DONALD HODGES, PhD, MSc, DSP – Study Director

CELEBRATING 3 YEARS AT CBSET...A neuroscientist and safety pharmacologist with expertise in behavioral assessments, Dr. Hodges is toxicology study director for small-molecule and biologic preclinical therapeutic research at CBSET. In this role, he advises Sponsors about in vivo preclinical study design and FDA expectations. In particular, he assists Sponsors in developing safety assessment studies, including regulatory toxicology studies (GLP).


1: He has substantial experience working with Pharma and Biotech companies to develop safety assessment studies, including regualtory tox studies (GLP).

Prior to CBSET, Donald spent nearly 3 decades as a preclinically focused research scientist at prominent pharma and biotech companies, including: Vertex Pharmaceuticals, Bristol-Myers Squibb, Alkermes, and Interneuron Pharmaceuticals. At Vertex, he served as Research Scientist II for Global Research, was subsequently promoted to Non-Clinical Development Scientist II for Drug Safety Evaluation, and most recently served as Senior Scientist for Preclinical Safety Assessment. He began his professional career in 1993 at Interneuron as a Research Neuroscientist in preclinical development of the dopamine D1 receptor agonist Dihydrexidine for Parkinson’s disease, eventually leading to the discovery of a novel therapeutic application of Dihydrexidine as a cognition enhancer.

2: He has presented at numerous scientific and medical meetings.

As an acknowledged expert in the scientific interpretation of preclinical study data and the ensuing preparation of study reports that meet both published regulatory requirements and the FDA’s expectations, Donald has presented at various scientific congresses and industry sessions, including: Society for Neuroscience, Safety Pharmacology Society, and Society of Toxicology. Based in his extensive scientific understanding and industry experience, Donald is convinced that CBSET’s reputation is fortified by its expansive, GLP-compliant, AAALAC-accredited facilities that include vivaria, procedure rooms, cath/imaging labs, surgical and necropsy suites, histopathology, SEM, and a broad range of complementary technologies. “I know firsthand that CBSET is science-focused and, hence, the perfect fit for companies who are looking for a preclinical ally not only to underpin their product development efforts but also to differentiate their technology and fortify their regulatory submissions — with a single partner.”

3: He is  a well-published research scientist.

Donald earned his PhD in psychology at the University of Connecticut, his MSc degree in zoology at Texas A&M University, and his BS in biological sciences from the University of Lowell. He is a co-author of a number of published scientific papers in various publications, including: Advances in Metabolic Mapping Techniques for Brain Imaging of Behavioral and Learning Functions; Bioorganic and Medicinal Chemistry; Psycho-pharmacology; Journal of Pharmacology and Experimental Therapeutics; Behavioral Brain Research; Journal of Pharmacological and Toxicological Methods; Pharmacology, Biochemistry, and Behavior; Annals of the New York Academy of Sciences; and Journal of Biological Rhythms. He was Chair of the Continuing Education Course for the Society of Toxicology (SOT) in 2022. He has held numerous leadership roles with the Safety Pharmacology Society (SPS), including: Board of Directors, Program Committee, Continuing Education Committee (Co-Chair), and Annual Meeting (Co-Chair).

At SPS 2023, Dr. Hodges discusses the wider adoption of swine as an alternative to dogs and NHPs in the context of shortages and rising costs.