About Monica Metea PhD

Dr. Monica Metea has over 15 years of experience spanning safety pharmacology (GLP and discovery), telemetry (cardiovascular, respiratory and EEG), regulatory toxicology, medical device development, neuroscience, and medicine. In her current role as Senior Scientist, Cardiovascular Pharmacology/Safety at Covance she provides scientific oversight for in vivo safety pharmacology and telemetry studies and staff management. She is involved in the design of studies, method development and instrumentation, also providing consultation to clients on experimental strategies, data analysis, and results interpretation for cardiovascular telemetry studies. Prior to joining Covance, she served in various roles including manager of a GLP safety pharmacology team at WIL Research and neuroscientist at Wicab, Inc . Dr. Metea holds a PhD in neuroscience from the University of Minnesota and a medical degree from Cluj, Romania.

The Role of the CRO in Frontloading Cardiovascular Safety

The Role of the CRO in Frontloading Cardiovascular SafetyCardiovascular safety remains a leading cause of drug attrition during preclinical and clinical development, accounting for discontinuation of approximately one third of marketed drugs.

These liabilities, which pertain to both cardiovascular- and non-cardiovascular-targeted drugs, can be identified during early development by addressing cardiovascular safety endpoints prior to the selection of a drug candidate, a process known as ‘frontloading’. Although not mandated by the key regulatory guidance for safety pharmacology (ICH S7A; US FDA, 2001), an increasing number of companies choose to conduct early non-GLP cardiovascular safety studies in support of decisions on the progression of their compounds. Continue reading