- Daniel Hanley, MD
- Professor, Division Director, Brain Injury Outcomes
- PI, Johns Hopkins-Tufts Trial Innovation Center
Since 1996, Dr. Hanley has been a Professor of Neurology, Neurosurgery and Anesthesia/Critical Medicine at Johns Hopkins Medical Institutions. Since 1999, Dr. Hanley has also been Professor in the School of Nursing, the Jeffrey and Harriett Legum Professor of Acute Care Neurology and Director of Brain Injury Outcomes Program at Johns Hopkins Medical Institutions. Dr. Hanley is a graduate of Williams College and Cornell University Medical College and has board certification in internal medicine, neurology and psychiatry.
Dr. Hanley is a leading expert on multiple types of brain injury and has received more than 40 clinical and basic research grants, predominately from the National Institutes of Health and the FDA Orphan drugs program. He has published more than 250 articles in peer-reviewed journals, has received the Alexander Humboldt Research Prize for his accomplishments in brain injury research and has extensive clinical trials experience in that field. His trainees are directors of more than 25 brain intensive care units across the United States.
Dr. Hanley is on the board of directors of the National Stroke Association, for which he has developed nationally recognized education and training programs. He has significant experience in the areas of clinical trials design, organization and interpretation of drug and device development, and FDA regulatory compliance. He is the principal investigator for the NIH-sponsored MISTIE and CLEAR trials investigating minimally invasive neurosurgical techniques to treat hemorrhagic stroke. He is the principal investigator for Johns Hopkins-Tufts NCATS Trial Innovation Center, and as such, he leads the collaborative efforts with the National Institute on Aging to advance education and therapeutics in well-designed CTSA clinical trials investigating Alzheimer’s disease and other diseases of aging.
- Karen Lane, CCRP
- Assistant Professor of Neurology
- Administrative Director of Research, Brain Injury Outcomes
Karen Lane, an Assistant Professor of Neurology and the Administrative Director of Research, Division of Brain Injury OutcomeS (BIOS), Johns Hopkins University, has been developing, demonstrating, and disseminating the principles of clinical trials for more than two decades. Her primary focus as a clinical scientist has been intracranial hemorrhage, orphan diseases, neurocritical care, and racial and ethnic diversity within clinical trials.
With more than 30 publications in the areas of clinical trials and intracranial hemorrhage, she has developed technical and organizational trial innovations including processes integral to web-based electronic data collection systems, trial performance metrics and summaries, trial management techniques resulting in site and subject retention, websites for investigators and the scientific community, an online training facility for skill certification, and electronic regulatory depositories. She is the project leader for the Johns Hopkins-Tufts Trial Innovation Center, part of the newly created NCATS Trial Innovation Network.
- Nichol McBee, MPH, CCRP
- Division Manager, Brain Injury Outcomes
Nichol McBee has been part of the Brain Injury Outcomes Division since its inception. Her expertise is in the management of clinical trials, specifically in the areas of protocol compliance, adverse events monitoring, serious adverse event reporting, follow-up and documentation of potential outcome events. As the senior program manager, she supervises the medical monitoring processes, the central adjudication of safety endpoints and the regulatory documents specialist. She is an on-call resource to the site managers and clinical teams during randomizations, and she serves on multiple protocol development committees. She ensures that daily activities meet regulatory compliance, and she is responsible for implementing and maintaining quality assurance and quality control systems by managing the production of the SOPs to ensure that all BIOS trials are documented and reported in compliance with each protocol and the applicable regulatory requirements in a timely and correct manner. She has been a vital part of the BIOS program responsible for the FDA IND applications since 1995.
In addition to her protocol compliance and safety monitoring roles, she continues to serve as the program manager for multiple trials including the Intraventricular Hemorrhage Thrombolysis trial, managing 15 sites from 2003 to 2006; the EQUIGEN Chronic Dose and Single Dose trials, managing six CTSA centers from 2012 to 2015; the HeadSense Medical trial for FDA approval of a non-invasive intracranial pressure device, managing six centers from 2014 to 2016; and the Independent Oversight Committee for the ATACH II trial, reviewing the first three subjects at each site for protocol compliance and intensity as well as safety monitoring.
