advanced melanoma, these drugs are expected to bring new hope to the more than 76,000 people in the U.S. diagnosed annually with this deadly form of skin cancer. Checkpoint inhibitor drugs act as a natural immune system ‘brake’ known as PD-1, which some tumors use to evade immune system attack. Studies at CPMC’s Center for Melanoma Research and Treatment were key to approval of the drug, with the Center’s investigators entering more patients on the pivotal study than any other cancer center worldwide. Nivolumab is an immunosuppressive agent that releases a natural immune system brake known as PD-1 which some tumors use to evade immune system attack. Studies have shown that anti-PD1 antibodies show a higher rate of durable responses with less severe toxicity than previously approved immunotherapies for melanoma. “This research is changing the landscape of cancer therapy, based on these new insights into tumor biology and the molecular pathways underlying metastasis,” says David Minor, M.D., clinician-scientist at CPMCRI. “Many of our patients treated with the drug are continuing to do well and show no signs of tumor progression.” 14 R E S E A R C H FOR BE TTE R ME DICINE “The drug shows significant promise in saving the lives of patients with late-stage disease who have few options for therapy,” says Mohammed Kashani-Sabet, M.D., Director of CPMC’s Center for Melanoma Research and Treatment, and Senior Scientist at CPMCRI. “Anti-PD-1 drugs, because they are effective in other diseases such as lung cancer and melanoma, will make the immunotherapy of cancer a mainstream treatment like surgery, radiation, and chemotherapy.” Dr. Minor and Dr. Kashani are already seeing dramatic improvements in patients treated with the drug. Fifty-six year old John Heebink, for example, had advanced melanoma and was told he’d live about five months, before being treated with nivolumab at CPMC. After two months his tumors had shrunk by 80 per cent. Two years later, Heebink has had continued success on the drug and feels “as if this therapy has been a game changer for my path of recovery,” he says. David Minor, M.D., clinician-scientist at CPMCRI “This research is changing Intrigued by the potential of immunotherapies to engage the body’s cellular defense mechanisms to fight cancer, CPMC’s melanoma team began investigating checkpoint inhibitors several years ago. They found that agents like PD-1 inhibitors reactivate T cells after their suppression during the cancerous process, thus boosting the immune system’s capacity to stop metastasis. the landscape of cancer Dr. Minor worked with scientists at Bristol-Myers-Squibb to expand the eligibility criteria for the study. This enabled he and other physicians to place more patients on the study sooner, speeding FDA approval of the drug. metastasis,” says therapy, based on these new insights into tumor biology and the molecular pathways underlying David Minor, M.D. 15 CPMC’s Ray Dolby Brain Health Center boosts its research initiatives to expand the Center’s innovative approach to caring for patients with memory disorders Alireza Atri, M.D., Ph.D, joins the Center as Endowed Chair in Brain Health Research The Ray Dolby Brain Health Center (RDBHC) at CPMC built upon its impressive reputation for patient care with the successful recruitment of Alireza Atri, M.D., Ph.D., an internationally renowned Alzheimer’s disease (AD) clinicianscientist and educator, to lead the Center’s clinical and discovery research into healthy brain aging, AD and dementia. Alireza Atri, M.D., Ph.D., internationally renowned Alzheimer’s disease (AD) clinician-scientist and educator More than 500,000 Californians are affected by AD, dementia, or a related memory disorder. The RDBHC —one of the only programs of its kind in Northern California and first to develop partnership with the Alzheimer’s Association—opened its doors in 2012, and has delivered comprehensive and innovative evaluation, support and treatment for thousands of Bay Area residents. 16 Dr. Atri will work closely with the Center’s Founder and Director, Catherine Madison, M.D., and with CPMCRI Scientific Director Michael Rowbotham, M.D. He joins CPMC from Massachusetts General Hospital and Harvard Medical School in Boston, where he and colleagues published the first long-term study to show sustained benefits of combination therapies to slow clinical decline in Alzheimer’s disease. “The Bay Area is so fortunate to entice a clinician-researcher with the depth of knowledge and devotion evident in Dr. Atri. We look forward to his work advancing the delivery of evidence-based care for our patients and helping us all address the epidemic of dementia,” says Dr. Madison. Rachelle S. Doody, M.D., Ph.D., the Effie Marie Cain Chair and Director of the Alzheimer’s Disease and Memory Disorders Center at Baylor College, says, “Dr. Atri brings tremendous clinical excellence and a rare dedication to research-based patient care to the Center. He is poised to lead the group in providing standard care while advancing new treatment approaches, which will translate into new options for patients in the region. Dr. Atri will continue to advance the field of AD therapeutics research while training an array of care providers to deliver care in the future.” A lead investigator for international AD treatment trials, Dr. Atri studies new diagnostic and therapeutic strategies to detect and slow cognitive disorders. He will collaboratively initiate new clinical trials at Sutter Health, and establish partnerships for treatment trials, cohort and epidemiological studies, and dementia education programs throughout Northern California. “Few of us will be spared the personal effects of cognitive changes and—what is increasingly recognized as one of the most challenging afflictions of our time— dementia,” says Dr. Atri. “The Bay Area is a hub for research innovation, collaboration, community and progress. With equal spirit and drive in our approach to research advances at CPMC, I believe we can substantially ameliorate the significant health and social impacts of dementia.” R E S E A R C H FOR BE TTE R ME DICINE The Sutter Cancer Research Consortium and the Sutter Neuroscience Research Consortium Overview A coordinated approach to implementing clinical research and trials in key areas of Sutter Health expertise was a vision yet to be realized until Sutter Health’s Lea Ann Bernick, MHA, met with several system-wide oncologists two years ago to discuss its execution; but her initial work (with the support of oncology investigator leadership) in helping organize and implement a more efficient strategy for initiating large National Cancer Institute (NCI) and industrysponsored oncology clinical trials soon led to the genesis of the Sutter Cancer Research Consortium (SCRC). The consortium now represents efforts of the Sutter Research Enterprise to streamline and expand its system-wide clinical oncology research. “From the start, there has been overwhelming support and collaboration for a new means to coordinate more efficient initiation of system-wide oncology clinical trials,” says Bernick. “It’s incredibly motivating to see physician engagement in this process, and the knowledge that our patients are benefiting from faster, easier access to promising new therapies and follow-up services.” Lea Ann Bernick, MHA, Sutter Cancer Research Consortium Director As the SCRC continued to grow and achieve early success, a similar strategy to coordinate system-wide clinical neuroscience research evolved a year later with leadership from CPMCRI Scientific Director Michael Rowbotham, M.D., in creating the Sutter Neuroscience Research Consortium (SNRC). “Neuroscience research is amazing in its diversity,” says Dr. Rowbotham. “There is no equivalent of the NCI cooperative groups in the neurosciences. The SNRC is organized to bring together research experts from all sub-specialties to share ideas, develop new investigator-led studies, and work toward including multiple sites within Sutter for all major clinical trials.” Together, the consortia are key initiatives enabling an efficient shared services model that eliminates redundancies, provides consistent administrative and regulatory support, and reduces costs to CPMCRI and other Sutter Health research affiliates. SCRC and SNRC facilitate dissemination of the One Sutter approach into clinical research programs system-wide. While maintaining a strong physician-scientist orientation, an integrated system gives patients access to a cutting-edge, large, diverse range of treatment options and programs to support their care plan and their entry into oncology and neuroscience clinical trials. 17 Why create consortia centered around Sutter’s oncology and neuroscience research expertise? For patients: • Expands options for clinical care and prevention research across a wide range of tumor types and neurological disorders • Provides coordinated access to cutting-edge clinical research, even in remote and/ or urban areas within the Sutter system • Assures patients that the clinical research excellence they seek can be found at Sutter affiliates For physicians: • Offers a broader array of clinical trial options to deliver care unavailable by other means • Provides an efficient infrastructure to support physician-scientists who offer patients innovative clinical trial treatment options • Enhances the scientific peer-review process via a system-wide science committee • Encourages collaborative research opportunities among oncologists and neurologists, and other specialized care providers • Provides a more efficient structure for investigator-initiated studies and participation in large-scale pharmaceutical studies For Sutter: • Aligns the affordability agenda with an efficient consortia structure • Facilitates the work of RISA toward a consolidated operations and budget • Encourages interdependence for clinical expertise, with less patient ‘leakage’ to outside academic systems in Northern and Central California • Provides a model for other Sutter service lines to consider duplicating, and enables bridge-building between institutions and clinical staff • Presents an attractive structure to pharmaceutical companies and academic networks for including Sutter patients and physician-scientists in large clinical trials and cohort studies 18 R E S E A R C H FOR BE TTE R ME DICINE The Sutter Cancer Research Consortium: A robust clinical trials portfolio By simplifying the process for patient entry into clinical trials and facilitating the development of a Sutter-wide tumor biorepository, Sutter Health oncologists are coordinating their efforts to improve cancer research and treatment outcomes for patients, and collaborating in large, phase 1-3 national clinical studies sponsored by NCI and the pharmaceutical industry. By the numbers: How SCRC leadership and expertise improves patient care • There are 115 registered NCI investigators at 21 sites across the Sutter Health network. • In 2014, 110 patients were enrolled into national NCI funded clinical trials. • On any given day, the SCRC offers 65-70 clinical studies open to enrollment. One hundred and five studies are in long-term follow-up with thousands of patients formerly on active treatment. • We ranked as the ninth-largest main member within the national NRG Oncology Group, one of the four cooperative groups led by the NCI. Historically, Sutter NCI research programs have been recognized by the NCI as one of the top community based enrolling entities. • Seven of our oncologists are appointed to sit on NCI national cooperative group Disease Committees, helping lead the design and creation of these studies. Their findings are published in peer-reviewed journals with our physicians as lead or co-authors who present at national oncology meetings. SCRC Governance: Comprised of a 12-member Executive Committee, the SCRC is governed by Stacy D’Andre, M.D., Executive Committee Chair. Ari Baron, M.D., acts as Science Committee Chair and organizes review of all new NCI studies. The Executive Committee makes policy decisions, ensures representation of all oncology subspecialties and Sutter geographies, and helps inform the direction of SCRC. They participate on national NCI cooperative group investigator committees where these trials are designed, and enroll patients into the studies. Michael Rowbotham, M.D., is a non-voting member of the Executive Committee. Lynne Day, Operations Director at CPMCRI, provides logistical support through her role in integrating research services across the system. Lea Ann Bernick is the Director of the SCRC. She and her team coordinate SCRC physicians, manage all NCI-sponsored trials at Sutter Health, educate and train staff on studies and quality assurance, and provide a critical link to the NCI and the rapidly changing world of oncology clinical trials. 19 Regional Leads Stacy D’Andre, M.D., Sacramento-Sierra Lead and SCRC Executive Committee Chair; Medical Director, Gastrointestinal and Gynecologic Tumor Programs at the Sutter Health Cancer Center; Department Chair of Medical Oncology Leading research advances in the treatment of gynecologic and gastrointestinal cancers in the elderly Ari Baron, M.D., West Bay Lead Medical Director of the Clinical Oncology Research Program at CPMC; Chief of the Division of Hematology-Oncology Renowned for expertise in advancing clinical trials for pancreatic, prostate, colon, liver, lung, breast, and ovarian cancers Peter Yu, M.D., Peninsula Coastal Lead Director of Cancer Research at Palo Alto Medical Foundation; President, American Society of Clinical Oncology Pioneering health information technologies to improve the quality of cancer diagnosis, care, and prevention Milana Dolezal, M.D., East Bay Lead Medical Director of Gastrointestinal Oncology at Alta Bates Summit Comprehensive Cancer Center Enabling new approaches to the treatment of solid tumors and hematologic malignancies David Shiba, M.D., Central Valley Lead Oncologist/hematologist; Sutter Gould Medical Foundation physician Leading clinical trials to advance the treatment of patients with solid tumors and hematological malignancies 20 R E S E A R C H FOR BE TTE R ME DICINE System Leads Gregory Graves, M.D., Surgical Oncology Lead Surgical Oncologist; Regional Medical Director of Cancer Services, Sacramento-Sierra Region; Medical Director, Sutter Cancer Center, Sacramento; Chief of the Department of Surgery, Sutter Medical Center Developing new surgical and radiotherapy techniques to treat cancer Elizabeth Kim, M.D., FACS, Surgical Oncology Lead Surgical Oncologist; Sutter Roseville Medical Center Pioneering surgical advances for the treatment of high-risk breast diseases and breast cancer John Chung-Kai Chan, M.D., Gynecologic Oncology Lead Sutter Health Director of Gynecologic Oncology Leading research advances in the treatment of gynecologic cancers Kathleen Grant, M.D., Symptom Control Lead Medical Oncologist-Hematologist; Chief of the Division of Hematology-Oncology at CPMC Advancing the diagnosis and treatment of hematological malignancies; developing novel therapies for breast, esophageal, and bowel cancer Kevin Knopf, M.D., M.P.H., Prevention Lead Medical Oncologist and Hematologist at CPMC Improving research into the cost-effectiveness of cancer care; implementing clinical pathways, decision analysis, and health economics modeling; leading large-scale database analytics in cancer care; studying patterns of cancer care and health disparities Christopher Jones, M.D., F.A.C.R., Radiation Oncology Co-Lead Radiation Oncologist, Sutter Health Medical Group Leading advances in new radiotherapy techniques; optimizing imaging technologies to predict tumor recurrence and visualize response to therapy; internationally renowned expertise in head and next cancers Jamie Rembert, M.D., Radiation Oncology Co-Lead Radiation Oncologist, Alta Bates Comprehensive Cancer Center; Chair of Clinical Services, Alta Bates Hospital Pioneering new radiotherapy techniques to treat cancer; optimizing imaging technologies to predict tumor recurrence and visualize response to therapy 21 Sutter Health Neuroscience Research Consortium: Research to advance the treatment of neurological disorders Sutter Health offers its adult and pediatric patients some of the leading neurosurgery, neurology, and neuro-oncology specialists in Northern California, with state-of-the-art diagnostic and surgical technologies. Sutter’s neuroscience experts are at the forefront of clinical research in essentially all areas of clinical neuroscience. Their coordinated efforts include research on new treatments, diagnostic tools, and disease biology; multidisciplinary teams with enhanced clinical expertise and personalized approaches to patient care, and; coordinated access to a large portfolio of clinical trials and other innovative clinical research studies. SNRC Governance: Nobl Barazangi, M.D., Ph.D., Director of the Stroke/Neurocritical Care Research and Education Program at CPMC Comprised of a 30-member Executive Committee, the SNRC is governed by Executive Committee Chair Michael Rowbotham, M.D. The Executive Committee has four Regional Leads ensuring representation and perspectives from all geographic areas of Sutter Health. The SNRC is comprised of 16 disease areas, some with up to four Executive Committee members to better integrate longstanding individual affiliate research programs. The entire spectrum of neuroscience subspecialties are represented, including brain tumors and other cancers of the nervous system, Alzheimer’s disease and dementia, pain and peripheral nerve disorders, migraine and headache, multiple sclerosis, pediatric neurology and autism, movement disorders and Parkinson’s Disease, ALS and