National CTSA Consortium
Accelerating Discoveries Toward Better Health
The National Center for Advancing Translational Sciences funds the national CTSA program. Visit CTSACentral.org to find out more!
Accelerating Discoveries Toward Better Health
The National Center for Advancing Translational Sciences funds the national CTSA program. Visit CTSACentral.org to find out more!
Center for Human Experimental at the URMC. He is the Robert J. Joynt Professor in Neurology and Professor of Public Health Sciences and Environmental Medicine. CHET conducts learning phase clinical trials in a wide spectrum of disorders in collaboration with investigators within the University of Rochester Medical Center (URMC) as well as with colleagues throughout North America, Europe, Asia and Oceania. Dr Kieburtz’s primary clinical and research interests are neurodegenerative diseases affecting the basal ganglia, particularly Parkinson disease, Huntington disease, and HIV related neurologic disorders. He is the Principal Investigator for the NINDS sponsored trials of neuroprotective agents for PD (NET-PD) and directs the Coordination Center for an NEI-funded consortium in Neuro-opthalmology. He completed his MD and MPH degrees at the University of Rochester, as well as his Neurology residency and a fellowship in Experimental Therapeutics. Therapeutics (CHET), is Senior Associate Dean for Clinical Research and Director of the
|Joan E. Adamo, PhD, serves as Co-Director of the Regulatory Knowledge and Support Key Function. Dr. Adamo is Associate Director for Regulatory Support Services at the CTSI. In this position, she provides guidance for researchers who are planning studies regulated by the FDA, and general research-navigation support. She serves as an FDA liaison for the University, supporting researchers conducting clinical studies of medical devices and therapeutics under Investigational Device Exemption (IDE) and Investigational New Drug (IND) mechanisms and managing a framework for preclinical Good Laboratory Practice (GLP) compliance within the University. Prior to joining URMC, Dr. Adamo served as a researcher and regulator at the Center for Biologics Evaluation and Research in the U.S. Food and Drug Administration. As a credentialed FDA inspector, she audited national and international vaccine manufacturers, and her work in the Division of Viral Products was focused on the research and approval of viral vaccines such as Influenza, Smallpox and West Nile Virus. Previously, she performed research as a Leukemia and Lymphoma Society fellow studying human cytomegalovirus at Princeton University. Dr. Adamo received her BS in Biochemistry from Cornell University and her PhD in molecular genetics from Cornell Medical College.|
|Nancy M. Bennett, MD, MS, is Director of the Community Engagement Key Function within the CTSI and Director of the Center for Community Health (CCH). She is a Professor of Medicine and Public Health Sciences, and Associate Vice President of URMC. Dr. Bennett has directed numerous studies and community interventions funded by the NIH, CDC, NYSDOH, and national and regional foundations related to the prevention of communicable and chronic disease. She is the Principal Investigator for the Rochester Emerging Infections Program (CDC), the Community Transformation Grant, Health Engagement and Action for Rochester’s Transformation (HEART) (CDC), and the Healthy Living Research Center (NIH). Dr. Bennett served for 17 years as the Deputy Director of the Monroe County Department of Public Health, and for the last six years as the Director of the CCH. Dr. Bennett is a graduate of New York University School of Medicine and did her residency and Chief Residency at Bellevue Hospital in NYC. During her fellowship in general medicine at Columbia-Presbyterian Hospital, she earned a Masters Degree in Epidemiology. She was an Assistant Professor of Medicine, a Mellon Fellow in Epidemiology, and taught in the School of Public Health at Columbia University before moving to Rochester. Dr. Bennett is an author of more than 60 peer-reviewed articles, and serves on a variety of local and national advisory boards. The CCH fosters community health research, provides infrastructure for community health planning and improvement, supports innovative approaches to working with local residents and agencies to improve health, and provides community-based, interdisciplinary educational opportunities for health professional students. The work of the Center is guided by a broad-based Community Advisory Council and a URMC Faculty Advisory Group.|
