Neal R. Cutler, MD


Chief Executive Officer
Worldwide Clinical Trials

Dr. Neal Cutler is currently the CEO of Worldwide Clinical Trials, a global CRO that offers a full range of product development services to the pharmaceutical and biotechnology industries. Before this position, he was founder and director of California Clinical Trials from 1987-1999, which was one of the largest Phase I–III clinical pharmacology and investigational sites in the United States. This was expanded into a global CRO, also named Worldwide Clinical Trials, which he successfully merged into a subsidiary of UnitedHealth Group Inc.

From 2000-2006, Dr. Cutler founded and served as president and CEO of Alamo Pharmaceuticals, LLC. During this time, Dr. Cutler also developed and obtained FDA approval for a new drug to treat schizophrenia, FazaClo®, which is currently on the market today. He successfully merged Alamo into Avanir Pharmaceuticals in 2006.

Dr. Cutler is a board-certified psychiatrist and board-qualified in both neurology and clinical pharmacology. He was active at the National Institutes of Health (NIH) for over nine years, and served as deputy clinical director of the National Institute on Aging. He was previously president of the American Foundation for Clinical Pharmacology, and currently serves on a special emphasis panel review committee for the National Institute on Aging for the NIH.

Dr. Cutler has been instrumental in the design and clinical development of nearly 200 compounds in numerous therapeutic areas, with particular expertise in central nervous system disorders. He developed the revolutionary “dynabridge” and “bridging” study methodologies, which made feasible the study of the dynamic activity of a compound in the brain, and facilitated the rapid and effective development of a number of subsequent compounds.

Dr. Cutler has given several hundred international and national presentations in the fields of aging, clinical pharmacology and drug development. He has authored over 278 publications, including 9 books on the topics of clinical pharmacology, aging, Alzheimer’s disease, schizophrenia, anxiety disorders and diabetes.


Bivariate evaluation of thromboembolism and bleeding in clinical trials of anticoagulants in patients with atrial fibrillation.

Kittelson JM, Steg PG, Halperin JL, Goldenberg NA, Schulman S, Spyropoulos AC, Kessler CM, Turpie AG, Cutler NR, Hiatt WR; Antithrombotic Trials Leadership and Steering (ATLAS) Group.

Balancing Risk and Benefit in Venous Thromboembolism Trials: Concept for a Bivariate Endpoint Trial Design and Analytic Approach.

Kittelson JM, Spyropoulos AC, Halperin JL, Kessler CM, Schulman S, Steg G, Turpie AG, Cutler NR, Hiatt WR, Goldenberg NA; Antithrombotic Trials Leadership and Steering (ATLAS) Group.

Comparative effectiveness and safety of the novel oral anticoagulants: Do the pivotal clinical trials point to a new paradigm?

Spyropoulos AC, Goldenberg NA, Kessler CM, Kittelson J, Schulman S, Turpie AG, Cutler NR, Hiatt WR, Halperin JL; Antithrombotic Trials Leadership and Steering Group (ATLAS).

Improving academic leadership and oversight in large industry-sponsored clinical trials: TheARO-CRO model.

Goldenberg NA, Spyropoulos AC, Halperin JL, Kessler CM, Schulman S, Turpie AG, Skene AM, Cutler NR, Hiatt WR; Antithrombotic Trials Leadership and Steering Group.

Critical Pathways to Success in CNS Drug Development, 1st Edition.

Neal R. Cutler, John J. Sramek, Michael F. Murphy, Henry Riordan, Peter Biek, Angelico Carta.

Sertraline in Children and Adolescents With Obsessive-Compulsive Disorder –
A Multicenter Randomized Controlled Trial.

John S. March, MD, MPH; Joseph Biederman, MD; Robert Wolkow, MD; Allan Safferman, MD; Jack Mardekian, PhD; Edwin H. Cook, MD; Neal R. Cutler, MD; Roberto Dominguez, MD; James Ferguson, MD; Betty Muller, MD; Robert Riesenberg, MD; Murray Rosenthal, DO; Floyd R. Sallee, MD, PhD; Karen D. Wagner, MD, PhD.

For additional research publications please visit: https://www.researchgate.net/researcher/2047689785_Neal_R_Cutler