Drug Development In Psychiatry

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. 

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. 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.

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.