- Steve Mayo, PD, CCRA, PMP
- Director of Quality Assurance, Brain Injury Outcomes
Steven W. Mayo is the founder and president of Emissary International, LLC, a contract research organization providing clinical trial management services in North America and Europe. After starting his career as a retail and hospital pharmacist, he entered the pharmaceutical industry in 1987 as a Clinical Research Associate and was quickly promoted to a management position with international responsibilities. During this time, Dr. Mayo was the project manager for the company's hypertension program and was also instrumental in the development of new drugs for congestive heart failure, obesity, diabetes, burns, pain, and hypothyroidism. He also led the protocol and case report form committees, chaired an international data standards group, headed a group responsible for adverse event and concomitant medication coding, and championed the introduction of innovative new technologies designed to speed the clinical research process (EDC, fax retrieval, OCR, CTMS).
Dr. Mayo founded Emissary in 1995 and now manages an international team of clinical trial professionals involved in clinical study monitoring, project management, clinical data management, regulatory affairs, and medical writing. Under his guidance, Emissary has remained profitable each year while rapidly growing into an internationally respected operation, ranking among the top contract research organizations worldwide. In 2008, Emissary and Johns Hopkins Brain Injury Outcomes (BIOS), an academic research organization, established a long-term strategic collaboration. Emissary’s clinical research associates provide monitoring support on the trials conducted via this collaboration
- David Newman-Toker, MD, PHD
- Professor of Neurology, Ophthalmology and Otolaryngology
- Director, Division of Neuro-Visual and Vestibular Disorders, Department of Neurology
- Director, Armstrong Institute Center for Diagnostic Excellence
- Core Faculty, BIOS Clinical Trials Unit; Co-Investigator, Johns Hopkins-Tufts Trial Innovation Center
Dr. David E. Newman-Toker is an internationally recognized leader in neuro-otology, acute stroke diagnosis, and the study of diagnostic errors. He completed his undergraduate studies at Yale University, his medical degree at University of Pennsylvania, his residency training at Harvard University, and his doctoral degree in clinical research methods at the Johns Hopkins Bloomberg School of Public Health. He has served as a full-time faculty member at the Johns Hopkins University School of Medicine since 2002. He is Professor of Neurology, Otolaryngology, and Ophthalmology, with joint appointments in Emergency Medicine, Acute Care Nursing, Health Sciences Informatics, Epidemiology, and Health Policy and Management.
Dr. Newman-Toker’s clinical focus is in diagnosis of acute disorders affecting the brainstem and cranial nerves, particularly stroke. His research mission is to achieve better outcomes through better diagnosis. He has been the principal investigator for multiple NIH, AHRQ, and foundation grants. He has published over 100 journal articles and given more than 200 invited lectures on dizziness and diagnostic errors. He is a leader in the national movement to eliminate patient harms from diagnostic error. Dr. Newman-Toker directs the Johns Hopkins Center for Diagnostic Excellence that seeks to catalyze efforts to improve diagnostic performance, develop the science of diagnostic safety, and enhance diagnostic research. He is a founding member of the Society to Improve Diagnosis in Medicine (SIDM) and serves as Vice President of SIDM’s Board of Directors as well as Chair of SIDM’s Policy Committee.
- James F. Casella, MD
- Rainey Professor of Pediatric Hematology
- Chief of the Division of Pediatric Hematology
Dr. James Casella received his medical degree from SUNY-Upstate Medical Center and completed his residency in pediatrics at the Johns Hopkins University School of Medicine, where he was subsequently a fellow in hematology/oncology, and joined the Hopkins faculty. Early in his career, Dr. Casella discovered and characterized the actin-capping protein Cap Z, which plays a fundamental role in cell biology.
