Potential Strategies to Address during Trial Design & Study Execution
Join Andrew Roche, PhD, a senior member of ICON's NASH team, as he speaks about overcoming the challenges and considerations associated with NASH Clinical Trials and examination of potential strategies to address during trial design or study execution.
Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of clinical conditions which range from the relatively benign hepatic steatosis to the more serious non-alcoholic Steatohepatitis (NASH) which puts subjects at significant risk of liver failure, cirrhosis and hepatocellular carcinoma.
Currently there are no approved medicines to treat subjects with or at risk of developing NASH. However a number of pioneering companies have taken up the challenge to address this unmet clinical need. One of the many challenges encountered during this process is the process of enrolling subjects into a clinical trial via utilization of centralized assessments of liver biopsy specimens. During the course of this discussion ICON will share considerations that will aid cost effective and timely enrolment of subjects.
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Andrew Roche, PhD
Scientific Director, Global Validation, Scientific Affairs - ICON plc
Andrew has over 15 years’ experience in the clinical trial industry. He began his career within the infectious disease arena of biotech where he successfully led projects designed to identify and validate large molecule drug targets within pathogenic microorganisms. Andrew then moved into the field of biomarkers and led projects that created marketed immunoassay products for the detection of novel biomarkers of organ toxicity. Prior to joining ICON Andrew co-founded a bioanalytical CRO dedicated to the development, validation and utilization of customised methods for the quantification of large molecule drugs, anti-drug antibodies and biomarkers.
Andrew holds a B.A. Mod, and Ph.D. in Medical Microbiology from Trinity College Dublin and has authored several scientific publications.