Participating Organizations

Rick Williams, Ph.D.

Dr. Rick Williams is a fellow of the American Statistical Association (ASA) with more than 30 years of experience in medical and epidemiological research. He has led eight major multisite research projects coordinating the efforts of dozens of research sites across the US. He designs and leads population surveys, observational studies, and randomized clinical trials. He frequently conducts workshops and training classes on the use of statistical analysis methods for cluster-correlated, longitudinal, or repeated measures data, such as generalized estimating equations for marginal models, hierarchical linear and nonlinear mixed models, and multilevel models. He has also led the selection and implementation of data capture and data management systems for clinical studies at RTI International. He holds a Ph.D. in Biostatistics with specialization in Epidemiology.

www.rti.org

Tracy Nolen, DrPH

Dr. Tracy Nolen is a senior research statistician with more than 13 years of experience providing and managing analytic support for observational studies and clinical trials funded by commercial pharmaceutical and device companies, the Department of Defense (DoD), Department of Veteran Affairs (VA), and the National Institutes of Health (NIH). Dr. Nolen holds a Doctorate of Public Health degree in Biostatistics from the University of North Carolina at Chapel Hill’s Gillings School of Global Public Health and a Master’s degree in Statistics from North Carolina State University. She specializes in the design, set-up, operation, analysis as well as scientific and regulatory reporting of clinical trials. Her statistical experience includes causal inference in observational and randomized trials settings; alternative study designs including adaptive dose finding designs and adaptive randomization algorithms; and the use of various statistical methods (e.g., regression analysis, including generalized linear models; longitudinal data analysis, including generalized estimating equation (GEE) and mixed models; survival analysis; nonparametric analysis; dose-proportionality analysis). Dr. Nolen holds a doctorate of public health in biostatistics from the University of North Carolina at Chapel Hill’s Gillings School of Global Public Health and a master’s degree in statistics from North Carolina State University.

www.rti.org

Whitney Battestilli

Whitney Battestilli is a research programmer/analyst at RTI International. He has 16 years of experience in professional software architecture and development, as well as extensive experience with organizing and managing complex software projects. Mr. Battestilli has worked in the fields of strategic planning, statistical language translation, three-dimensional (3-D) graphics, and manufacturing robotics. He has led geographically distributed development teams and has single-handedly delivered projects. He is proficient in various programming languages and is experienced with every aspect of the software development lifecycle.

www.rti.org

Lauren Bradley, MHS

Lauren Bradley is a research public health analyst at RTI International. She has extensive experience working in public health, with experience in medical school curriculum design and management, public health research, global education research, and environmental health research and program management. Ms. Bradley’s particular public health interests include public health laboratories and preparedness, field epidemiology training and education, medical curriculum development and implementation, and environmental health. In her current role at RTI international, she provides research support and project management expertise for clinical trials and drug development projects for a variety of conditions and research topics in the fields of epidemiology and public health.

www.rti.org

Ben Carper, MS

Benjamin Carper is a research statistician at RTI International. He has more than 7 years of experience in analyzing data, writing reports, and leading tasks from a variety of different scientific and financial disciplines, including preclinical studies and clinical trials, terrorism risk assessment, travel surveys, financial credit risk modeling, and infectious disease outbreak modeling. Additional scientific disciplines include adverse health outcome prediction, environmental pollutant impact studies, biological and chemical agent exposure and treatment efficacy modeling, and genetic clustering. Mr. Carper has experience with using many statistical methods, including survival analysis, multivariate regression, nonlinear and mixed models, machine learning, classification algorithms, text analysis, risk assessment, meta-analysis, pattern recognition, and power analysis. He also has extensive experience in data simulation and analysis and in combining data from multiple sources.

www.rti.org

Ivy Carroll, Ph.D.

