Subject Matter Experts
David G. Daniel, M.D., Senior Vice President and Chief Medical Director
David Daniel provides overall scientific, clinical and strategic direction for Bracket’s Scientific Services.
Dr. Daniel was the founder and president of Global Learning, LLC, which was acquired by United BioSource Corporation in July 2006. Dr. Daniel has formerly served as Medical Director of the NIMH Neuroscience Center at Saint Elisabeth's and Director of Clinical Trials for the Stanley Foundation and was a founding principal of Best Practice, LLC.
Dr. Daniel has over 20 years' experience supervising and training raters in psychiatric clinical trials in the US and globally. He has published numerous scientific articles involving clinical trials and investigations of the psychopathology of mental illness. He has received patent protection for new treatment approaches in epilepsy, anxiety disorders and psychotic disorders.
Dr. Daniel graduated Phi Beta Kappa and Magna Cum Laude from Emory University and obtained his medical school and psychiatry post-graduate training at Vanderbilt University, where he served as chief resident. He was a medical staff fellow and senior staff fellow within the intramural program of the National Institute of Mental Health (DIRP, NIMH) for 5 years.
Joan Busner, Ph.D., Therapeutic Area Leader
Dr. Busner has over 25 years' experience as an academic clinical psychiatric researcher. She has served as the Principal Investigator for 49 industry-sponsored psychiatric clinical trials and Sub-Investigator for 35 additional clinical trials. She has served continuously on Institutional Review Boards (IRBs) for the 20 years that preceded her move to Bracket. Dr. Busner has held medical school faculty appointments since 1985 and is currently the Clinical Associate Professor of Psychiatry at Penn State College of Medicine.
Dr. Busner is an active contributor to psychopharmacology literature and has authored or coauthored over 100 peer-reviewed articles and national or international scientific presentations. She serves as Bracket’s Expert Presenter and Scientific Lead for US and multinational studies of depressive disorders, anxiety disorders, attention deficit hyperactivity disorder and all child and adolescent psychiatric indications.
She has trained thousands of psychiatric clinical trial investigators across the globe and lectures frequently on the application of objective rating scales in the assessment of diagnosis and efficacy in psychopharmacology, ethics in psychiatric research, the placebo effect in psychiatric research and techniques for its minimization, the role of IRBs and clinical trial methodology.
Dr. Busner received her Ph.D. in Experimental Social Psychology and her MA in General Psychology from Adelphi University. She is licensed to practice psychology in Pennsylvania, Missouri and New York.
David Miller, M.D., Therapeutic Area Leader
Dr. Miller has over 20 years of clinical research and teaching experience. In addition to being board certified in psychiatry, he also has added qualifications in the specialty of geriatric psychiatry. After completing his two-year fellowship in geriatric psychiatry at the University of Pennsylvania, he joined the faculty and served as an Assistant Professor of Psychiatry. Dr. Miller then went on to the University of Medicine and Dentistry of New Jersey, where he served as an Associate Professor of Psychiatry.
Prior to joining Bracket, Dr. Miller served as Chief of Geriatric Psychiatry, Medical Director of ECT and President of the Medical Staff at Friends Hospital in Philadelphia, PA. At all of these institutions, he oversaw the education and training of medical students, residents and fellows in geriatric psychiatry, and was recognized with a departmental teaching award. Dr. Miller has served as a principal investigator in a number of dementia clinical trials. In addition, he has lectured locally, nationally and internationally on his dementia-related research.
Since joining Bracket, Dr. Miller has consulted on multiple dementia protocols and has served as the expert presenter at dozens of investigators’ meetings across the globe.
Gary Sachs, M.D., Therapeutic Area Leader
Dr. Sachs is the Therapeutic Area Leader in bipolar disease and mood disorders. Dr. Sachs previously co-founded Concordant Rater Systems, a specialty provider of technologies to improve CNS clinical research. Dr. Sachs is a recognized expert clinical trialist with extensive experience in rater training and the methodologies of mood and anxiety disorder research. He has been instrumental in developing technology-based solutions for randomized controlled trials that identify correlates of high placebo response, improve signal detection and reduce the risk of failed trials.
Dr. Sachs is the founder and director of the Bipolar Clinic and Research Program at Massachusetts General Hospital (MGH) and is an Associate Professor of Psychiatry at the Harvard Medical School. After graduating from the University of Pennsylvania and the University of Maryland Medical School, he completed his residency at MGH. His areas of academic interest include psychopharmacology, chronobiology, bipolar mood disorder and development of pragmatic measure-based practice guidelines.
Dr. Sachs is Chair of the National Alliance on Mental Illness Scientific Advisory Board and serves on the Scientific Advisory Board of the Depression and Bipolar Support Alliance. He has authored over 200 articles, abstracts, books and book chapters.
