About Karen Cornelissen, PhD, Scientific Director, Clinical Pharmacology

Dr. Karen Cornelissen, PhD, Scientific Director, Clinical Pharmacology, is based at our CRU in Leeds UK. After having graduated with a degree in Pharmacology, Karen obtained a PhD from Bath University, studying pre-clinical and clinical metabolism. She has worked in the fields of Drug Metabolism, Pharmacokinetics and Clinical Pharmacology in both a large Pharmaceutical company and Covance. In the last 12 years, whilst working at Covance, Karen has had input into over 200 Clinical Pharmacology study designs, conducted in both healthy volunteers and patients. This has included advising on study design for over 50 FIH trials, which have spanned multiple therapeutic areas. Upon study award, Karen is assigned the role of Scientific Reviewer which involves review of the study protocol, acting as scientific support to the internal team during study conduct, interpreting data (both interim blinded data and post database lock) and reviewing the draft clinical study report. In addition to her role as Scientific Director, Karen is a transitional QP and works closely with her CMC colleagues at Covance, having input into fit for purpose formulations suitable for use in early Clinical Pharmacology studies.

Maximize Phase I Study Timelines through Innovative Clinical Trial Design

karen-cEarly clinical research continues to be a high stakes industry requiring increasingly complex studies, procedures, and protocol designs all of which take longer to complete, which in turn drives up cost. The introduction of combined protocol designs—also called umbrella protocols—is gaining popularity among drug developers as a way to bring the first subject visit for the all-important proof-of-concept study forward by months, as well as saving significant cost.

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