Dr. Ivy Carroll has varied research interests, but since 1990, a major thrust of his research efforts involved development of pharmacotherapies for substance abuse. This research identified the dopamine transporter-selective analog RTI-336 as a pharmacotherapy for treating cocaine abuse. It is expected that the IND for RTI-336 will be submitted in December 2006. Other 3-phenyltropane analogs synthesized by Dr. Carroll are in development for treating nicotine addiction (smoking). Dr. Carroll’s 3-phenyltropane research also led to the development of the 3-phenyltropane radioligand [125I]RTI-55, which is presently marketed by PerkinElmer Life and Analytical Sciences. Dr. Carroll’s research also led to the development of [123I]RTI-55, now called Dopascan, as a single photon emission computed tomography (SPECT) imaging ligand. It has been used to diagnose thousands of patients for Parkinson’s disease. Dr. Carroll also developed [125I]RTI-353 and [125I]iodo-MLA, which are highly useful radioligands for studying the serotonin and α7 nicotinic receptors, respectively. Other recent and continuing research resulted in identification of mu-, delta-, and kappa-selective opioid antagonists. Dr. Carroll's kappa opioid antagonist JDTic has been selected for preclinical development as a potential pharmacotherapy for cocaine relapse. He also developed 4-nitro-PFEB as the most potent and α4β2 selective AChR antagonist thus far reported. In addition, Dr. Carroll developed other novel agonists and antagonists for α4β2 and α7 nicotinic receptors.

www.rti.org

Doreen Collins, MPH

Doreen Collins, a program manager in the Center for Clinical Research Network Coordination (CRNC) at RTI International, has 19 years of health research and clinical experience in large survey studies, neurology, cardiovascular disease, and HIV. As program manager of the PASA Management and Operations Group, she is responsible for the career development and performance oversight of 14 clinical research associates and contract specialists. In addition, until recently, she was the project manager on the Chronic Effects of Neurotrauma Consortium (CENC), a multicenter collaboration linking basic science, translational, and clinical neuroscience researchers… Ms. Collins also is involved with several business development initiatives and has been a project director on two projects with the Clinical Trials Transformation Initiative (CTTI), a joint effort between the Food and Drug Administration (FDA) and Duke University… Before joining RTI, she was project director of a multinational pediatric/maternal HIV clinical research network of 41 sites in Argentina, Brazil, and the US. She is a former Peace Corps Volunteer in Cameroon and is a Certified Project Management Professional.

www.rti.org

Madelyn Johnson

Madelyn Johnson is a public health analyst at RTI International. In this capacity, she provides administrative and research support for clinical research studies, ensuring adherence to Good Clinical Practice (GCP) guidelines. She contributes to data management and analysis, global health experimental research design, clinical research regulatory oversight, Python/HTML coding, and copywriting. Ms. Johnson’s research interests include maternal and child health, emerging infectious diseases, global health intervention design and evaluation, and genetic counseling.

www.rti.org

Grier Page, Ph.D.

Dr. Grier P. Page, a senior statistical geneticist in RTI International’s Genomics and Statistical Genetics Research unit, has been conducting research in all areas of statistical genetics since 1993 and in systems biology since 2002. Dr. Page has developed methods for the analysis of linkage and association data, as well as microarray, proteomic, and next-generation sequencing methods. He is particularly interested in methods for the design and power and sample size calculations for statistical genetics experiments, as well as design and statistical methods for quality assurance and quality control( of genetic and genomic data.

www.rti.org

Russ Vandermaas-Peeler, MS

Russ Vandermaas-Peeler, a health policy analyst, worked at RTI International from 1989 to 1991 and returned in 1996. He has 20 years of research management, including research study and instrument design, IRB documentation, data collection management, and data analysis and reporting. Mr. Vandermaas-Peeler has extensive experience managing data collection efforts for large military studies, using multiple modes and methodologies.

www.rti.org

Kristine Rae Olmsted, MSPH

- Kristine L. Rae Olmsted is a research epidemiologist with more than 15 years of research experience in epidemiology and psychology. Her research background includes extensiveexperience in designing, implementing, managing, and analyzing primarily quantitative research protocols for military populations. Her primary areas of interest are mental health, substance abuse, and pain among military personnel and other issues related to military health. She has broad experience in survey research, including coordination and management of large-scale epidemiologic studies.

www.rti.org

Callie Riggs, MBA

Callie Riggs joined RTI International in 2006 as a financial analyst. She has since transitioned to the role of project administration specialist. In this role, Ms. Riggs has managed the contractual, administrative, and fiscal affairs for an international multisite research project, several small international projects, and several national multisite projects. Ms. Riggs assisted with the development of the capitation payment system for a large research project, and she is knowledgeable about making capitation payments in a multisite, multiple protocol project. - She has previous experience developing proposal budgets for a variety of contract types at RTI International. Ms. Riggs also has experience with program administration, cost accounting, contract management, and financial reporting.

www.rti.org

Diana Severynse-Stevens, Ph.D.

