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9524 Kalpana M. Merchant, Ph.D. (2020) Kalpana M. Merchant, Ph.D., is president and chief scientific officer at TransThera Consulting Co., where she has developed scientific and business strategies for integrating translational science into drug discovery and development for neuroscience, metabolic disorders and oncology. Merchant’s extensive knowledge of psychiatric (schizophrenia, major depression, anxiety, attention deficit hyperactivity disorder) and neurodegenerative (Alzheimer’s disease and Parkinson’s disease) disorders has contributed to the discovery and validation of multiple new targets using genomic and genetic technologies and to the clinical development of therapeutic agents directed toward those targets. Merchant previously served as chief scientific officer, Tailored Therapeutics (neuroscience), and chief scientific officer, Translational Sciences and Technologies, at Eli Lilly and Company and currently serves as an advisor and consultant to the Michael J. Fox Foundation for Parkinson’s Research, Third Rock Ventures, angel investors, and several small biotechnology startups. Merchant holds adjunct faculty positions at Northwestern University Feinberg School of Medicine and Purdue University School of Science at Indiana University–Purdue University Indianapolis. She contributes to the broader scientific community through service to the Wellcome Trust, NIH/National Academy of Medicine workshops and advisory panels, the American College of Neuropsychopharmacology, the New York Academy of Sciences, the American Association for the Advancement of Science and the Dystonia Medical Research Foundation. Merchant received her Ph.D. in neuropharmacology from the University of Utah. Dr. Merchant is president and chief scientific officer at TransThera Consulting Co. Kalpana M. Merchant, Ph.D. (2020) Dr. Merchant is president and chief scientific officer at TransThera Consulting Co. Kalpana M. Merchant, Ph.D. (2020)
9520 Gilbert “Lynn” Marks, M.D. (2020) Gilbert “Lynn” Marks, M.D., is a senior advisor at Tunnell Government Services, Inc., where he supports the Office of the Director, Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. Prior to joining Tunnell, Marks retired from GlaxoSmithKline (GSK) pharmaceuticals, where he served as senior vice president of research and development (R&D). During his 25-year tenure at GSK, he took on increasing levels of global accountability, including serving as head of the Infectious Diseases Therapy Area and later overseeing a large global organization that delivered, analyzed and reported clinical trials, Phase I-IV, covering all therapeutic areas for Pharma and across more than 55 countries. In addition, Marks managed the clinical development teams in Japan and China. Furthermore, he helped stand up the cross-Pharma organization, Transcelerate BioPharma, focusing on quality, safety and efficiency for R&D organizations. Marks is a member of the board of directors for WOAR Women Organized Against Rape, Philadelphia’s nonprofit, social services organization, supporting victims of sexual violence and rape. He is board certified in internal medicine and infectious diseases. Dr. Marks is a senior advisor at Tunnell Government Services, Inc., where he supports the Office of the Director, Biomedical Advanced Research and Development Authority. /sites/default/files/Lynn_Marks_900x1000px.jpg G. Lynn Marks, M.D. (2020) Dr. Marks is a senior advisor at Tunnell Government Services, Inc., where he supports the Office of the Director, Biomedical Advanced Research and Development Authority. /sites/default/files/Lynn_Marks_900x1000px.jpg Gilbert “Lynn” Marks, M.D. (2020)
9522 Brad Margus, M.B.A. (2020) Brad Margus is the co-founder and chief executive officer (CEO) of Exigence Neurosciences, Inc., a company that intends to explore promising target discovery platforms and therapeutic assets for brain diseases. Previously, Margus co-founded and served as the CEO of Perlegen Sciences, Inc., which developed a massively parallel DNA analysis technology that included the design of photolithographic masks for synthesizing oligonucleotide microarrays, proprietary sample preparation techniques, unique fluidics, new laser scanners and laboratory information systems, and high-throughput data analysis pipelines. Margus also co-founded and served as the CEO of Envoy Therapeutics, Inc., which harnessed a unique technology, identified proteins specifically expressed in the disrupted circuitry of brain diseases, and advanced compounds acting on those proteins toward the clinic. Concurrent with his business career, Margus served as founder and volunteer president of the A-T Children’s Project, a nonprofit organization that coordinates research on ataxia-telangiectasia syndrome (also known as Louis–Bar syndrome), a rare, inherited, neurodegenerative, autosomal recessive disorder that affects the nervous, immune and other body systems. Margus holds an M.B.A. from Harvard University. Mr. Margus is the co-founder and CEO of Exigence Neurosciences, Inc., a company that intends to explore promising target discovery platforms and therapeutic assets for brain diseases. /sites/default/files/Brad-Margus_900x1000px.jpg Brad Margus, M.B.A. (2020) Mr. Margus is the co-founder and CEO of Exigence Neurosciences, Inc., a company that intends to explore promising target discovery platforms and therapeutic assets for brain diseases. /sites/default/files/Brad-Margus_900x1000px.jpg Brad Margus, M.B.A. (2020)