neuromuscular diseases, neuro-critical care, neuro-imaging, neuro-interventions (such as stents to prevent stroke and deep brain stimulation for movement disorders), epilepsy, neuro-trauma (including head injury and sports concussions), spine disorders, rehabilitation, and stroke. Lynne Day advises the SNRC through her role in integrating research services across the system. CPMCRI’s Virginia Giblin and Sutter Institute for Medical Research’s Bobbie Benabides coordinate all SNRC activities. Regional Leads Michael Rowbotham, M.D. Scientific Director of CPMCRI, SNRC Executive Committee Chair Unraveling the mechanisms and improving management of chronic pain; advancing pain research Nobl Barazangi, M.D., Ph.D., Stroke/Neurocritical Care Lead Director of the Stroke/Neurocritical Care Research and Education Program at CPMC Pioneering advances in stroke research and care, including neuroimaging, neurovascular disorders, and neuromonitoring 22 R E S E A R C H FOR BE TTE R ME DICINE Shawn Kile, M.D., Dementia and Cognition Lead Medical Director of Neurology, Sutter Medical Group Neurology Care Center; Medical Director, Sutter Neuroscience Concussion and Traumatic Brain Injury Clinic; Co-Director, Sutter Neuroscience Memory Clinic Leading research advances in the treatment of dementia, traumatic brain injury, autism, encephalopathy, and other neurocognitive illnesses; conducting physicianinitiated trials and phase 2-3 clinical studies assessing the efficacy of new therapies for Alzheimer’s disease and adult autism Joanna Cooper, M.D., Multiple Sclerosis Lead Medical Director of the Alta Bates Summit Medical Center Research Institute (REDI) Developing new approaches to the treatment of multiple sclerosis, epilepsy, spasticity disorders, and other neurologic conditions Disease Area Leads Jonathan Katz, M.D., Neuromuscular/Peripheral Nerve Lead Director of Neuromuscular Research at the Forbes Norris MDA/ALS Research and Treatment Center at CPMC Investigating treatments to delay the progression of motor neuron diseases including ALS and myasthenia gravis; initiating clinical trials for pain management, peripheral neuropathy, poliomyelitis, radiculopathies, and spinal muscular atrophy Edie Zusman, M.D., F.A.C.S., Neurosurgery Lead Medical Director, Sutter Health East Bay Neuroscience Institute at Eden Medical Center Advancing the neurosurgical treatment of brain tumors, neurovascular conditions, epilepsy and spinal disorders Richard Riemer, D.O., Spine Lead Regional Medical Director of Sutter Spine Care, Sutter Neuroscience Institute and Sutter Medical Foundation Advancing the treatment of spinal disorders and chronic pain; investigating opioid use and the ‘opioid epidemic’, chronic pain, and conservative treatment for spine disorders Michael Chez, M.D., Pediatric Neurology Lead Director of Pediatric Neurology at Sutter Memorial Hospital, Director of the Pediatric Epilepsy and Autism Programs for the Sutter Neuroscience Group Expertise in pediatric neurology; pioneering new treatments for childhood epilepsy, autism and autism spectrum disorders Kenneth Laxer, M.D., Epilepsy Lead Director of the Sutter Pacific Epilepsy Program Leading research on neuroimaging techniques, cerebellar physiology, and pharmacologic approaches to treating epilepsy 23 Tyler Kang, M.D., Neuro-Oncology Lead Hematologist and Medical Oncologist, Alta Bates Summit Medical Center Conducting research and clinical trials to advance the treatment of pediatric brain and spinal tumors; seeking new insights into the molecular and genetic mechanics underlying brain cancer metastasis Lawrence Dickinson, M.D., Neuro-Trauma Lead Medical Director, Intensive Care Unit, Sutter Health Eden Medical Center Developing new approaches to the treatment of traumatic brain and spinal injuries; advancing the surgical management of stroke and cerebrovascular illnesses Scott Rome, M.D., Rehabilitation Lead Medical Director of Stroke and Brain Injury Rehabilitation Programs at CPMC Pioneering research that facilitates patients’ rehabilitation after traumatic brain injury Jennifer Ault, D.O., Pain Lead Neurologist, Sutter East Bay Medical Foundation, Alta Bates Summit Medical Center Leading studies to advance the treatment of musculoskeletal injuries; pioneering new approaches to the diagnosis and treatment of spinal disorders including disc herniations, spinal stenosis, and sciatica, as well as complex regional pain syndrome, thoracic outlet syndrome, and refractory pain after back surgery Arshia Sadreddin, M.D., Movement Disorders Lead Medical Director of Movement Disorders and Deep Brain Stimulation, Sutter Pacific Medical Foundation at CPMC Developing novel therapies for Parkinson’s disease and essential tremor, and the treatment of dystonia; developing strategies to refine and improve the use of deep brain stimulation for movement disorders David Tong, M.D., Stroke/Neuro-Intensive Care Lead Director of the Center for Stroke Research at CMPC Leading advances in early diagnosis, treatment and recovery of acute stroke; helping lead effective strategies for use of SMART (Simplified Management of Acute Stroke using Revised Treatment) criteria for IV rt-PA treatment; creating stroke telemedicine networks across Northern California Alireza Atri, M.D., Dementia and Cognition Lead Endowed Chair in Brain Health Research and Education, Ray Dolby Brain Health Center at CPMC Improving the diagnosis and care of patients with memory disorders and dementia; leading clinical and discovery research into healthy brain aging, dementia, and Alzheimer’s disease and memory disorders David Chesak, M.D., Multiple Sclerosis Lead Neurologist, Sutter Neuroscience Group, East Bay Region Creating new approaches to the treatment of multiple sclerosis, epilepsy and seizure disorders, headaches and migraines, and neuromuscular disease 24 R E S E A R C H FOR BE TTE R ME DICINE Bradley Wrubel, M.D., Headache Lead Neurologist, Sutter East Bay Medical Foundation Leading clinical research and trials to advance the treatment of migraine and other headaches Joey English, M.D., Neuro-interventional Lead Neurointerventional surgeon and Medical Director of Neurointerventional Services at CPMC Developing novel neurointerventional approaches including endovascular therapies to treat acute ischemic stroke and other cerebrovascular diseases David Seidenwurm, M.D., Neuroimaging Lead Neuroradiologist, Sutter Medical Group, Sacramento Pioneering appropriate use and performance measurement of leading-edge radiology techniques to advance the diagnosis of brain and spinal injuries Featured SNRC Research Program Areas at CPMC: The Sutter Pacific Epilepsy Program maintains a comprehensive research program with approximately 13 active approved protocols for studies of neuromodulation devices, new anti-epileptic drugs, and brain pathology in epilepsy patients. CPMC’s stroke researchers are using telemedicine to rapidly and remotely evaluate and treat patients with acute stroke, and to study neurovascular techniques such as stents and vascular reconstruction devices. Several researchers in the stroke group are involved in industry-sponsored trials of new therapies. The Forbes Norris MDA/ALS Research and Treatment Center at CPMC—one of the largest clinical research centers worldwide—has been integral to essentially every significant study of ALS treatment conducted over the past 15 years. The Center’s physicians are active in many ALS research consortia, and lead research into myasthenia gravis, muscular dystrophy, and peripheral neuropathies. CPMC’s Ray Dolby Brain Health Center collaborates with the Alzheimer’s Association of Northern California to provide patient care, education and research in memory loss. Employing a multidisciplinary team of health professionals, the Brain Health Center provides a variety of services for individuals with early memory loss, dementia, and Alzheimer’s disease, and to support patients’ caregivers. CPMC has added a movement disorder physician specialist that treats and conducts research on neurological conditions such as Parkinson’s disease, essential tremor, dystonia, Huntington’s disease, and others. Providing both medical management and surgical options such as deep brain stimulation, our movement disorder team is skilled and knowledgeable in treating a wide array of movement-related conditions. 25 26 KEY INVESTIGATORS AND TEAM MEMBERS Liliana Soroceanu,caption Ph.D., M.D. here Senior Scientist 27 CPMCRI scientist a game-changer in brain cancer research Leading cutting-edge work in a new area of cancer research: the hypothesis that viruses can cause cancer, and that anti-viral therapies can prevent tumor growth Liliana Soroceanu, M.D., Ph.D. Approximately 23,000 Americans are diagnosed with a primary brain and other nervous system tumor every year, and almost 60% of them will eventually die from the illness. Glioblastoma multiforme (GBM) is the most common, aggressive type of primary malignant brain tumor, accounting for approximately 40% of cases. Patients with GBM deteriorate quickly; 90% die within two years after starting therapy, and only five per cent are alive after five years. A disheartening prognosis, and one that drives Liliana Soroceanu, M.D., Ph.D., to search for new treatments. One of the country’s few female scientist authorities on GBM, Dr. Soroceanu had a banner year, publishing research on human cytomegalovirus (HCMV), the causal link to GBM, and the effects of anti-viral therapy. “We anticipate these findings will revolutionize the treatment of brain tumors,” says Dr. Soroceanu. “No prior evidence has shown a role for cidofovir as a potent anti-cancer agent against glioblastoma. We were surprised that, even in the absence of HCMV infection, the drug caused tumor cell death and augmented the effects of radiation in delaying tumor progression.” Nine years ago, her first breakthrough work at CPMCRI arose in collaboration with the leading neurosurgeon Charles Cobbs, M.D., and involved a novel avenue of inquiry— research to explore the role of HCMV, a common herpes virus, in tumor growth and metastasis. Dr. Soroceanu’s other pivotal research this year revealed, for the first time, a specific HCMV gene signature and related mechanisms underlying the viral attack that triggers GBM progression. After infecting human glioblastoma stem cells with several HCMV strains and measuring the viral gene expression patterns, tumor stem cells infected with HCMV were shown to persist twice as long as uninfected cells. Prolonged survival was accompanied by the activation of signaling pathways that drive glioblastoma survival and recurrence. “We found a specific set of genes common to the GBM cells infected with HCMV that contributes to multiple tumor-promoting pathways,” says Dr. Soroceanu, who led the research. “Developing anti-viral therapies to target this signature could therefore help prevent disease progression and the recurrence of brain tumors.” 28 K E Y I N V E S TIGATOR S AND TE AM ME MB E R S Investigating the mechanisms underlying peripheral neuropathy Research leads to new strategies to preserve nerve function in the elderly Greg Tranah, Ph.D. Loss of touch sensation, poor motor nerve function, and in some cases pain, burning or tingling in the feet or hands—these and other symptoms of poor peripheral nerve function commonly afflict the elderly, and can severely impact quality of life, physical functioning, and wellbeing. Greg Tranah, Ph.D., CPMCRI and San Francisco Coordinating Center (SFCC) scientist, and Adjunct Professor in the Department of Epidemiology & Biostatistics at UCSF, studies mitochondrial dysfunction in age-related illnesses including dementia and Alzheimer’s disease. As mitochondrial dysfunction is a common characteristic of several neuropathies including peripheral neuropathy, Dr. Tranah focused key investigations this year on understanding sensory deficits and neuropathic impairments. He is among a select group of researchers in the U.S. uncovering how alterations in mitochondrial DNA (mtDNA) play a much greater role than once believed in neurodegeneration and age-related brain illnesses. And while the study of mtDNA is well established, the availability of inexpensive, high-throughput genotyping and DNA sequencing has allowed researchers to examine mtDNA in much larger studies of disease and aging. “The genetic information Dr. Tranah’s latest study expanded upon this work and examined the influence of inherited and acquired mtDNA mutations on peripheral neuropathies in the elderly. insight into new targets Studying over 2,000 elderly participants from the Health, Aging and Body Composition (Health ABC) cohort, Dr. Tranah and colleagues investigated the role of mtDNA sequence variation on peripheral nerve function. nerve function in the coding for mitochondrial protein synthesis and assembly is associated with peripheral nerve function, and may provide for therapies that preserve elderly,” says Dr. Tranah. Even though common individual genetic variants were found to play a much smaller role in peripheral nerve functioning than initially hypothesized, groups or aggregates of multiple sequence variants had a stronger impact on motor nerve conduction velocity and amplitude. “The genetic information coding for mitochondrial protein synthesis and assembly is associated with peripheral nerve function, and may provide insight into new targets for therapies that preserve nerve function in the elderly,” says Dr. Tranah. “Since poor peripheral nerve function strongly correlates with diminished physical functioning, new approaches to safeguarding the mitochondrial DNA governing the integrity of these nerves can help extend physical wellbeing in the elderly and prevent sensory and motor nerve degradation.” New directions in this area of research will see Dr. Tranah and colleagues at the SFCC explore how proportions of normal and mutant mtDNA impact the risk of inherited mitochondrial diseases. 29 Targeting the molecular underpinnings of cancer for more precise, personalized melanoma treatments Kevin B. Kim, M.D. Previously appointed at the University of Texas MD Anderson Cancer Center in Houston, Kevin B. Kim, M.D., joined CPMC’s melanoma program as Medical Director of Clinical Research. A prominent medical oncologist, Dr. Kim investigates targeted therapies, immunotherapies, and melanoma. Collaborating with Medical Director for Cancer Programs Mohammed Kashani-Sabet, M.D., Dr. Kim is leading phase 1 and 2 clinical trials on the biology of genetic mutations in melanoma, and new combinations of targeted and immunotherapies. “This is an incredibly exciting time in melanoma research,” says Dr. Kim. “With the advancement of these treatments and our expanding knowledge of biomarkers, we can focus our efforts on bringing novel, more personalized therapies to patients.” “This is an incredibly exciting time in melanoma research,” says Dr. Kim. “With the advancement of these treatments and our expanding knowledge of biomarkers, we can focus our efforts on bringing novel, more personalized therapies to patients.” Research into targeted treatments for cancer has rapidly increased over the past 15 years with the discovery that agents including trastuzumab (Herceptin®) could disrupt specific receptors in a cancer cell’s membrane, halting tumor growth and progression. More recently, small-molecule targeted therapies including BRAF and MEK inhibitors against melanoma have significantly improved patients’ prognosis and increased momentum in this area of research. “But despite these targeted treatments, cancer is incredibly insidious in that a tumor can mutate and become resistant to therapy,” says Dr. Kim. “The goal is to overcome a tumor’s resistance and adaptive capabilities by attacking the cancer at multiple pathways and critical points of cell growth, with combination therapy.” With experience in translational melanoma research into novel molecular targeted therapies, Dr. Kim was an integral part of the early drug development of small molecules that are now FDA-approved drugs for patients with BRAF-mutant metastatic melanoma. As Director of Clinical Research in the melanoma group and in collaboration with Dr. Kashani-Sabet and others, Dr. Kim will lead CPMC’s efforts to build a database and tumor bank of tissue samples from patients with melanoma—an initiative that will advance personalized therapies. 30 K E Y I N V E S TIGATOR S AND TE AM ME MB E R S Pioneering new approaches to the treatment of Parkinson’s disease and movement disorders Arshia Sadreddin, M.D. One of the few neurologists in the U.S. with special training and expertise in deep brain stimulation for the treatment of Parkinson’s disease, Arshia Sadreddin, M.D., was recruited to lead CPMC’s new movement disorders program. Dr. Sadreddin was Assistant Professor of Neurology, previously appointed as physician and Director of the Hyperkinetic Movement Disorders and Huntington’s Disease Program at the prestigious Barrow Neurological Institute/Muhammad Ali Parkinson Center at St. Joseph’s Hospital & Medical Center in Phoenix. A renowned neurologist, Dr. Sadreddin specializes in medical and surgical treatments of movement disorders. She conducts research studies in Parkinson’s disease (assessing motor and non-motor functions), Huntington’s disease, and dystonia, and has experience as a Principal Investigator on numerous national, multicenter clinical trials evaluating the efficacy and safety of new treatments for these nervous system disorders. Collaborating with other Sutter Health movement disorders specialists including Matthew Arnold, M.D., and Nicklesh Thakur, M.D., Dr. Sadreddin will lead investigator-initiated and industry-sponsored clinical trials investigating new approaches to the treatment of Parkinson’s disease and other movement disorders. “This is an exciting time in movement disorders research,” says Dr. Sadreddin. “With advances in new technologies, surgical and pharmacologic therapies and our expanding knowledge of disease mechanisms, we can focus our efforts on bringing novel treatments to patients to improve their symptoms and quality of life. I am thrilled to collaborate among the renowned expertise of Sutter Health’s leaders in this area to help further these discoveries.” With support from CPMC’s Women’s Board and donors, Dr. Sadreddin is championing a Parkinson’s disease resource center at the hospital to provide a full range of care services including educational and support materials, classes, and various activities for patients and their caregivers. Dr. Sadreddin began her medical training at Ross University School of Medicine in Dominica, West Indies, and completed her clinical clerkships at a UCLA-affiliated hospital. This was followed by residency training in neurology and a fellowship in movement disorders and deep brain stimulation at the world-renowned Barrow Neurological Institute/Muhammad Ali Parkinson Center in Phoenix, Arizona. 