Devon Gessert is the Director of Clinical Operations at USC’s Alzheimer’s Therapeutic Research Institute (ATRI) and the Director of the Clinical Operations Unit for the Alzheimer’s Clinical Trials Consortium (ACTC).  She earned undergraduate degrees in Biology and Anthropology from the University of California, San Diego (UCSD) and a Certificate in Bioinformatics from the UCSD Extension.  

Ms. Gessert began her career in the Alzheimer’s Disease Cooperative Study’s (ADCS) Data Core in 2000, and has had the opportunity to work with a variety of groups from academia and industry across a spectrum of clinical research and in a variety of roles – in data management, software development and project management.  In her time with the Biostatistics and Bioinformatics Laboratory at UCSD, she gained experience supporting and developing data capture systems in diverse therapeutic areas beyond Alzheimer’s disease, including stroke, HIV, and multiple system atrophy.

As Director of Clinical Operations for the ADCS from 2008 to 2015, Ms. Gessert built and oversaw teams responsible for project management and data management and played a critical leadership role in helping the organization evolve into one that excelled in managing the full range of clinical studies from observational studies to early phase treatment trials to late phase registration trials sponsored by government agencies, pharmaceutical companies and public-private partnerships.  She has continued this work as the Director of Clinical Operations for the Alzheimer’s Therapeutic Research Institute (ATRI) since it was founded in 2015, building teams that have successfully transitioned into managing clinical studies with increasingly complex collaboration models, involving multiple academic groups, industry groups, CROs and vendors, in an ever-widening geographic range, currently extending from North America, to Europe, Australia, and Asia.  

Dr. Donohue co-leads the Biostatistics Unit. His primary interests include modeling the long-term, multivariate evolution of Alzheimer’s Disease, and utilizing these models to inform ACTC clinical trial design. Dr. Donohue guides the unit on the use of analytic power calculations and model-based simulations to drive clinical trial design decisions regarding sample size, duration, analysis approach, and outcome measures. He helps ensure that ACTC trials are conducted with maximum statistical power and minimum participant burden. He helped develop the first Preclinical Alzheimer’s trials, and the Preclinical Alzheimer’s Cognitive Composite (PACC). Research funded by his R01 lead to a novel hierarchical Bayesian model, the Latent Time Joint Mixed-Effects Model (LTJMM). The model can simultaneously estimate long-term trajectories of several disease markers and includes a subject-specific latent time shift parameter to account for heterogeneity in disease stage.

Michael Weiner, MD, is Co-Lead of the ACTC MRI Unit.  He is a Professor in Residence in Radiology and Biomedical Imaging, Medicine, Psychiatry, and Neurology at the University of California, San Francisco. He is Principal Investigator of the Alzheimer’s Disease Neuroimaging Initiative, which is the largest observational study in the world concerning Alzheimer’s Disease. He is the former Director of the Center for Imaging of Neurodegenerative Diseases (CIND) at the San Francisco Veterans Affairs Medical Center. After graduating from the Johns Hopkins University in 1961, he obtained his M.D, from SUNY Upstate Medical Center in Syracuse, New York in 1965, and he completed his internship and residency in Medicine from Mt. Sinai Hospital in 1967. From 1967-1968, Dr. Weiner completed a residency and clinical fellowship in Metabolism from Yale-New Haven Medical Center. In 1970, he completed a research fellowship in Nephrology from Yale University School of Medicine and a research fellowship in Biochemistry from the University of Wisconsin Institute for Enzyme Research in 1972, followed by a joint appointment in the Department of Medicine, Renal Section from the University of Wisconsin Institute in 1972. In 1974 he became an Assistant Professor of Medicine (Nephrology) at Stanford University, and in 1980 he became an Associate Professor of Medicine (Nephrology) at UCSF. In 1983, he established the Magnetic Resonance Unit at the San Francisco VA Medical Center, which became the Center for Imaging of Neurodegenerative Diseases in 2000. In 1990, he became a Professor of Radiology, Medicine, Psychiatry and Neurology at UCSF.