9529 Richard E. Kuntz, M.D., M.Sc. Richard E. Kuntz, M.D., M.Sc., is senior vice president, chief medical and scientific officer in the Department of Neuromodulation at Medtronic, Inc., and serves as a member of the company’s executive committee. In this role, Kuntz oversees the company’s medical affairs, health policy and reimbursement, clinical research activities, and corporate technology. Kuntz joined Medtronic in October 2005 as senior vice president and president of Medtronic Neuromodulation, which encompasses the company’s products and therapies for the treatment of chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis. In this role, he was responsible for the research, development, operations, and product sales and marketing for each of these therapeutic areas worldwide. Kuntz brings to Medtronic a broad background and expertise in many different areas of healthcare. Prior to his tenure at Medtronic, he was the founder and chief scientific officer of the Harvard Clinical Research Institute, a university-based contract research organization that coordinates National Institutes of Health and industry clinical trials with the U.S. Food and Drug Administration. Kuntz has directed over 100 multicenter clinical trials and has authored more than 250 original publications. His major interests are traditional and alternative clinical trial design and biostatistics. Kuntz also served as associate professor of medicine at Harvard Medical School, chief of the Division of Clinical Biometrics, and an interventional cardiologist in the division of cardiovascular diseases at the Brigham and Women’s Hospital in Boston, Massachusetts. Kuntz has served as a member of the Board of Governors of the Patient Centered Outcomes Research Institute since it was established in 2010 as part of the Affordable Care Act. Kuntz graduated from Miami University and earned his M.D. in surgery from Case Western Reserve University School of Medicine. He completed his residency and chief residency in internal medicine at the University of Texas Southwestern Medical School, and then completed fellowships in cardiovascular diseases and interventional cardiology at the Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, Massachusetts. Kuntz received his M.Sc. of science in biostatistics from the Harvard School of Public Health. Dr. Kuntz is the senior vice president and chief scientific, clinical and regulatory officer of Medtronic, Inc. /sites/default/files/Richard%20Kuntz_900x600.jpg Richard E. Kuntz, M.D., M.Sc. Dr. Kuntz is the senior vice president and chief scientific, clinical and regulatory officer of Medtronic, Inc. /sites/default/files/Richard%20Kuntz_900x600.jpg Richard E. Kuntz, M.D., M.Sc.
9532 Matthew Might, Ph.D. Matthew Might, Ph.D., is a professor in the Division of General Internal Medicine at the University of Alabama at Birmingham, where he also is the Hugh Kaul Endowed Chair in Personalized Medicine and serves as the director of the Hugh Kaul Personalized Medicine Institute. Might also serves on the faculty in the Department of Biomedical Informatics at Harvard Medical School. His primary medical research area is precision medicine — the use of data (particularly genomic data) to optimize health care outcomes and to deliver the best possible treatment to patients. He is interested in drug repurposing and individualized novel drug development. His primary computer science research area is static analysis of higher-order programs. Might’s broader interests include language design, compiler implementation, security, program optimization, parallelism and program verification. Previously, Might served as an associate professor in the School of Computing at the University of Utah, where he led the U Combinator software systems research lab. He also has served as a strategist in the Executive Office of the President at the White House for both the Obama and Trump administrations. Might earned his Ph.D. in computer science from Georgia Tech. Dr. Might is a professor in the Division of General Internal Medicine at the University of Alabama at Birmingham, where he also is the Hugh Kaul Endowed Chair in Personalized Medicine. /sites/default/files/Matthew_Might_900x1000px.jpg Matthew Might, Ph.D. Dr. Might is a professor in the Division of General Internal Medicine at the University of Alabama at Birmingham, where he also is the Hugh Kaul Endowed Chair in Personalized Medicine. /sites/default/files/Matthew_Might_900x1000px.jpg Matthew Might, Ph.D.
