Non-alcoholic steatohepatitis (NASH) is widely recognized as a challenging disease for drug development. Phase 3 clinical trials require a substantial investment of time and money, and failure can cause costly delays or trial cancellation, wasting resources. Lack of cost-effective patient enrollment methods and the inability to demonstrate efficacy have been cited as the primary obstacles to conducting phase 3 clinical trials. Getting patients enrolled in NASH clinical trials has been challenging as endpoints still require an invasive biopsy and patients are reluctant to have multiple biopsies. As the race to bring the first NASH treatment to market heats up, sponsors will need to rely on cost-effective, non-invasive solutions not just to accelerate patient recruitment, but also to determine their response to treatment.
Key Topics Covered:
Non-invasive imaging and wet biomarkers
- What are the most successful non-invasive biomarkers that are currently available in NASH clinical trials?
- Which biomarkers have the most clinical utility to assess metabolic, inflammatory or fibrotic changes as a result of NASH treatment?
Enrollment and enrichment strategies
- How can non-invasive biomarkers be applied to pre-screen patients for enrollment in NASH trials and reduce screen fails?
- Differentiate patients with simple fatty liver and those with NASH
- Differentiate low- and high-risk NASH (e.g. NAS>3, F>1) patients
- Differentiate cirrhotic and non-cirrhotic NASH patients
Monitoring treatment efficacy
- How to incorporate non-invasive biomarkers for early efficacy signaling?
- How can non-invasive biomarkers be leveraged to monitor trial participants on a long-term basis?
Enrollment, Enrichment, and Monitoring Strategies to Accelerate Phase 3 Clinical Trials in NASH
Original Air Date: Friday, 28 February 2020
Time: 12 pm (EST) | 9 am (PST) | 6 pm (CET)
About the Presenters
Jack Snyder, M.D., J.D., Ph.D.
Asst. Managing Director, CATO SMS Washington
Dr. Jack Snyder, BS, MD (Northwestern), JD (Georgetown), PhD (MCV), MFS (GeoWash), MPH-MBA-MSIS (Johns Hopkins) currently directs the Washington office of CATO-SMS Research, serves on the Board of Directors of the American Board of Toxicology, holds a New York Certificate of Qualification to direct clinical laboratories, maintains board-certifications in Addiction Medicine, Medical Toxicology, General Toxicology, Clinical Informatics, Occupational Medicine, General Preventive Medicine, Pathology (Anatomic, Clinical & Chemical), Chemistry (Toxicological & Clinical), Quality Assurance & Utilization Review, Legal Medicine, Public Health, and Regulatory Affairs (US, Europe, Canada, Global), and has been certified as a Project Management Professional, Physician Investigator, Physician Executive, and Medical Review Officer.
Carlos Duncker, M.D., Ph.D.
Medical Science Liaison, Perspectum Diagnostics