Dr. Diana M. Severynse-Stevens is a regulatory project manager in the Global Heath Technologies group within the RTI International Social, Statistical & Environmental Sciences (SSES) research division. Dr. Severynse-Stevens has 15 years of experience in the pharmaceutical industry, including drug discovery and preclinical and clinical drug development. Therapeutic areas of focus include metabolic diseases, dermatology, and cardiovascular and infectious disease. Positions held by Dr. Severynse-Stevens prior to joining RTI International include program manager at DARA BioSciences, Director of Pharmacology for Nobex Corporation… Dr. Severynse-Stevens did her postdoctoral fellowship at the Howard Hughes Institute at Duke University in dopamine receptors and neurobiology. Her graduate studies at University of North Carolina at Chapel Hill were focused in molecular biology, genome characterization, and transcriptional regulation.

www.rti.org

Douglas Theriaque, MS

Douglas W. Theriaque is a research programmer/analyst with more than 18 years of experience in biomedical informatics. With a background in both information technology (IT) and statistics, Mr. Theriaque has expertise in Web-based application development using open-source tools, database development, data management, and programming methodologies. In addition to his work with electronic data capture (EDC) systems, he has extensive experience in developing and implementing data validation and data quality control plans, and managing data entry staff and related data acquisition activities. He is a capable statistical programmer, having productively collaborated with researchers on projects that span numerous disciplines. As an educator and mentor Mr. Theriaque has provided both hands-on and didactic instruction in the design of EDC systems and data management best practices. He is knowledgeable in Good Clinical Practice (GCP) and HIPAA guidelines and has served on numerous scientific advisory committees for center-sponsored projects and Food and Drug Administration (FDA)–regulated clinical trials.

www.rti.org

Gene Turner

Gene Turner is a senior clinical data manager at RTI International. He has 22 years of experience in the pharmaceutical industry and has comprehensive knowledge of the clinical drug development process for project-lead clinical data management. As a senior clinical data manager at RTI International, Mr. Turner ensures database accuracy according to departmental operating procedures, performs a quality control review of the data and coordinates corrections to the database with the clinical sites, and designs case report forms (CRFs) for data acquisition and data entry. Mr. Turner also oversees development of electronic case report forms (eCRFs), develops data management plans, and monitors study metrics.

www.rti.org

Thomas Kosten, M.D.

Dr. Kosten is a professor and the Jay H. Waggoner Endowed Chair in the Menninger Department of Psychiatry and Behavioral Sciences at Baylor College of Medicine (BCM), as well as the co-director of the Dan L. Duncan Institute for Clinical and Translational Research (ICTR) at BCM. He has led National Institutes of Health (NIH) and VA Research Centers and randomized clinical trials for over 30 years and has been PI on several national multisite studies for developing new medications in many addictions and post-traumatic stress disorder (PTSD). He has directed a National Institute on Drug Abuse (NIDA) Medications Development Center since 1988, and has been the Research Director of the VA National Substance Use Disorders Quality Enhancement Research Initiative (QUERI) based at the Michael E. DeBakey VA Medical Center (MEDVAMC). He is the founding Vice Chair for Addiction Psychiatry of the American Board of Psychiatry and Neurology, and Past President of both the American Academy of Addiction Psychiatry (AAAP) and the College on Problems of Drug Dependence (CPDD). He is a Distinguished Life Fellow in the American Psychiatric Association (APA) and a Fellow of the American College of Neuropsychopharmacology (ACNP). He has served as a Congressional Fellow in the US House of Representatives and has been a long-standing member of various substance abuse commissions for the National Academy of Sciences (NAS), as well as various advisory boards for the Food and Drug Administration (FDA) and the Department of Defense (DoD). He is the current editor for the American Journal on Addictions, past Editor for the American Journal of Drug and Alcohol Abuse, and serves on the board of several notable journals in substance abuse. He has published over 700 papers, books, and reviews describing his contributions, particularly in the use of pharmacotherapeutics for treating cocaine and opioid addictive disorders, as well as his work in vaccine development for cocaine and methamphetamine addictions.

www.bcm.edu

Christopher Verrico, Ph.D.