|Robert Block, MD, MPH, FACP, is Managing Co-Director of the UNYTE Translational Research Network of the CTSI. He also serves as an Assistant Professor in the Epidemiology Division in the Department of Public Health Sciences, and as Director of the Epidemiology and Prevention of Cardiovascular Disease course and Co-Director of the Epidemiology and Prevention of Chronic Diseases course in the University of Rochester’s graduate programs. His secondary appointments are in the Division of Cardiology (as a Diplomate of the American Board of Clinical Lipidology) and the Center for Community Health. Dr. Block’s clinical, research, and teaching expertise encompass the treatment and prevention of cardiovascular diseases. His research training has focused on the translation of novel findings from bench to bedside, which includes training in domains that include epidemiology, clinical trials, and laboratory science methods. Dr. Block has been a KL2 Clinical and Translational Research Career Development awardee since 2006; the focus of his KL2 research has been the study of the role of omega-3 fatty acids and their metabolites in the prevention of atherosclerosis. Dr. Block’s close collaboration with Dr. Steve Georas, one of his KL2 mentors over the past two and a half years, has focused on this type of translational research.|
|Ann Dozier, RN, PhD, is Director of the Evaluation Working Group Key Function for the CTSI, and as part of Community Engagement, leads recruitment and retention initiatives. Dr. Dozier's current research and fieldwork focus on the social ecological model, community level evaluation, and maternal child health outcomes. The latter includes data analysis, program evaluation, and data driven program planning. She has worked with a federally funded Healthy Start Program, the National Center for Deaf Health Research (a Prevention Research Center), and with other NIH funded projects, including evaluations of pregnancy prevention, telemedicine and worksite nutrition, and physical activity interventions. She is the Principal Investigator of an NIH R01 that seeks to improve breastfeeding among low income women through community level changes using CBPR methodologies. Internationally, she has conducted fieldwork in the Caribbean, Asia, and Antarctica, including leading teams conducting qualitative methods (using Rapid Appraisal Procedures) to inform interventions. Dr. Dozier is an Associate Professor, also serving as Chief of the Division of Social and Behavioral Medicine in the Department of Public Health Sciences.|
|Kevin Fiscella, MD, is Co-Director of the Community Engagement Key Function within the CTSI. He is a tenured Professor of Family Medicine, Community & Preventive Medicine, and Oncology, and also Associate Director of the Rochester Center to Improve Communication in Health Care. He received his medical degree from the Medical College of Virginia and his Master’s in Public Health and health services research training from the University of Rochester. His research focuses on identifying and addressing causes of racial, ethnic, and socioeconomic disparities in health care, particularly as they pertain to quality improvement. He is currently directing a randomized trial of patient navigation sponsored by the National Cancer Institute, and is conducting a randomized trial of concurrent peer review to improve ambulatory care for low-income and minority diabetic and cardiovascular disease patients, sponsored by the Robert Wood Johnson Foundation.|
|Thomas T. Fogg, MS, MPH, serves as Executive Director for Operations for the Clinical and Translational Science Institute. His primary oversight responsibilities include communications, information technology, education and career development programs, pilot funding programs, the UNYTE Translational Research Network, program evaluation, and the CTSI’s administrative core. He is the internal liaison for technology transfer, public-private partnerships, development and advancement, and the Eastman Institute of Oral Health. Mr. Fogg served as Chair of the national CTSA Consortium Communications Key Function committee from 2007 to 2009, and has been a member of the Consortium Management Group, a team of NIH staff and CTSA administrators dedicated to improving the operational effectiveness of the consortium, since 2009. From 2004 to 2010, Mr. Fogg was responsible for administrative oversight of the CDC-sponsored Rochester Prevention Research Center: the National Center for Deaf Health Research, one of 33 prevention research centers across the country. Mr. Fogg served as administrator and evaluator for the Cardiovascular Health Intervention Research and Translation Network, another CDC-sponsored program, between 2005 and 2009. Mr. Fogg holds a Master of Science in Public Policy Analysis from the University of Rochester and a Master’s in Public Health from the same institution. Prior to entering academia, Mr. Fogg worked as the Director of Regulatory Affairs at a major gas and electric utility company.|
