- Daniel F. Hanley, MD
- Division Director, BIOS
- PI, Johns Hopkins-Tufts Trial Innovation Center
- Deputy Director for Support and Innovation in Multicenter Trials, Johns Hopkins Institute for Clinical and Translational Research
- Jeffrey and Harriet Legum Professor of Acute Care Neurology
- Professor of Neurology, Neurosurgery, and Anesthesiology/Critical Care Medicine, Johns Hopkins University School of Medicine
A leading expert on multiple types of brain injury, Daniel F. Hanley has been a professor of neurology, neurosurgery, and anesthesiology/critical care medicine at the Johns Hopkins University School of Medicine since 1996. In 1999, he founded and became director of the Division of Brain Injury Outcomes and was named the Jeffrey and Harriet Legum Chair of Acute Care Neurology. 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’s 35 years in medicine have centered on the areas of clinical trial design, organization and interpretation of drug and device trials, development of strategic research plans, and FDA regulatory compliance. He was the principal investigator for the NIH-sponsored MISTIE III and CLEAR III trials investigating minimally invasive neurosurgical techniques to treat hemorrhagic stroke. As the principal investigator for the National Center for Advancing Translational Sciences (NCATS) Johns Hopkins-Tufts Trial Innovation Center, Dr. Hanley leads collaborative efforts to advance education and therapeutics via well-designed and innovative CTSA clinical trials.
Dr. Hanley has received more than 70 clinical and basic research grants, predominately from the National Institutes of Health and the FDA Orphan drugs program. He has published more than 300 articles in peer-reviewed journals, mentored nearly 100 researchers, and received the Humboldt Research Award for his accomplishments in brain injury research. His trainees have led more than 25 brain intensive care units across the United States, and more than 40 have been named full professors, research program leaders, or department chairs. He has had broad leadership and fiduciary experience as principal investigator of three clustered UO1 awards as well as serving on public boards, including the American Academy of Neurology, National Stroke Association, NIH National Institute of Nursing Research, NMT Medical, and Cereneo Center for Neurology and Rehabilitation.
- Karen Lane, CCRP
- Assistant Professor of Neurology
- Administrative Director of Research, BIOS
Karen Lane 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 45 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 NCATS Trial Innovation Network.
- Nichol McBee, MPH, CCRP
- Division Manager, BIOS
Nichol McBee has been an integral part of BIOS 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 division manager, she has direct oversight of day-to-day operations and human resources, and she provides input into overall project forecasting and staff capacity needs. She also serves as the project administrator of the Johns Hopkins-Tufts Trial Innovation Center, an NIH/NCATS program award to develop, demonstrate, and disseminate innovations for clinical trial efficiency.
In addition to these leadership roles, Nichol supervises the data management core, medical monitoring processes, central adjudication of safety endpoints, and regulatory documents specialists. She is an on-call resource to site managers and clinical teams during randomizations, and she serves on multiple protocol development committees. Nichol is responsible for implementing and maintaining quality assurance and quality control systems by managing SOP production to ensure 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 and the management of the Brain Hemorrhage Thrombolysis clinical trial program since 1995.
- Steve Mayo, PD, CCRA, PMP
- Director of Quality Assurance, BIOS
Steven W. Mayo is the founder and president of Emissary International, a contract research organization that provides 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 and was quickly promoted to a management position with international responsibilities. During this time, he was 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 BIOS 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, Johns Hopkins University School of Medicine
- 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 a 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 and research focus is in diagnosis of acute disorders affecting the brainstem and cranial nerves, particularly stroke. He leads the Division of Neuro-Visual and Vestibular Disorders in the Department of Neurology. He also directs the Armstrong Institute Center for Diagnostic Excellence, whose mission is to catalyze efforts to improve diagnostic performance, develop the science of diagnostic safety, and enhance diagnostic research. He has been the principal investigator for multiple NIH, AHRQ, and foundation grants. Dr. Newman-Toker 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 and international movements to eliminate patient harms from diagnostic error. He has served as an expert consultant on diagnostic safety and quality to AHRQ, the National Quality Forum, and the National Academy of Medicine. He is the 2018-2020 president of the Society to Improve Diagnosis in Medicine (SIDM).
- James F. Casella, MD
- Rainey Professor of Pediatric Hematology
- Chief, Division of Pediatric Hematology
The chief of pediatric hematology at Johns Hopkins Children's Hospital since 1997, Dr. James Casella is director of the Basic and Translational Research Program in Sickle Cell Disease, Comprehensive Sickle Cell Center and the Maryland Hemophilia Treatment Center at Johns Hopkins. He co-founded and co-directs the JHU/NCI Pediatric Hematology and 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, which trains young investigators. Early in his career, he discovered and characterized the actin-capping protein Cap Z, which plays a fundamental role in cell biology.