Jina Swartz, M.D., Ph.D., Therapeutic Area Leader
Dr. Swartz is the Therapeutic Area Leader in neurology indications (excluding Alzheimer’s Disease), with special interest in neurodegenerative disorders (encompassing dementias and movement disorders, including Parkinson’s disease, Huntington’s disease, amyotrophic lateral sclerosis and spinocerebellar degenerations), cerebrovascular disease, infectious neurology (and HIV/AIDS), migraine, pediatric neurology and neurogenetics.
Dr. Swartz has a clinical training obtained in both South Africa and the United Kingdom, having worked as a clinician in internal medicine, neurology, infectious diseases (with a particular emphasis on tropical diseases and HIV/AIDS), pediatric surgery, plastics surgery and psychiatry.
Following the award of a post-doctoral research fellowship in 1998, she completed a PhD at the University of Cambridge in the Department of Medical Genetics at the Cambridge Institute for Medical Research (CIMR). This research explored the molecular mechanisms of neurodegeneration in cellular models of Huntington's disease. It encompassed work on apoptotic cell death pathways, protein-ubiquitination, proteasomal function, microarray technology, differential gene expression and aberrant transcriptional pathways governing such events in Huntington’s disease. The thesis entitled ‘Consequences of polyglutamine expansion mutations in cellular models of Huntington’s disease’ and the PhD was awarded in 2001. This research consolidated Dr Swartz’s expertise in Huntington’s disease, particularly from a mechanistic point of view.
Dr. Swartz’s clinical development career started in early phase work (to proof-of-concept), developing exploratory modalities, including neuroimaging, EEG, genetics and novel cognitive assessment tools, for the clinical development of new compounds for the Exploratory Medicine department in the Neurology CEDD at GlaxoSmithKline in Harlow, UK. Her areas of expertise included mainly Alzheimer’s disease and minimal cognitive impairment, vascular dementia, Parkinson's disease, stroke and, to a lesser extent, migraine, epilepsy and pain. She served as a neurology consultant to the Genetics Research department at GSK, where she was involved with several large neurology pharmacogenomic and pharmacogenetic projects.
Immediately prior to Bracket, Dr. Swartz worked at Eisai Ltd. in London as Senior Medical Director in the CNS therapeutic area, focusing on the dementia spectrum of pathologies (Alzheimer's disease, vascular dementia and Parkinson’s disease dementia), multiple sclerosis and epilepsy. While on a yearlong sabbatical from her position with Eisai, Dr. Swartz worked in Bogotá, Colombia as a consultant to the pharmaceutical industry.
Dr. Swartz has participated as an academic investigator in multiple clinical studies evaluating patients with multiple sclerosis, migraine, Alzheimer's disease, cerebrovascular disease and stroke.
In terms of clinical work, Dr Swartz previously performed sessions at the Medical Foundation for the Care of the Victims of Torture, in London, UK. This involved general medical, neurological and psychiatric assessment of victims of torture/ abuse, followed up by recommendations for ongoing therapy and the compilation of medico-legal reports for representation of these individuals in the UK courts. She currently works as an Honorary Consultant for Imperial College London, where she performs weekly clinical sessions at the West London Cognitive Disorders Treatment and Research Unit, treating patients with cognitive disorders and dementias.
Keith Wesnes, BSc Ph.D. FSS CPsychol FBPsS, Practice Leader
Professor Keith Wesnes is the Practice Leader for cognitive function assessment, work that spans across therapeutic areas.
Professor Wesnes developed and validated a computer-based cognitive assessment system (the CDR System™) from 1976 to 1986 and established its sensitivity for assessing both improvements and impairments in volunteer and patient populations. In 1986, Professor Wesnes founded Cognitive Drug Research Ltd. to offer the CDR System as a service in international clinical trials. The CDR System has become the most widely used automated method in worldwide drug development. In 2009, the CDR System was acquired by the United BioSource Corporation and is now part of the company’s offering to life science companies to facilitate the development and commercialization of their products.
Professor Wesnes graduated with First-Class BSc Honors in Experimental Psychology from Reading University in 1973, and then from 1973 to 1976 undertook an MRC-funded PhD using nicotine and scopolamine to identify the role of the brain cholinergic systems in human attention. He has held academic positions at Indiana University, Reading University, Guy’s Hospital Medical School, East London University and Bristol University. He currently holds professorships at Northumbria University (Newcastle, since 1997) and Swinburne University (Melbourne, since 2007).
Professor Wesnes became a Chartered Psychologist in 1988 and was made Fellow of the British Psychological Society in 1989 and Fellow of the Royal Statistical Society in 1983. He has published over 250 peer-reviewed papers and chapters, and nine students have received PhDs under his supervision. He belongs to numerous national and international societies and regularly sits on specialist advisory boards for various pharmaceutical companies.