31 New Advances in ALS Research at California Pacific Medical Center Research Institute Focus on the Forbes Norris MDA/ALS Research and Treatment Center For the 30,000 people in the U.S. with amyotrophic lateral sclerosis (ALS), progressive neurodegeneration and death of motor neurons causes loss of control of voluntary muscles and resulting symptoms including muscle weakness, spasticity, slurred speech and respiratory difficulties. While a cure is elusive, researchers at CPMCRI are exploring new approaches to treatment, and pioneering advances that bring improved quality of life for people with ALS. Robert Miller, M.D., Director of the Forbes Norris MDA/ALS Research Center Robert Miller, M.D., Jonathan Katz, M.D., and colleagues at CPMC’s Forbes Norris MDA/ALS Research and Treatment Center have begun new studies of approaches to reduce the neuroinflammation suspected to underlie the gradual progression of ALS. “We are seeking to understand the mechanisms that selectively trigger motor neurons to degenerate in ALS, and to find effective approaches that halt the processes leading to cell death,” says Dr. Miller, Director of the Forbes Norris MDA/ALS Research Center. Currently, the only FDA-approved drug treatment for ALS (riluzole/Rilutek®) reduces damage to motor neurons by decreasing the release of glutamate. The drug has established safety data and prolongs survival in patients by several months. Ongoing clinical trials led by Dr. Miller and Dr. Katz will assess the efficacy and safety of a new drug (NP-001) that has shown promise in halting disease progression in a subset of patients. A separate trial of the drug tirasemtiv is nearing completion. This drug is a fast skeletal muscle troponin activator, which is helpful in a disease such as ALS characterized by weakened and wasted muscles. Other trials led by the ALS team will determine optimal use of non-invasive ventilation (NIV) machines to ease breathing in patients, and a multicenter, randomized study of the NeuRX® Diaphragm Pacing System—an approach to support patients with diaphragm weakness. 32 K E Y I N V E S TIGATOR S AND TE AM ME MB E R S Later this year, the ALS group will begin collaborating with Cedars-Sinai Regenerative Medicine Institute on a study funded by the California Institute for Regenerative Medicine (CIRM). The new project will test the effects of combined stem cell and gene therapy, along with the protein GDNF (glial cell-derived neurotrophic factor) to promote the survival of damaged motor neurons in ALS patients. Other collaborative initiatives include a project with researchers at the University of California, San Diego to study mutations in RNA-binding proteins that cause neuronal dysfunction and death, and several studies of cognition and behavioral issues in ALS patients. More About CPMC’s Forbes Norris MDA/ALS Research and Treatment Center Jonathan Katz, M.D., Director of CPMC’s Neuromuscular Research Program and Director of the ALS Clinic In recognition of the ALS group’s successes and leadership in the area of motor neuron disease research, the Forbes Norris Clinic was one of only five centers selected to present research on quality and outcomes measures at the AAN’s meeting last year. The research on “Quality improvement in neurology: Quality measures in ALS” was published in a December 2013 issue of Neurology. Furthermore, the non-profit organization ALS Worldwide published a book about best practices in the management of the illness, and highlighted the Forbes Norris Clinic. 33 34 CPMCRI TEAM MEMBERS CPMCRI’s Grants Administrations Team 35 Lynne Day, Director of Research Operations A career spanning more than 20 years in research administration gives Lynne Day breadth of knowledge and experience unparalleled and invaluable to CPMCRI. Day began work with CPMC at its Heart Research Institute, next as Administrative Manager of the Department of Cardiovascular Surgery, and then founded the CPMCRI clinical trial operations office that provides support for physician investigators—and which has been expertly led by Jamey Schmidt since 2005. “I have been fortunate to work with a very strong, collaborative management team and a talented group of basic scientists and physician investigators at CPMCRI. A day does not go by that I don’t learn something new,” says Day. “I have been fortunate to work with a very strong, collaborative management team and a talented group of basic scientists and physician investigators at CPMCRI. A day does not go by that I don’t learn something new,” says Day, Director of Research Operations. Her responsibilities comprise oversight of administration, finance and facilities for the institute. As well, for the past several years Day has been collaborating with Sutter’s research institute operations leaders and the system-wide Research, Development & Dissemination group. Together, they are spearheading initiatives to integrate processes and provide compliant support that enhances research opportunities for Sutter’s patients and investigators. Day adds that “It has always been an honor to work with the investigators and staff at CPMCRI and Sutter, as we are all dedicated to enhancing the patient experience.” Last year through Day’s leadership in collaboration with Scientific Director Michael Rowbotham, MD, a novel project to advance CPMCRI’s cancer research was initiated—involving a cross-disciplinary approach and including the institute’s leading oncology investigators. 36 C P M C R I T E AM ME MBE R S Jamey Schmidt, Director of Clinical Research “It’s all about the patient,” says Jamey Schmidt. “The success of the clinical research program at CPMC is based on the entire team working together for the patients we serve. It is that simple.” Schmidt—who joined the Research Institute in 2002 and has served as its Director of Clinical Research since 2005—explains that multiple teams at the hospital and among other Sutter Health affiliates collaborate to ensure provision of the best clinical trials for CPMC’s patients. Teams of specially trained staff of clinical research coordinators, supervisors, finance analysts, lawyers, and compliance and regulatory analysts partner with CPMC’s physicians toward this common goal. “As a team, we enjoyed numerous accomplishments resulting in improved care for our patients,” says Schmidt. In 2014, her group adopted a new clinical trials management software that efficiently documents the course of clinical trials, as well as patient enrollment and clinic visits. The entire clinical research team utilizes this database to ensure billing compliance. This year, Schmidt’s team also developed pathways to document clinical research patients in the Sutter Health electronic health record. Working in small groups and led by the nursing expertise of Supervisor Nata DeVole, R.N., they developed guidance to inform inpatient and outpatient medical staff when patients are enrolled in a clinical trial—an important clinical safety measure and one that ensures patients are not charged for research-associated tests and procedures. “It’s all about the patient,” says Jamey Schmidt. “The success of the clinical research program at CPMC is based on the entire team working together for the patients we serve. It is that simple.” Schmidt commends her team’s work in helping lead development of CPMC’s gynecological oncology program with surgeon leadership by John Chan, M.D. and clinical research supervisor Lilian Hu. Collectively, the group enrolled 16 patients in just six months. “Clinical research is an integral part of the ‘gyn/onc’ program, and each patient entering the clinic is assessed to determine if a clinical trial is an option for their care,” she says. David Minor, M.D.—an oncologist specializing in melanoma who worked tirelessly with CPMCRI for 20 years on improving the care and drugs available to treat melanoma until his retirement this year—initiated hundreds of clinical trials including ones that led to the approval of two new breakthrough immunotherapy drugs. “Our collaborations with Dr. Minor exemplify the dedication of CPMC’s clinical team,” says Schmidt. “With only two days to prepare, the oncology team led by Manager Peter Gasper prepared for the audit. The post-audit review provided CPMCRI with many opportunities to improve our current process, ensuring we provide even better care for our melanoma patients.” 37 Joy Becker, Administrator of Comparative Medicines “CPMCRI held unique appeal because of its smaller size and the opportunity for closer proximity to support researchers,” says Becker. “Now, more than 15 years since I joined the Institute, we have average days within the animal facility but it’s more common to experience twists and turns not unlike working with human patients.” Much of the inner workings and success of the animal care facility at CPMCRI are credited to the dedicated efforts of Joy Becker, Administrator of Comparative Medicines. Having previously worked at UCSF as the Academic Coordinator managing several research animal facilities city-wide, Becker joined CPMCRI in 1999 and initially resided at the Pacific Campus Gerbode building. Her leadership and technician skills, as well as specialized knowledge of disease areas such as oncology, quickly led to her reputation for professionalism, efficiency, and unique capabilities. “CPMCRI held unique appeal because of its smaller size and the opportunity for closer proximity to support researchers,” says Becker. “Now, more than 15 years since I joined the Institute, we have average days within the animal facility but it’s more common to experience twists and turns not unlike working with human patients.” Becker comments on the highly regulated work and strict adherence to national guidelines and internal procedures—used to assess the health status of study animals, review proposed studies before final approval by the Institutional Animal Care and Use Committee, and liaise with vendors to procure appropriate mice for each study. In an average year, 25 studies are supported by Becker and her staff, including procurement and care of over 1,000 animals. This year, it was a coup for Becker to help lead recruitment of several biotechnology companies now working near the animal facility, some of which have begun collaborations with CPMCRI investigators and that are expected to broaden the Institute’s research expertise and impact. 38 C P M C R I T E AM ME MBE R S Martin Wu, Facilities Manager Few people have as much history invested in the Research Institute as Martin Wu, nor as varied responsibilities for its day-to-day maintenance at the Brannan campus. After almost 40 years supporting facilities at CPMCRI, Wu is on-call 24/7 and now oversees all aspects of the laboratory, including support for equipment, employees, supplies, and telecommunications, and ensuring the lab’s compliance with regulatory agencies. “My aim is to help the Institute function effectively, and to provide a safe, efficient and comfortable working environment for staff,” says Wu. He also assists with the on-boarding process for new personnel—providing access cards, setting up phones, computer access and work areas, and training scientists and general lab staff in facilities safety—and providing audio-visual support for Research Institute venues before staff meetings and other research-related speaking events. Wu’s days start early with a complete walkthrough of the Brannan facility to verify that processes are running safely, effectively and on schedule. His knowledge about technologies and equipments in the lab is critical for their upkeep and his liaison with service vendors and staff that maintain the building systems. In 2014, Wu and his team trained 12 new staff in lab safety, oversaw the implementation of a new next-generation sequencer, leading-edge microscope and autostainer, and successfully condensed the lab to allow for shared space with potential collaborators. “Overall, I’m greatly satisfied seeing a project through to completion, using my knowledge and experience to help my customers achieve their objectives,” says Wu. 39 CPMCRI’s Grants Administrations Team Love The Grants and Contracts Office at CPMCRI promotes the research mission of CPMC by providing high-quality financial and administrative services to CPMC’s researchers, collaborators and staff. Collectively, the grants team processes applications and proposals for submission to federal, commercial and foundation sponsors . “We strive to provide timely preparation of all grant and contract applications and skillful administration of research awards,” says Sarah Love, CPMC’s Grants and Contracts Director. Matin Jackson In 2014, the ease and efficiency of CPMCRI grants and contracts applications and proposals were significantly enhanced with division of the grants administration group into pre- and post-award teams. Pre-award processes, compliance, and subcontracting are led by Sarah Love and Humaira Matin, pre-award supervisor. The post-award team is led by Linda Jackson, Director of Research Finance, with Valerie Pascual as postaward supervisor. “As a team, our office is entrusted with adhering to the rules and regulations of our funding agencies, and protecting the legal and intellectual interests of our investigators and the institute,” says Linda Jackson. “We make every effort to deliver clear and concise information that fosters confidence and trust in our customers.” Both teams also provide grant support services to the Research, Development & Dissemination group (led by Sutter Health’s Buzz Stewart, Ph.D., MPH, and Josh Liberman, Ph.D.), Samuel Merritt University, Sutter Care at Home and Eden Hospital. Pascual 40 C P M C R I T E AM ME MBE R S FEATURED STUDIES Katie Stone, Ph.D. Senior Scientist, CPMCRI 41 Sutter Health launched its first system-wide clinical trial for patients with advanced squamous cell lung cancer Involvement in National Cancer Institute’s Lung-MAP initiative expected to provide patients with faster, streamlined access to promising therapies An unprecedented collaboration among federal health agencies, pharmaceutical companies, advocacy groups and cancer specialists—and involving Sutter Health as one of only a few study sites in Northern California—was announced in September with the launch of the Lung Cancer Master Protocol (Lung-MAP) trial. Lung-MAP will simultaneously test five experimental drugs in patients with advanced squamous cell lung cancer. 42 F E AT U R E D S TUDIE S Lung-MAP will simultaneously test five experimental drugs, and will enroll between 500 to 1,000 patients from 200 medical centers nationwide. Patients with advanced squamous cell lung cancer will be screened annually for more than 200 cancer-related genes. Trial investigators will then use the results of these tests to assign each patient to a study arm best matched to their tumor’s unique genetic profile. Lung cancer is the leading cancer killer among men and women, and will affect approximately 225,000 people in the U.S. this year alone. While other cancers such as breast cancer and melanoma have benefited from earlier advances in targeted or precision therapies—in essence the ability to match a therapy to the patient’s specific genetic tumor type—similar approaches have progressed at a slower pace in lung cancer research. Lung-MAP will attempt to change that, providing the first means to efficiently study a large number of rare, advanced lung cancer tumor subsets under one ‘parent’ trial protocol. “This approach to clinical trials is a first for cancer research and a significant advance in giving more patients faster access to promising therapies,” says Alan Kramer, M.D., a medical oncologist at CPMC who leads Sutter Health’s participation in the trial and sits on the South West Oncology Group (SWOG) Lung Committee overseeing the study. “Through Lung-MAP and via Sutter Health’s involvement, the entire clinical trial infrastructure will be made more efficient and reduce recruitment roadblocks for patients and their physicians.” Sutter Health enrolls hundreds of patients annually in cancer clinical trials, and has integrated oncology research and studies across its Northern California affiliate medical centers through the newly formed Sutter Cancer Research Consortium. This gives patients access to a large, diverse range of treatment options and follow-up services to support their care plan, and facilitates their entry into National Cancer Institute (NCI) and industry-sponsored clinical trials. Alan Kramer, M.D., Medical Oncologist, CPMC This fall, Sutter opened the trial at 17 sites from Auburn to Santa Cruz, where patients are being screened for enrollment. “We envision the trial as a paradigm shift in how we conduct clinical research,” says Dr. Kramer. “It’s of significant benefit to our patients and our communities to participate in these state-of-the art clinical trials aimed at not only identifying the genetic mutations driving cancer, but understanding how best to stratify patients for appropriate, targeted therapies.” Lung-MAP is the first of several similarly structured trials that will be conducted by the National Institutes of Health/NCI’s newly formed National Clinical Trials Network. 