Co-PI of the Yale CTSA and co-director of the YCCI
- Brian R. Smith MD is Deputy Dean for Clinical and Translational Research at the Yale School of Medicine, as well as Co-Director of the Yale Center for Clinical Investigation (Co-PI of Yale's CTSA Award), Chair of the Department of Laboratory Medicine and Professor of Laboratory Medicine, Biomedical Engineering, Internal Medicine and Pediatrics at Yale University. He is the Chief of Laboratory Medicine and Attending Physician at Yale New Haven Hospital and also an attending physician at the Connecticut VA Medical Center and the Bridgeport Hospital.Dr. Smith received his undergraduate degree summa cum laude from Princeton University, his medical degree from the Harvard Medical School, and his residency/fellowship training at The Brigham & Women’s Hospital, Boston Children’s Hospital, and Dana Farber Cancer Center. He is board certified in Pathology / Hematopathology and in Internal Medicine / Hematology-Oncology. In addition to his clinical work, Dr. Smith has an investigative interest in the inflammation-hemostasis interface, especially in relation to biomaterials, as well as in cellular immunotherapeutics, with over 175 publications. His work extends from basic wet bench research through clinical and epidemiological trials (T1-T4). He has been continuously funded by the NIH at the PI-level for over 35 years. In these various roles, Dr. Smith has major administrative responsibility for the School’s research enterprise across the T1-T4 spectrum, as well as educational responsibilities across the scientific pipeline from STEM high school student programs through undergraduate, graduate, and post-graduate training, for MDs, PhDs, and MD/PhDs. He is the initiator and long-standing PI of Laboratory Medicine’s post-doctoral T32 training program in Immunohematology and has personally mentored over 50 MD, MD/PhD, and PhD trainees, most of whom hold tenure-track positions at major research universities. In addition to directing trainees in bench and translational research, Dr. Smith has extensive experience in the didactic aspects of comprehensive training and career development for clinician-scientists, having developed and published curricula in Laboratory Medicine, developed and published new physician-scientist training paradigms in his field, and, in his capacity as the Chair of the Research Committee for the Association of Pathology Chairs, initiated and helped negotiate a dialogue with the American Board of Pathology that, with the work of many other Chairs of Pathology and Laboratory Medicine, resulted in the adoption of a specific Physician-Scientist residency pathway by the Board. Similarly, through his research experience, dean position, and appointment in the Graduate School of Arts and Sciences, he is very involved with all aspects of PhD training at both the pre- and post-doctoral levels. He has been an invited lecturer on Bioethics and previously served on the NIH Recombinant DNA Advisory Committee. Dr. Smith has also played a significant role in gender equity initiatives at Yale. In addition, he has overseen the implementation of research core facilities in Translational Immune Monitoring, Flow Cytometry, and Clinical Sample Real Time Acquisition, chairs the Clinical Research Technology Committee, and has been a guiding member of a Cellular Therapy core resource, all of which have been used successfully by Yale investigators as well as by investigators from other universities.
Co-PI of the Yale CTSA and co-director of the YCCIDr. Krystal is a leading expert in the areas of alcoholism, post-traumatic stress disorder, schizophrenia, and depression. His work links psychopharmacology, neuroimaging, molecular genetics, and computational neuroscience to study the neurobiology and treatment of these disorders. He is best known for leading the discovery of the rapid antidepressant effects of ketamine in depressed patients.He is a member of the U.S. National Academy of Medicine. He also serves in a variety of advisory and review capacities for NIAAA, NIMH, Wellcome Trust, Brain and Behavior Research Foundation, the Broad Institute, the Karolinska Institutet, and the U.S. Department of Veterans Affairs.Dr. Krystal previously served on the National Alcohol Abuse and Alcoholism Advisory Council (NIAAA), the Department of Defense Psychological Health Advisory Committee, the National Institute of Mental Health (NIMH) Advisory Council, and the NIMH Board of Scientific Counselors (chair, 2005-2007). He has led the American College of Neuropsychopharmacology (president, 2012), and International College of Neuropsychophamacology (president, 2016-2018). Currently, he is co-chair of the Forum on Neuroscience and Nervous System Disorders (NeuroForum) of the National Academies of Sciences, Engineering, and Medicine, and he edits the journal, Biological Psychiatry (impact factor: 13.382).
