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

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?

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

Carlos started his career as an MD and completed residency programs in Internal Medicine and Nuclear Medicine as well as a PhD in Medicine and Surgery. He was previously the head of the Nuclear Medicine and Molecular Imaging Department at the Children’s Hospital of Mexico, was Medical Advisor to the National Commission of Nuclear Safety and Safeguards and was Professor of Medical Physics at Autonomous National University of Mexico. He has published 176 medical papers and was a Reviewer for the European Journal of Nuclear Medicine and Molecular Imaging for over a decade. He is a Distinguished Fellow of the American College of Nuclear Medicine and a Senior Member of the Mexican Academy of Surgery. Before Perspectum, Carlos managed the hepatology research at the Texas Digestive Disease Consultants. During his time at TDDC, Carlos positioned the hepatology research site as a top enroller for NASH clinical trials with the lowest screen failure rate among all US sites for multiple trials.

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