He has been the Chief of Pediatric Hematology since 1997. He is also the Director of the Maryland Comprehensive Hemophilia Treatment Center and the Basic and Translational Program in Sickle Cell Disease at Johns Hopkins Hospital. Dr. Casella has been awarded the Alexander "Buck" Schaffer Award for Outstanding Contribution to the Teaching of House Officers. He is one of the founders and co-director of the JHU/NCI Pediatric Hematology/Oncology Fellowship Program and is an adjunct senior investigator at the National Cancer Institute. He is the director of the NHLBI-funded K12 Career Development in Benign Hematology program at Johns Hopkins that trains young clinical investigators in benign hematology and transfusion medicine.
Dr. Casella is currently involved in basic and translational research to understand neurologic injury in sickle cell disease (SCD), and has participated in the development of numerous clinical trials to test treatment to prevent complications of SCD, including BABY HUG, SIT, STOP II, and the EPIC Trial. He is the PI for the NHLBI-funded HU Prevent Study “Hydroxyurea to Prevent CNS Complications in Children with Sickle Cell Disease.”
- Rick Thompson, PhD
- Biostatistician for the NCATS-funded JHU-Tufts Trial Innovation Center (TIC)
Richard “Rick” Thompson’s field of expertise is in the area of Biostatistics and Data Analysis. He is a Senior Scientist in the Department of Biostatistics at the Johns Hopkins Bloomberg School of Public Health. He has also served in leadership roles in the Johns Hopkins Biostatistics Center (Assistant Director and Executive Director) and the Johns Hopkins Institute for Clinical and Translational Research (Managing Director).
During his 18-year tenure as a faculty member at Johns Hopkins, Dr. Thompson co-authored over 100 peer-reviewed papers in several fields of clinical and translational research, including neurology, surgery, pediatrics, cardiology, radiology, gastroenterology and medical genetics. In addition, he is currently the PI of the Data Coordinating Center for the Minimally-Invasive Surgery Plus t-PA for Intracerebral Hemorrhage Evacuation (MISTIE) study, a phase III, international, multi-site clinical trial testing the effect of novel, minimally-invasive surgical techniques for the treatment of hemorrhagic stroke. In this capacity, Dr. Thompson provides oversight and guidance on all statistical aspects of this trial, from study design to publications. In addition, he was the lead statistician for the recently completed Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR) phase III trial.
- Constantine Frangakis, PhD
- Professor of Biostatistics at the Johns Hopkins Bloomberg School of Public Health
Dr. Constantine Frangakis develops designs and methods of analyses to evaluate treatments in medicine, public health and policy (causal inference). The increased quality and number of available treatments, and increasing ethical and practical constraints, are transforming the field of intervention research: the factors of research interest are no longer (and correctly so) the same as factors that we can intervene on humans. To address this, we have been developing new designs and methods for partially controlled studies, studies that explore the factors that can be controlled, in order to investigate the effects of the factors of research interest.
Andrew Mould, MPH
As a project manager, Andrew Mould supports investigators through the entire project cycle, from grant writing and development through trial implementation and closeout. Andrew has managed several NIH- and industry-sponsored trials focusing on neurological disorders. With his background in neuroimaging, he also manages the Brain Injury Outcomes NeuroImaging Center (BIONIC). His team assesses all CTs and MRIs for qualitative and quantitative metrics across BIOS brain hemorrhage and traumatic brain injury studies. He has a specific research interest in perihematomal edema and has presented his work at multiple international conferences.
Research Program Assistant
Christina Grabarits is a Research Assistant for the Brain Injury Outcomes NeuroImaging Center (BIONIC) as of May 2017. Her responsibilities include assessing volumetric and qualitative measures for brain hemorrhages within the MISTIE-III trial and managing the sample collections for the MISTIE-III substudy, MTI-M3. She is also a part of the Communications Team for multiple TIC projects. With a B.S. in Psychology and Neuroscience from Syracuse University, she hopes to further her career within BIOS.
