Maureen O’Brien

Maureen T. O'Brien is a board certified veterinary anatomic pathologist with experience in preclinical safety assessment (toxicologic pathology) of drugs and implantable medical devices. Prior to joining the Food and Drug Administration as a Veterinary Medical Officer with the Plastic Surgery, Skin, and Wound Devices Team (OHT4), she was a Senior Veterinary Pathologist at Charles River Laboratories where she was responsible for preparing reports delineating pathology findings in preclinical safety studies in a variety of animal models and guiding sponsors on the design and execution of preclinical implantable medical device studies. During this time, she chaired a working group for the Society of Toxicologic Pathology that served to translate best practices in preclinical drug safety assessment pathology for implantable devices into the manuscript, "Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies." She has authored or co-authored nine peer-reviewed publications, and has authored or co-authored twenty five poster presentations relevant to veterinary pathology. At FDA, she reviews preclinical animal study data and maintains a strong interest in safety assessment pathology practices and methodology to optimise information gleaned from nonclinical safety studies to demonstrate device safety and effectiveness.