Deputy Director for Translational ScienceAs a researcher who does both basic science and clinical research, Kevan Herold, MD, is ideally positioned to engage the basic science community in translational research that benefits patients.After spending 20 years doing research and teaching at the University of Chicago and Columbia University, Dr. Herold joined Yale in 2006 as the first recruit of the Human and Translational Immunology (HIT) program. He is widely recognized for his work on anti-CD3, a monoclonal antibody that quiets the T cells responsible for destroying insulin-producing beta cells in the pancreas. Starting in preclinical models and moving to investigations in humanized mice, Dr. Herold and his collaborators found that anti-CD3 induced T cells to migrate from the circulatory and lymph systems to the small intestine, where they produced the anti-inflammatory protein interleukin-10. When the cells returned to circulation, they had become regulators of the immune response that play a role in arresting the destruction of beta cells.He has translated this work to clinical trials in patients, where he has shown that anti-CD3 has a significant effect on preserving insulin production in patients with new onset Type 1 diabetes. He also developed a novel assay to measure beta cell death by determining the level of insulin DNA in the blood that contains epigenetic markers that identify it as being of beta cell origin. He most recently used this assay in subjects at risk for Type 1 diabetes that has challenged previous notions of disease mechanisms.Dr. Herold serves as director of the TrialNet Center at Yale, part of a consortium that conducts clinical trials to prevent Type 1 diabetes in those who are at high risk of developing the disease and treat newly diagnosed patients. Relatives of people with Type 1 diabetes have a 10 to 15 times greater risk for developing the disease than people with no family history. Family members are screened for diabetes-related antibodies; those who test positive can participate in studies designed to test medications – including an unprecedented multicenter trial with anti-CD3 - to prevent the disease from occurring. Dr Herold is also collaborating on studies to identify biomarkers in at-risk patients who progress to Type 1 diabetes.The treatments Dr. Herold is developing may have an impact on the lives of people who haven’t yet developed diabetes or aren’t aware they are at risk for developing it. “These are the people we’ll ultimately be able to help and that’s quite a strong motivation,” he said.In his role as YCCI’s deputy director, Dr. Herold has been instrumental in developing the Immune Monitoring Core and establishing a centralized biorepository for storing and tracking samples that is linked to Yale’s clinical research management system. “The depth it adds to the research is phenomenal,” he said.
Deputy DirectorAn athlete her entire life, Melinda Irwin, PhD, MPH, originally planned on specializing in orthopedics. But college courses in human anatomy, physiology, nutrition, statistics and epidemiology led her to shift gears to public health. She ultimately decided to pursue a PhD, rather than an MD, in order to explore the connection between lifestyle factors and chronic disease. Since joining Yale in 2001, Dr. Irwin has concentrated on the role of lifestyle behaviors in cancer prevention and prognosis.This is increasingly relevant for breast cancer – the focus of much of her work - since mortality has decreased during the past two decades but survivors are at risk for recurrence and debilitating side effects due to treatment. Her work has shown that even after women have been diagnosed with breast cancer, they can substantially lower the risk of both recurrence and mortality by exercising. This holds true even for women who don’t become physically active until after their diagnosis. She has expanded her research into other cancers, showing that a moderate-intensity walking program improved physical functioning and reduced cancer-related fatigue in patients diagnosed with ovarian cancer. Dr. Irwin, who considers herself a biobehavioral researcher, is also examining the effect of exercise and weight loss on cancer biomarkers, showing that weight loss decreased C-reactive protein, a marker of systemic inflammation related to cancer. Her current research interests are focused on examining whether lifestyle behaviors also indirectly improve survival via improvements in medication adherence. “Given the improvement in treatment for many diseases, especially cancer, some people have a window of opportunity to change their lifestyle,” she said. “Others may already be living a healthy lifestyle but have difficulty maintaining it because of treatment, so we need to help them do that.”Dr. Irwin hopes that this line of research will lead to incorporating weight management and exercise management into the clinic as part of reimbursable cancer care, in much the same way that cardiac rehabilitation is now standard of care.Dr. Irwin is interested in the effects of exercise on other chronic diseases and is excited about her role at YCCI, which is allowing her to collaborate with faculty across the Yale campus. She is focusing on creating efficiencies between centers and expanding resources and opportunities for public health and population science research. She is equally eager to foster opportunities for junior faculty and feels better equipped to mentor younger colleagues after taking YCCI’s course on mentoring. “I hope to be able to give back in terms of more collaborations, synergies, efficiencies, and training opportunities,” she said.