Cindy MacInnis, MBA, CCRP
Research Services Navigator for the NCATS-funded JHU-Tufts Trial Innovation Center (TIC)
Cindy MacInnis oversees research services projects for TIC projects receiving Central IRB and standard agreements services and is responsible for managing trial innovation center project workflow between principal investigators, participating sites, IRB and research administration. She has over 14 years of clinical research management experience. Prior to working with the JHU-Tufts TIC, she liaised between Johns Hopkins University and Greater Baltimore Medical Center to facilitate expanding university-led research to the community hospital setting and support cross-institutional investigator collaborations with the Johns Hopkins Clinical Research Network. She also managed the medical oncology clinical trials program at the Berman Institute at GBMC, overseeing 50 active studies and the department’s research team staff.
Ms. MacInnis earned a bachelor’s degree in biological sciences from University of Maryland Baltimore County in 2004 and a master’s degree in Business Administration from Johns Hopkins Carey Business School in 2017.
Daniel Amirault is a Research Assistant for the Brain Injury Outcomes (BIOS) division. Since joining BIOS in September of 2018, his main responsibilities include project support, management of central IRB documents and agreements in online repositories, and assisting in the preparation of IRB related documents. Daniel graduated from Worcester Polytechnic Institute with a B.S. in Biomedical Engineering, and is hoping to further his career and education at BIOS and Johns Hopkins University.
Hasan Ali, MPH
Research Program Supervisor of BIONIC
Hasan joined BIOS following his graduation from JHU in 2014 and is currently the Research Program Supervisor of Brain Injury Outcomes' Neuroimaging Center (BIONIC). Hasan provides oversight to research and training endeavors involving the quantitative assessment of neuroimaging received as a part of clinical trials coordinated by the BIOS Team. His research interests include traumatic brain injury, concussion, intracerebral hemorrhage, intraventricular hemorrhage, and perihematomal edema.
Jennifer Houser has been responsible for the financial management of the BIOS Coordinating Center since 2012 and for the JHU-Tufts Trial Innovation Center since its inception. She assists with the development of project budgets. She coordinates the submission of progress, financial and other sponsor required reports, as well as the submission of new grant applications. Ms. Houser received her interdisciplinary degree in math, finance and economics from the University of Arizona and has more than 20 years of experience working within the financial field.
Kevin Treine is a Research Program Manager with 20 years of research experience with the Johns Hopkins University. His expertise are in management, monitoring, and ensuring compliance with FDA regulations when working with primary investigators conducting clinical trials. He also has experience coordinating research projects funded by the NIH as well as industry sponsored pharmaceutical companies. His primary role at the Brain Injury Outcomes (BIOS) is to serve as program manager for research studies from start to finish. He coordinates research related tasks between investigators, research staff, and medical experts to ensure compliance training for human subjects research.
Lindsay Eyzaguirre, MS
Lindsay M. Eyzaguirre is a Research Program Manager with a master’s degree in epidemiology and 15 years of research experience. Her expertise is in training personnel in resource-limited settings in areas such as viral diagnostics and monitoring techniques, molecular virology techniques, biological sample management, and Human Research Compliance. She also has experience managing and coordinating research projects funded by the NIH, CDC and private companies. She brings proficiency in designing and implementing research studies, and providing guidance and technical expertise in grant writing. Her primary role at the JHU-Tufts Trial Innovation Center (TIC) is to conduct the TIN Initial and Comprehensive Consults from start to finish. She serves as the liaison between investigators, research staff, and experts.
Marianne Gildea, RN, BSN, MS, CCRC
Research Nurse Navigator
Marianne Gildea was a bedside nurse for many years in the emergency department, recovery room and pediatric intensive care unit. Her primary clinical research focus has been in trauma and pediatrics. She was a trauma research coordinator for years in a level 1 trauma center. Then she became a project manager and eventually the program director of a multi-country, multi-site clinical trial in pediatric critical care. She has been working on the Trial Innovation Network since its inception in 2016. Her main focus is overseeing the consultations, refining processes and project planning. She holds a Bachelor’s Degree in Nursing from Georgetown University and a Master’s Degree in Journalism from The Columbia University Graduate School of Journalism.
