The prevalence of NASH in global populations continues to expand in conjunction with the ongoing obesity and diabetes epidemic. Over the next decade, the disease is projected to become the leading indication for a liver transplant.

With no current approved drug treatment interest from the pharmaceutical industry, efforts by regulatory authorities and investigators to facilitate the development of new therapies that decrease the severity of NASH remains very strong, despite the high rates of attrition seen within pipelines to date.

The performance of NASH clinical trials presents many challenges unique to the field. This webinar will focus on:

  • The ability for digital technologies including magnetic resonance imaging (MRI), magnetic resonance elastography (MRE) and whole slide imaging (WSI) to address NASH clinical trial challenges
  • The ability of MRI and MRE to provide timely, high quality non-invasive solutions to enrolment
  • The ability of WSI to facilitate rapid complex workflows that assure consistent high quality assessments of primary efficacy endpoints by enabling expert histopathologists to interact remotely and in real time

Presenters

Paul McCracken, PhD

Vice President, Global Head of Medical Imaging, ICON

Dr. McCracken is the Vice President, Global Head of ICON Medical Imaging and Blue Bell Site Head (US Headquarters) at ICON Plc. Paul has over 20 years’ experience in imaging and pharmaceuticals, with a strong track record of applying imaging and biomarkers to drug discovery and development across a range of therapeutic areas.

Debbie Marshall

Program Manager

Over the past seven years Debbie has managed eight NAFLD/NASH trials, phase I-III. Through her extensive NASH study experience, Ms. Marshall maintains relationships with many NASH investigators in the regions of NA, LATAM, APAC, EU. Additionally, she has collaborated with radiology and histopathology central readers. Her experience focuses on the nuances of NASH studies, which includes a strong understanding of liver biopsy interpretations, emerging competition, and NASH-specific imaging procedures and biomarkers.

Christina Gonzalez

Project Manager, Pathology, ICON Central Laboratories

Christina (Tina) has worked as a project manager with ICON Central Laboratories for just over three years. During that time she has worked on numerous trials, including multiple large-scale NASH trials. Prior to ICON, Tina worked at the University of Pennsylvania.

Audience

  • Pharma and biotech professionals involved in NASH clinical research, including:
  • Medical directors
  • Therapy area directors
  • Clinical trial directors and managers
  • Research managers