NASH Clinical Trials: Challenges and Considerations

Life Sciences, Clinical Trials, Pharmaceutical, Patient Recruitment & Retention,
  • Tuesday, July 17, 2018

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 examines potential strategies to address these challenges 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 enrollment of subjects.



Dr. Andrew Roche, PhD, Scientific Director, Global Validation, Scientific Affairs, ICON

Andrew, a PhD with in-depth knowledge of the intricacies of analytical methods and their applications within clinical trials, oversees the Scientific Affairs and Global Validations functions of ICON Central Laboratories.

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.

Message Presenter

Who Should Attend?

This program is intended for senior professionals from biopharmaceutical companies working within NASH clinical research.

What You Will Learn

  • Overcoming the challenges and considerations associated with NASH clinical trials
  • How to enroll subjects into a trial via utilization of centralized assessments of liver biopsy specimens in a cost-effective and timely manner

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ICON plc is a global provider of outsourced development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programmes that support clinical development. With headquarters in Dublin, Ireland, ICON currently operates from 87 locations in 38 countries and has approximately 12,300 employees. Further information is available at

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