The NeuroCog Team
The NeuroCog Trials team consists of a carefully selected group of scientists, clinicians, project managers, data monitors and certification specialists. Below are brief profiles for several key members of our leadership team.
Dr. Keefe is Professor of Psychiatry and Behavioral Sciences and Psychology at Duke University Medical Center and Adjunct Professor at the Duke-University of Singapore Graduate Medical School. His work for the past 20 years has focused on applying innovative strategies in neuroscience to measure human cognition. He has published over 150 peer-reviewed scientific papers on cognition, schizophrenia, dementia, and other CNS disorders. Dr. Keefe has had a leadership role for cognitive methods and coordinating center data review for several large NIMH studies including the CATIE, MATRICS, TURNS, and TENETS projects. He is Associate Editor for Psychological Medicine, and on the Editorial Board of Schizophrenia Bulletin, Schizophrenia Research, and Innovations in Clinical Neuroscience. He is a Fellow of the American College of Neuropsychopharmacology, and on the Scientific Board of NAMI and the Brain and Behavior Research Foundation. He was President of the International Society for CNS Clinical Trials and Methodology in 2012 through 2014.
He graduated from Princeton University in 1980, and received his PhD in clinical psychology from NYU in 1990. He completed his clinical psychology internship at Yale University School of Medicine in 1990.
In order to bring cutting-edge innovation and academic quality standards to industry trials collecting neurocognitive data, Dr. Keefe founded NeuroCog Trials.
Caren Gadigian is the founder and president of NeuroCog Trials.
Ms. Gadigian has broad knowledge of finance and business which she developed during her 20 years working with private investment firms providing equity management, syndicate and operational expertise. During her 10 plus year career at NeuroCog, Ms. Gadigian has spearheaded the organization’s growth and strategic global expansion of services.
Ms. Gadigian is responsible for jointly managing the human resources, financial operations, facility & operational functions, and recruiting processes that bolster NeuroCog Trials’ ability to maintain the high standard of excellence across new therapeutic areas in pharmaceutical development. Assuring an atmosphere that recruits, retains and supports quality staff and consultants.
Mr. Spiegel serves as the Chief Operating Officer. Mr. Spiegel brings to the company more than 16 years of experience in finance and consulting and has worked for companies in many industries including healthcare, business services and technology. Prior to joining NeuroCog Trials, he was a founding partner and Principal at Cypress Associates LLC, a New York based Investment Banking firm, where he was responsible for a broad range of transactions including mergers and acquisitions, restructurings, and equity offerings. Before joining Cypress, he was with CIBC World Markets contributing as an Investment Banking Analyst in the technology group.
Mr. Spiegel received his B.A. in Economics and Public Policy Studies from Duke University and holds the Chartered Financial Analyst® designation.
Dr. Saxby leads the strategic development of new products and services, drawing on a strong scientific background in clinical trials and computerized cognitive testing, and a successful track record of product and service innovation.
Dr. Saxby has worked in clinical trials for over 15 years. He joined a computerized cognitive test provider in a scientific role in 2004. After relocating to Chicago, IL, in 2009, he transitioned into business development, responsible for new clinical trial business with US clients. Most notably, Dr. Saxby led the development of Cambridge Cognition’s service offering for Human Abuse Liability trials, creating a new revenue stream for the company. More recently as Senior Director at ProPhase, Dr. Saxby has been involved in Rater Training and in-study surveillance methods for ensuring quality of Clinician-Reported Outcomes (ClinROs) in psychiatry and neurology.
Dr. Saxby obtained his BSc in Psychology and his PhD at Newcastle University, UK, and continues to hold a Visiting Researcher position at the Institute for Ageing, where he has published over 30 papers on a range of disorders including dementia, late-life depression, surgery and hypertension.
Dr. Atkins is an Experimental Psychologist with expertise in cognitive psychology, cognitive neuroscience and mental health research. Prior to attending graduate school, she worked as a Study Coordinator at Weil Medical College, Cornell University where she managed clinical trials for a wide range of CNS disorders including Alzheimer’s disease, Huntington’s disease, ALS, headache disorders and stroke.
Dr. Atkins received a B.A. in Psychology from Oberlin College and an interdisciplinary Master’s degree from the University of Chicago prior to earning her Ph.D. in Psychology from the University of Michigan in 2009. She completed post-doctoral training at the Center for Cognitive Neuroscience at Duke University.
Dr. Atkins’ past research has used cognitive testing in conjunction with functional neuroimaging techniques to examine the cognitive and neural mechanisms of memory distortion and executive functioning. She has received National Research Service Awards from both the National Institute of Mental Health (NIMH) and the National Institute on Aging (NIA), and has authored numerous peer-reviewed publications and presentations. She brings to NeuroCog Trials expertise in neurocognitive assessment, experimental methodology and the biological basis of behavior.
