Drug Development in Psychiatry

ISBN-13: 9783031210532 / Angielski / Twarda / 2023 / 519 str.

Matthew Macaluso; Sheldon H. Preskorn; Richard C. Shelton

Opis

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 observationb.       The last 50 years – refined targeting of CNS drugs without the discovery of mechanistically new drugsc.       The future – the discovery and development of mechanistically new drugs. The examination of new targets, genetics and biomarkers. 

Spis treści

Contents

1.       Chapter 1: Drug Development in Psychiatry: The Long and Winding Road from Chance Discovery to Rational Development

Author: Sheldon H. Preskorn

2.       Chapter 2: The History of Drug Development in Psychiatry: A Lesson in Serendipity

Author: Abhishek Wadhwa, MD* (Corresponding author)

3.       Chapter 3: The Evolving Role of Animal Models in the Discovery and Development of Novel Treatments for Psychiatric Disorders

Author: Laura Teal, Shalonda Ingram, Michael Bubser, Elliott McClure and Carrie K. Jones* (Corresponding author)

4.       Chapter 4: Discovery and Development of Monoamine Transporter Ligands

Author: Dr Mortensen* and Dr. Aggarwal* (*Corresponding authors)

5.       Chapter 5: Drug Development for New Psychiatric Drug Therapies

Author: M. Lynn Crismon (Corresponding author), Janet Walkow, Roger Sommi

6.       Chapter 6: Post-Approval Research in Drug Development: Priorities and Practices

Author: David Williamson (Corresponding author), Jack Sheehan, and Ella Daly

7.       Chapter 7: Discovery of new transmitter systems and hence new drug targets

Author: Tiffany Schwasinger-Schmidt (Corresponding author) and Sheldon Preskorn

8.       Chapter 8: Reverse engineering drugs

Author: Tiffany Schwasinger-Schmidt (Corresponding author) and Sheldon Preskorn

9.       Chapter 9: Back to the Future of Neuropsychopharmacology

Author: Anton Bespalov (Corresponding author), Marcel van Gaalen, Thomas Steckler

10.   Chapter 10: Targeted Treatments for Fragile X Syndrome

Author: Devon Johnson MD (Corresponding author), Courtney Clark BS, Randi Hagerman MD

11.   Chapter 11: The Difficult Path to the Discovery of Novel Treatments in Psychiatric Disorders Diseases

Author: Valentin K. Gribkoff* and Leonard K. Kaczmarek* (*Corresponding authors)

12.   Chapter 12: Biomarkers in Psychiatric Drug Development: From Precision Medicine to Novel Therapeutics

Author: Rudy Lozano Carreon, M.D., Ana Maria Rivas-Grajales, M.D., Nicholas Murphy, Ph.D., Sanjay J. Mathew, M.D., Manish K. Jha, M.B.B.S. (Corresponding author)

13.   The role of fMRI in drug development: an update

Author: Owen Carmichael (Corresponding author)

14.   Monoamine Oxidase B (MAO-B): A Target for Rational Drug Development in Schizophrenia Using PET Imaging as an Example

Author: Kankana Nisha Aji, Jeffrey H. Meyer, Pablo M. Rusjan , Romina Mizrahi (Corresponding author)

15.   Genomics in Treatment Development

Author: Yogesh Dwivedi, PhD and Richard C. Shelton, MD (Corresponding author)

16.   Increased Inflammation and Treatment of Depression: from Resistance to Reuse, Repurposing and Redesign

Author: Jennifer C. Felger, Ph.D., M.S. (Corresponding author)

17.  Experimental medicine approaches in early phase CNS drug development

Author: Brett A. English (Corresponding author) and Larry Ereshefsky

O autorze

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

Blurb

This new book reviews clinical trial methodology as it pertains to drug development in psychiatry. The authors will describe the process of drug development in psychiatry from discovery through marketing with the help of clinically relevant examples. The history of drug development in psychiatry is explored dating back to the era of serendipitous discovery and culminating in an era of new and highly focused targets. The book will delineate how drug development in psychiatry has changed and adapted with the discovery of drugs with novel mechanisms of action. Drug Development in Psychiatry 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 charts the early years of drug discovery by chance observation, reviews the developments of the past 50 years of refined targeting of CNS drugs without the discovery of mechanistically new drugs, and looks to the discovery of mechanistically new drugs, the examination of new targets, genetics, and biomarkers.