Dr. Christopher Verrico is an assistant professor in the Department of Pharmacology at Baylor College of Medicine (BCM) with nearly 20 years of training and experience conducting research in the area of substance use disorders (SUD). His past research has focused on discovering and evaluating treatments for narcotic and alcohol addictions. He has experience in both animal and clinical research on different forms of addiction. He has led clinical research projects with Veterans at the Michael E. DeBakey VA Medical Center (MEDVAMC) and the National Institutes of Health (NIH), including the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). He currently directs two NIH-funded clinical studies that are being conducted at the MEDVAMC. For the past year, he has lead Dr. Newton’s NIDA-funded study (R01 DA 035513) evaluating the efficacy of treatment with both modafinil and doxazosin for reducing cocaine-induced effects. He also directs Dr. Newton’s NIAAA-funded study (R42 AA 22049) exploring the efficacy of carisbamate for treating alcohol use disorder (AUD) in civilians. Dr. Verrico is the PI of the PASA-funded 2016R1A3b clinical trial entitled “PT150 (formerly ORG 34517) as a Potential Treatment for Alcohol Dependence – Alcohol Interaction Study” and the PI of the PASA-funded 2016R1A5 clinical trial entitled “Carisbamate as a New Treatment for PTSD & Co-Occurring AUD”.

www.bcm.edu

Elisabeth Wilde, Ph.D.

Dr. Elisabeth Wilde is the Scientific Director of the Imaging Core for the Traumatic Brain Injury (TBI) Center of Excellence (COE) at the Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston. She is currently directing the Neuroimaging Core for the Chronic Effects of Neurotrauma Consortium (CENC). She has a background in TBI in Veterans and service personnel, including a focus on factors that moderate recovery such as post-traumatic stress disorder (PTSD) and substance use disorders (SUD). She served as the director of the Imaging Core for a National Institutes of Health (NIH)-funded program project on mild TBI (mTBI) which involved advanced modalities, and directed analysis of DTI data in a large Department of Defense (DoD)-funded consortium project on mTBI (Mission Connect Consortium).

www.bcm.edu

Ronald Marcus, M.D.

Dr. Ronald Marcus serves as the Chief Medical Officer and Head of Regulatory Affairs at Cerecor. He has more than 24 years of experience in the development of neuroscience drugs at both Bristol-Myers Squibb and Spinifex Pharmaceuticals. Dr. Marcus held various positions while at Bristol-Myers Squibb, including Group Director of Neuroscience Strategic Unit and Executive Director of Neuroscience Global Clinical Research. In these roles, he led the development of treatments for neuropathic pain, schizophrenia, migraines, and depression. During his time at Spinifex, Dr. Marcus was the Chief Medical Officer and was responsible for leading the clinical development and regulatory strategy of the company’s lead compound for neuropathic pain. He has extensive experience in early drug development and possesses both breadth and depth in all of the key functional areas of exploratory and late development, disease biology and regulatory affairs. Dr. Marcus has been recognized within the biopharmaceutical industry for his excellence in overall drug development, innovative strategic leadership, and executional excellence. He is a co-investigator of the PASA-funded 2016R1A2 preclinical study entitled “Assessing Pharmacotherapies in Animal Models of PTSD and AUD”.

http://www.cerecor.com/

Howard C. Becker, Ph.D.

Dr. Howard C. Becker is a professor in the Departments of Psychiatry and Neuroscience at the Medical University of South Carolina (MUSC) and a Senior Research Career Scientist at the Ralph H. Johnson VA Medical Center. Dr. Becker has over 30 years of research experience in the use of animal models to determine the basic mechanisms of alcohol and drug action in the brain. Additionally, as Director of the Charleston Alcohol Research Center, Dr. Becker coordinates preclinical and clinical investigations that focus on identifying and evaluating alcohol treatment targets and strategies. He also serves as the Scientific Director for the NIAAA-supported Integrative Neurobiology Initiative on Alcoholism (INIA-Stress) Consortium, a multi-institutional consortium focused on understanding the neuroadaptive changes that result from the complex interaction between stress, anxiety, and alcohol use/misuse in several species (rodents, monkeys, and humans). He is the PI of the PASA-funded 2016R1A1 preclinical study entitled “Preclinical Analysis of Combined Carisbamate and Doxazosin Treatments in Stress-Alcohol Drinking Models”.

http://academicdepartments.musc.edu/musc/

Marcelo Lopez, Ph.D.