9534 Geoffrey Shiu Fei Ling, M.D., Ph.D. Geoffrey Shiu Fei Ling, M.D., Ph.D., is the director of the Biological Technologies Office at the Defense Advanced Research Project Agency. He has spent his career providing critical care to patients suffering from neurological trauma. Ling served as an officer in the United States Army Medical Corps for 27 years before retiring as a colonel in 2012. Ling also serves as a professor of neurology, anesthesiology and neuroscience at the Uniformed Services University of the Health Sciences. His research portfolio spans neuroscience, infectious disease, pharmacology and battlefield medicine. He is an attending neurocritical care physician at Johns Hopkins Hospital and is board certified in both neurology and neurocritical care. Ling has published more than 150 peer-reviewed journal articles, reviews and book chapters, including the traumatic brain injury chapter in the Cecil Textbook of Medicine and several Department of Defense guidelines for managing head injuries. Ling received his medical degree from Georgetown University and his Ph.D. in pharmacology from Cornell University’s Graduate School of Medical Sciences. Dr. Shiu Fei Ling is the director of the Biological Technologies Office at the Defense Advanced Research Project Agency. /sites/default/files/Geoffrey_Ling_900x1000px.jpg Geoffrey Shiu Fei Ling, M.D., Ph.D. Dr. Shiu Fei Ling is the director of the Biological Technologies Office at the Defense Advanced Research Project Agency. /sites/default/files/Geoffrey_Ling_900x1000px.jpg Geoffrey Shiu Fei Ling, M.D., Ph.D.
9537 Eric J. Topol, M.D. Eric J. Topol, M.D., is a professor of genetics at The Scripps Research Institute, director of the Scripps Translational Science Institute, West Endowed Chair of Innovative Medicine at Scripps Health, and senior consultant in the Division of Cardiovascular Diseases at the Scripps Clinic. Before joining Scripps, Topol held leadership roles at the Cleveland Clinic and Case Western Reserve University, founded the Cleveland Clinic Lerner College of Medicine and served as its provost. His research is on individualized medicine, using the genome and digital technologies to understand each person at the biologic, physiologic granular level to determine appropriate therapies and prevention. In addition to having more than 1,140 original publications in scientific journals to his credit, Topol has authored several textbooks, book chapters, and two books: The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care and The Patient Will See You Now: The Future of Medicine Is in Your Hands. Topol holds a B.A. in biomedicine from the University of Virginia. He earned his M.D. from the University of Rochester. Dr. Topol is a professor of genetics at The Scripps Research Institute. /sites/default/files/Eric%20Topol_900x600.jpg Eric J. Topol, M.D. Dr. Topol is a professor of genetics at The Scripps Research Institute. /sites/default/files/Eric%20Topol_900x600.jpg Eric J. Topol, M.D.
9400 2017 CCIA Projects Development, Implementation and Assessment of Novel Training in Domain-Based Competencies Investigating Teleconsent to Improve Clinical Research Access in Remote Communities Measure Development to Accelerate the Translation of Evidence Based Clinical Guidelines into Practice Modulation of Gut-Brain Axis Using Fecal Microbiome Transplant Capsules in Cirrhosis Open Health Natural Language Processing Collaboratory Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care Development, Implementation and Assessment of Novel Training in Domain-Based Competencies (DIAMOND) University of Michigan Principal Investigators: Vicki L. Ellingrod, Pharm.D., Carolynn Thomas Jones, D.N.P., M.S.P.H., RN, Sarah E. Peyre, Ed.D., and Harry P. Selker, M.D., M.S.P.H. Grant Number: 1-U01TR002013-01 Collaborating Institutions: Tufts University, University of Rochester, Ohio State University Critical impediments currently exist regarding how clinical trials are conducted, which include inconsistent (or absent) training as well as passive learning techniques used for developing the clinical research workforce. There exists a critical need to develop, demonstrate and publicly disseminate competency-based training for clinical research personnel involved in executing clinical trials throughout the CTSA Program consortium. This proposal, entitled “Development, Implementation and Assessment of Novel Training in Domain-Based Competencies (DIAMOND),” will develop an online educational portal (DIAMOND portal) for competency-based educational offerings and assessments and demonstrate integration of this curriculum into CTSA Program clinical trial education programs at DIAMOND hubs and partner sites in ways that promote more effective, efficient and safe execution of clinical trials, allowing for dissemination to a broader audience. Learn more about this project in the NIH RePORTER. Investigating Teleconsent to Improve Clinical Research Access in Remote Communities Medical University of South Carolina Principal Investigator: Jihad