The book reviews clinical trial methodology as it pertains to drug development in psychiatry. The reader will understand the process of drug development in psychiatry from discovery through marketing with the help of clinically relevant examples. The reader will appreciate the history of drug development in psychiatry dating back to the era of serendipitous discovery and culminating in an era of new and highly focused targets. Readers will understand how drug development in psychiatry has changed and adapted with the discovery of novel mechanism of action drugs. Novel drugs and disease targets have changed the way developers and regulatory agencies think about clinical trial methodology.
The book elucidates how biomarkers, genetics and advances in neuroscience and neuroimaging have influenced drug development approaches, which will ultimately change the practice of psychiatry. The book will be broken down into the following sections:
a. Prior to the 1960s - Drug discovery by chance observation
b. The last 50 years - refined targeting of CNS drugs without the discovery of mechanistically new drugs
c. The future - the discovery and development of mechanistically new drugs. The examination of new targets, genetics and biomarkers.
Dr. Macaluso is the Bee McWane Reid Professor and Vice Chair for Clinical Affairs in the Department of Psychiatry and Behavioral Neurobiology as well as the Clinical Director of the UAB Depression and Suicide Center. His research focus is on clinical psychopharmacology and it's translation to clinical practice with a focus on treatment resistant major depression. As clinical director, Dr. Macaluso oversees clinical trials of novel mechanism of action drugs, devices and biologics to treat patients with severe forms of depression that are not responsive to currently marketed treatments. He is a highly experienced investigator in complex clinical trials and the translational neuroscience of mood disorders and has contributed most significantly in the area of novel treatment development. Dr. Macaluso completed medical school at the University of Medicine and Dentistry of New Jersey in Stratford, NJ and graduated from the psychiatry residency program at the University of Kansas School of Medicine, where he was on faculty for 11 years before joining UAB in 2020.Dr. Preskorn is generally considered one of the world's foremost experts in psychiatric drug development research having worked with over 145 pharmaceutical, biotechnology, devices, and diagnostic companies around the work and was a principal site investigator in all antidepressants and antipsychotics marketed in a 25-year period.His overarching goal has been throughout his career to bring science to the practice of psychiatry. His research focus is on clinical psychopharmacology and its translation to clinical practice with a focus on otherwise treatment resistant psychiatric illnesses.In addition to being a consultant broadly to companies bring products to the market, he has also worked with the FDA in many different capacities.Dr. Preskorn did his basic medical training at the University of Kansas School of Medicine where he also two-year residency in anatomical pathology with a focus on neuropathology. He did his psychiatric residency at Washington University School of Medicine in St. Louis MO. During his residency, he did seminal work on the role of the locus in the brain. He has continued related work throughout his more than 40-year career in academic medicine.Dr. Shelton is the Charles Byron Ireland Professor and Co-Director of the UAB Depression and Suicide Center in the Department of Psychiatry and Behavioral Neurobiology in the Heersink School of Medicine at the University of Alabama at Birmingham. He is an internationally-recognized researcher in the areas of translational neuroscience and clinical psychopharmacology of mood disorders.Dr. Shelton founded and co-directs the UAB Depression and Suicide Center with Dr. Yogesh Dwivedi. The Center has a clinic that provides advanced treatment options for depression including esketamine, electroconvulsive therapy, and vagal nerve stimulation and it also conducts research ranging from basic molecular neuroscience and genomics to clinical applied research in mood disorders and suicide. Dr. Shelton is a translational neuroscientist and his work spans from molecules to clinical trials. Recent work has included research on genomic predictors of depression and suicide and advanced therapies for depression.Dr. Shelton graduated from the University of Louisville School of Medicine and graduated from the psychiatry residency program at the Massachusetts Mental Health Center (now part of the Brigham and Women's residency program) of Harvard Medical School in Boston. He then was a research fellow in the intramural program of the National Institute of mental Health. He was professor in the Department of Psychiatry at Vanderbilt University School of Medicine for 26 years before joining UAB in 2012