Dr. Sharlee More is a board-certified toxicologist with knowledge and experience in toxicology and human health risk assessment. At MCRA, Dr. More provides state-of-the-art device toxicology services that remain in line with current and future regulatory expectations. She is proficient in conducting toxicological risk assessments (TRA), designing and evaluating both in vitro and in vivo biological testing, compiling benefit-risk assessments, writing state of the science reviews, building and applying physiologically based pharmacokinetic models, and helping address deficiencies from US FDA and European Union (EU) notified bodies, all in accordance with international guidelines (e.g., ISO 10993 series, ISO 14971, ISO 18562 series, ICH M7, EU MDR).
Dr. More received her B.S. from the University of Wyoming and Ph.D. from the University of Pittsburgh in chemical engineering. During her time at the University of Pittsburgh, her research focused on studying the toxicity associated with metal/silica complex engineered nanomaterials using both in vivo and in vitro models. Her research aimed to understand the impact structure had on toxicity which led to the derivation of structure-toxicity correlations that can be used to design safer nanomaterials.
Prior to joining MCRA, Dr. More spent 7 years performing toxicology and human health risk assessment consulting work in a wide variety of fields including medical devices, electronic nicotine delivery systems (ENDS), and consumer products. During this time, she assisted with preparing premarket tobacco applications (PMTA) submissions to FDA, designed toxicity experiments in accordance with OECD guidelines, executed systematic literature reviews to understand toxicology and health risk of medical devices, pharmaceuticals, and consumer products, and performed qualitative and quantitative exposure and risk assessments. Dr. More has published over 30 abstracts and peer-reviewed publications on various toxicology, environmental, occupational, and risk assessment-related topics. Specifically, Dr. More is an author in a series of recent publications that review the reproductive toxicity and carcinogenic potential of Cobalt-containing alloys and evaluate their benefits and risks.
Manuscript series addressing European Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPR) pertaining to reproductive toxicity and carcinogenicity of alloys containing cobalt
Dr. Sharlee More is excited to use her knowledge and experience to assist MCRA clients with critical toxicology assessments throughout the medical device lifecycle.