Obeid, M.D. Grant Number: 1-R21TR002088-01 Collaborating Institution: University of North Carolina at Chapel Hill Recruitment and enrollment of eligible research participants into clinical trials is a major challenge in most clinical settings, including informed consent at remote sites. Studies often fail to meet enrollment goals, resulting in costly time extensions, underpowered results and, in some cases, early termination. Informed consent is an essential process involving trained research personnel meeting face-to-face with participants, which can be especially challenging during busy clinic schedules or recruitment at remote locations. An innovative informed consent approach that leverages telemedicine technology (teleconsent) was developed at the Medical University of South Carolina (MUSC). Teleconsent enables research personnel to: 1) meet and discuss the study with a prospective participant virtually using a video feed; 2) share an informed consent document that can be collaboratively filled out by the participant and personnel in real time; and 3) generate an electronically signed informed consent that is available for immediate download or print by both parties. The objective of this proposal is to evaluate teleconsent in real-world environments across two institutions, MUSC and the University of North Carolina at Chapel Hill. This includes the examination of ethical and privacy concerns by stakeholders and the community and identification of barriers to adoption. Learn more about this project in the NIH RePORTER. Measure Development to Accelerate the Translation of Evidence-Based Clinical Guidelines into Practice New York University School of Medicine Principal Investigators: Donna R. Shelley, M.D., M.P.H., and Carolyn A. Berry, Ph.D. Grant Number:  1-U01TR002008-01 Collaborating Institutions: Albert Einstein College of Medicine, Oregon Health & Science University, Medical University of South Carolina Half of the U.S. adult population has one or more preventable risk factors for cardiovascular disease (CVD), including high blood pressure and high cholesterol, but only 10 percent of individuals are meeting all of their clinical goals due to suboptimal adoption of guideline-recommended care. This is largely because primary care practices and health care systems are struggling to identify which combination of care structures and processes they need to implement to become high-performing practices. The objective of this proposal is address this translational gap by developing a reliable, valid and pragmatic assessment tool that will identify core features of primary care practices that are related to high performance on CVD-related outcomes. Learn more about this project in the NIH RePORTER. Modulation of Gut-Brain Axis Using Fecal Microbiome Transplant Capsules in Cirrhosis  Virginia Commonwealth University Principal Investigator: Jasmohan S. Bajaj, M.D. Grant Number:  1-R21TR002024-01 Collaborating Institution: Medical College of Wisconsin Cirrhosis and its complication, hepatic encephalopathy (HE), are one of the leading causes of morbidity and mortality in the U.S. HE is associated with gut dysbiosis that is usually treated with antibiotics, prebiotics or probiotics. However, HE often continues to recur and cause readmissions despite this standard of care. Multiple episodes of HE can result in cumulative irreversible brain injury. Therefore, the prevention of recurrent HE is an important unmet need that requires translational intervention. Ultimately the goal of this project is to define oral fecal microbiota transplant as a viable treatment approach for recurrent HE patients. Thw hypothesis is that fecal transplants from a rationally derived donor delivered via capsules are safe and well tolerated in patients with cirrhosis and HE and are associated with significant improvement in gut microbiota composition and mucosal defenses. Learn more about this project in the NIH RePORTER. Open Health Natural Language Processing Collaboratory Mayo Clinic Rochester Principal Investigators: Hongfang Liu, Ph.D., Xiaqian Jiang, Ph.D., and Serguei V.S. Pakhomov, Ph.D. Grant Number:  1-U01TR002062-01 Collaborating Institutions: Columbia University Health Sciences, University of California, San Diego, University of Minnesota, University of Texas One of the major barriers in leveraging electronic health record (EHR) data for clinical and translational science is the prevalent use of unstructured or semistructured clinical narratives for documenting clinical information. Natural language processing (NLP), which extracts structured information from narratives, has received great attention and has played a critical role in enabling secondary use of EHRs for clinical and translational research. This project aims to address the challenges of using EHRs by extending the existing collaboration among multiple CTSA Program hubs on open health natural language processing to share distributional information of NLP artifacts (i.e., words, n-grams, phrases, sentences, concept mentions, concepts