Meghan Hildreth, MS
Meghan Hildreth joined Brain Injury Outcomes (BIOS) in October 2018 as a Research Assistant in the neuroimaging reading center. Her primary duties consist of perihematomal edema segmentation for the MISTIE-III clinical trial and management of neuroimaging workflow for the AVERT clinical trial, among various other relevant tasks. Meghan graduated with her B.S. and M.S. in Neuroscience from Tulane University, and hopes to pursue a PhD in Clinical Anatomy and Neurobiology after gaining more research experience at BIOS.
Research Program Assistant
Nataly Montano is a Research Assistant for the Brain Injury Outcomes Division since June 2017. She graduated from Texas Tech University in May 2016 with a Bachelor of Science in Biology. Her main job duties include intracerebral/intraventricular hemorrhage segmentation and edema segmentation for our MISTIE-III clinical trial. She is also part of the communications team for our TIC trials. She plans on going to medical school and applying her experience at BIOS to her future medical career.
Noeleen Ostapkovich, MS
Project and QA Manager
Noeleen Ostapkovich has 31 years of experience as a research coordinator, research manager and regulatory specialist for Neuroanesthesia and Neurocritical Care research. She began working with the CLEAR projects since 2000, and came to Johns Hopkins as a member of the Brain Injury Outcomes (BIOS) team in 2012.
Radhika Avadhani, MS
Radhika Avadhani has served as a data manager for the Brain Injury Outcomes (BIOS) since December 2016. Her prior experience involves working as an analyst in both research and hospital-based setting for maintenance of standard analytics and reports, validation of the data integrity, and the summarization and distribution of analytics and statistical reports. She will continue to perform data management duties for the TIC projects.
Data Manager and Regulatory Documentation Specialist
Ryan Majkowski came to Brain Injury Outcomes in 2010 and works as a Regulatory Documentation Specialist. Within the JHU-Tufts TIC, he provides expertise to the development of the multicenter trial startup/execution team in terms of creating regulatory document requirements, structures, and processes. Within the JHU Data Management team, he works to better standardize regulatory data metrics for analysis.
Research Program Assistant
Shannon Hillery came to Brain Injury Outcomes (BIOS) in October of 2017 as a Research Program Assistant. Her responsibilities consist of project support, performance tracking, report management and distribution and more to aid in BIOS operations. She also plays a main role in the Communications Team and Study Start-Up Management team for several multicenter clinical trials. As a graduate from Towson University she enters BIOS with a background in Psychology and experience in conducting Biopsychology research. She hopes to develop her career within BIOS as well as further her education through Johns Hopkins University.
Tracey Economas, LPN, CCRP
Tracey K. Hartmann is a Senior Research Program Coordinator with 15 years of research experience with the BIOS division. She began as a study coordinator, managing NIH and industry-sponsored drug and device trials. Ms. Hartmann transitioned to a site startup specialist in the NIH-funded CLEAR III trial. She trained and initiated over 100 sites in the U.S. and internationally. She continued this role for the MISTIE III trial and transitioned into site management, working with U.S. and international sites. She also serves as a safety event officer for the Safety Event Committee. Her primary role at the JHU-Tufts Trial Innovation Center (TIC) is managing site startup activities.
Yi Hao, PhD
Yi Hao has been a Biostatistician for the Brain Injury Outcomes Division since April 2018. She was an independent statistician for DSMB and safety committee report in a clinical research organization. In BIOS, she’s been working on trial design, sampling size and power calculation, hypothesis testing, data description, advanced statistical analysis, statistical consultant for theory and methodology. She is also responsible for preparing and creating datasets for trials, research and publications. As a blinded DSMB statistician, she has individually created reports and data summaries for trial committee meeting. .
Ying Wang, MS
Ying Wang is a data manager with over 15 years of experience. She has master’s degree in both information systems and biology. She provided overall data management for NIH-funded collaborative genetic studies and joined the BIOS group in December 2016. Her expertise is in data management planning, database development, data ETL (extraction, transforming and loading), data reporting and web development. She will support the data management in TIC projects.