Dr. Casella is involved in basic and translational research to understand neurologic injury in sickle cell disease, and has participated in the development of numerous clinical trials to test treatment to prevent its complications, including BABY HUG, SIT, STOP II, and the EPIC Trial. He is the PI for the NHLBI-funded HU Prevent (Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease) trial.
- Richard Thompson, PhD
- Biostatistician, JHU-Tufts Trial Innovation Center
- Senior Scientist, Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health
Rick Thompson’s expertise is in biostatistics and data analysis. A senior scientist in the Department of Biostatistics at the Johns Hopkins Bloomberg School of Public Health, he has served in leadership roles in the Johns Hopkins Biostatistics Center and the Johns Hopkins Institute for Clinical and Translational Research.
During his 21-year tenure as a faculty member at Johns Hopkins, Dr. Thompson has co-authored over 140 peer-reviewed papers in several fields of clinical and translational research, including neurology, surgery, pediatrics, cardiology, radiology, gastroenterology, and medical genetics. In addition, he was the PI of the data coordinating center for the MISTIE III study, an international multisite phase 3 clinical trial testing the effect of novel, minimally invasive surgical techniques for the treatment of hemorrhagic stroke. In this capacity, Dr. Thompson provided 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 3 trial.
- Constantine Frangakis, PhD
- Professor of Biostatistics, 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 in humans are no longer (and correctly so) the same as the factors in which we can intervene. To address this, Dr. Frangakis and colleagues are 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.
Since joining BIOS in September 2018, Daniel Amirault’s main responsibilities have included 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 BS in biomedical engineering, and he looks forward to furthering his career and education at BIOS and Johns Hopkins University.
Radhika Avadhani, MS
Radhika Avadhani has served as a data manager for BIOS since December 2016. Her prior experience includes working as an analyst in both research and hospital-based settings for maintenance of standard analytics and reports, validation of the data integrity, and the summarization and distribution of analytics and statistical reports. She performs data management duties for the TIC projects.
Shervin Badihian is a postdoctoral research fellow in the Department of Neurology, Division of Neuro-Visual and Vestibular Disorders. His main responsibilities for the AVERT project include managing final diagnosis adjudication committee (FDAC) meetings, troubleshooting, coordinating AVERT fellow reviews during recruitment, and handling some technical tasks in coordination with the AVERT IT team. He also works on other research projects in the field of neuro-vestibular disorders and diagnostic errors in medicine.
Amanda Bistran-Hall has 12 years of research experience with the BIOS Division. She was the project manager for the ICES and MISTIE II Trials and served as site manager for the CLEAR III and MISTIE III trials. She was also a monitor for Edge Pharmaceutical’s Newton 2 trial. Amanda’s expertise is in sponsor-to-site communications, where she manages the BIOS communications team, and she also is responsible for monthly webinars, newsletters, and website maintenance. In addition to communications, she is currently serving as a site manager for the VICTAS trial.
Senior Administrative Coordinator
Jamie Braun provides administrative support for Dr. Daniel Hanley and Karen Lane, as well as the JHU-Tufts TIC. She was an integral part of the organizing committee for the World IntraCranial Hemorrhage (WICH) conference in 2017. Prior to joining BIOS in 2014, she maintained support roles in the travel management program for a global marketing services and consulting firm in the Washington, D.C., area. Jamie received her certification in professional travel management from Florida Atlantic University and a professional administrative assistant certificate from Johns Hopkins University. Outside of BIOS, her life revolves around family and community. When not attending her children’s sporting and school events, she volunteers and serves on the board of a local youth sports organization and community association.
Tracey Economas, LPN, CCRP
Tracey K. Economas 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. She transitioned to a site startup specialist in the NIH-funded CLEAR III trial, for which 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, and also served as a safety event officer. Her primary role at the JHU-Tufts TIC is managing site startup activities.
Lindsay Eyzaguirre, MS
With 17 years of research experience and a master’s in epidemiology, Lindsay Eyzaguirre’s primary role is to conduct initial and comprehensive consults from start to finish for the JHU-Tufts TIC. She serves as the liaison between investigators, research staff, and experts. An author of 30 peer-reviewed scientific manuscripts, Lindsay’s expertise is in managing and coordinating research projects, leading collaborations with internal/external collaborators, communicating with sponsors (e.g., NIH, CDC, private foundations), producing reports and scientific publications, preparing presentations for scientific meetings, and providing guidance and technical expertise in grant writing. She also has experience 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.