Deputy Director of Healthy Equity Research and Workforce DevelopmentGrowing up in St. Thomas, U.S. Virgin Islands, a health professional shortage area, Marcella Nunez-Smith, MD, MHS, remembers countless stories of loved ones and members of her community who struggled with their health or died prematurely. That experience led her to pursue a career in medicine and conduct research that focuses on vulnerable populations and their interactions with healthcare systems.Ever since her arrival at Yale as a fellow in the Robert Wood Johnson Foundation Clinical Scholars Program (CSP), Dr. Nunez-Smith has been on a mission to develop ways of addressing health and healthcare inequities wherever they are found: in patient settings, in the healthcare workforce, and in medical education. As a 2006 YCCI Scholar, she gathered preliminary data for what is now known as PreDict (Patient-Reported Experiences of Discrimination in Care Tool). PreDict is a tool that assesses the patient care experience and measures hospital performance with the goal of improving the quality of care delivery. “The Scholar award was tremendously helpful because it allowed me to launch a line of inquiry that was new and then provided me with the resources to complete the preliminary work that allowed us to be competitive for major NIH grants,” she said.Dr. Nunez-Smith went on to develop the Eastern Caribbean Health Outcomes Research Network (ECHORN), a collaborative multi-million dollar research study funded by the National Institute for Minority Health Disparities (NIMHD). ECHORN examines the risk factors and prevalence of cancer, diabetes, and heart disease in the Eastern Caribbean, a region for which such data are lacking.Both ECHORN and PreDict – which has spurred several related projects undertaken by her mentees – are now incorporated into the Equity Research and Innovation Center (ERIC), for which Dr. Nunez-Smith serves as director. ERIC builds on the local, national, and global experience of Dr. Nunez-Smith and 60 team members that are involved in research aimed at narrowing health and healthcare inequities, as well as disparities in the healthcare workforce and medical education.As a former YCCI Scholar, Dr. Nunez-Smith appreciates the benefits of mentorship and serves as academic advisor to Yale School of Medicine students. She also continues her involvement with the CSP as a core faculty member of the Scholars Program and co-director of Community Research Initiatives. “I’m working towards synergy across all of these programs so they’re not siloed,” she said. “The idea is to think about core elements of knowledge for our faculty for population health and health equity and engage stakeholders in our work.”
Deputy Director for Clinical Trials InnovationEric J. Velazquez, MD, the Robert W. Berliner Professor of Medicine, is an internationally recognized authority in heart failure, cardiovascular clinical trials, and cardiac imaging.Velazquez serves as the section chief for Cardiovascular Medicine for Yale School of Medicine and the Physician-in-Chief of the Heart and Vascular Center for Yale New Haven Health where he coordinates a high-volume enterprise and an outstanding group of clinician-investigators, physician scientists, and staff who make important contributions across patient care, research and educational domains. He leads more than 150 specialists who focus on every area of cardiac medicine, tapping into a broad array of tools, technologies, and expertise. Additionally, he is the Deputy Director, Clinical Trials Innovation at the Yale Center for Clinical Investigation. Velazquez chose to pursue a career in cardiovascular medicine twenty years ago and through key leadership positions, he has pursued clinical, research, and methodologic interests and facilitated multicenter clinical research programs and quality initiatives with substantive focus and impact on vulnerable and underserved populations at high medical risk, and has honed the administrative skills required to implement challenging programs in diverse settings globally. Today, much of his research and clinical work focuses on the intersection between heart failure and coronary heart disease. As a clinical investigator, he has made major contributions in the design, development, and implementation of landmark clinical trials that have altered international guidelines and the treatment of patients with chronic heart failure. These programs have established the evidence for best practice standards, modified treatment guidelines, and have had a direct impact on the U.S. public health.