|Robert Holloway, MD, MPH, is Director of the CTSI Research, Education, Training and Career Development Key Function and Co-Director of the Clinical Research Ethics Key Function within the CTSI. He is Professor and Chair of the Department of Neurology, as well as Professor in the Department of Public Health Sciences. Dr. Holloway received his medical degree from the University of Connecticut School of Medicine and Dentistry. He completed his neurology residency, received his master's degree in public health, and completed a fellowship in health services research in the Department of Public Health Sciences at the University of Rochester School of Medicine and Dentistry. Dr. Holloway is board certified in Neurology and in Hospice & Palliative Medicine. His major research interests are technology assessment and cost-effectiveness of neurological practices and policies, methods to improve the quality and safety of medical care, and conflicts of interest in research and practice.|
|Kathleen Jensen, RN, MHSA, is the Executive Director of Finance for the Clinical and Translational Science Institute. Ms. Jensen has extensive experience in clinical and research administration. After working as an ICU nurse for eight years, she obtained a Master’s degree in Health Services Administration and was Vice President of a 177-bed hospital in Myrtle Beach, South Carolina for eight years before coming to Rochester. Since 2003, she has been the Administrative Manager of the CRC. She has served as the financial officer of the Institute since its inception in 2006.|
|Gene D. Morse, PharmD., FCCP, BCPS, is Co-Director of the CTSI UNYTE Translational Research Network.Gene D. Morse, PharmD., FCCP, BCPS, is Co-Director of the CTSI UNYTE Translational Research Network. Dr. Morse assumed the position of Associate Director of the University at Buffalo’s New York State Center of Excellence in Bioinformatics and Life Sciences in 2009 where he also directs the Translational Pharmacology Research Core. He holds appointments as Professor in the Department of Pharmacy Practice and Research Professor of Medicine and Pediatrics at the University at Buffalo; Adjunct Professor of Medicine, Physiology and Pharmacology at the University of Rochester. He was previously the Associate Dean of Clinical and Translational Research in the School of Pharmacy and Pharmaceutical Sciences at the University at Buffalo. Dr. Morse has an active research and training program in clinical and translational pharmacology and has been a researcher in the HIV epidemic since the introduction of antiretrovirals in 1986, with more recent emphasis on HCV infection and drug development. Dr. Morse received his Doctor of Pharmacy degree from the University at Buffalo, where he also completed a fellowship in Clinical Pharmacokinetics.|
|Richard T. Moxley III, MD, Professor of Neurology and Pediatrics, is Co-Director of the Pilot and Collaborative Studies Key Function within the CTSI. Dr. Moxley is also the Director of the Neuromuscular Disease Center and Associate Chair of the Department of Neurology at Strong Memorial Hospital. Dr. Moxley's research interests include investigation into the cause for muscle wasting and weakness in myotonic dystrophy and related disorders.|
|David Oakes, PhD, is Co-Director of the Design, Biostatistics and Clinical Research Ethics Key Function within the CTSI and a Professor in the Department of Biostatistics and Computational Biology. Since coming to Rochester in 1983 Dr. Oakes has become deeply involved in clinical trials. He directs the Biostatistics Centers of the Parkinson and Huntington Study Groups, two consortia of scientific investigators and researchers, and he is committed to advancing knowledge about these diseases through the planning, implementation and reporting of clinical trials of promising therapeutic interventions. Dr. Oakes has also worked in cardiology, infectious diseases and pediatrics, and is the Director of the Biostatistics Core facility for the Environmental Health Science Center at the University of Rochester.|