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 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.
Research Program Coordinator
Christina Grabarits joined BIOS in May 2017. Her responsibilities include screening and enrolling patients for the AVERT and TIMELESS clinical trials, as well as ensuring the research protocols are followed. She recruits and performs assessments in the emergency department and neuro-ICU. In her previous role in the Brain Injury Outcomes NeuroImaging Center, she assessed volumetric and qualitative measures for brain hemorrhages within the MISTIE III trial and managed the sample collections for the MISTIE III substudy, MTI:M3. She also was a member of the communications team for multiple TIC projects. With a BS in psychology and neuroscience from Syracuse University, she hopes to further her career within BIOS.
Yi Hao, PhD
Yi Hao joined BIOS as a biostatistician in April 2018. She was an independent statistician for the DSMB and safety committee report in a clinical research organization. At BIOS, she works on trial design, sampling size and power calculation, hypothesis testing, data description, advanced statistical analysis, and statistical consultation 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 meetings.
Meghan Hildreth, MS
Meghan Hildreth joined the Brain Injury Outcomes NeuroImaging Center (BIONIC) in October 2018. 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 BS and MS in neuroscience from Tulane University and hopes to pursue a PhD in clinical anatomy and neurobiology after gaining more research experience at BIOS.
Shannon Hillery came to BIOS in October 2017. Her responsibilities consist of project support, performance tracking, report management and distribution, and other assistance 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 of 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.
Jennifer Houser has been responsible for the financial management of BIOS 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. Jennifer 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.
Mani Keita is a research assistant at BIOS and doctoral student in health services research at the Johns Hopkins Bloomberg School of Public Health. At BIOS, she conducts economic evaluations of diagnostic strategies for reducing missed strokes and assists with analyses on equity and disparities in stroke research. Her doctoral research focuses on the economic and social implications of chronic disease for older adults and caregivers. She received her bachelor’s degree in public health from Johns Hopkins University.
Yunke Li, MD
Yunke Li is a research trainee from China who came to BIOS in October 2018. He is a neurosurgery fellow in West China Hospital, Chengdu, who majored in cerebrovascular disease and hemorrhage stroke research. During his year at BIOS, he has participated in several sub-projects of the MISTIE III trial and its image analysis under the guidance of Dr. Hanley. He and his colleagues have translated the MISTIE III trial results into Chinese and helped raise awareness of the trial and BIOS in China.
Cindy MacInnis, MBA, CCRP
Research Services Navigator
Cindy MacInnis oversees research services projects for TIC projects receiving central IRB and standard agreements services and manages 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. Cindy 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.
Data Manager and Regulatory Documentation Specialist
Ryan Majkowski joined BIOS in 2010 as a research program assistant and regulatory documentation monitor. Within both BIOS and the JHU-Tufts TIC, he provides expertise in the development of the multicenter trial startup/execution team by creating regulatory document requirements, structures, and processes. A member of the BIOS data management team, he works to better standardize regulatory and site startup data metrics for analysis.
Andrew Mould, MPH
As a project administrator, 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. 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.
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 in 2000 and came to Johns Hopkins as a member of the BIOS team in 2012.
Kevin Treine is a research program manager with 20 years of research experience with the Johns Hopkins University. His expertise is in management, monitoring, and ensuring compliance with FDA regulations when working with primary investigators conducting clinical trials. He also has experience coordinating NIH-funded and industry-sponsored research projects. His primary role at 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.
Ying Wang, MS
Ying Wang is a data manager with over 15 years of experience. She has master’s degrees 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 and administration, data ETL (extraction, transforming, and loading), data reporting, and web development. She supports the data management in TIC projects.
Myriha Wrencher, MBA
Myriha Wrencher supports the division leadership and BIOS team. She provides human resource coordination, coordinating the candidate interview process and managing new employee onboarding and employee training compliance. She also provides coordination of BIOS operations and TIC consultations. Myriha supports the finance core with budgets, grants, and proposal development and serves as the JHU-Tufts TIC Data and Safety Monitoring Board administrator. As the administrator, she works with DSMB chairs and principal investigators in creating meeting agendas, facilitating meeting coordination and communications, and drafting and transmitting minutes and recommendations to the PI, sponsor, and study team. She started at BIOS in February 2017 and received her MBA in 2018.