Dr. Marcelo Lopez is an associate professor in the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina (MUSC), a PI of the INIA-Stress Consortium Mouse Chronic Intermittent Ethanol (CIE) Core, and the Animal Core Supervisor of the Shared Resources Core within the Charleston Alcohol Research Center. Dr. Lopez has extensive experience in conducting behavioral pharmacology studies that utilize numerous rodent models of alcohol exposure, including a CIE exposure model that produces escalation of drinking. Dr. Lopez was instrumental in the development of the CIE model, which is now widely employed in the alcohol research field. He has also studied the complex interaction of stress and alcohol, work which led to the development of several stress/post-traumatic stress disorder (PTSD) models. He is a co-investigator of the PASA-funded 2016R1A1 preclinical study entitled “Preclinical Analysis of Combined Carisbamate and Doxazosin Treatments in Stress-Alcohol Drinking Models”.

http://academicdepartments.musc.edu/musc/

Michael Roy, M.D.

Dr. Roy is Professor of Medicine and Director of the Division of Military Internal Medicine at USUHS, and Director of the Recruitment Core for CNRM. He is a graduate of Brown University and Brown University School of Medicine. Dr. Roy completed his residency in internal medicine and his general medicine fellowship at Walter Reed Army Medical Center, and retired as a Colonel after 24 years in the Army. He has twice served as president of the Society for Brain Mapping and Therapeutics, and is a Fellow of the American College of Physicians. Dr. Roy is the principal investigator on multiple studies on war-related health, often using new brain imaging techniques and other cutting edge technologies such as virtual reality and smart phone applications. He has authored well over 100 publications including the books Physician’s Guide to Terrorist Attack and Novel Approaches to the Diagnosis and Treatment of Posttraumatic Stress Disorder.

http://www.usuhs.mil/

Colin N. Haile, M.D., Ph.D.

Dr. Colin N. Haile is a research assistant professor in the Department of Psychology and Operations Director of the Animal Behavioral Core (ABC), a core facility designed to conduct experimental procedures in rats and mice, at the University of Houston. Dr. Haile has nearly 20 years of experience in evaluating potential pharmacotherapies for psychiatric diseases in humans and in animal models. He has a broad range of experience in molecular, behavioral, and clinical experimental procedures, and has published extensively on using a variety of behavioral assays for medication development. Dr. Haile also has a joint appointment at the Michael E. DeBakey VA Medical Center (MEDVAMC), where he is involved in clinical trials assessing medications for anxiety and substance use disorders (SUD) in Veterans. He is the PI of the PASA-funded 2016R1A2 preclinical study entitled “Assessing Pharmacotherapies in Animal Models of PTSD and AUD”.

http://www.uh.edu/

Therese Kosten, Ph.D.

Therese A Kosten PhD is Professor of Psychology at the University of Houston. The overarching theme of her research program is to understand the contributions of genetic and environmental factors that influence and shape behavior via the involvement of the hypothalamic-pituitary-adrenal (HPA) axis and dopaminergic and noradrenergic systems. She studies how behaviors reflective of addiction (e.g., self-administration, conditioned place preference, etc) are affected by stress, sex, and early life manipulations. Another aspect of her research can be considered translational as it involves medication development. For example, her laboratory is constructing and testing vaccines for methamphetamine abuse, and they are identifying new pharmacological targets for alcoholism that they test using maintenance and reinstatement of operant responding for alcohol procedures. Broadly, her research program encompasses the areas of motivation, emotion, and learning with a focus on limbic regions, such as the nucleus accumbens and hippocampus.

http://www.uh.edu/

Dewleen Baker, M.D.