|Ed Puzas, PhD, is Co-Director of the University’s CTSA program. He believes that an integrated approach between the basic and clinical sciences has the best chance for benefiting human health. He has been strong proponent of research translation and is leading this effort in the basic science laboratories of the University of Rochester School of Medicine and Dentistry. Dr. Puzas' research interests span all areas of bone, cartilage, orthopaedics and oral biology, especially at the cellular and molecular level. Research from his laboratory is aimed at translational approaches that extend discoveries made at the lab bench to higher order life forms. He currently has active programs that examine the molecular mechanisms by which environmental agents affect skeletal health as well and the discovery of new signaling pathways that control bone formation during the remodeling process. He is also currently heading two clinical trials related to these lines of investigation. Understanding the cellular and molecular mechanisms of these effects will open new possibilities for diagnosis and treatment of bone diseases. Dr. Puzas currently holds the Donald and Mary Clark Chair in Orthopaedics at the University of Rochester School of Medicine. He is also the Senior Associate Dean for Basic Research at that institution. Dr. Puzas has been a past president of the Orthopaedic Research Society and the United States Bone and Joint Decade. He has been continuously funded by the NIH for over 25 years.|
|Eric P. Rubinstein, JD, MPH, serves as Executive Director for Research Services and Director of the Regulatory Knowledge and Support Key Function for the Clinical and Translational Science Institute. As Executive Director for Research Services, Mr. Rubinstein is responsible for organizing unique research services and resources that are housed within the CTSI, as well as coordinating with researcher-focused resources that are available throughout the University of Rochester, the UNYTE Translational Research Network, and the Consortium of CTSA-funded Academic Institutions. Mr. Rubinstein serves as Chair of the CTSA Consortium Champions of Change, a group of institutional leaders who assume the responsibility of facilitating process-improvement activities within the research infrastructure of their home institutions, in addition to many other contributory and leadership roles within Consortium activities. As Director of the University of Rochester Office of Regulatory Support, Mr. Rubinstein is responsible for creating a process that ensures the efficient review and implementation of research projects. He and his team work directly with investigators and their teams to facilitate the translation of a research idea into an implemented research protocol, working through the required regulatory, compliance, and financial steps. He also works with staff in the Office of Human Subject Protection (OHSP), the Office of Research Project Administration (ORPA), the Office of Research Accounting and Costing Standards (ORACS), and other University administrative offices to identify actions that would improve efficiency and responsiveness to investigator needs. Finally, Mr. Rubinstein is responsible for overseeing development of novel educational programs to improve researchers’ understanding of regulatory issues, especially as they impact clinical and translational research. Prior to joining the University, Mr. Rubinstein worked for the Massachusetts Department of Public Health, where he served in various roles such as Department Privacy Officer, Director of the Office of Research and Evaluation Policy in the HIV/AIDS Bureau, and Epidemiologist. He earned his MPH at the University of Massachusetts School of Public Health and his law degree at the Suffolk University Law School.|
|Edward M.Schwarz, PhD is the Co-Director of the Pilot and Collaborative Studies Key Function within the CTSI. Dr. Schwarz is the Burton Professor of Orthopaedics and Director of the Center for Musculoskeletal Research at the University of Rochester Medical Center, in Rochester, NY. His laboratory focuses on inflammatory bone loss, such as that seen in rheumatoid arthritis, infections, tumor metastasis and wear debris-induced osteolysis around loose prosthetic implants. Dr. Schwarz is also a leader in orthopaedic biologic therapy and stem cell research, for which his lab has developed a novel passive immunization for MRSA and revitalizing allograft approaches for bone and tendon regeneration. Dr. Schwarz’s lab is also interested in developing translational in vivo imaging outcome measures include near infrared imaging of lymphatic flow to detect arthritic flare, and cone beam CT to assess bone healing in patients with orthopaedic implants. More recently, Dr. Schwarz’s lab has combined these biologic therapy technologies and outcome measures with biocompatible carriers and stem cells to generate novel tissue engineering constructs for bone, cartilage, ligament and tendon.|