Ms. Turcotte brings more than 10 years of experience and expertise in the management of organizational and clinical trial teams. At NeuroCog Trials, she has managed a full range of administrative, logistical and operational duties in a wide variety of areas including development of SOPs, budgeting, information technology, scale procurement and translation, as well as trial management.
Ms. Turcotte began her work with Dr. Keefe at his lab at Duke University where she worked as a research assistant acquiring normative data for the Brief Assessment of Cognition in Schizophrenia (BACS). Joining NeuroCog Trials at its inception, she has played an integral role in its growth over the years. She began her career at NeuroCog Trials as a data monitor and certification specialist, quickly progressing into a project management role and eventually assuming a director role. She has experience managing data collection on Phases II through IV clinical trials and has managed numerous global drug development projects. Ms. Turcotte has considerable experience providing supervision, guidance, and oversight for numerous schizophrenia trials as well as normal aging, weight loss, and RLS.
Ms. Turcotte holds a Bachelor of Arts degree in Psychology from Saint Anselm College and a Master of Arts in Organizational Leadership from Gonzaga University where she also earned a Graduate Certificate in Servant Leadership. Additionally, Ms. Turcotte maintains memberships with DIA and ISTAART.
Ms. Walker is an experienced Project Manager with expertise in direct patient interaction and both large academic and industry trials. She has been working in the mental health field since graduation and has 15 years experience working with schizophrenia and bipolar populations. For the past 10 years, she has worked at Duke University Medical Center and John Umstead Hospital doing research on neurocognition. Mrs. Walker has extensive experience with cognitive assessment and has supervised the collection of data and data quality for several domestic and international multi-site trials, including the collection of data for over 1600 patients in the CATIE schizophrenia and dementia trials. She has also helped develop several cognitive instruments, including the Brief Assessment of Cognition in Schizophrenia (BACS), the Schizophrenia Cognition Rating Scale (SCoRS) and the Cognitive Assessment Interview (CAI).
Ms. Walker received her B.A. in Rehabilitation Therapy from the University of North Carolina at Chapel Hill in 1996 and received an A.D. in Nursing in 2005
As Senior Director of Program Development, Ms. Piunti serves as the primary point of contact for all contract and budget negotiations including project initiation, amendments and change orders. During her tenure at NeuroCog Trials, Ms. Piunti has served as Project Lead on several Phase 2 and Phase 3 studies, with a special emphasis on international trials in Asia and South America. Ms. Piunti received her B.A. in English from Siena College.
Mr. Baldwin serves as the Director of Quality Assurance. He has over 20 years of experience in clinical trial research. He started his career in Data Management and held various positions in Information Technology, Regulatory and Quality Assurance departments at Contract and Academic Research Organizations. Prior to joining NeuroCog Trials, he worked in the Quality Assurance department of a local pharmaceutical company for over 6 years and progressed into the position of Associate Director of QA. In his role at NeuroCog Trials, Mr. Baldwin oversees the development and maintenance of a Quality Assurance program for NeuroCog Trials that includes compliance, training, auditing, documentation and QA support of sponsor projects to insure adherence to global regulations that apply to the work that NeuroCog Trials completes for their partners.
Mr. Baldwin received his B.A. in English from North Carolina State University.
Dr. Davis serves as NeuroCog Trial’s chief biostatistician. She has 30 years of experience in clinical trial research, including 9 years in CNS diseases. Prior to joining NeuroCog Trials, Dr. Davis worked as a Research Investigator for the Collaborative Studies Coordinating Center in the Department of Biostatistics at UNC, Chapel Hill. She assisted investigators with data analysis and manuscript preparation for the Clinical Antipsychotic Trials of Intervention Effectiveness study (CATIE) and the Atherosclerosis Risk in Community Studies (ARIC). From 1985 to 1996, Dr. Davis was a Senior Research Statistician in the Center for Medical, Environmental and Energy Statistics at Research Triangle Institute. Her responsibilities primarily included statistical support for cardiovascular clinical trials such as the Multicenter Investigation of the Limitation of Infarct Size (MILIS), the Asymptomatic Carotid Artery Plaque Study (ACAPS), and Thrombolysis in Myocardial Infarction (TIMI 4). At NeuroCog Trials, Dr. Davis collaborates with project leads and data monitors to support their projects. She assists with manuscript preparation and presentations including statistical analysis, table and graphics design, writing of statistical methods and results, and review of all results prior to submission. Dr. Davis has developed software to perform ongoing review of tests for potential data problems, to assess test-retest reliability, to impute missing data, and to generate interim analyses and final reports. In addition, she is available to review statistical analysis plans and provide results from efficacy analyses of cognition data in the form of computer-generated tables and figures at the request of the sponsor.
Dr. Davis earned her Bachelor of Science, Master of Science, and Doctor of Public Health degrees in Biostatistics from the University of North Carolina in Chapel Hill.