43 Global database assessing pain trial results shows significant gaps in reporting of study results CPMCRI investigators expand the RReACT repository to all international trial registries, for a broader snapshot of registered analgesic clinical trials and a scorecard of publicly available results Results from more than half of clinical trials for common chronic pain disorders on the world’s registries are not readily available, according to an updated and thorough analysis. In May, global results from the Repository of Registered Analgesic Clinical Trials (RReACT) database were published in the journal PAIN®. Michael Rowbotham M.D., Scientific Director of CPMCRI To capture a snapshot of registered clinical trials related to neuropathic pain and a scorecard of the availability of trial results, Michael Rowbotham, M.D.—Scientific Director of CPMCRI and lead study author—and colleagues created RReACT in 2012, a project of the Analgesic Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION). This year’s updated survey includes results from trials of 15 major registries accessible through the World Health Organization (WHO)’s International Clinical Trials Registry Platform (ICTRP). “By initiating RReACT, our goal was to enable greater public access to the results of clinical research,” says Dr. Rowbotham. Clinical trials conducted in the U.S. are required to be registered on ClinicalTrials.gov—the world’s largest global registry and a service of the National Institutes of Health (NIH)—and certain categories of industry-sponsored trial results must be posted within one year of a study’s completion. Earlier findings published by Dr. Rowbotham and colleagues included a survey of the results from postherpetic neuralgia, fibromyalgia, and diabetic peripheral neuropathy trials registered on ClinicalTrials.gov. In the present study, they analyzed trial registration, registry functionality, and results reporting on all 15 primary registries in the ICTRP for these three most frequently studied pain disorders. Trial results were searched for in the peer-reviewed literature and the ‘grey literature’ (conference abstracts and/or posters, and press releases), and only unique trials were analyzed. In the new project, the researchers identified 447 unique trials, 86 (19%) of which were located on multiple registries. ClinicalTrials.gov contained 82% of all trials analyzed. Overall, only 46% of all trials had results available, and peer-reviewed publications could be found for a disappointing 30% of trials. “Creating a global database of registered trials proved surprisingly difficult for several reasons,” says Dr. Rowbotham. “Because the ICTRP does not reliably identify trials listed on multiple registries, manual searches are necessary. Additionally, searching 44 F E AT U R E D S TUDIE S ICTRP in its entirety yields different results than searching individual registries, and outcome measure descriptions for multiply registered trials vary across registries.” According to Dr. Rowbotham, the grey literature is not peer-reviewed nor consistently archived or indexed, and is therefore an unreliable and impermanent source of findings. “Analyses and reviews of published evidence need to consider not only the absence of over half of findings, but also the known problem of publication bias,” notes Dr. Rowbotham, referring to the phenomenon in which positive results from clinical trials are more likely to be published, and studies with negative findings (in the researchers’ evaluation) are often published in ways that convey positive outcome. “There is a significant public health benefit to providing a full picture of “There is a significant public health benefit to providing a full picture of trial results to patients,” says Dr. Rowbotham. “Many patients enter clinical trials with the belief that by taking part in research, they will help other patients in the future. For that to happen, the results of this research must be transparent and fully available.” trial results to patients,” The next steps of the research will be to expand the range of painful disorders analyzed, and update the scorecards. belief that by taking part The study was funded by the ACTTION initiative, a public-private partnership between the FDA, NIH, industry, and academia. The RReACT database is freely accessible via the ACTTION website (http://www.acttion.org/). says Dr. Rowbotham. “Many patients enter clinical trials with the in research, they will help other patients in the future. Graph above: The Repository of Registered Analgesic Clinical Trials (RReACT) database: a scorecard for trial results availability. Green bars represent the total number of completed trials for postherpetic neuralgia (PHN), fibromyalgia, and diabetic peripheral neuropathy (DPN). Blue bars represent the number of completed trials with any results available, and orange bars represent the number of studies for which results were available in a peer-review publication. Percentages displayed represent the percentage of the total number of completed studies. 45 MrOS study links poor sleep quality to cognitive decline in older men Research by Terri Blackwell and Katie Stone, Ph.D., highlights the importance of sleep quality in preventing cognitive decline in the elderly Since almost half of older adults report habitual sleep problems, and at least 10 per cent of people older than 65 years will develop cognitive impairment, investigators at CPMCRI are seeking new ways to determine prospective associations between sleep and cognitive decline. In April, new results published in the journal Sleep showed that higher levels of fragmented sleep and lower sleep efficiency were associated with a 40 to 50 per cent increase in the risk of clinically significant decline in cognitive function over three to four years. Sleep duration, however, was not related to cognitive decline. Wrist actigraphy is a ‘sleep watch’ device that measures total sleep time, sleep efficiency, wake after sleep onset, etc. 46 F E AT U R E D S TUDIE S “Our study provides new evidence supporting the importance of sleep quality in preventing cognitive decline over time, especially in older people,” says Terri Blackwell, study author and a Senior Statistician at CPMCRI. In the population-based, longitudinal study, Blackwell and colleagues measured sleep parameters in 2,822 men free of cognitive impairment aged 67 years and older who were enrolled in the multicenter Outcomes of Sleep Disorders in Men (MrOS Sleep) Study. Objectively measured sleep data including total sleep time, sleep efficiency, wake after sleep onset, and number of long-wake episodes were collected from study participants over an average of five nights’ sleep, using wrist actigraphy (a ‘sleep watch’ device). Katie Stone, Ph.D. Senior Scientist, CPMCRI Cognitive function was assessed by evaluation of attention and executive function (i.e., abstract thinking, and the ability for decision making) using the Trails B test. Results were adjusted for depressive symptoms, comorbidities, medication use and other potential confounding factors. “The effect of lower levels of sleep quality on cognitive decline seen in our study is equivalent to the effects of a five-year increase in age,” says Katie Stone, Ph.D., lead author and a Senior Scientist at CPMCRI. “With this study we’re seeing a reminder that—as a key factor in a healthy lifestyle—sleep is essential for optimal cognitive functioning.” Dr. Stone notes that the findings may not be generalized to other populations other than community-dwelling older men, and that more research is needed to determine if these associations hold after longer follow-up. The study was funded by the National Institutes of Health (NIH) with support for the MrOS Sleep study from National Heart, Lung, and Blood Institute (NHLBI), as well as from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute on Aging (NIA), and the National Cancer Institute (NCI). 47 48 MEDIA ACTIVITY AND EXPOSURE 49 Media Outlet Date Topic San Francisco Chronicle/SF Gate December 24 NeuroPace and the research of David King-Stephens, M.D. Several, including MedPage Today, Washington Post, Medical Daily, and Medical News Today November 5-6 Use of NSAIDS (especially COX-2 inhibitors) and stroke risk, as published in Nov. 5 Neurology San Francisco Chronicle/SF Gate October 28 Lung-MAP Sutter-wide clinical trial San Francisco Chronicle/SF Gate October 22 Stroke warning signs San Francisco Chronicle/SF Gate (synopsis only; full article in print) September 18 New funds support Alzheimer’s disease and dementia research at CPMC’s Brain Health Center Virtual Strategy Magazine September 7 Transparency of clinical trial data reporting in migraine trials Market Wired August 25 FDA grants orphan drug status to cannabidiol for the treatment of glioblastoma multiforme Time Magazine August 11 Osteoporosis drugs and the risk of breast cancer in select groups of patients San Francisco Chronicle July 23 Risk of melanoma in Marin County Pharmaceutical Business Review July 29 Phase II clinical trial of new agent for the prophylaxis of delayed graft function in donor kidney transplant patients ABC News July 18 NeuroPace for epilepsy California Healthline June 12 PACT consortium launched to promote clinical trial efficiency Medical Xpress News May 14 RReACT database, and transparency of clinical trial data reporting San Francisco Chronicle May 7 New clinical diagnosis: dismobility News Medical April 16 New criteria for diagnosing sarcopenia in older adults Nature World News April 1 Sleep quality, and cognitive decline in older men International Innovation March15 Profiles of international scientists Anesthesiology News February 26 Reporting of clinical trial data/transparency of findings Oncology Report February 12 Final results validate sentinel-node biopsy for melanoma San Francisco Chronicle February 5 Sleep in the elderly, and risk of falls Pain Medicine News January 10 Clinical trial reporting, and the RReACT database 50 M E D I A A C T IV ITY AND E X POSUR E Spokesperson (where relevant) Additional Notes David King-Stephens, M.D. Morten Schmidt, M.D. (who was mentored by Karin Petersen, M.D., CPMCRI Clinical Research Fellowship Program Director) Alan Kramer, M.D. Appeared on the front page of the Health section Nobl Barazangi, M.D. Catherine Madison, M.D. Michael Rowbotham, M.D. Sean McAllister, Ph.D. Steven Cummings, M.D. (though not quoted in the story about the paper, he co-authored with Trisha Hue) Also received other coverage in specialty media Mohammed Kashani-Sabet, M.D. V. Ram Peddi, M.D. Peter Weber, M.D. Michael Rowbotham, M.D. Michael Rowbotham, M.D. Steven Cummings, M.D. Peggy Cawthon, Ph.D. (though not specifically quoted in the story) Also received other coverage in specialty media Katie Stone, Ph.D. Also received other coverage in specialty media Liliana Soroceanu, Ph.D. Michael Rowbotham, M.D. Mohammed Kashani-Sabet, M.D. Katie Stone, Ph.D. Michael Rowbotham, M.D. 51 FINANCIALS Revenue Funding Source Account Amount ($) Number of Studies Philanthropic/Internal 55010432,926 590451,532,529 1,965,455 96 State 55011 188,363 1 Federal 55013 10,387,145 64 Industry 55012 3,058,124 211 Private Foundation/Other Funding 55012 1,124,241 37 Total Science/Research Funding 16,723,328 409 New Studies FY 2014 The new studies are comprised of: 52 FINANCIALS 12 Federal (3 prime, 9 subcontracts) 4 Private Foundation/Non-Profit Org 3 Professional Services Agreements 10 Intramural — Discretionary, Internal Funding, Residuals, Sutter, etc. 43 Industry 72 Scientific Activities of the California Pacific Medical Center Research Institute Compendium of Peer-Reviewed Publications for Key Program Areas 2014 Peggy Cawthon (Ph.D., M.P.H.), Scientist at CPMCRI. Discovery researchers at CPMCRI are investigating changes on the surface of cancer cells. Li-Xi Yang (Ph.D., M.D.) and Garret Yount (Ph.D.), Scientists at CPMCRI. www.cpmcri-currents.org 53 NOTE: Journal names listed in orange are high-impact publications recognized by the ISI Web of Knowledge as having an impact factor higher than 10. Addiction Pharmacology Gantt Galloway (Ph.D.), Scientist; Co-Director of the Addiction and Pharmacology Research Laboratory Publications Korcha RA, Polcin DL, Evans K, Bond JC, Galloway GP (2014). Intensive Motivational Interviewing for women with concurrent alcohol problems and methamphetamine dependence. Journal of Substance Abuse Treatment, 46:113-119. De La Garza III R, Galloway GP, Newton TF, Mendelson J, Haile CN, Dib E, Hawkins RY, Chen C-YA, Mahoney III JJ, Mojsiak J, Lao G, Anderson A, Kahn R (2014). Assessment of safety, cardiovascular and subjective effects after intravenous cocaine and lofexidine. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 50:44-52. Kirkpatrick MG, Baggott MJ, Mendelson JE, Galloway GP, Liechti ME, Hysek CM, de Wit H (2014). MDMA effects consistent across controlled laboratories. Psychopharmacology, 231:3899–3905. Polcin DL, Bond J, Korcha R, Nayak MB, Galloway GP, Evans K (2014). Randomized trial of Intensive Motivational Interviewing for methamphetamine dependence. Journal of Addictive Diseases, 33(3):253-265. Book Chapter Pal R, Mendelson J, Galloway GP (2014). GHB. In Ries RK, Fiellin DA, Miller SC, Saitz R (eds.): Principles of Addiction Medicine (5th ed.), pp. 128-129. Chevy Chase, Maryland: The American Society of Addiction Medicine. Presentations Mendelson J, Clavier O, Kynor D, Galloway G. Attitudes, Beliefs, and Barriers to Adopting an Automated Naloxone Delivery System to Overcome Opioid Overdose: Interviews of Opioid Injectors. Presented as a poster at the College on Problems of Drug Dependence 76th Annual Meeting, San Juan, Puerto Rico. Pal R, Galloway G, Clavier O, Garrison K, Mendelson J. Adherence Monitoring for Substance Abuse Clinical Trials. Presented as a poster at the College on Problems of Drug Dependence 76th Annual Meeting, San Juan, Puerto Rico. John Mendelson (M.D.), Senior Scientist; Co-Director of the Addiction and Pharmacology Research Laboratory Publication Pal, R., Mendelson, J., & Galloway, G. P. (2014). GHB. In R. Ries, D. Fiellin, S. Miller, & R. Saitz (Eds.), Principles of Addiction Medicine (5th ed.). Lippincott Williams & Wilkins. Book Chapter R, P., Mendelson, J., Flower, K., Garrison, K., Yount, G., Coyle, J., & Galloway, G. (2015, January 22). Impact of Prospectively Determined A118G Polymorphism on Treatment Response to Injectable Naltrexone Among Methamphetamine-Dependent Patients: An Open-Label, Pilot Study. Journal of Addiction Medicine. Presentations Mendelson, J., Clavier, O., Kynor, D., & Galloway, G. (2014). Attitudes, Beliefs, and Barriers to Adopting an Automated Naloxone Delivery System to Overcome Opioid Overdose: Interviews of Opioid Injectors and Physicians. San Juan, puert Rico: The College on Problems of Drug Dependence. Pal, R., Galloway, G., Clavier, O., Garrison, K., & Mendelson, J. (2014). Adherence Monitoring For Substance Abuse Clinical Trials. San Juan, Puerto Rico: The College on Problems of Drug Dependence. 54 C O M P E N D IUM Cancer John Chung-Kai Chan (M.D.), Scientist; Gynecologic Oncologist Publications Chan JK, Urban R, Capra AM, Jacoby V, Osann K, Whittemore A, Habel LA. Ovarian cancer rates after hysterectomy with and without salpingo-oophorectomy. Obstet Gynecol. 2014 Jan;123(1):65-72. Lin JF, Berger JL, Krivak TC, Beriwal S, Chan JK, Sukumvanich P, Monk BJ, Richard SD. Impact of facility volume on therapy and survival for locally advanced cervical cancer. Gynecol Oncol. 2014 Feb;132(2):416-22. Chan, JK, Blansit, K., Kiet, T., Sherman, A., Wong, G., Earle, C., Bourguignon, L.Y.W., The inhibition of miR21 promotes apoptosis and chemosensitivity in ovarian cancer. Gynecol Oncol. 2014 Mar;132(3):739-44. Lefkowits C, W Rabow M, E Sherman A, K Kiet T, Ruskin R, Chan JK, Chen LM. Predictors of high symptom burden in gynecologic oncology outpatients: who should be referred to outpatient palliative care? Gynecol Oncol. 2014 Mar;132(3):698-702. Previs RA, Bevis KS, Huh W, Tillmanns T, Perry L, Moore K, Chapman J, McClung C, Kiet T, Java J, Chan JK, Secord AA. A prognostic nomogram to predict overall survival in women with recurrent ovarian cancer treated with bevacizumab and chemotherapy. Gynecol Oncol. 2014 Mar;132(3):531-6. Chan JK, Kiet TK, Monk BJ, Young-Lin N, Blansit K, Kapp DS, Amanam I. Applications for oncologic drugs: a descriptive analysis of the oncologic drugs advisory committee reviews. Oncologist. 2014 Mar;19(3):299-304. Chan JK, Herzog TJ, Hu L, Monk BJ, Kiet T, Blansit K, Kapp DS, Yu X. Bevacizumab in treatment of high-risk ovarian cancer--a cost-effectiveness analysis. Oncologist. 2014 May;19(5):523-7. Chan, JK, Kiet, T., Blansit, K., Kapp, D.S., Ramasubbaiah, R., Hilton, J.F., Matei, D.E., MicroRNA 378 as a Biomarker for Response to Bevacizumab in Recurrent Ovarian Cancer. Gynecol Oncol. 2014 Jun;133(3):568-74. Simons E, Blansit K, Tsuei T, Brooks R, Ueda S, Kapp DS, Chan JK. Foreign- vs US-born patients and the association of type I uterine cancer. Am J Obstet Gynecol. 