Dr. Dewleen Baker is a professor in the Department of Psychiatry at the University of California, San Diego (UCSD), Director of Neuroscience/Research at the San Diego Center of Excellence (CESAMH), Director of the Research and Neuroscience Unit, and a teaching attending in the Anxiety Disorders Unit of the San Diego VA Health System (VASDHS). Her research focuses on various aspects of stress and mental health, particularly post-traumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI). Within this focus, her clinical and research activities include projects in neuroscience and neurobiology), treatment of PTSD and mTBI and co-occurring mental and physical disorders (e.g. metabolic and immune-related disorders). She is the PI of the PASA-funded 2016R1A3a clinical trial entitled “Efficacy and Safety Study of ORG 34517 in Veterans with Co-morbid PTSD/AUD” and co-PI of the PASA-funded 2016R1A3b clinical trial entitled “PT150 (formerly ORG 34517) as a Potential Treatment for Alcohol Dependence – Alcohol Interaction Study”.

http://ucsd.edu/

Victoria Risbrough, Ph.D.

Dr. Victoria Risbrough is an associate professor in the Department of Psychiatry at the University of California, San Diego (UCSD), Associate Director of Neuroscience/Research at the San Diego Center of Excellence (CESAMH), a member of the Molecular Neuropharmacology and Signaling study section for National Institutes of Health (NIH), and Director of the Neurocognition Project for the Marine Resiliency Study funded by the US Navy Bureau of Medicine and Surgery (BUMED). Dr. Risbrough’s research is centered on translational mechanisms and treatments of anxiety disorders using preclinical and clinical approaches. Her primary focus is to identify mechanisms of risk and resilience to anxiety disorders, particularly post-traumatic stress disorder (PTSD), as well as development of new pharmacological treatments for these disorders. Her program also identifies genetic and environmental contributions to stress behavior and fear learning. By measuring physiological responses to stress (including heart rate and startle reactivity) in animal models and in clinic, her research develops translational probes of anxiety responding and treatment efficacy. She is the co-PI of the PASA-funded 2016R1A3a clinical trial entitled “Efficacy and Safety Study of ORG 34517 in Veterans with Co-morbid PTSD/AUD”.

http://ucsd.edu/

Richard L. Hauger, M.D.

Dr. Richard L. Hauger is a professor in the Department of Psychiatry at the University of California, San Diego (UCSD), a staff psychiatrist with the San Diego VA Health System (VASDHS), and Chief of the Biomarkers and Bioassay Unit at the San Diego Center of Excellence (CESAMH). Dr. Hauger is nationally and internationally known researcher in the area of the molecular biology of stress disorders and post-traumatic stress disorder (PTSD). He is a co-investigator of the PASA-funded 2016R1A3a clinical trial entitled “Efficacy and Safety Study of ORG 34517 in Veterans with Co-morbid PTSD/AUD”.

http://ucsd.edu/

Sonya Norman, Ph.D.

Dr. Sonya Norman is an associate professor in the Department of Psychiatry at University of California, San Diego (UCSD), Director of the VA’s Post-traumatic Stress Disorder (PTSD) Consultation Program through the National Center for PTSD, and Co-Chair of the VA's workgroup on PTSD-substance use disorder (SUD) implementation research through the Health Services Research & Development unit. Dr. Norman’s research primarily involves etiology, assessment, and treatment of PTSD. She is particularly interested in co-occurring PTSD and alcohol/substance use disorders, as well as in developing and evaluating psychotherapy treatments for guilt and PTSD in recently deployed combat Veterans. She is a co-Investigator of the PASA-funded 2016R1A3a clinical trial entitled “Efficacy and Safety Study of ORG 34517 in Veterans with Co-morbid PTSD/AUD”.

http://ucsd.edu/

Luba Yammine, Ph.D., RN, FNP-C

Dr. Luba Yammine is a Certified Family Nurse Practitioner (FNP-C) and an assistant professor at the University of Texas, Houston (UTH). She practices as a FNP-C in a clinic that provides primary care to underserved residents of rural Texas. Her research interests focus on biological and behavioral pathways linking psychosocial factors (i.e., depression, post-traumatic stress disorder) to cardiovascular disease, and how better to integrate mental health and treatment for substance use disorders (SUDs) into routine medical care. She is a co-investigator of the PASA-funded 2016R1A5 clinical trial entitled “Carisbamate as a New Treatment for PTSD & Co-Occurring AUD”.

http://uth.edu