|Patricia J. (“PJ”) Simpson-Haidaris, PhD, is Director of the PhD Program in Translational Biomedical Science, and a tenured Associate Professor of Medicine Hematology-Oncology Division, Microbiology & Immunology, and Pathology & Laboratory Medicine. Dr. Simpson-Haidaris received her BS degree with a double major in Chemistry and Biology from Indiana University, after which she was employed in industry (Miles Laboratories, renamed Bayer Corp) on the research, development and production of diagnostic test kits following cGMP and FDA regulations, and biologicals using recombinant DNA. She obtained her MS and PhD in Microbiology/Virology from the University of Notre Dame while on paid academic leave from Miles Laboratories. After 12 years in industry, Dr. Simpson-Haidaris was recruited to the University of Rochester. Since 1985, she has received significant NIH and other agency grant support as PI or Co-Investigator. This includes funding for several projects and a Hybridoma and Tissue Culture Core on a program project (P01) grant, R01 grants, and grants from the Department of Defense, the Komen Foundation, and the American Heart Association. The research funded by these grants has addressed important questions on the molecular mechanisms regulating the expression of fibrinogen and its functional significance in wound repair, lung infection, cardiovascular disease, and prostate and breast cancer-associated angiogenesis and metastasis.|
Giovanni Schifitto, MD, MS, Professor of Neurology and Imaging Sciences, is Director of the Clinical Research Center. Dr. Schifitto completed his MD at the University of Milan in Milan, Italy. His postgraduate training includes a residency in Neurology, a fellowship in Experimental Therapeutics, and a Masters in Medical Management, all completed at the University of Rochester. Dr. Schifitto’s primary research interests include neurologic disorders associated with HIV infection, neuroimaging biomarkers, Parkinson’s Disease, and Huntington’s Disease. He has over 15 years of experience in the design and implementation of clinical trials. Dr. Schifitto is a member of the AIDS Clinical Trial Group and serves in the Antiretroviral Strategies Subcommittee and Neurology Collaborative Science Group. He is board certified in Neurology and provides clinical care to patients with disorders of the autonomic nervous system.
|Scott Steele, PhD, serves as Director of the Public-Private Partnerships Key Function within the CTSI. Dr. Steele also serves as Director of Research Alliances at the University of Rochester. In this role, he fosters strategic research partnerships between the University and industry, government agencies, and other academic institutions. Additionally, he holds an adjunct appointment in the Department of Public Health Sciences. Prior to joining the University, Dr. Steele served in the White House Office of Science and Technology Policy (OSTP), initially as a policy analyst and was later designated as the Executive Director of the President’s Council of Advisors on Science and Technology (PCAST). Dr. Steele coordinated PCAST studies exploring issues in nanotechnology, energy technologies, personalized medicine, and approaches to enhance university-private sector research partnerships. Dr. Steele received his BS with Honors in Biology from Union College in Schenectady, NY. Following this, he performed research at the General Electric Center for Research and Development and was a fellow at the National Institutes of Health in Bethesda, MD. Dr. Steele completed his MA and PhD in Molecular Biology at Princeton University.|
|Peter Szilagyi, MD, MPH, is Co-Director of the Community Engagement Key Function within the CTSI. Dr. Szilagyi is a Professor of Pediatrics, Chief of the General Pediatrics Division, Director of Ambulatory Pediatrics at Strong Memorial Hospital, Director of the General Pediatrics Academic Fellowship Program and Associate Director of the Strong Children's Research Center. Dr. Szilagyi is a health services researcher and studies methods to improve the quality of care and health outcomes for children and adolescents, and he directs a large research operation in the Robert J Haggerty Health Services Research Laboratory. His major areas of research are: (1) improving immunization coverage for children; (2) evaluating the effect of health insurance or lack of insurance in pediatric health care; and (3) improving the quality of care and outcomes for high risk children including impoverished children, and those with chronic medical or psychosocial problems.|