2014 Jul 17. Usach I, Blansit K, Chen LM, Ueda S, Brooks R, Kapp DS, Chan JK. Survival differences in women with serous tubal, ovarian, peritoneal, and uterine carcinomas. Am J Obstet Gynecol. 2014 Aug 18. Grendys EC Jr, Fiorica JV, Orr JW Jr, Holloway R, Wang D, Tian C, Chan JK, Herzog TJ. Overview of a chemoresponse assay in ovarian cancer. Clin Transl Oncol. 2014 Sep;16(9):761-9. Fuh KC, Shin JY, Kapp DS, Brooks RA, Ueda S, Urban RR, Chen LM, Chan JK. Survival Differences of Asian and Caucasian Epithelial Ovarian Cancer Patients in the United States. Gynecol Oncol. 2014 Oct 16. Thompson CA, Gomez SL, Chan A, Chan JK, McClellan SR, Chung S, Olson C, Nimbal V, Palaniappan LP. Patient and Provider Characteristics Associated with Colorectal, Breast, and Cervical Cancer Screening among Asian Americans. Cancer Epidemiol Biomarkers Prev. 2014 Nov;23(11):2208-17. Plamadeala V, Kelley JL, Chan JK, Krivak TC, Gabrin MJ, Brower SL, Powell MA, Rutherford TJ, Coleman RL. A cost-effectiveness analysis of a chemoresponse assay for treatment of patients with recurrent epithelial ovarian cancer. Gynecol Oncol. 2014 Nov 25. Shanaz Dairkee (Ph.D.), Senior Scientist Publications Luciani-Torres MG, Moore DH, Goodson WH 3rd, Dairkee SH. Exposure to the polyester PET precursorterephthalic acid induces and perpetuates DNA damage-harboring non-malignant human breast cells. Carcinogenesis. 2015 Jan;36(1):168-76. 55 Zhang H, Cohen AL, Krishnakumar S, Wapnir IL, Veeriah S, Deng G, Coram MA, Piskun CM, Longacre TA, Herrler M, Frimannsson DO, Telli ML, Dirbas FM, Matin AC, Dairkee SH et al. Patient-derived xenografts of triple-negative breast cancer reproduce molecular features of patient tumors and respond to mTOR inhibition. Breast Cancer Res. 2014 Apr 7;16(2):R36. Book Chapter Dairkee SH. Translational Cellular Models of Breast Cancer Progression and Outcome. In: Linda M. McManus, Richard N. Mitchell, editors. Pathobiology of Human Disease. San Diego: Elsevier, 2014. p. 952-962. Altaf Dar (Ph.D.), Associate Scientist Publications Sun V, Zhou WB, Nosrati M, Majid S, Thummala S, de Semir D, Bezrookove V, de Feraudy S, Chun L, Schadendorf D, Debs R, Kashani-Sabet M, Dar AA. Antitumor Activity of miR-1280 in Melanoma by Regulation of Src. Mol Ther. 2015 Jan;23(1):71-8. Sun V, Zhou WB, Majid S, Kashani-Sabet M, Dar AA. MicroRNA-mediated regulation of melanoma. Br J Dermatol. 2014 Aug;171(2):234-41. Bezrookove V, De Semir D, Nosrati M, Tong S, Wu C, Thummala S, Dar AA, Leong SP, Cleaver JE, Sagebiel RW, Miller JR 3rd, Kashani-Sabet M. Prognostic impact of PHIP copy number in melanoma: linkage to ulceration. J Invest Dermatol. 2014 Mar;134(3):783-90. David De Semir (Ph.D.), Associate Scientist Publication Bezrookove V, De Semir D, Nosrati M, Tong S, Wu C, Thummala S, Dar AA, Leong SP, Cleaver JE, Sagebiel RW, Miller JR 3rd, Kashani-Sabet M. Prognostic impact of PHIP copy number in melanoma: linkage to ulceration. J Invest Dermatol. 2014 Mar;134(3):783-90. Pierre-Yves Desprez (Ph.D.), Senior Scientist Publication R. Murase, R. Kawamura, E. Singer, A. Pakdel, P. Sarma, J. Judkins, E. Elwakeel, S. Dayal, E. MartinezMartinez, M. Amere, R. Gujjar, A. Mahadevan, PY Desprez, and S.D. McAllister (2014) Targeting multiple cannabinoid antitumor pathways with a resorcinol derivative leads to inhibition of advanced stages of breast cancer. Br. J. Pharmacol., 171:4464-4477. William Goodson (M.D.), Surgeon Publication Dairkee SH, Luciani-Torres MG, Moore DH, Goodson WH 3rd. Bisphenol-A-induced inactivation of the p53 axis underlying deregulation of proliferation kinetics, and cell death in non-malignant human breast epithelial cells. Carcinogenesis. 2013 Mar;34(3):703-12. Mohammed Kashani-Sabet (M.D.), Senior Scientist; Director of the Center for Melanoma Treatment and Research; Endowed Chair in Melanoma Treatment and Research Publications Kashani-Sabet M. Molecular markers in melanoma. Br J Dermatol. 170: 31-5, 2014. Nosrati M, Kashani-Sabet M. Immunohistochemical diagnostic and prognostic markers for melanoma. Methods Mol Biol. 2014; 1102:259-73. Sun V, Zhou WB, Majid S, Kashani-Sabet M, Dar AA. MicroRNA-mediated regulation of melanoma. Br J Dermatol 171: 234-41, 2014. 56 C O M P E N D IUM Bezrookove V, De Semir D, Nosrati M, Tong S, Wu C, Thummala S, Dar AA, Leong SPL, Cleaver JE, Sagebiel RW, Miller JR III, Kashani-Sabet M. Prognostic impact of PHIP copy number in melanoma: linkage to ulceration. J Invest Dermatol. 134: 783-790, 2014. Morton DL, Thompson JF, Cochran AJ, Mozillo N, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Puleo CA, Coventry BJ, Kashani-Sabet M, Smithers BM, Paul E, Kraybill WG, McKinnon JG, Wang J-J, Elashoff R, Faries MB, for the MSLT group. Final trial report of sentinel-node biopsy versus nodal observation in melanoma. N Engl J Med. 370: 599-609, 2014. Sun V, Zhou WB, Nosrati M, Majid S, Thummala S, de Semir D, Bezrookove V, de Feraudy S, Chun L, Schadendorf D, Debs R, Kashani-Sabet M, Dar AA. Antitumor activity of miR-1280 in melanoma by regulation of Src. Mol Ther. Epub 2014 Sep 8. Kevin Kim (M.D.), Medical Director of the Melanoma Clinical Research Program Publications Kainthla R, Kim KB, Falchook GS. Dabrafenib for treatment of BRAF-mutant melanoma. Pharmacogenomics and Personalized Medicine. 7:21-29, 01/2014. Zhou JH, Kim KB, Fox PS, Myers JN, Hasanein H, Prieto VG. Immunohistochemical expression of hormone receptors in melanoma of pregnant women, non-pregnant women and men. Am J Dermatol. 36(1):74-9, 01/2014. Trinh VA, Davis JE, Anderson JE, Kim KB. Dabrafenib therapy for advanced melanoma. Ann Pharmacother. 48(4):519-29, 03/2014. Curry JL, Torres-Cabala CA, Kim KB, Tetzlaff MT, Duvic M, Tsai K, Hong D, Prieto VG. Dermatologic toxicities to targeted cancer therapy: shared clinical and histologic adverse skin reactions. Int J Dermatol. 53(3):376-84, 03/2014. Amaria RN, Kim KB. Dabrafenib for the treatment of melanoma. Expert Opin. Pharmacother. 15(7):10431050, 3/2014. Kainthla R, Kim KB, Falchook GS. Dabrafenib. Recent Results Cancer Res. 201:227-40, 3/2014. Curry JL, Tetzlaff MT, Nicholson K, Duvic M, Kim KB, Tsai KY, Hwu WJ, Hong DS, Prieto VG, Torres-Cabala CA. Histological features associated with vemurafenib-induced skin toxicities: examination of 141 cutaneous lesions biopsied during therapy. Am J Dermatopathol. 36(7):557-61, 7/2014. Kim CY, Kim DW, Kim K, Curry J, Torres-Cabala C, Patel S. GNAQ mutation in a patient with metastatic mucosal melanoma. BMC Cancer 2014, 14(1):516. 07/2014. Yorio JT, Mays SR, Ciurea AM, Cohen PR, Wang WL, Hwu WJ, Gonzalez N, Richard JL, Kim KB. A case of vemurafenib-induced Sweet’s syndrome. J Dermatol. 41(9):817-20, 09/2014. Alrwas A, Papadopoulos NE, Cain S, Patel SP, Kim KB, Deburr TL, Bassett R Jr, Hwu WJ, Bedikian AY, Davies MA, Woodman SE, Hwu P. Phase I trial of biochemotherapy with cisplatin, temozolomide, and dose escalation of nab-paclitaxel combined with interleukin-2 and interferon-α in patients with metastatic melanoma. Melanoma Res. 24(4):342-8, 08/2014. Kim KB, Alrwas A Treatment of KIT-mutated metastatic mucosal melanoma. Chin Clin Oncol. 3(3):35, 10/2014. Ott PA, Hamid O, Pavlick AC, Kluger H, Kim KB, Boasberg PD, Simantov R, Crowley E, Green JA, Hawthorne T, Davis TA, Sznol M, Hwu P. A phase I/II study of the antibody-drug conjugate, glembatumumab vedotin (CDX-011 or CR011-vcMMAE), in patients with advanced melanoma. J Clin Oncol. 32(32):3659-66, 11/2014. Falchook GS, Long GV, Kurzrock R, Kim KB, Arkenau HT, Brown MP, Hamid O, Infante JR, Millward MJ, Pavlick A, Chin M, O’Day S, Blackman SC, Curtis MC Jr, Lebowitz PF, Ma B, Ouellet D, Kefford RF. Dose Selection, Pharmacokinetics, and Pharmacodynamics of BRAF-inhibitor Dabrafenib (GSK2118436). Clin Cancer Res. 20(17):4449-58, 09/2014. 57 Johnson D, Flaherty K, Weber J, Infante J, Kim KB, Kefford R, Hamid O, Schuchter L, Cebon J, Sharfman W, McWilliams R, Sznol M, Lawrence D, Gibney G, Burris H, Falchook G, Algazi A, Lewis K, Long G, Patel K, Ibrahim N, Sun P, Cunningham E, Sosman J, Daud A, Gonzalez R. Combined BRAF (Dabrafenib) and MEK Inhibition (Trametinib) in Patients With BRAFV600-Mutant Melanoma Progressing on Single-Agent BRAF Inhibitor. J Clin Oncol. 32(33):3697-704, 11/2014. Siroy AE, Boland GM, Milton DR, Roszik J, Frankian S, Malke J, Haydu L, Prieto VG, Tetzlaff M, Ivan D, Wang WL, Torres-Cabala C, Curry J, Roy-Chowdhuri S, Broaddus R, Rashid A, Stewart J, Gershenwald JE, Amaria RN, Patel SP, Papadopoulos NE, Bedikian A, Hwu WJ, Hwu P, Diab A, Woodman SE, Aldape KD, Luthra R, Patel KP, Shaw KR, Mills GB, Mendelsohn J, Meric-Bernstam F, Kim KB, Routbort MJ, Lazar AJ, Davies MA. Beyond BRAFV600: Clinical Mutation Panel Testing by Next-Generation Sequencing in Advanced Melanoma. J Invest Dermatol. 135(2):508-15, 02/2015. Menzies AM, Ashworth MT, Swann S, Kefford RF, Flaherty K, Weber J, Infante JR, Kim KB, Gonzalez R, Hamid O, Schuchter L, Cebon J, Sosman JA, Little S, Sun P, Aktan G, Ouellet D, Jin F, Long GV, Daud A. Characteristics of pyrexia in BRAFV600E/K metastatic melanoma patients treated with combined dabrafenib and trametinib in a phase I/II clinical trial. Ann Oncol. 2015 Feb;26(2):415-21. Kevin Knopf (M.D.), Medical Oncologist and Hematologist Publications Knopf KB, Duh MS, Lafeuille MH, Gravel J, Lefebvre P, Niculescu L, Ba-Mancini A, Ma E, Shi H, Comenzo RL. Meta-analysis of the efficacy and safety of bortezomib re-treatment in patients with multiple myeloma. Clin Lymphoma Myeloma Leuk. 2014 Oct;14(5):380-8. Epub 2014 Jun 11. Nordstrom BL, Knopf KB, Teltsch DY, Engle R, Beygi H, Sterchele JA. The safety of bendamustine in patients with chronic lymphocytic leukemia or non-Hodgkin lymphoma and concomitant renal impairment: a retrospective electronic medical record database analysis. Leuk Lymphoma. 2014 Jun;55(6):1266-73. Epub 2013 Oct 3. Stanley Leong (M.D.), Chief of Cutaneous Oncology; Associate Director of the Center for Melanoma Research and Treatment Publications Miranda EP, Bellevue OC, Leong SP. Reoperative selective sentinel lymphadenectomy combined with lymphoscintigraphy is technically feasible for cutaneous tumors of the upper extremity after radical dissection of regional lymph node basins for breast cancer. Eplasty. 2014 Sep 12;14:e32. Parrett BM, Kashani-Sabet M, Leong SP, Buncke N, Singer MI. The safety of and indications for immediate reconstruction of head and neck melanoma defects: our early experience. Ann Plast Surg. 2014 May;72 Suppl 1:S35-7. Balch CM, Thompson JF, Gershenwald JE, Soong SJ, Ding S, McMasters KM, Coit DG, Eggermont AM, Gimotty PA, Johnson TM, Kirkwood JM, Leong SP, et al. Age as a predictor of sentinel node metastasis among patients with localized melanoma: an inverse correlation of melanoma mortality and incidence of sentinel node metastasis among young and old patients. Ann Surg Oncol. 2014 Apr;21(4):1075-81. Epub 2014 Feb 15. Leong SP, Tseng WW. Micrometastatic cancer cells in lymph nodes, bone marrow, and blood: Clinical significance and biologic implications. CA Cancer J Clin. 2014 May-Jun;64(3):195-206. Epub 2014 Feb 5. Review. Slagelse C, Petersen KL, Dahl JB, Finnerup K, Greene K, Leong SP, Levine J, Rowbotham M, Werner MU, Finnerup NB. Persistent postoperative pain and sensory changes following lymph node excision in melanoma patients: a topical review. Melanoma Res. 2014 Apr;24(2):93-8. Review. Bezrookove V, De Semir D, Nosrati M, Tong S, Wu C, Thummala S, Dar AA, Leong SP, Cleaver JE, Sagebiel RW, Miller JR 3rd, Kashani-Sabet M. Prognostic impact of PHIP copy number in melanoma: linkage to ulceration. J Invest Dermatol. 2014 Mar;134(3):783-90. Epub 2013 Sep 4. 58 C O M P E N D IUM Sean McAllister (Ph.D.), Scientist Publications McAllister SD, Soroceanu L, Desprez PY (2014). The antitumor activity of plant-derived non-psychoactive cannabinoids. Journal of Neuroimmune Pharmacology (invited review). Murase R, Kawamura R, Singer E, Pakdel A, Sarma P, Judkins J, Elwakeel E, Dayal S, Amere M, Gujjar R, Mahadevan A, Desprez P and McAllister SD (2014). Targeting multiple cannabinoid antitumor pathways with a resorcinol derivative leads to inhibition of advanced stages of breast cancer. British Journal of Pharmacology. (Epub ahead of print) Cobbs C, Khan S, Matlaf L, McAllister SD, Zider A, Yount G, Rahlin K, Harkins L, Bezrookove V, Singer E, and Soroceanu L (2014). HCMV glycoprotein B is expressed in primary glioblastomas and enhances growth and invasiveness via PDGFR-alpha activation. Oncotarget Feb 28;5(4):1091-100. David Minor (M.D.), Associate Director of the Center for Melanoma Research and Treatment Publications Minor DR, Kashani M: Biochemotherapy with interleukin-2 for metastatic melanoma: long term results in 100 patients. J Clin Onc 32:5s,2014 (suppl; abstr 9047). Hamid O, Minor DR, Orford KW, et al:Phase 1 study of the BRAF inhibitor dabrafenib (D) with or without the MEK inhibitor trametinib (T) in combination with ipilimumab (Ipi) for V600E/K mutation positive unresectable or metastatic melanoma MM) J Clin Onc 32:5s, 2014 (suppl; abstr 2511). Coventry J, Neuhasu SJ, Minor DR et al: Efficacy of intralesional Rose Bengal in patients receiving injection of all existing melanoma in phase II study PV-10-MM-02 J Clin Onc 32: 5s, 2014 (suppl: abstr 9027). Ascierto PA, Minor DR, Singer JM, et al: Long-term safety and overall survival update for BREAK-2, a phase 2, single-arm, open-label study of dabrafenib in previously treated metastatic melanoma (NCT01153763) J Clin Onc 32:5s, 2014 (suppl: abstr 9034). Hans R, Andbacka I, Minor DR, et al: Primary analysis of a phase 1b multicenter trial to evaluate the safety and efficacy of talimogene laherparapvec (T-VEC) and ipilimumab (Ipi) in previously untreated, unresected stage IIIB-IV melanoma J Clin Onc 32: 5s, 2014(9029). Liliana Soroceanu (M.D., Ph.D.), Scientist Publications Singer E, Judkins J, Salomonis N, Matlaf L, Soteropoulos P, McAllister S, Soroceanu L. Reactive oxygen species-mediated therapeutic response and resistance in glioblastoma. Cell Death Dis. 2015 Jan 15;6:e1601. Fiallos E, Judkins J, Matlaf L, Prichard M, Dittmer D, Cobbs C, Soroceanu L. Human cytomegalovirus gene expression in long-term infected glioma stem cells. PLoS One. 2014 Dec 30;9(12):e116178. doi: 10.1371/ journal.pone.0116178. eCollection 2014. Cobbs C, Khan S, Matlaf L, McAllister S, Zider A, Yount G, Rahlin K, Harkins L, Bezrookove V, Singer E, Soroceanu L. HCMV glycoprotein B is expressed in primary glioblastomas and enhances growth and invasiveness via PDGFR-alpha activation. Oncotarget. 2014 Feb 28;5(4):1091-100. Presentation Reactive oxygen species mediate therapeutic response and resistance in glioblastoma. Abstract DR-06. Presented as a poster at the Society for Neuro-Oncology Annual Meeting, Miami, November 2014. 59 Esther K. Wei (Sc.D.), Scientist Publications Austin SB, Pazaris MJ, Wei EK, Rosner B, Kennedy GA, Bowen D, Spiegelman D. Application of the RosnerWei Risk-Prediction Model to Estimate Sexual Orientation Patterns in Colon Cancer Risk in a Prospective Cohort of U.S. Women. Cancer Causes Control. 2014 Aug;25(8):999-1006. Holt EW, Wei EK, Bennett N, Zhang LM. Low skin carotenoid concentration measured by resonance Raman spectroscopy is associated with metabolic syndrome in adults. Nutr Res. 2014 Sep 6. pii: S02715317(14)00168-7. Presentation Esther K. Wei, Graham A. Colditz, Edward L. Giovannucci, Kana Wu, Charles S. Fuchs, Meir Stampfer, Walter Willett, Shuji Ogino, Bernard A. Rosner. A comprehensive model of colorectal cancer by risk factor status and sub-site using data from the Nurses’ Health Study. Presented at the Society for Epidemiologic Research (SER) Annual Meeting. June 2014. Seattle, Washington. Li-Xi Yang (M.D., Ph.D.), Senior Scientist Publications Le DL, Cao H and Yang LX. Cardiotoxicity of Molecular Targeted Drug Therapy. Anticancer Research. 34(7):3243-3249, 2014. Anticancer Res. 2014 Jul;34(7):3243-9. Oliai C and Yang LX. Radioprotectants To Reduce The Risk of Radiation-induced Carcinogenesis. International Journal of Radiation Biology. 90(3):203-213, 2014. Int J Radiat Biol. 2014 Mar;90(3):203-13. doi: 10.3109/09553002.2014.859762. Epub 2013 Nov 14. Garret Yount (Ph.D.), Scientist; Director of the Mind-Body Medicine Research Group Publications Yount G & Rachlin K. A novel mouthwash protocol for noninvasive genomic analyses. Intl. J. Psychosocial & Cultural Genomics Consciousness & Health Res. 2014 Oct Issue 1:12-15. Cobbs C, Khan S, Matlaf L, McAllister S, Zider A, Yount G, Rahlin K, Harkins L, Bezrookove V, Singer E, Soroceanu L. HCMV glycoprotein B is expressed in primary glioblastomas and enhances growth and invasiveness via PDGFR-alpha activation. Oncotarget. 2014 Feb 28;5(4):1091-100. Cardiology Richard Hongo (M.D.), Cardiac Electrophysiologist, Assistant Director of the Electrophysiology Laboratory Publications Mohanty S, Santangeli P, Mohanty P, Di Biase L, Trivedi C, Bai R, Horton R, Burkhardt JD, Sanchez JE, Zagrodzky J, Bailey S, Gallinghouse JG, Hranitzky PM, Sun AY, Hongo R, Beheiry S, Natale A. Outcomes of atrioesophageal fistula following catheter ablation of atrial fibrillation treated with surgical repair versus esophageal stenting. J Cardiovasc Electrophysiol. 2014 Jun;25(6):579-84. Mohanty S, Mohanty P, Di Biase L, Bai R, Trivedi C, Santangeli P, Santoro F, Hongo R, Hao S, Beheiry S, Burkhardt D, Gallinghouse JG, Horton R, Sanchez JE, Bailey S, Hranitzky PM, Zagrodzky J, Natale A. Long-term outcome of catheter ablation in atrial fibrillation patients with coexistent metabolic syndrome and obstructive sleep apnea: impact of repeat procedures versus lifestyle changes. J Cardiovasc Electrophysiol. 