Dr. Weiner’s research activities involve the development and utilization of MRI and PET for investigating and diagnosing neurodegenerative diseases. In 1980, Dr. Weiner was one of the first to perform MRS on an intact animal, and subsequently pursued his goal to develop MRI/S as a clinical tool. In 1988, his group used MRS to show that the amino acid N acetyl aspartate (NAA), a marker of healthy nerve cells, is reduced in the epileptic focus in the brain. In 2004, Dr. Weiner’s group reported that reduced NAA predicts development of Alzheimer’s disease in mildly impaired elderly subjects. During the past 25 years he has worked to develop and optimized the use of MRI, PET, and blood based biomarker methods to diagnose Alzheimer’s disease and other neurodegenerative disorders. Also, Dr. Weiner’s research focuses on monitoring effects of treatment to slow progressions in Alzheimer’s disease, and detecting Alzheimer’s disease early in patients who are not demented, but risk subsequent development of dementia. He is the Principle Investigator of the Alzheimer’s Disease Neuroimaging Initiative, a 14-year national longitudinal study of over 1,500 subjects which is aimed at validating biomarkers for Alzheimer’s disease at 60 sites across the USA and Canada for cognitive testing, MRI, PET, and lumbar puncture. He also launched the BrainHealthRegistry.org which is an internet based registry with the overall goal of accelerating development of effective treatments for brain diseases. This website registry recruits, screens, and longitudinally monitors brain function on more than 60,000 participants. His overall research goals are to participate in the development of effective treatments and methods for early detection of Alzheimer’s disease and other brain disorders. Recently he has focused on developing inexpensive, scalable, tools to identify normal elders at risk for cognitive decline and dementia, and to provide the Brain Health Registry software to facilitate the work of other investigators. Dr. Weiner has mentored over 120 postdoctoral fellows, has authored more than 860 peer-reviewed research papers and 62 book chapters. He holds 19 separate research grants. He has received numerous honors including the Middleton Award for outstanding research in the Veterans Administration, the Ronald and Nancy Reagan Award for research from the Alzheimer’s Association, and the Potamkin Prize for research in Picks Disease, Alzheimer’s disease, and other neurodegenerative disorders from the American Association of Neurology and the American Brain Foundation.

Gustavo Jimenez-Maggiora, MBA, is the Director of Informatics for the Alzheimer’s Therapeutic Research Institute (USC ATRI), Keck School of Medicine, at the University of Southern California, providing the informatics leadership for all research programs conducted and managed by the Institute. As an informatician with an applied research interest in the field of neurology, he provides the informatics leadership as a co-investigator on several national and international initiatives and programs.

Gustavo is the Director of the Alzheimer’s Clinical Trials Consortium (ACTC) Informatics Unit. He leads the development of the ACTC Informatics Platform (ACTC-IP) to support the ACTC program and its scientific aims. The ACTC-IP serves as an extensible, secure, and scalable information, collaboration, and process management infrastructure to facilitate the effective execution of program- and study-related research activities by ACTC Units, investigators, study teams, and performance sites. The ACTC-IP provides facilities to collect, store, process, analyze, visualize, audit, and share scientific, operational, and administrative data using standardized data models, formats, and taxonomies.

Gustavo also serves as the informatics lead for the Alzheimer’s Disease Neuroimaging Initiative (ADNI) Clinical Core, the informatics co-Director for the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), and the lead informatician for the Trial-Ready Cohort for Preclinical/Prodromal Alzheimer’s Disease (TRC-PAD).

Dr. Rissman is the founding Director of the ATRI Biomarker Laboratory and Biorepository, and ACTC Biomarker Unit Lead. The facility is comprised by a wet laboratory and a large biorepository of -80 freezers to store specimens from clinical trials and longitudinal cohort studies. Using single analyte and multiplex bioassays, the goal of the lab is to identify biomarkers for preclinical AD and better understand how treatment parameters may impact these biomarkers. Concurrently with work at ATRI, Dr. Rissman is a PI at the VA San Diego, Professor of Neurosciences at UC San Diego and leads the ADCS Biomarker Core and ADRC Neuropathology Core.

The goal of Dr. Rissman’s basic science research is on novel biomarker discovery in Alzheimer’s Disease (AD) and preclinical studies in experimental. A major focus of his lab in AD biomarkers is on the utility and mechanistic underpinnings of neuronal exosomes and his group has published manuscripts demonstrating the ability of tau and abeta in neuronal exosomes to predict conversion from MCI to AD. The lab also investigate the contribution of stress and changes in stress signaling intermediates in Alzheimer’s disease neuropathology. Using transgenic mice and in vivo pharmacology, experiments are focused on identifying the role of corticotropin-releasing factor (CRF) receptors in beta-amyloid deposition, tau phosphorylation and behavioral and synaptic changes.