Who We Are
Nonclinical Safety Solutions, LLC, is a pharmaceutical development consulting firm that provides scientific services and strategic advice on nonclinical safety testing to the pharmaceutical industry.
Dr. Thomas D. Steele has over 25 years of experience within the pharmaceutical industry, including toxicology leadership positions at Hoffmann-LaRoche, ImClone (Eli Lilly) and Ariad Pharmaceuticals, and as a Pharmacology/Toxicology reviewer at the US FDA. Tom earned his MS and PhD in Pharmacology and Toxicology from Purdue University, and received postdoctoral training at the University of Maryland and Johns Hopkins Schools of Medicine.
During his career in industry, Tom has designed and executed the nonclinical toxicology/safety assessment programs to support human testing for a vast array of novel small molecule and biological therapeutic candidates across a wide range of therapeutic areas including oncology, diabetes, neuroscience, inflammation, virology and imaging. Tom has a proven track record in addressing and troubleshooting toxicologic/safety concerns through the development of sound scientific arguments and experimental strategies. His approach is based on rapid identification and understanding of the key issues for success of individual programs, and tailoring specific studies to efficiently resolve outstanding questions. Tom has authored or co-authored the nonclinical sections of numerous successful regulatory applications (INDs, NDAs, MAAs), and peer-reviewed publications and has extensive experience working on global project teams with scientists from different disciplines and cultures, with international health authorities, and with external collaborators and service providers (CROs). While toxicology is his key strength, his experience at FDA and in Nonclinical Safety Leadership positions has provided well-rounded knowledge in affiliated disciplines including pharmacokinetics, drug metabolism and safety pharmacology. Oral and written communications are focused on delivering of clear, concise, meaningful messages. In addition to leading and executing individual development programs, Tom welcomes the challenges of specialty projects including conducting due diligences and impurity evaluations. In short, NCSS can be a one-stop resolution to meet your nonclinical pharmaceutical safety assessment needs.