Professional Biography of Dr Charles M Beasley Jr MD

Professional Biography of Dr Charles M Beasley Jr MD

Dr. Beasley was born in Tokyo, Japan in 1950. He completed his undergraduate degree in psychology at Yale University in 1977, having done substantial additional course work at the graduate level in computer science.

Following graduation in 1977, he was employed as a research programmer in an artificial intelligence project in the Department of Psychology at Yale under the direction of John R. Anderson, Ph.D. (1977-1978) and later in the development of database management systems for the evoked potentials laboratory of Donald Goff, PhD, Department of Neurology, Yale University School of Medicine (1978-1979).

Dr. Beasley received his medical education at the University of Kentucky, graduating in 1983 with high distinction. He was elected to AΩA (medical honor society) and president of his AΩA chapter in his third year. He received the American Medical Association Education and Research Foundation Rock Sleyster Memorial Scholarship during his senior year. His internship was in the Department of Psychiatry, Yale University School of Medicine. He moved with his dermatologist spouse, Rebecca L. Bushong, M.D., to the University of Cincinnati where he completed his residency in general psychiatry in 1987. In his fourth year of residency, he was named a Laughlin Fellow by the American College of Psychiatrists. He received board certification in general psychiatry in 1988.

After completing residency, Dr. Beasley joined Eli Lilly and Company in July 1987 as an Associate Clinical Research Physician. His career in clinical psychiatric research and pharmaceutical development has covered over 27 years with Lilly with promotions to Research Physician, Senior Research Physician, Research Advisor, Lilly Research Fellow and, in 2004, Distinguished Lilly Scholar (the most senior title within the Lilly academic track promotions system and equivalent to Vice-President). He retired from Lilly in April, 2015.

Dr. Beasley’s initial work with Lilly was in Phase IV research with fluoxetine (Prozac®) and he had primary medical responsibility for this compound through 1991. He developed and executed 10 Phase IV studies, including a long-term maintenance-continuation study that is one of the most often cited studies of serotonin reuptake inhibitor clinical activity in the academic literature. During this period, he also had primary medical responsibility for Phase III research (3 studies) with atomoxetine (Strattera®; generic name at that time was tomoxetine) that at the time was being studied as a potential antidepressant. During this period, the work with fluoxetine and tomoxetine lead to extensive involvement with the topics of: 1) placebo response in randomized clinical trials with potential psychotherapeutic medications; and 2) the potential relationship between antidepressants and suicidal ideation and behavior.

From 1991 through 1996, Dr. Beasley had primary medical responsibility for the worldwide development of olanzapine (Zyprexa®) for its initial indication as an antipsychotic medication. This development was based on 5 Phase III studies that he conducted. One of these, at the time it was conducted, was the largest single, prospective, randomized clinical trial in psychopharmacology, including 1996 patients. He designed and wrote major sections of the NDA and European submission documents that resulted in regulatory approval of olanzapine in the US (including negotiation of final product labeling) only 13 months after the submission of the NDA and simultaneous European (EMEA) approval.

From 1997 through 2001 Dr. Beasley was primarily involved in the ongoing evaluation of the safety of olanzapine, the development of olanzapine as an antipsychotic in Japan, the development of additional olanzapine formulations, and studies supporting registration of additional indications for olanzapine. He also served the role of team leader for a molecule with activity at the metabotropic glutamate receptor 2 as a potential anxiolytic agent. Additionally, he consulted across a broad range of both safety topics and efficacy matters in neuroscience as well as other therapeutic areas.

In July of 2001, Dr. Beasley became Medical Director for the tadalafil (Cialis®) product team, shortly after the international regulatory submissions for the indication of erectile dysfunction had been filed. During his medical directorship, a number of additional Phase I studies for tadalafil were required along with one additional Phase III efficacy study prior to regulatory approval. He participated extensively in the design of these studies. One of these studies was the first of two “Thorough QT (TQT) Studies” to ever be required by a regulatory agency. The objective of a TQT study is to study in a very sensitive manner whether a drug candidate results in any delay in the electrical repolarization of the ventricular heart muscle that can be a potential risk factor for a cardiac arrhythmia. These studies are now a standard pre-approval requirement. Since that time, he has been involved in the design and analyses of these studies.

In January of 2003, with tadalafil approved in Europe and all studies necessary for U.S. approval completed or well under way, Dr. Beasley assumed a consultative position across both program phase and product team phase neuroscience compounds as well as consulting on compounds outside neuroscience.

In May of 2004, Dr. Beasley moved from the neuroscience medical area to a special technical consulting position within Lilly’s Global Patient Safety Organization where he continued his functional activities with even greater emphasis on a broad range of safety matters and the development of standardized methods of analysis and review. During his last 10 years with Lilly, his internal activities in safety included: 1) in-depth involvement in the development of analyses and reports pertinent to many topics of special interest for a number of compounds; 2) developing a standardized approach to both the formal analyses and cognitive processing of the extensive quantities of diverse safety data accumulated in an initial development program in order to propose those events and numerical data findings that potentially constitute adverse reactions for the purpose of product labeling; 3) special, intensive due diligence reviews of molecules with regard to safety matters of interest as well the probability of the ability to convincingly demonstrate efficacy; and 4) in-depth review of statistical methods for development of reference limits that define outliers for continuous numerical safety data (e.g., laboratory analyte results, vital sign measurements) and their application in developing such limits optimized for comparisons of treatment group incidences of outliers in randomized clinical trials. He has also served on the internal Lilly committee for the implementation of CDISC case report form standards.

During Dr. Beasley’s last several years at Lilly, external involvement included a variety of activities such as: 1) participation as the primary clinical author of the CFAST Therapeutic User’s Guide for QT studies during 2013-2014 (a guidance document for the conduct of a TQT study and storage of the study data in a CDISC compliant database structure); 2) participation with a group of pharmaceutical industry statisticians in developing standardized statistical analyses and formats for statistical results tables and figures for TQT studies during 2014.

Throughout his career, Dr. Beasley has published 100 peer-reviewed journal articles, principally concerning various aspects of fluoxetine and olanzapine. Additional publications are in the areas of TQT study results, aspects of the QT interval pertinent to TQT study design, and safety assessment methods related to randomized clinical trial data. He is an inventor of record on eight patents for olanzapine. He is a member of AΩA, the American Psychiatric Association (elevated to Fellow in 2012, Life Fellow in 2015, and Distinguished Life Fellow in 2016), the American College of Neuropsychopharmacology (served as a committee chairperson 2009-2010; elected to Fellow in 2011), and the American College of Psychiatrists (elected to Fellow in 2012). He is also a Fellow of the American Society for Clinical Psychopharmacology and a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.

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