2014 Sep;25(9):930-8. Mohanty S, Santangeli P, Mohanty P, Di Biase L, Holcomb S, Trivedi C, Bai R, Burkhardt D, Hongo R, Hao S, Beheiry S, Santoro F, Forleo G, Gallinghouse JG, Horton R, Sanchez JE, Bailey S, Hranitzky PM, Zagrodzky J, Natale A. Catheter ablation of asymptomatic longstanding persistent atrial fibrillation: impact on quality of life, exercise performance, arrhythmia perception, and arrhythmia-free survival. J Cardiovasc Electrophysiol. 2014 Oct;25(10):1057-64. 60 C O M P E N D IUM Haines DE, Beheiry S, Akar JG, Baker JL, Beinborn D, Beshai JF, Brysiewicz N, Chiu-Man C, Collins KK, Dare M, Fetterly K, Fisher JD, Hongo R, Irefin S, Lopez J, Miller JM, Perry JC, Slotwiner DJ, Tomassoni GF, Weiss E. Heart Rythm Society expert consensus statement on electrophysiology laboratory standards: process, protocols, equipment, personnel, and safety. Heart Rhythm. 2014 Aug;11(8):e9-51. Di Biase L, Burkhardt JD, Santangeli P, Mohanty P, Sanchez JE, Horton R, Gallinghouse GJ, Themistoclakis S, Rossillo A, Lakkireddy D, Reddy M, Hao S, Hongo R, Beheiry S, Zagrodzky J, Rong B, Mohanty S, Elayi CS, Forleo G, Pelargonio G, Narducci ML, Dello Russo A, Casella M, Fassini G, Tondo C, Schweikert RA, Natale A. Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial. Circulation. 2014 Jun 24;129(25):2638-44. Bai R, di Biase L, Mohanty P, Santangeli P, Mohanty S, Pump A, Elayi CS, Reddy YM, Forleo GB, Hongo R, Beheiry S, Dello Russo A, Casella M, Pelargonio G, Santarelli P, Horton R, Sanchez J, Gallinghouse J, Burkhardt JD, Ma C, Lakkireddy D, Tondo C, Natale A. Catheter ablation of atrial fibrillation in patients with mechanical mitral valve: long-term outcome of single procedure of pulmonary vein antrum isolation with or without nonpulmonary vein trigger ablation. J Cardiovasc Electrophysiol. 2014 Aug;25(8):824-33. Andrea Natale (M.D., FACC), Electrophysiologist Publications Santoro F, DI Biase L, Hranitzky P, Sanchez JE, Santangeli P, Perini AP, Burkhardt JD, Natale A. Ventricular tachycardia originating from the septal papillary muscle of the right ventricle: electrocardiographic and electrophysiological characteristics. J Cardiovasc Electrophysiol. 2015 Feb;26(2):145-50. Santangeli P, Di Biase L, Natale A. Ablation versus drugs: what is the best first-line therapy for paroxysmal atrial fibrillation? Antiarrhythmic drugs are outmoded and catheter ablation should be the first-line option for all patients with paroxysmal atrial fibrillation: pro. Circ Arrhythm Electrophysiol. 2014 Aug;7(4):739-46. Price MJ, Gibson DN, Yakubov SJ, Schultz JC, Di Biase L, Natale A, Burkhardt JD, Pershad A, Byrne TJ, Gidney B, Aragon JR, Goldstein J, Moulton K, Patel T, Knight B, Lin AC, Valderrábano M. Early safety and efficacy of percutaneous left atrial appendage suture ligation: results from the U.S. transcatheter LAA ligation consortium. J Am Coll Cardiol. 2014 Aug 12;64(6):565-72. Mohanty S, Santangeli P, Mohanty P, Di Biase L, Trivedi C, Bai R, Horton R, Burkhardt JD, Sanchez JE, Zagrodzky J, Bailey S, Gallinghouse JG, Hranitzky PM, Sun AY, Hongo R, Beheiry S, Natale A. Outcomes of atrioesophageal fistula following catheter ablation of atrial fibrillation treated with surgical repair versus esophageal stenting. J Cardiovasc Electrophysiol. 2014 Jun;25(6):579-84. Di Monaco A, Pelargonio G, Narducci ML, Manzoli L, Boccia S, Flacco ME, Capasso L, Barone L, Perna F, Bencardino G, Rio T, Leo M, Di Biase L, Santangeli P, Natale A, Rebuzzi AG, Crea F. Safety of transvenous lead extraction according to centre volume: a systematic review and meta-analysis. Europace. 2014 Oct;16(10):1496-507. Santoro F, Di Biase L, Hranitzky P, Sanchez JE, Santangeli P, Perini AP, Burkhardt JD, Natale A. Ventricular fibrillation triggered by PVCs from papillary muscles: clinical features and ablation. J Cardiovasc Electrophysiol. 2014 Nov;25(11):1158-64. Mohanty S, Mohanty P, Di Biase L, Bai R, Trivedi C, Santangeli P, Santoro F, Hongo R, Hao S, Beheiry S, Burkhardt D, Gallinghouse JG, Horton R, Sanchez JE, Bailey S, Hranitzky PM, Zagrodzky J, Natale A. Long-term outcome of catheter ablation in atrial fibrillation patients with coexistent metabolic syndrome and obstructive sleep apnea: impact of repeat procedures versus lifestyle changes. J Cardiovasc Electrophysiol. 2014 Sep;25(9):930-8. Mohanty S, Santangeli P, Mohanty P, Di Biase L, Holcomb S, Trivedi C, Bai R, Burkhardt D, Hongo R, Hao S, Beheiry S, Santoro F, Forleo G, Gallinghouse JG, Horton R, Sanchez JE, Bailey S, Hranitzky PM, Zagrodzky J, Natale A. Catheter ablation of asymptomatic longstanding persistent atrial fibrillation: impact on quality of life, exercise performance, arrhythmia perception, and arrhythmia-free survival. J Cardiovasc Electrophysiol. 2014 Oct;25(10):1057-64. 61 Pillarisetti J, Reddy N, Biria M, Ryschon K, Nagarajan D, Murray C, Atkins D, Bommana S, Reddy MY, DiBiase L, Pimentel R, Berenbom L, Dawn B, Natale A, Lakkireddy D. Elevated brain natriuretic peptide level in patients undergoing atrial fibrillation ablation: is it a predictor of failed ablation or a mere function of atrial rhythm and rate at a point in time? J Interv Card Electrophysiol. 2014 Aug;40(2):161-8. Di Biase L, Burkhardt JD, Santangeli P, Mohanty P, Sanchez JE, Horton R, Gallinghouse GJ, Themistoclakis S, Rossillo A, Lakkireddy D, Reddy M, Hao S, Hongo R, Beheiry S, Zagrodzky J, Rong B, Mohanty S, Elayi CS, Forleo G, Pelargonio G, Narducci ML, Dello Russo A, Casella M, Fassini G, Tondo C, Schweikert RA, Natale A. Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial. Circulation. 2014 Jun 24;129(25):2638-44. Lakkireddy D, Kanmanthareddy A, Biria M, Madhu Reddy Y, Pillarisetti J, Mahapatra S, Berenbom L, Chinitz L, Atkins D, Bommana S, Tung R, DI Biase L, Shivkumar K, Natale A. Radiofrequency ablation of drug refractory ventricular tachycardia related to cocaine use: a feasibility, safety, and efficacy study. J Cardiovasc Electrophysiol. 2014 Jul;25(7):739-46. Bai R, di Biase L, Mohanty P, Santangeli P, Mohanty S, Pump A, Elayi CS, Reddy YM, Forleo GB, Hongo R, Beheiry S, Dello Russo A, Casella M, Pelargonio G, Santarelli P, Horton R, Sanchez J, Gallinghouse J, Burkhardt JD, Ma C, Lakkireddy D, Tondo C, Natale A. Catheter ablation of atrial fibrillation in patients with mechanical mitral valve: long-term outcome of single procedure of pulmonary vein antrum isolation with or without nonpulmonary vein trigger ablation. J Cardiovasc Electrophysiol. 2014 Aug;25(8):824-33. Dello Russo A, Fassini G, Casella M, Bologna F, Al-Nono O, Colombo D, Biagioli V, Santangeli P, Di Biase L, Zucchetti M, Majocchi B, Marino V, Gallinghouse JJ, Natale A, Tondo C. Simultaneous assessment of contact pressure and local electrical coupling index using robotic navigation. J Interv Card Electrophysiol. 2014 Jun;40(1):23-31. Di Biase L, Gaita F, Toso E, Santangeli P, Mohanty P, Rutledge N, Yan X, Mohanty S, Trivedi C, Bai R, Price J, Horton R, Gallinghouse GJ, Beheiry S, Zagrodzky J, Canby R, Leclercq JF, Halimi F, Scaglione M, Cesarani F, Faletti R, Sanchez J, Burkhardt JD, Natale A. Does periprocedural anticoagulation management of atrial fibrillation affect the prevalence of silent thromboembolic lesion detected by diffusion cerebral magnetic resonance imaging in patients undergoing radiofrequency atrial fibrillation ablation with open irrigated catheters? Results from a prospective multicenter study. Heart Rhythm. 2014 May;11(5):791-8. Reddy YM, Chinitz L, Mansour M, Bunch TJ, Mahapatra S, Swarup V, Di Biase L, Bommana S, Atkins D, Tung R, Shivkumar K, Burkhardt JD, Ruskin J, Natale A, Lakkireddy D. Percutaneous left ventricular assist devices in ventricular tachycardia ablation: multicenter experience. Circ Arrhythm Electrophysiol. 2014 Apr;7(2):244-50. Michowitz Y, Rahkovich M, Oral H, Zado ES, Tilz R, John S, Denis A, Di Biase L, Winkle RA, Mikhaylov EN, Ruskin JN, Yao Y, Josephson ME, Tanner H, Miller JM, Champagne J, Della Bella P, Kumagai K, Defaye P, Luria D, Lebedev DS, Natale A, Jais P, Hindricks G, Kuck KH, Marchlinski FE, Morady F, Belhassen B. Effects of sex on the incidence of cardiac tamponade after catheter ablation of atrial fibrillation: results from a worldwide survey in 34 943 atrial fibrillation ablation procedures. Circ Arrhythm Electrophysiol. 2014 Apr;7(2):274-80. Altman RK, Proietti R, Barrett CD, Paoletti Perini A, Santangeli P, Danik SB, Di Biase L, Natale A. Management of refractory atrial fibrillation post surgical ablation. Ann Cardiothorac Surg. 2014 Jan;3(1):91-7. Giglio AF, Basile E, Santangeli P, Di Biase L, Trotta F, Natale A. Increased risk of myocardial infarction with dabigatran: fact or fiction? J Cardiovasc Med (Hagerstown). 2014 Jan;15(1):19-26. Lakkireddy D, Reddy YM, Di Biase L, Vallakati A, Mansour MC, Santangeli P, Gangireddy S, Swarup V, Chalhoub F, Atkins D, Bommana S, Verma A, Sanchez JE, Burkhardt JD, Barrett CD, Baheiry S, Ruskin J, Reddy V, Natale A. Feasibility and safety of uninterrupted rivaroxaban for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol. 2014 Mar 18;63(10):982-8. Proietti R, Santangeli P, Di Biase L, Joza J, Bernier ML, Wang Y, Sagone A, Viecca M, Essebag V, Natale A. Comparative effectiveness of wide antral versus ostial pulmonary vein isolation: a systematic review and metaanalysis. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):39-45. 62 C O M P E N D IUM Whitbeck MG, Charnigo RJ, Shah J, Morales G, Leung SW, Fornwalt B, Bailey AL, Ziada K, Sorrell VL, Zegarra MM, Thompson J, Hosn NA, Campbell CL, Gurley J, Anaya P, Booth DC, Di Biase L, Natale A, Smyth S, Moliterno DJ, Elayi CS; AFFIRM investigators. QRS duration predicts death and hospitalization among patients with atrial fibrillation irrespective of heart failure: evidence from the AFFIRM study. Europace. 2014 Jun;16(6):803-11. Richard Shaw (Ph.D.), Director of Clinical Informatics and Reporting; Research Director of the Cardiology Fellowship Training Program Publications Grau JB, Johnson CK, Kuschner CE, Ferrari G, Shaw RE, Brizzio ME, Zapolanski A. Impact of pump status and conduit choice in coronary artery bypass: A 15-year follow-up study in 1412 propensity-matched patients. J Thorac Cardiovasc Surg. 2014 Dec 20. Branchetti E, Bavaria JE, Grau JB, Shaw RE, Poggio P, Lai EK, Desai ND, Gorman JH, Gorman RC, Ferrari G. Circulating soluble receptor for advanced glycation end product identifies patients with bicuspid aortic valve and associated aortopathies. Arterioscler Thromb Vasc Biol. 2014 Oct;34(10):2349-57. Holt EW, Yimam KK, Ma H, Shaw RE, Sundberg RA, Verhille MS. Patient tolerability of bowel preparation is associated with polyp detection rate during colonoscopy. J Gastrointestin Liver Dis. 2014 Jun;23(2):135-40. Ferrari G, Quackenbush J, Strobeck J, Hu L, Johnson CK, Mak A, Shaw RE, Sayles K, Brizzio ME, Zapolanski A, Grau JB. Comparative genome-wide transcriptional analysis of human left and right internal mammary arteries. Genomics. 2014 Jul;104(1):36-44. Steinberg JS, Romanov A, Musat D, Preminger M, Bayramova S, Artyomenko S, Shabanov V, Losik D, Karaskov A, Shaw RE, Pokushalov E. Prophylactic pulmonary vein isolation during isthmus ablation for atrial flutter: the PReVENT AF Study I. Heart Rhythm. 2014 Sep;11(9):1567-72. Arshad A, Johnson CK, Mittal S, Buch E, Hamam I, Tran T, Shaw RE, Musat D, Preminger M, Sichrovsky T, Herweg B, Shivkumar K, Hummel J, Steinberg JS. Comparative safety of periablation anticoagulation strategies for atrial fibrillation: data from a large multicenter study. Pacing Clin Electrophysiol. 2014 Jun;37(6):665-73. Edwards FH, Shahian DM, Grau-Sepulveda MV, Grover FL, Mayer JE, O’Brien SM, DeLong E, Peterson ED, McKay C, Shaw RE, Garratt KN, Dangas GD, Messenger J, Klein LW, Popma JJ, Weintraub WS. Composite outcomes in coronary bypass surgery versus percutaneous intervention. Ann Thorac Surg. 2014 Jun;97(6):1983-8; discussion 1988-90. Park LG, Mahar D, Shaw RE, Dracup K. The impact of a heart failure educational program for physicians varies based upon physician specialty. J Clin Med Res. 2014 Jun;6(3):173-83. Weilert F, Bhat YM, Binmoeller KF, Kane S, Jaffee IM, Shaw RE, Cameron R, Hashimoto Y, Shah JN. EUSFNA is superior to ERCP-based tissue sampling in suspected malignant biliary obstruction: results of a prospective, single-blind, comparative study. Gastrointest Endosc. 2014 Jul;80(1):97-104. Steinberg JS, Palekar R, Sichrovsky T, Arshad A, Preminger M, Musat D, Shaw RE, Mittal S. Very long-term outcome after initially successful catheter ablation of atrial fibrillation. Heart Rhythm. 2014 May;11(5):771-6. Ren X, Banki NM, Shaw RE, McNulty EJ, Williams SC, Pencina M, Schiller NB. Doppler-detected valve movement in aortic stenosis: a predictor of adverse outcome. Clin Cardiol. 2014 Mar;37(3):167-71. Mittal S, Shaw RE, Michel K, Palekar R, Arshad A, Musat D, Preminger M, Sichrovsky T, Steinberg JS. Cardiac implantable electronic device infections: incidence, risk factors, and the effect of the AigisRx antibacterial envelope. Heart Rhythm. 2014 Apr;11(4):595-601. Shaw RE, Johnson CK, Ferrari G, Brizzio ME, Sayles K, Rioux N, Zapolanski A, Grau JB. Blood transfusion in cardiac surgery does increase the risk of 5-year mortality: results from a contemporary series of 1714 propensity-matched patients. Transfusion. 2014 Apr;54(4):1106-13. 63 Gastrointestinal Disorders Yasser Bhat (M.D.), Medical Director of Esophageal Imaging and Therapy Publications Bhat YM, Kane SD, Shah JN, Hamerski CM, Binmoeller KF. Single-session circumferential EMR and metal stent placement for the treatment of long-segment Barrett’s esophagus with high-grade intraepithelial neoplasia. Gastrointest Endosc. 2014 Aug;80(2):331. Weilert F, Bhat YM, Binmoeller KF, Kane S, Jaffee IM, Shaw RE, Cameron R, Hashimoto Y, Shah JN. EUSFNA is superior to ERCP-based tissue sampling in suspected malignant biliary obstruction: results of a prospective, single-blind, comparative study. Gastrointest Endosc. 2014 Jul;80(1):97-104. Binmoeller KF, Shah JN, Bhat YM, Kane SD. Suck-ligate-unroof-biopsy by using a detachable 20-mm loop for the diagnosis and therapy of small subepithelial tumors (with video). Gastrointest Endosc. 2014 May;79(5):750-5. Bhat YM. Tissue adhesives for endoscopic use. Gastroenterol Hepatol (N Y). 4014 Apr;10(4):251-3. Vohra S, Holt EW, Bhat YM, Kane S, Shah JN, Binmoeller KF. Successful single-session endosonographybased endoscopic retrograde cholangiopancreatography without fluoroscopy in pregnant patients with suspected choledocholithiasis: a case series. J Hepatobiliary Pancreat Sci. 2014 Feb;21(2):93-7. Oral Presentation Nett AS, Shah JN, Binmoeller K, Kane SD, Hamerski CM, Bhat YM. Comparison of ERCP Versus EUSGuided Biliary Interventions in Patients with Surgically altered anatomy. Digestive Disease Week, 2014. Chicago, IL. Posters Lee A, Bhat YM, Binmoeller K, Cello JP, Day LW, Hamerski CM, Kane SD, Shah JN. EUS-Guided Interventions Decrease the Rate of Therapeutic Biliary ERCP Failures: Comparison of ERCP Outcomes at Centers with and without Interventional EUS. Digestive Disease Week, 2014. Chicago, IL. Shah JN, Bhat YM, Hamerski C, Kane SD, Binmoeller KF. Feasibility of EUS-directed biliary stone removal without fluoroscopy in patients with uncomplicated choledocholithiasis. Digestive Disease Week, 2014. Chicago, IL. Hamerski C, Binmoeller KF, Shah JN, Bhat YM, Kane SD. Underwater Endoscopic Mucosal Resection (UEMR) without submucosal injection of polyps with prior resection attempts. Digestive Disease Week, 2014. Chicago, IL. Kenneth Binmoeller (M.D.), Interventional Endoscopy Program Director Publications Weilert F, Binmoeller KF. Gastroenterol Clin North Am. 2014 Dec;43(4):807-18 Bhat YM, Kane SD, Shah JN, Hamerski CM, Binmoeller KF. Single-session circumferential EMR and metal stent placement for the treatment of long-segment Barrett’s esophagus with high-grade intraepithelial neoplasia. Gastrointest Endosc. 2014 Aug;80(2):331. Weilert F, Bhat YM, Binmoeller KF, Kane S, Jaffee IM, Shaw RE, Cameron R, Hashimoto Y, Shah JN. EUS-FNA is superior to ERCP-based tissue sampling in suspected malignant biliary obstruction: results of a prospective, single-blind, comparative study. Gastrointest Endosc. 2014 Jul;80(1):97-104. Binmoeller KF, Shah JN, Bhat YM, Kane SD. Suck-ligate-unroof-biopsy by using a detachable 20-mm loop for the diagnosis and therapy of small subepithelial tumors (with video). Gastrointest Endosc. 2014 May;79(5):750-5. Vohra S, Holt EW, Bhat YM, Kane S, Shah JN, Binmoeller KF. Successful single-session endosonographybased endoscopic retrograde cholangiopancreatography without fluoroscopy in pregnant patients with suspected choledocholithiasis: a case series. J Hepatobiliary Pancreat Sci. 2014 Feb;21(2):93-7. 64 C O M P E N D IUM Oral Presentation Nett AS, Shah JN, Binmoeller K, Kane SD, Hamerski CM, Bhat YM. Comparison of ERCP Versus EUSGuided Biliary Interventions in Patients with Surgically altered anatomy. Digestive Disease Week, 2014. Chicago, IL. Posters Lee A, Bhat YM, Binmoeller K, Cello JP, Day LW, Hamerski CM, Kane SD, Shah JN. EUS-Guided Interventions Decrease the Rate of Therapeutic Biliary ERCP Failures: Comparison of ERCP Outcomes at Centers with and without Interventional EUS. Digestive Disease Week, 2014. Chicago, IL. Shah JN, Bhat YM, Hamerski C, Kane SD, Binmoeller KF. Feasibility of EUS-directed biliary stone removal without fluoroscopy in patients with uncomplicated choledocholithiasis. Digestive Disease Week, 2014. Chicago, IL. Hamerski C, Binmoeller KF, Shah JN, Bhat YM, Kane SD. Underwater Endoscopic Mucosal Resection (UEMR) without submucosal injection of polyps with prior resection attempts. Digestive Disease Week, 2014. Chicago, IL. Janak Shah (M.D.), Director of Pancreatic and Biliary Endoscopy Publications Bhat YM, Kane SD, Shah JN, Hamerski CM, Binmoeller KF. Single-session circumferential EMR and metal stent placement for the treatment of long-segment Barrett’s esophagus with high-grade intraepithelial neoplasia. Gastrointest Endosc. 