and text segments) acquired from real EHRs across multiple institutions. Learn more about this project in the NIH RePORTER. Translating Research into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care   Boston Medical Center* Principal Investigators: Tracy A. Battaglia, M.D., Karen Freund, M.D., M.P.H., Jennifer S. Haas, M.D., M.S.P.H., and Stephanie C. Lemon, Ph.D. Grant Number:  1-U01TR002070-01 Collaborating Institutions: Tufts University, University of Massachusetts, Harvard Medical School, University of Chicago. The transfer and application of scientific evidence into everyday practice is necessary to mitigate health disparities, yet roadblocks persist in broad implementation of evidence-based interventions among vulnerable communities experiencing disparities. The Boston Breast Cancer Equity Coalition was formed in 2014 in response to persistent city-wide disparities in breast cancer mortality among minority, low-income women. The Coalition identified three evidence-based strategies known to reduce delays in care that have yet to be deployed into clinical practice due to a lack of implementation strategies. Translating Research into Practice (TRIP) draws upon the principles of community-engaged dissemination and implementation science to systematically facilitate deployment and use of regional patient registries, systematic screening for social barriers to care with a personalized referral plan, and patient navigation services in one integrated model of care to improve the quality and effectiveness of care delivery, in this case for minority and/or low-income women with breast cancer. The four Massachusetts CTSA Program hubs (Boston University, Harvard University, Tufts University and University of Massachusetts) partnered with the Coalition to overcome barriers to widespread implementation and dissemination of evidence-based practices that will improve the delivery of guideline-concordant care to vulnerable women. The main hypothesis of this project is that widespread implementation will eliminate care delivery disparities, and CTSA Program hubs have the translational expertise to overcome barriers to such implementation. *Note: This U01 was co-funded by NCATS and the NIH Office of Behavioral and Social Sciences Research. Learn more about this project in the NIH RePORTER. In 2017, NCATS funded the second set of CCIA projects. 2017 CCIA Projects In 2017, NCATS funded the second set of CCIA projects. 2017 CCIA Projects
9371 NIH Hosts Rare Disease Day Event on March 1, 2018 Join the conversation on advancing gene therapy and research collaborationsFor Immediate ReleaseTuesday, Feb. 20, 2018Contacts:NCATS Communicationsbobbi.gardner@nih.gov, 301-435-0888NIH Clinical Centermolly.freimuth@nih.gov, 301-594-5789Why/What:Several thousand rare diseases affect an estimated 25 million people in the United States. Only a few hundred of these diseases have an approved treatment. On March 1, 2018, the National Institutes of Health (NIH) will host a Rare Disease Day event and open its doors to public and private researchers, patients and their support organizations, policymakers and other members of the community. Together, attendees will raise awareness about rare diseases, the people they affect, and opportunities for new and better treatments.The event will feature presentations, interactive panel discussions, posters, an art exhibit, videos and tours of the NIH Clinical Center — the nation’s research hospital where scientists are studying more than 500 rare diseases in partnership with nearly 2,250 patients.Agenda: https://events-support.com/Documents/RDD_NIH_2018_Agenda.pdf (PDF - 170KB)Watch the event live: https://videocast.nih.gov/summary.asp?live=26851&bhcp=1When/Where:March 1, 20188:30 a.m. to 4:00 p.m.NIH Clinical Center (Building 10), Masur Auditorium, 10 Center Drive, Bethesda, MarylandWho:The event is sponsored by the NIH National Center for Advancing Translational Sciences (NCATS) and the NIH Clinical Center. Partners include: The Children’s Inn at NIH, Food and Drug Administration, National Organization for Rare Disorders, Genetic Alliance, Global Genes®, EveryLife Foundation for Rare Diseases, Uplifting Athletes, Alpha-1 Foundation, Batten Disease Support and Research Association, The Calliope Joy Foundation, Children's Tumor Foundation, Curing Retinal Blindness Foundation, Erdheim-Chester Disease Global Alliance, The Foundation for Prader-Willi Research, Lysosomal Disease Network, and the Vasculitis Foundation.Featured Speakers:Rep. Leonard Lance (NJ), co-chair, Congressional Rare Disease CaucusFrancis S. Collins, M.D., Ph.D., director, NIHChristopher P. Austin, M.D., director, NCATSJames K. Gilman, M.D., chief executive officer, NIH Clinical CenterPress: Members of the media should contact Molly.Freimuth@nih.gov or Bobbi.Gardner@nih.gov for more information and to discuss interview, filming and photography opportunities.About the National Center for Advancing Translational Sciences (NCATS): NCATS conducts and supports research on the science and operation of translation — the process by which interventions to improve health are developed and implemented — to allow more treatments to get to more patients more quickly. For more information about how NCATS is improving health through smarter science, visit https://ncats.nih.gov.About the NIH Clinical Center: The NIH Clinical Center is the clinical research hospital for the National Institutes of Health. Through clinical research, clinician-investigators translate laboratory discoveries into better treatments, therapies and interventions to improve the nation's health. More information: https://clinicalcenter.nih.gov.About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov.