Accelerating Breakthrough Discoveries into Medicines

Charles Lindamood III, PhD, DABT

Charles Lindamood III, PhD, DABT

Dr. Lindamood is a toxicology and drug development expert. He has 30 years experience in pharmaceutical and biopharmaceutical toxicology and drug development to include small and large molecules, and multiple administration routes and therapeutic areas. His expertise includes study and program design and execution, Contract Research Organization selection and oversight, regulatory submissions and health authority interactions, in-licensing reviews and due diligences.

Over his career he has addressed and resolved a wide variety of study and program findings to the satisfaction of regulatory agencies, resulting in numerous drug approvals. This diverse experience makes him uniquely qualified to advise clients on non-clinical safety findings, study designs, drug development programs, regulatory strategies, portfolio management, and business development opportunities.

Dr. Lindamood has supported business development, drug discovery, drug development, global drug registration, and life-cycle programs of approved compounds, including indication extension and new formulations. These activities involved the psychiatry, neurology, gastro-intestinal, cardiovascular, metabolic disorders, endocrine, women’s health, anti-infective, respiratory, inflammation disorders, and oncology therapeutic areas. His accomplishments included major contributions to 13 NDA / eCTD approvals to include Celexa®, Benicar®, Namenda®, Lexapro®, Bystolic®, Savella®, Daliresp®, Viibryd®, Teflaro®, Combunox®, Aerospan®, Trudorza®, and Linzess®.

Dr. Lindamood worked for over 15 years at Forest Laboratories, Inc. most recently as Executive Director, Early Development. His responsibilities included oversight of the discovery and early stage development portfolio, and full administrative and technical responsibility for the discovery, pharmacology, DMPK, toxicology, and clinical pharmacology disciplines.

Dr. Lindamood began his career at Southern Research Institute where Charles worked for 10 years as client interface and study director in the full range of toxicological studies in rodents and large animals conducted under GLP and global regulatory guidelines. Additionally, he worked for 4 years at Solvay Pharmaceuticals (now AbbVie). At Solvay, he provided the US subsidiary core expertise in pharmacology and toxicology, both investigative and regulatory, and he served as primary non-clinical liaison to the FDA for the US and all international subsidiaries.

Dr. Lindamood earned a BS in Chemistry from California State University, San Diego, and a PhD in Pharmacology and Toxicology from West Virginia University Medical Center. He did a post-doctoral fellowship at the Chemical Industry Institute of Toxicology (now Hammer Institutes). Being very active in professional development, he has held various officer and committee membership roles in professional societies and trade associations, and has assisted government institutes with grant and policy reviews.