|Sally W. Thurston, PhD, is Director of the Design, Biostatistics and Clinical Research Ethics Key Function within the CTSI. Dr. Thurston is an Associate Professor of Biostatistics at the University of Rochester. Much of her statistical work is motivated by problems arising in environmental and occupational health. Areas of methodological research include modeling multiple outcomes, correction for measurement error bias, exposure assessment, using biomarkers to improve cancer risk estimates, and Bayesian inference. Dr. Thurston works closely with faculty in the Departments of Environmental Medicine, Public Health Sciences, and others. She was recently elected a member of the International Statistical Institute. Dr. Thurston received her PhD in Statistics from Harvard University, and was a postdoctoral fellow and research associate in Biostatistics at the Harvard School of Public Health prior to her appointment at the University of Rochester in 2002.|
Title: Secretary IV
Title: Education Program Coordinator
Areas of Responsibility: Katie is primarily responsible for the support of the Research, Education and Career Development Key Function. She assists in the coordination of the KL2 Mentored Career Development Program, Academic Research Track Program, and the PhD in Translational Biomedical Science Program.
Title: Administrative Assistant
Areas of Responsibility: Mary is the Administrative Assistant for the CTSI. She serves as the office manager and supervises the clerical team in the Directors' Office. She provides support for the CTSI Executive Committee and the CTSI Pilot Project and Incubator Programs and coordinates CTSI-sponsored events. Mary also provides secretarial assistance for the Executive Director for Operations.
| Mary Lyons
Title: Research Administrator
Areas of Responsibility: Mary serves as the Research Administrator for the CTSI grant and research programs originating from it. She provides information as to NIH guidelines for financial budgeting, expenses, and ledger reconciliations for CTSI program directors and pilot project awardees.
|Nancy A. Needler
Title: Research Subject Advocate (RSA)
Areas of Responsibility: Nancy is an independent resource for research volunteers and assists University researchers and coordinators with many facets of study management, including the informed consent process and Data & Safety Monitoring Plan development.
|Nicole O’Dell, MLS
Title: Senior Information Analyst
Areas of Responsibility: Nicole works closely with Dr. Ann Dozier to collect data and complete data analysis for the evaluation component of the CTSI, and also coordinates the annual work planning process. Nicole maintains numerous CTSI databases which serve to track the progress of individuals who receive support through the Clinical and Translational Science Award. She produces the CTSI Weekly Update. Nicole received a Master’s of Library Science Degree from the University at Buffalo.
Title: Clinical Research Informaticist
Areas of Responsibility:Adam is responsible for promoting the use of the University’s Electronic Health Record, eRecord, for research purposes. Adam assists researchers with a wide variety of needs, such as access to clinical data, locating appropriate data, and use of the eRecord system itself for research purposes. Adam also assists with the planning, development, and implementation of new eRecord functionality specific to research. In addition, Adam also provides consultations on the entry of research data into ClinicalTrials.gov for researchers.
Title: Secretary IV
Celine provides support for the Regulatory Knowledge and Support Key Function and the UNYTE Translational Research Network. She also supports the Clinical Research Review Process Improvement Team (CRRPIT) and Study Coordinators Organization for Research and Education (SCORE) Program. Celine ensures compliance related to the NIH’s public access policy through follow up with research investigators. In addition, she provides secretarial assistance to the Executive Director for Research Services and Regulatory Knowledge and Support.
Title: Accounting Bookkeeper IV
Debbie assists with maintenance and processing of all financial transactions and ledger reconciliations for the CTSI and National Center for Deaf Health Research (NCDHR), and assists with budget preparation. Debbie also handles other financial paperwork and record-keeping for the CTSI and NCDHR.