2014 Aug;80(2):331. Weilert F, Bhat YM, Binmoeller KF, Kane S, Jaffee IM, Shaw RE, Cameron R, Hashimoto Y, Shah JN. EUSFNA is superior to ERCP-based tissue sampling in suspected malignant biliary obstruction: results of a prospective, single-blind, comparative study. Gastrointest Endosc. 2014 Jul;80(1):97-104. Binmoeller KF, Shah JN, Bhat YM, Kane SD. Suck-ligate-unroof-biopsy by using a detachable 20-mm loop for the diagnosis and therapy of small subepithelial tumors (with video). Gastrointest Endosc. 2014 May;79(5):750-5. Vohra S, Holt EW, Bhat YM, Kane S, Shah JN, Binmoeller KF. Successful single-session endosonographybased endoscopic retrograde cholangiopancreatography without fluoroscopy in pregnant patients with suspected choledocholithiasis: a case series. J Hepatobiliary Pancreat Sci. 2014 Feb;21(2):93-7. Oral Presentation Nett AS, Shah JN, Binmoeller K, Kane SD, Hamerski CM, Bhat YM. Comparison of ERCP Versus EUSGuided Biliary Interventions in Patients with Surgically altered anatomy. Digestive Disease Week, 2014. Chicago, IL. Posters Lee A, Bhat YM, Binmoeller K, Cello JP, Day LW, Hamerski CM, Kane SD, Shah JN. EUS-Guided Interventions Decrease the Rate of Therapeutic Biliary ERCP Failures: Comparison of ERCP Outcomes at Centers with and without Interventional EUS. Digestive Disease Week, 2014. Chicago, IL. Shah JN, Bhat YM, Hamerski C, Kane SD, Binmoeller KF. Feasibility of EUS-directed biliary stone removal without fluoroscopy in patients with uncomplicated choledocholithiasis. Digestive Disease Week, 2014. Chicago, IL. Hamerski C, Binmoeller KF, Shah JN, Bhat YM, Kane SD. Underwater Endoscopic Mucosal Resection (UEMR) without submucosal injection of polyps with prior resection attempts. Digestive Disease Week, 2014. Chicago, IL. 65 William Snape (M.D.), Medical Director of the Center for Neurogastroenterology and Motility Services Publication Bernard CE, Gibbons SJ, Mann IS, Froschauer L, Parkman HP, Harbison S, Abell TL, Snape WJ, Hasler WL, McCallum RW, Sarosiek I, Nguyen LA, Koch KL, Tonascia J, Hamilton FA, Kendrick ML, Shen KR, Pasricha PJ, Farrugia G; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Association of low numbers of CD206-positive cells with loss of ICC in the gastric body of patients with diabetic gastroparesis. Neurogastroenterol Motil. 2014 Sep;26(9):1275-84. Abstracts Kedar A, Abell TL, Bernard CR, Farrugia G, Lahr CJ, Hasler WL, et al. Intra-Operative Electrophysiological and Interstitial Cell of Cajal Findings in Patients With the Symptoms of Gastroparesis. Digestive Diseases Week 2014:Washington, DC May 2014. Gastroenterology 2014; 146(5 Suppl): S609. Pasricha PJ, Yates KP, Clarke JO, Unalp A, Tonascia J, Koch KL, et al. Morbidity, Mortality and Predictors of Improvement in Patients With Gastroparesis: 4-Year Outcomes From the Gastroparesis Clinical Research Consortium. Digestive Diseases Week 2014:Washington, DC May 2014. Gastroenterology 2014; 146(5 Suppl): S136. Hasler WL, Belt P, Wilson L, McCallum RW, Parkman HP, Koch KL, et al. Correlation of Fermentable Carbohydrate Consumption With Symptoms and Quality of Life in Patients With Diabetic and Idiopathic Gastroparesis. Digestive Diseases Week 2014:Washington, DC May 2014. Gastroenterology 2014; 146(5 Suppl): S610. Koch KL Hasler WL, Parkman HP, VanNatta ML, Abell TL, McCallum RW, et al. Correlations of Liquid Nutrient Meal-Induced Symptpoms With Satiety Test Volumes in Idiopathic Gastroparesis: Relation to Gastric Emptying and Myoelectric Activity. Digestive Diseases Week 2014:Washington, DC May 2014. Gastroenterology 2014; 146(5 Suppl): S608. Calles-Escandon J, Hasler WL, Koch KL, VanNatta ML, Vaughn IA, Parkman HP, et al. Continuous Blood Glucose Patterns in Diabetic Patients With Gastroparesis: Baseline Findings From the GPCRC GLUMIT-DG Study. Digestive Diseases Week 2014:Washington, DC May 2014. Gastroenterology 2014; 146(5 Suppl): S616. Snape W, Lin, M., Shaw, R The importance of the pylorus in patients with gastroparesis evaluated by concurrent intraluminal pressure and EndoFLIP Abstracts of the 1st Federation Neurogastroenterology and Motility Scientific Meeting, September 5-7, 2014, Guangzhou, China NEUROGASTROENTEROL MOTIL 2014, 26, SUPPLEMENT 1, pages 1–88. Liver Diseases Lia Avanesyan (Ph.D.), Associate Scientist Publication Crane CA, Austgen K, Haberthur K, Hofmann C, Moyes KW, Avanesyan L, Fong L, Campbell MJ, Cooper S, Oakes SA, Parsa AT, Lanier LL. Immune evasion mediated by tumor-derived lactate dehydrogenase induction of NKG2D ligands on myeloid cells in glioblastoma patients. Proc Natl Acad Sci U S A. 2014 Sep 2;111(35):12823-8. Maurizio Bonacini (M.D.), Transplant Hepatologist at the Hepatology and Gastroenterology Research Center Presentation Edward J. Gane, Richard A. Robson, Maurizio Bonacini, Benedict Maliakkal, Brian Kirby, Lin Liu, Karim Sajwani,Luisa M. Stamm, Diana M. Brainard, John G. McHutchison, Catherine A. Stedman, Eric Lawitz. Safety, Antiviral Efficacy, and Pharmacokinetics of Sofosbuvir in Patients With Severe Renal Impairment. Prsented at the 2014 AASLD Meeting. 66 C O M P E N D IUM Stewart Cooper (M.D.), Senior Scientist; Chief, Division of Hepatology; Director of Research & Kalmanovitz Liver Immunology Laboratory Publications Rachakonda V, Gabbert C, Raina A, Bell LN, Cooper S, Malik S, Behari J. Serum metabolomic profiling in acute alcoholic hepatitis identifies multiple dysregulated pathways. PLoS One. 2014 Dec 2;9(12):e113860. eCollection 2014. Crane CA, Austgen K, Haberthur K, Hofmann C, Moyes KW, Avanesyan L, Fong L, Campbell MJ, Cooper S, Oakes SA, Parsa AT, Lanier LL. Immune evasion mediated by tumor-derived lactate dehydrogenase induction of NKG2D ligands on myeloid cells in glioblastoma patients. Proc Natl Acad Sci U S A. 2014 Sep 2;111(35):12823-8. Epub 2014 Aug 18. Ghany MG, Perrillo R, Li R, Belle SH, Janssen HL, Terrault NA, Shuhart MC, Lau DT, Kim WR, Fried MW, Sterling RK, Di Bisceglie AM, Han SH, Ganova-Raeva LM, Chang KM, Lok AS; Hepatitis B Research Network. Characteristics of adults in the hepatitis B research network in North America reflect their country of origin and hepatitis B virus genotype. Clin Gastroenterol Hepatol. 2015 Jan;13(1):183-92. Timothy Davern (M.D.), Gastroenterologist/Hepatologist; Director of the Acute Liver Failure Program Publications Holt EW, DeMartini S, Davern T. Acute Liver Failure Due to Acetaminophen Poisoning in Patients With Prior Weight Loss Surgery: A Case Series. J Clin Gastroenterol. 2014 Dec 30. Navarro VJ, Barnhart H, Bonkovsky HL, Davern T, Fontana RJ, Grant L, Reddy KR, Seeff LB, Serrano J, Sherker AH, Stolz A, Talwalkar J, Vega M, Vuppalanchi R. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology. 2014 Oct;60(4):1399-408. Long D, Fix OK, Deng X, Seielstad M, Lauring AS; Acute Liver Failure Study Group. Whole genome sequencing to identify host genetic risk factors for severe outcomes of hepatitis a virus infection. J Med Virol. 2014 Oct;86(10):1661-8. Dubin PH, Yuan H, Devine RK, Hynan LS, Jain MK, Lee WM; Acute Liver Failure Study Group. Micro-RNA-122 levels in acute liver failure and chronic hepatitis C. J Med Virol. 2014 Sep;86(9):1507-14. Fontana RJ, Hayashi PH, Gu J, Reddy KR, Barnhart H, Watkins PB, Serrano J, Lee WM, Chalasani N, Stolz A, Davern T, Talwakar JA; DILIN Network. Idiosyncratic drug-induced liver injury is associated with substantial morbidity and mortality within 6 months from onset. Gastroenterology. 2014 Jul;147(1):96-108.e4. Karvellas CJ, Cavazos J, Battenhouse H, Durkalski V, Balko J, Sanders C, Lee WM; US Acute Liver Failure Study Group. Effects of antimicrobial prophylaxis and blood stream infections in patients with acute liver failure: a retrospective cohort study. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1942-9.e1. Karvellas CJ, Fix OK, Battenhouse H, Durkalski V, Sanders C, Lee WM; US Acute Liver Failure Study Group. Outcomes and complications of intracranial pressure monitoring in acute liver failure: a retrospective cohort study. Crit Care Med. 2014 May;42(5):1157-67. Court MH, Peter I, Hazarika S, Vasiadi M, Greenblatt DJ, Lee WM; Acute Liver Failure Study Group. Candidate gene polymorphisms in patients with acetaminophen-induced acute liver failure. Drug Metab Dispos. 2014 Jan;42(1):28-32. Kleiner DE, Chalasani NP, Lee WM, Fontana RJ, Bonkovsky HL, Watkins PB, Hayashi PH, Davern T, Navarro V, Reddy R, Talwalkar JA, Stolz A, Gu J, Barnhart H, Hoofnagle JH; Drug-Induced Liver Injury Network (DILIN). Hepatic histological findings in suspected drug-induced liver injury: systematic evaluation and clinical associations. Hepatology. 2014 Feb;59(2):661-70. Karkhanis J, Verna EC, Chang MS, Stravitz RT, Schilsky M, Lee WM, Brown RS Jr; Acute Liver Failure Study Group. Steroid use in acute liver failure. Hepatology. 2014 Feb;59(2):612-21. Metushi IG, Sanders C; Acute Liver Study Group, Lee WM, Uetrecht J. Detection of anti-isoniazid and anticytochrome P450 antibodies in patients with isoniazid-induced liver failure. Hepatology. 2014 Mar;59(3):1084-93. 67 Todd Frederick (M.D.), Director of Clinical Protocol Development and Liver Support Services at CPMC; Director of the Transplant Hepatology Fellowship Program Publications Mullen KD, Sanyal AJ, Bass NM, Poordad FF, Sheikh MY, Frederick RT, Bortey E, Forbes WP. Rifaximin is Safe and Well Tolerated for Long-Term Maintenance of Remission From Overt Hepatic Encephalopathy. Clin Gastroenterol Hepatol. 2014 Aug 12(8):1390-1397. Kowdley KV, Gordon SC, Reddy KR et al, Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Eng J Med 2014 May 15;370(20):1879-88 (Listed as Collaborator). Afdhal N, Reddy KR, Nelson DR et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014 Apr 17;370(16):1483-93 (Listed as Collaborator). Chou C, Yimam K, Frederick RT, Swenson S. A rare case of icteric acute hepatitis C infection acquired through intranasal methamphetamine use. ACG Case Rep J 2014;1(2):112-114. Abstracts Sanyal A, Boyer TD, Frederick RT, et al. Reversal of hepatorenal syndrome Type 1 (HRS-1) with terlipressin plus albumin versus placebo plus albumin- Not all responses are created equal - An analysis of the REVERSE and OT-0401 trials. Hepatology 2014;60 (4 Suppl):322A. Boyer TD, Sanyal AJ, Wong F, Frederick RT et al. Initial report of a large, randomized, double blind, placebocontrolled, phase 3 trial of terlipressin plus albumin for the treatment of Type 1 hepatorenal syndrome (HRS-1): The REVERSE study. Hepatology 2014;60 (4 Suppl):255A. Ripper S, Holt EW, Cooper S, Wakil A, Davern T, Merriman R, Guy J, Frederick RT. Simeprevir plus Sofosbuvir for Patients with Recurrence of Genotype 1 Hepatitis C Infection after Liver Transplantation. Hepatology 2014;60 (4 Suppl): 684A. S Ripper, E Holt, S Cooper, A Wakil, R Merriman, J Guy, RT Frederick. Combination Therapy with Simeprevir and Sofosbuvir for Genotype 1 HCV after Liver Transplantation. Late Breaker Oral Abstract, World Transplant Congress, San Francisco, CA July 2014. Jennifer Guy (M.D.), Director of the Liver Cancer Program Publications Goel A, Mehta N, Guy J, Fidelman N, Yao F, Roberts J, Terrault N. Hepatic artery and biliary complications in liver transplant recipients undergoing pretransplant transarterial chemoembolization. Liver Transpl. 2014 Oct;20(10):1221-8. Frenette CT, Osorio RC, Stark J, Fok B, Boktour MR, Guy J, Rhee J, Osorio RW. Conventional TACE and drug-eluting bead TACE as locoregional therapy before orthotopic liver transplantation: comparison of explant pathologic response. Transplantation. 2014 Oct 15;98(7):781-7. Presentation Neil Mehta, M.D.; Jennifer Guy, M.D.; Catherine T. Frenette, M.D.; Monika Sarkar, M.D.; Robert W. Osorio, M.D.; William B. Minteer, M.D.; John P. Roberts, M.D.; Francis Y. Yao, M.D.. AASLD, Boston, MA November 2014. Clinical Plenary Session: Multicenter Study of Down-staging of Hepatocellular Carcinoma (HCC) to within Milan Criteria before Liver Transplantation. Assad Hassoun (M.D., FACS), Surgical Director, Transplant Surgery Publication Khalaf H, Marwan I, Al-Sebayel M, El-Meteini M, Hosny A, Abdel-Wahab M, Amer K, El-Shobari M, Kamel R, Al-Qahtani M, Khan I, Bashir A, Hammoudi S, Smadi S, Khalife M, Faraj W, Bentabak K, Khalfallah T, Hassoun A, Bukrah A, Mustafa I. Status of liver transplantation in the Arab world. Transplantation. 2014 Apr 15;97(7):722-4. 68 C O M P E N D IUM Presentation Hassoun A, Farajifar S, Rabkin JM, Osorio R: Innovative surgical techniques in Pacreaticoduodenectomy: Cohort analysis using validated outcomes0based quality metrics. International Hepato-Pacreato-Biliary Association (IHPBA) 11th World Congress, Seoul, South Korea, March 22-27, 2014. Oral Presentation. Garrett Hisatake (M.D., FACS), Surgeon Publication Wang Z, Hisatake G, Yang L. Liver-specific deceased donor risk indices. Hepatol Res. 2014 Feb;44(2):159-64. Edward Holt (M.D.), Director, Fatty Liver Disease Program; Transplant Hepatologist Publications Holt EW, Yimam KK, Ma H, Shaw RE, Sundberg RA, Verhille MS. Patient tolerability of bowel preparation is associated with polyp detection rate during colonoscopy. J Gastrointestin Liver Dis. 2014 Jun;23(2):135-40. Holt EW, Wei EK, Bennett N, Zhang LM. Low skin carotenoid concentration measured by resonance Raman spectroscopy is associated with metabolic syndrome in adults. Nutr Res. 2014 Oct;34(10):821-6. Holt EW, DeMartini S, Davern TJ. Acute Liver Failure Due to Acetaminophen Poisoning in Patients With Prior Weight Loss Surgery: A Case Series. J Clin Gastroenterol. 2014 Dec 30. [Epub ahead of print] Ralph Merriman (M.D.), Medical Director, Liver Transplantation; Director, Metabolic Liver Disease Research Publication American Association for the Study of Liver Diseases; European Association for the Study of the Liver. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. J Hepatol. 2014 Sep;61(3):642-59. Epub 2014 Jul 8. Robert W. Osorio (M.D., FACS) Chair of the Department of Transplantation and Surgical Director of the Liver Disease and Liver Transplant Program Publication Frenette CT, Osorio RC, Stark J, Fok B, Boktour MR, Guy J, Rhee J, Osorio RW. Conventional TACE and drug-eluting bead TACE as locoregional therapy before orthotopic liver transplantation: comparison of explant pathologic response. Transplantation. 2014 Oct 15;98(7):781-7. Microvascular Surgery Rudolf F. Buntic (M.D.), Chief of the Division of Microsurgery Publication Momeni A, Buntic RF, Buncke GM. Cross-leg flaps: preferred alternative to free flaps? J Am Coll Surg. 2014 Feb;218(2):308-9. Mind-Body Medicine Cassandra Vieten (Ph.D.), Scientist; Co-Director of the Mind-Body Medicine Research Group Publication Thomas M, Vieten C, Adler N, Ammondson I, Coleman-Phox K, Epel E, Laraia B. Potential for a stress reduction intervention to promote healthy gestational weight gain: focus groups with low-income pregnant women. Womens Health Issues. 2014 May-Jun;24(3):e305-11. 69 Garret Yount (Ph.D.), Scientist; Director of the Mind-Body Medicine Research Group Publications Yount G & Rachlin K. A novel mouthwash protocol for noninvasive genomic analyses. Intl. J. Psychosocial & Cultural Genomics Consciousness & Health Res. 2014 Oct Issue 1:12-15. Cobbs C, Khan S, Matlaf L, McAllister S, Zider A, Yount G, Rahlin K, Harkins L, Bezrookove V, Singer E, Soroceanu L. HCMV glycoprotein B is expressed in primary glioblastomas and enhances growth and invasiveness via PDGFR-alpha activation. Oncotarget. 2014 Feb 28;5(4):1091-100. Neuroscience Nobl Barazangi (M.D., Ph.D.), Director of the Stroke/Neurocritical Care Research and Education Program Publication Spokoyny I, Barazangi N, Jaramillo V, Rose J, Chen C, Wong C, Tong D. Reduced clopidogrel metabolism in a multiethnic population: prevalence and rates of recurrent cerebrovascular events. J Stroke Cerebrovasc Dis. 2014 Apr;23(4):694-8. Presentation Poster presented by Dr Chandra, CPMC medicine resident, at the Neurocritical Care Society Annual Meeting 2014 Cerebral Toxemia from Hyperammonemia: Adult-Onset Disorders of Urea Cycle Metabolism; Mekhala Chandra, M.D., Nobl Barazangi, M.D., Ph.D., Alan H. Yee, D.O. Jonathan Katz (M.D.), Director of Neuromuscular Research at the Forbes Norris MDA/ALS Research and Treatment Center Publications Miller RG, Zhang R, Block G, Katz J, Barohn R, Kasarskis E, Forshew D, Gopalakrishnan V, McGrath MS. NP001 regulation of macrophage activation markers in ALS: a phase I clinical and biomarker study. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):601-9. McElhiney M, Rabkin JG, Goetz R, Katz J, Miller RG, Forshew DA, David W, Cudkowicz M, Glass JD, Appel S, Simpson E, Mitsumoto H. Seeking a measure of clinically meaningful change in ALS. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Sep;15(5-6):398-405. Epub 2014 Aug 15. Erratum in: Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):627. Zhao Y, Cudkowicz ME, Shefner JM, Krivickas L, David WS, Vriesendorp F, Pestronk A, Caress JB, Katz J, Simpson E, Rosenfeld J, Pascuzzi R, Glass J, Rezania K, Harmatz JS, Schoenfeld D, Greenblatt DJ. Systemic pharmacokinetics and cerebrospinal fluid uptake of intravenous ceftriaxone in patients with amyotrophic lateral sclerosis. J Clin Pharmacol. 2014 Oct;54(10):1180-7. Rabkin J, Ogino M, Goetz R, McElhiney M, Hupf J, Heitzman D, Heiman-Patterson T, Miller R, Katz J, Lomen-Hoerth C, Imai T, Atsuta N, Morita M, Tateishi T, Matsumura T, Mitsumoto H. Japanese and American ALS patient preferences regarding TIV (tracheostomy with invasive ventilation): a cross-national survey. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Jun;15(3-4):185-91. Wills AM, Hubbard J, Macklin EA, Glass J, Tandan R, Simpson EP, Brooks B, Gelinas D, Mitsumoto H, Mozaffar T, Hanes GP, Ladha SS, Heiman-Patterson T, Katz J, Lou JS, Mahoney K, Grasso D, Lawson R, Yu H, Cudkowicz M; MDA Clinical Research Network. Hypercaloric enteral nutrition in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2014 Jun 14;383(9934):2065-72. Mitsumoto H, Factor-Litvak P, Andrews H, Goetz RR, Andrews L, Rabkin JG, McElhiney M, Nieves J, Santella RM, Murphy J, Hupf J, Singleton J, Merle D, Kilty M, Heitzman D, Bedlack RS, Miller RG, Katz JS, Forshew D, Barohn RJ, Sorenson EJ, Oskarsson B, Fernandes Filho JA, Kasarskis EJ, Lomen-Hoerth C, Mozaffar T, Rollins YD, Nations SP, Swenson AJ, Shefner JM, Andrews JA, Koczon-Jaremko BA; ALS COSMOS Study Group. ALS Multicenter Cohort Study of Oxidative Stress (ALS COSMOS): study methodology, recruitment, and baseline demographic and disease characteristics. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Jun;15(3-4):192-203. 70 C O M P E N D IUM Kenneth Laxer (M.D.), Director of the Sutter Pacific Epilepsy Program Publications Mueller SG, Bateman LM, Laxer KD. Evidence for brainstem network disruption in temporal lobe epilepsy and sudden unexplained death in epilepsy. Neuroimage Clin. 2014 Jul 9;5:208-16. Laxer KD, Trinka E, Hirsch LJ, Cendes F, Langfitt J, Delanty N, Resnick T, Benbadis SR. The consequences of refractory epilepsy and its treatment. Epilepsy Behav. 2014 Aug;37:59-70. Epub 2014 Jun 27. Robert Miller (M.D.), Director of the Forbes Norris MDA/ALS Research and Treatment Center Publications Miller RG, Zhang R, Block G, Katz J, Barohn R, Kasarskis E, Forshew D, Gopalakrishnan V, McGrath MS. NP001 regulation of macrophage activation markers in ALS: a phase I clinical and biomarker study. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):601-9. doi: 10.3109/21678421.2014.951940. Epub 2014 Sep 5. McElhiney M, Rabkin JG, Goetz R, Katz J, Miller RG, Forshew DA, David W, Cudkowicz M, Glass JD, Appel S, Simpson E, Mitsumoto H. Seeking a measure of clinically meaningful change in ALS. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Sep;15(5-6):398-405. doi: 10.3109/21678421.2014.942668. Epub 2014 Aug 15. Erratum in: Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):627. Miller RG, Brooks BR, Swain-Eng RJ, Basner RC, Carter GT, Casey P, Cohen AB, Dubinsky R, Forshew D, Jackson CE, Kasarskis E, Procaccini NJ, Sanjak M, Tolin FP. Quality improvement in neurology: amyotrophic lateral sclerosis quality measures. Report of the Quality Measurement and Reporting Subcommittee of the American Academy of Neurology. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Jun;15(3-4):165-8. doi: 10.3109/21678421.2013.875706. Epub 2014 Apr 7. Wills AM, Hubbard J, Macklin EA, Glass J, Tandan R, Simpson EP, Brooks B, Gelinas D, Mitsumoto H, Mozaffar T, Hanes GP, Ladha SS, Heiman-Patterson T, Katz J, Lou JS, Mahoney K, Grasso D, Lawson R, Yu H, Cudkowicz M; MDA Clinical Research Network. Lancet. 2014 Jun 14;383(9934):2065-72. doi: 10.1016/ S0140-6736(14)60222-1. Epub 2014 Feb 28. Hypercaloric enteral nutrition in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled phase 2 trial. Mitsumoto H, Factor-Litvak P, Andrews H, Goetz RR, Andrews L, Rabkin JG, McElhiney M, Nieves J, Santella RM, Murphy J, Hupf J, Singleton J, Merle D, Kilty M, Heitzman D, Bedlack RS, Miller RG, Katz JS, Forshew D, Barohn RJ, Sorenson EJ, Oskarsson B, Fernandes Filho JA, Kasarskis EJ, Lomen-Hoerth C, Mozaffar T, Rollins YD, Nations SP, Swenson AJ, Shefner JM, Andrews JA, Koczon-Jaremko BA; ALS COSMOS Study Group. ALS Multicenter Cohort Study of Oxidative Stress (ALS COSMOS): study methodology, recruitment, and baseline demographic and disease characteristics. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Jun;15(3-4):192-203. Michael C. Rowbotham (M.D.), Senior Scientist; Scientific Director of CPMCRI; Sutter Health Research Enterprise Integration Leader—Basic Science; Sutter Health Research Enterprise Integration Leader—Clinical Trials Publications Munch T, Dufka FL, Greene K, Smith SM, Dworkin RH, Rowbotham MC. RReACT goes global: perils and pitfalls of constructing a global open-access database of registered analgesic clinical trials and trial results. Pain. 2014 Jul;155(7):1313-7. Epub 2014 Apr 13. Slagelse C, Petersen KL, Dahl JB, Finnerup K, Greene K, Leong SP, Levine J, Rowbotham MC, Werner MU, Finnerup NB. Persistent postoperative pain and sensory changes following lymph node excision in melanoma patients: a topical review. Melanoma Res. 2014 Apr;24(2):93-8. Farrar JT, Troxel AB, Haynes K, Gilron I, Kerns RD, Katz NP, Rappaport BA, Rowbotham MC, Tierney AM, Turk DC, Dworkin RH. Effect of variability in the 7-day baseline pain diary on the assay sensitivity of neuropathic pain randomized clinical trials: an ACTTION study. Pain. 2014 Aug;155(8):1622-31. Epub 2014 May 14. 71 Gewandter JS, Dworkin RH, Turk DC, McDermott MP, Baron R, Gastonguay MR, Gilron I, Katz NP, Mehta C, Raja SN, Senn S, Taylor C, Cowan P, Desjardins P, Dimitrova R, Dionne R, Farrar JT, Hewitt DJ, Iyengar S, Jay GW, Kalso E, Kerns RD, Leff R, Leong M, Petersen KL, Ravina BM, Rauschkolb C, Rice AS, Rowbotham MC, Sampaio C, Sindrup SH, Stauffer JW, Steigerwald I, Stewart J, Tobias J, Treede RD, Wallace M, White RE. Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations. Pain. 2014 Sep;155(9):1683-95. Epub 2014 May 24. Dufka FL, Dworkin RH, Rowbotham MC. How transparent are migraine clinical trials? Repository of Registered Migraine Trials (RReMiT). Neurology. 2014 Oct 7;83(15):1372-81. Epub 2014 Sep 5. Gewandter JS, McDermott MP, McKeown A, Smith SM, Pawlowski JR, Poli JJ, Rothstein D, Williams MR, Bujanover S, Farrar JT, Gilron I, Katz NP, Rowbotham MC, Turk DC, Dworkin RH. Reporting of intention-totreat analyses in recent analgesic clinical trials: ACTTION systematic review and recommendations. Pain. 2014 Dec;155(12):2714-9. Epub 2014 Oct 2. Gewandter JS, McKeown A, McDermott MP, Dworkin JD, Smith SM, Gross RA, Hunsinger M, Lin AH, Rappaport BA, Rice AS, Rowbotham MC, Williams MR, Turk DC, Dworkin RH. Data interpretation in analgesic clinical trials with statistically non-significant primary analyses: An ACTTION systematic review. J Pain. 2014 Oct 23. [Epub ahead of print] Review. Susan Woolley-Levine (Ph.D., ABPP), Clinical Neuropsychologist Presentations Longitudinal Cognitive and Behavioral Results from the COSMOS Study. Platform Presentation, International Symposium on MND/ALS, Brussels, Belgium, Dec 2014. Neuropsychology of ALS: Screening Tools for ALS-FTD. Invited lecturer, ALS Research Group Meeting, Minneapolis, MN Sept 2014. Organ Transplant V. Ram Peddi (M.D.), Transplant Nephrologist; Director of Transplant Clinical Research Publications Ueda K, McCague KM, Wiland A, Peddi VR. Early corticosteroid withdrawal in the real world: a long-term analysis of kidney transplant recipients from the Mycophenolic Acid Observational Renal Transplant Registry. Ann Transplant. 2014;19:84-92. Roedder S, Sigdel T, Salomonis N, Hsieh S, Dai H, Bestard O, Metes D, Zeevi A, Gritsch A, Cheeseman J, Macedo C, Peddi VR, Medeiros M, Vincenti F, Asher N, Salvatierra O, Shapiro R, Kirk A, Reed E, Sarwal MM. The kSORT Assay to Detect Renal Transplant Patients at High Risk for Acute Rejection: Results of the Multicenter AART Study. PLoS Med. 2014 Nov 11;11(11). Presentations V. Peddi, Y. Qazi, D. Shaffer, F. Luan, F. Shihab, S. Tomlanovich, K. McCague, D. Patel, S. Mulgaonkar for CRAD001AUS92 Study Group. Effect of Everolimus With Low Dose Tacrolimus Vs Mycophenolate With Standard Tacrolimus Regimen in African-American De Novo Renal Transplant Recipients. World Transplant Congress. San Francisco, CA. July 2014. F. Shihab, D. Shaffer, Y. Qazi, B. Kaplan, F. Vincenti, K. McCague, D. Patel, S. Mulgaonkar, V. Peddi. For CRAD001AUS92 Study Group. Reduced Incidence of CMV and BK Virus Infection With Everolimus vs Mycophenolate Based Regimen in De Novo Renal Transplant Recipients. World Transplant Congress. San Francisco, CA. July 2014. F. Shihab, Y. Qazi, B. Kaplan, D. Kim, S. Mulgaonkar, V. Peddi, D. Shaffer, D. Patel, K. McCague, F. Vincenti for CRAD001AUS92 Study Group. Everolimus-Facilitated Tacrolimus Minimization Preserves Renal Function in De Novo Renal Transplant Recipients. World Transplant Congress. San Francisco, CA. July 2014. H. Tedesco-Silva, V. Peddi, A. Sanchez-Frutuoso, B. Marder, G. Russ, A. Flynn, C. Hahn, M. Tortorici, S. Schulman. Open-Label Study of Planned Transition From Tacrolimus to Sirolimus vs Continued Tacrolimus in Renal Allograft Recipients. World Transplant Congress. San Francisco, CA. July 2014. 72 C O M P E N D IUM F. Diekmann, H. Tedesco-Silva, V. Peddi, A. Sanchez-Fructoso, B. Marder, G. Russ, A. Flynn, C. Hahn, H. Li, M. Tortorici, S. Schulman. Transition From Tacrolimus to Sirolimus vs Continued Tacrolimus in Renal Allograft Recipients: Impact On Glycemic Parameters. World Transplant Congress. San Francisco, CA. July 2014. S. Roedder, T. Sigdel, N. Salomonis, S. Hsiehs, H. Dai, D. Metes, A. Zeevi, H. Gritsch, J. Cheeseman, V. Peddi, M. Medeiros, O. Bestard, F. Vincenti, N. Asher, R. Shapiro, A. Kirk, E. Reed, M. Sarwal. A 17 Gene Blood Assay (kSORT) for Diagnosis and Prediction of Acute Renal Transplant Rejection: Results of the Multicenter AART Study. World Transplant Congress. San Francisco, CA. July 2014. V. Peddi, L. Ratner, M. Cooper, O. Gaber, S. Feng, P. Tso, V. Bowers, R. Naraghi, K. Budde, M. Polinsky, E. Squiers, S. Erlich, for QPI-1002 Study Investigators Group. Treatment with QPI-1002, a Short Interfering (SI) RNA for the Prophylaxis of Delayed Graft Function. World Transplant Congress. San Francisco, CA. July 2014. Kimi Ueda (PharmD, BCPS), Kidney/Pancreas Transplant Pharmacist Publication Ueda K, McCague KM, Wiland A, Peddi VR. Early corticosteroid withdrawal in the real world: a long-term analysis of kidney transplant recipients from the Mycophenolic Acid Observational Renal Transplant Registry. Ann Transplant. 2014 Feb 17;19:84-92. Pulmonology/Critical Care George Horng (M.D.), Division Chief of Pulmonary and Critical Care Medicine Publication Carlsson A, Nair VS, Luttgen MS, Keu KV, Horng G, Vasanawala M, Kolatkar A, Jamali M, Iagaru AH, Kuschner W, Loo BW Jr, Shrager JB, Bethel K, Hoh CK, Bazhenova L, Nieva J, Kuhn P, Gambhir SS. Circulating tumor microemboli diagnostics for patients with non-small-cell lung cancer. J Thorac Oncol. 2014 Aug;9(8):1111-9. Sean R. Townsend (M.D.), Vice President of Quality & Safety Publications Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. Osborn TM, Phillips G, Lemeshow S, Townsend S, Schorr CA, Levy MM, Dellinger RP. Sepsis severity score: an internationally derived scoring system from the surviving sepsis campaign database. Crit Care Med. 2014 Sep;42(9):1969-76. Casserly B, Phillips GS, Schorr C, Dellinger RP, Townsend SR, Osborn TM, Reinhart K, Selvakumar N, Levy MM. Lactate Measurements in Sepsis-Induced Tissue Hypoperfusion: Results From the Surviving Sepsis Campaign Database. Crit Care Med. 2014 Dec 4. [Epub ahead of print] Levy MM, Rhodes A, Phillips GS, Townsend SR, Schorr CA, Beale R, Osborn T, Lemeshow S, Chiche JD, Artigas A, Dellinger RP. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Intensive Care Med. 2014 Nov;40(11):1623-33. San Francisco Coordinating Center Terri Blackwell (MA), Senior Statistician Publications Walsh CM, Blackwell T, Tranah GJ, Stone KL, Ancoli-Israel S, Redline S, Paudel M, Kramer JH, Yaffe K. Weaker Circadian Activity Rhythms are Associated with Poorer Executive Function in Older Women. Sleep. 2014 Dec 1;37(12):2009-16. Ensrud KE, Blackwell TL, Cauley JA, Dam TT, Cawthon PM, Schousboe JT, Barrett-Connor E, Stone KL, Bauer DC, Shikany JM, Mackey DC; Osteoporotic Fractures in Men Study Group. Objective measures of activity level and mortality in older men. J Am Geriatr Soc. 2014 Nov;62(11):2079-87. 73 Cauley JA, Blackwell TL, Redline S, Ensrud KE, Ancoli-Israel S, Fink HA, Orwoll ES, Stone KL. 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J Am Geriatr Soc. 2014 Aug;62(8):1476-83. doi: 10.1111/jgs.12954. Epub 2014 Jul 15. Cawthon PM, Haslam J, Fullman R, Peters KW, Black D, Ensrud KE, Cummings SR, Orwoll ES, BarrettConnor E, Marshall L, Steiger P, Schousboe JT; OsteoporoticFractures in Men (MrOS) Research Group. Methods and reliability of radiographic vertebral fracture detection in older men: the osteoporotic fractures in menstudy. Bone. 2014 Oct;67:152-5. Epub 2014 Jul 6. Mackey DC, Cauley JA, Barrett-Connor E, Schousboe JT, Cawthon PM, Cummings SR; Osteoporotic Fractures in Men Research Group. Life-space mobility and mortality in older men: a prospective cohort study. J Am Geriatr Soc. 2014 Jul;62(7):1288-96. Epub 2014 Jun 16. Lee DS, Markwardt S, Goeres L, Lee CG, Eckstrom E, Williams C, Fu R, Orwoll E, Cawthon PM, Stefanick ML, Mackey D, Bauer DC, Nielson CM. Statins and physical activity in older men: the osteoporotic fractures in men study. JAMA Intern Med. 2014 Aug;174(8):1263-70. Dam TT, Peters KW, Fragala M, Cawthon PM, Harris TB, McLean R, Shardell M, Alley DE, Kenny A, Ferrucci L, Guralnik J, Kiel DP, Kritchevsky S, Vassileva MT, Studenski S. An evidence-based comparison of operational criteria for the presence of sarcopenia. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):584-90. McLean RR, Shardell MD, Alley DE, Cawthon PM, Fragala MS, Harris TB, Kenny AM, Peters KW, Ferrucci L, Guralnik JM, Kritchevsky SB, Kiel DP, Vassileva MT, Xue QL, Perera S, Studenski SA, Dam TT. Criteria for clinically relevant weakness and low lean mass and their longitudinal association with incident mobility impairment and mortality: the foundation for the National Institutes of Health (FNIH) sarcopenia project. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):576-83. Cawthon PM, Peters KW, Shardell MD, McLean RR, Dam TT, Kenny AM, Fragala MS, Harris TB, Kiel DP, Guralnik JM, Ferrucci L, Kritchevsky SB, Vassileva MT, Studenski SA, Alley DE. 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Association between Sleep Duration and Mortality Is Mediated by Markers of Inflammation and Health in Older Adults: The Health, Aging and Body Composition Study. Sleep. 2014 Oct 28 [Epub ahead of print] Walsh CM, Blackwell T, Tranah GJ, Stone KL, Ancoli-Israel S, Redline S, Paudel M, Kramer JH, Yaffe K. Weaker Circadian Activity Rhythms are Associated with Poorer Executive Function in Older Women. Sleep. 2014; 37(12):2009-16. Song Y, Blackwell T, Yaffe K, Ancoli-Israel S, Redline S, Stone KL; for the Osteoporotic Fractures in Men (MrOS) Study Group. Relationships Between Sleep Stages and Changes in Cognitive Function in Older Men: The MrOS Sleep Study. Sleep. 2014 Oct 17. [Epub ahead of print] Cauley JA, Blackwell TL, Redline S, Ensrud KE, Ancoli-Israel S, Fink HA, Orwoll ES, Stone KL; Osteoporotic Fractures in Men Study. Hypoxia during sleep and the risk of falls and fractures in older men: the Osteoporotic Fractures in Men Sleep Study. J Am Geriatr Soc. 2014; 62(10):1853-9. Diem SJ, Ewing SK, Stone KL, Ancoli-Israel S, Redline S, Ensrud KE; the Osteoporotic Fractures in Men (MrOS) Study Group. Use of non-benzodiazepine sedative hypnotics and risk of falls in older men. J Gerontol Geriatr Res. 2014; 3(3):158. Gregory Tranah (Ph.D.), Scientist; Research Professor Publications Kripke DF, Kline LE, Nievergelt CM, Murray SS, Shadan FF, Dawson A, Poceta JS, Cronin J, Jamil SM, Tranah GJ, Loving RT, Grizas AP, Hahn EK.Genetic variants associated with sleep disorders. Sleep Med. 2014 Dec 5. Maglione JE, Ancoli-Israel S, Peters KW, Paudel ML, Yaffe K, Ensrud KE, Tranah GJ, Stone KL; Study of Osteoporotic Fractures Research Group.Depressive symptoms and circadian activity rhythm disturbances in community-dwelling older women. 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Evans DS, Cailotto F, Parimi N, Valdes AM, Castaño-Betancourt MC, Liu Y, Kaplan RC, Bidlingmaier M, Vasan RS, Teumer A, Tranah GJ, Nevitt MC, Cummings SR, Orwoll ES, Barrett-Connor E, Renner JB, Jordan JM, Doherty M, Doherty SA, Uitterlinden AG, van Meurs JB, Spector TD, Lories RJ, Lane NE. Genome-wide association and functional studies identify a role for IGFBP3 in hip osteoarthritis. Ann Rheum Dis. 2014 Jun 13. Broer L, Buchman AS, Deelen J, Evans DS, Faul JD, …Tranah GJ, Weir DR, Newman AB, van Duijn CM, Murabito JM.GWAS of Longevity in CHARGE Consortium Confirms APOE and FOXO3 Candidacy. J Gerontol A Biol Sci Med Sci. Epub 2014 Sep 8. Kripke DF, Klimecki WT, Nievergelt CM, Rex KM, Murray SS, Shekhtman T, Tranah GJ, Loving RT, Lee HJ, Rhee MK, Shadan FF, Poceta JS, Jamil SM, Kline LE, Kelsoe JR. Circadian polymorphisms in night owls, in bipolars, and in non-24-hour sleep cycles. Psychiatry Investig. 2014 Oct;11(4):345-62. 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Acosta M, Edwards R, Jaffee IM, Yee DL, Mahoney DH, Teruya J. A practical approach to pediatric patients referred with an abnormal coagulation profile. Arch Pathol Lab Med. 2005 Aug;129(8):1011-6. Erratum in: Arch Pathol Lab Med. 2005 Nov;129(11):1368. Lara-Torre E, Dietrich JE, Kaplan A, Lopez H, Jaffee I. A case of poorly differentiated Sertoli-Leydig tumor of the ovary. J Pediatr Adolesc Gynecol. 2004 Feb;17(1):49-52. Elliott Main (M.D.), Obstetrician-Gynecologist; Director of Maternal Fetal Medicine Publications Main EK, Menard MK. Maternal mortality: time for national action. Obstet Gynecol. 2013 Oct;122:735-6. Swank ML, Caughey AB, Farinelli CK, Main EK, Melsop KA, Gilbert WM, Chung JH. The impact of change in pregnancy body mass index on the development of gestational hypertensive disorders. J Perinatol. 2014 Jan 2. doi: 10.1038/jp.2013.168. [Epub ahead of print] D’Alton ME, Main EK, Menard MK, Levy BS. The national partnership for maternal safety. 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