### On March 1, 2018, NIH will host a Rare Disease Day event to raise awareness about rare diseases, the people they affect, and opportunities for new and better treatments. /sites/default/files/rdd-2018-logo.png NIH Hosts Rare Disease Day Event on March 1, 2018 On March 1, 2018, NIH will host a Rare Disease Day event to raise awareness about rare diseases, the people they affect, and opportunities for new and better treatments. /sites/default/files/rdd-2018-logo.png NIH Hosts Rare Disease Day Event on March 1, 2018
9338 Development of (2R,6R)-Hydroxynorketamine as a Treatment for Depression Depression is a disease that affects millions of Americans, and as many as a third of Americans suffering from depression are at least partially resistant to the current standard of care. The anesthetic ketamine has been discovered to have unique antidepressant properties, including the ability to successfully treat those patients who are resistant to standard antidepressants. However, ketamine’s side effects limit its ability to be widely prescribed for depression. Scientific Synopsis In a collaboration with the National Institute on Aging, the National Institute for Mental Health and the University of Maryland School of Medicine, NCATS discovered that a key metabolite of ketamine, (2R,6R)-hydroxynorketamine ((2R,6R)-HNK), replicated ketamine’s antidepressant effects in mice. Moreover, when the metabolism of ketamine was impeded, ketamine lost its antidepressant effects in mice. This implies that the metabolite is responsible for ketamine’s antidepressant effects in humans. Lastly, this metabolite had none of the side effects that ketamine had in mouse models. This chart demonstrates that ketamine is effective at 10 mg/kg dosing in the learned helplessness model of depression, compared with the placebo (saline). Likewise, (2R,6R)-HNK is effective at 5 mg/kg dosing and above. (Reprinted with permission from Zanos P, et al. NMDAR inhibition-independent antidepressant actions of ketamine metabolites. Nature. 2016;533(7604):481–6.) Copyright 2016 Nature) ​This figure shows that ketamine is effective in the learned helplessness model of depression at 10 mg/kg, while the placebo (saline) is not. When a deuterium-labelled version of ketamine ((R,S)-d2-KET) is used instead, it is not significantly effective in the learned helplessness model. This provides evidence that the metabolism of ketamine is necessary for its antidepressant effects. (Reprinted with permission from Zanos P, et al. NMDAR inhibition-independent antidepressant actions of ketamine metabolites. Nature. 2016;533(7604):481–6.) Copyright 2016 Nature) Ketamine is an addictive substance. This chart shows that when mice are given the option to self-administer ketamine (by pushing a lever), compared with the placebo (saline), they choose to administer themselves ketamine. However, when mice are allowed to self-administer (2R,6R)-HNK, compared with saline, there is no statistical difference.(Reprinted with permission from Zanos P, et al. NMDAR inhibition-independent antidepressant actions of ketamine metabolites. Nature. 2016;533(7604):481–6.) Copyright 2016 Nature) Lead Collaborators Ruin Moaddel, Ph.D., National Institute of Aging, NIH Carlos Zarate, Jr., M.D., National Institute on Mental Health, NIH Todd Gould, Ph.D., University of Maryland School of Medicine Publication Zanos P, Moaddel R, Morris PJ, Georgiou P, Fischell J, Elmer GI, Alkondon M, Yuan P, Pribut HJ, Singh NS, Dossou KS, Fang Y, Huang XP, Mayo CL, Wainer IW, Albuquerque EX, Thompson SM, Thomas CJ, Zarate CA Jr., Gould TD. NMDAR inhibition-independent antidepressant actions of ketamine metabolites. Nature. 2016;533(7604):481–6. Outcomes (2R,6R)-HNK has been found to be a safe, effective next-generation antidepressant in several different mouse models of depression. Work toward human clinical trials with (2R,6R)-HNK is currently underway. Public Health Impact Depression remains a serious medical illness for more than 10 million Americans annually. For a large percentage, the existing treatment options fail, and there are no current options for these individuals. The goal of this project is to develop a treatment for patients with resistant depression. Development of (2R,6R)-Hydroxynorketamine Development of (2R,6R)-Hydroxynorketamine

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