- Robin Whittemore is a Professor at Yale School of Nursing, Director of the PhD program, and the Co-Director of the National Clinician Scholars Program at Yale. Dr. Whittemore’s research focus is on lifestyle change to prevent and treat type 2 diabetes as well as the psychosocial adjustment to chronic illness. Initially her work focused on adults with type 2 diabetes, specifically in translating theory-based interventions with established efficacy into a new setting, such as modifying the Diabetes Prevention Program for delivery by nurse practitioners in primary care and by visiting nurses and community health workers (CHWs) in subsidized housing. She has modified behavioral interventions for adults and adolescents to a technology platform. She has translated an in-person coping skills training program and an obesity prevention program for youth to the internet and has used text messaging to provide a positive psychology intervention for adolescents with type 1 diabetes, Currently, she is developing an internet program for parents of adolescents with type 1 diabetes, and modifying a group-based program for adults of low socioeconomic status with T2D in Mexico that includes a theory-based mHealth component.Activities:Teens with type 1 diabetes, (South Central University, Changsha China). Collaboration with Dr. Jia Guo to adapt and evaluate a coping skills training program for tees with type 1 diabetes in China.Gestational diabetes, (South Central University, Changsha China). Collaboration with Dr. Jia Guo to evaluate a lifestyle change program for rural women in China with a history of gestational diabetesAdults with type 2 diabetes, (Iberoamerica University, Mexico City, Mexico). Collaboration with Dr. Rafael Perez Escamilla, Dr. Vilar Compte, and Ana Bertha Perez to evaluate a self-management program plus mHealth for adults with type 2 diabetes in Seguro Popular Clinics.
Deputy Director and Chief Operating Officer, Yale Center for Clinical Investigation; Director for Clinical Research Yale School of MedicineTesheia Johnson, MBA, MHS, is Deputy Director and Chief Operating Officer of YCCI and the Director for Clinical Research for Yale School of Medicine, where she provides leadership and direction in the area of clinical research. Her career has focused on the development of clinical research programs and support infrastructure. She is the co-founder, along with community leaders of the AME Zion Church and Junta for Progressive Action, of the Yale Cultural Ambassadors program, launched more than ten years ago with a mission to catalyze the sustainable advancement of patient diversity, equity, and inclusion in clinical research. Prior to assuming her current position, she held positions as Assistant Dean for Clinical Research at the University of Vermont College of Medicine and Director of Clinical Trials at the University of Wisconsin Madison. She has served as a consultant for several academic centers interested in establishing clinical research programs and as a grant reviewer for the National Institutes of Health.Ms. Johnson is nationally recognized for her expertise in the design and setup of clinical research programs. She has been an invited speaker at many national and international conferences on topics such as developing funding for central support for clinical research, staffing models for clinical and translational research, training programs for research professionals, clinical research regulation, and contracting and budget negotiation. She has served as Chair and co-Chair for several National Clinical and Translational Science Award (CTSA) Consortium Group/Committees. She sits on the external scientific advisory boards for the CTSAs at Stanford University, NYU, Washington University, Rockefeller, the Universities of Buffalo, Colorado, Florida, Rochester and Washington and at University College London Hospitals’ Biomedical Research Centre. Ms. Johnson also one of the team leaders chairing the, Clinical Trials Transformation Initiative (CTTI) on clinical trials diversity. She serves as the Yale Leader for the School of Medicine partnership with the FDA Office of Minority Health and Health Equity which also focuses on diverse participation in clinical research.