Original Air Date:  Tuesday, June 23, 2020
Time:  12:00 PM EST

Inflammatory Bowel Disease (IBD) encompasses a cluster of disorders that cause chronic inflammation of the gastrointestinal tract. Crohn’s Disease (CD) and Ulcerative Colitis (UC) are the most common forms of this prototypically complex disorder that presents multiple diagnostic and therapeutic challenges. The advent of machine learning, big data, and artificial intelligence has enabled modeling of huge amounts of clinical trial data to enhance development of novel biomarkers and quantitative histopathologic image processing techniques that may, in turn, improve delivery of targeted treatments, monitoring of disease progression, and detection of meaningful clinical outcomes. Pragmatic trial designs focused on effectiveness, rather than traditional trial designs focused on efficacy, are emerging in the deliberations of regulatory bodies as sponsors push for recognition of the value of new investigative tools and approaches.

In this webinar, experts from Perspectum, CATO SMS, and ProPath will review past and current complexities of IBD clinical trials, and will explore how currently available, cutting edge solutions can change the regulatory landscape and future-proof IBD investigations in the not-too-distant future.

Webinar Key Learning Objectives will focus on improved understanding of:

  • Past and present challenges in IBD clinical trials
  • Present and future aspects of imaging and histopathologic diagnosis in IBD trials
  • Current traditional IBD trial designs and future pragmatic IBD trial designs
  • Evolution of FDA expectations regarding applications of machine learning, big data, and AI in IBD product development

Featured Speakers

Jack Snyder, M.D., J.D., Ph.D.
Assistant 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.

Cory Roberts, MD, MBA
CEO, ProPath

Dr. Roberts has keen knowledge of gastrointestinal and hepatic pathology; a skill honed during his decades of practice in clinical and anatomic pathology. As a well-respected public speaker and author, Dr. Roberts has published numerous books, book chapters and peer-reviewed articles on topics such as celiac disease, metastatic hepatocellular carcinoma, eosinophilic esophagitis, and atrophic gastritis and endocrine cell hyperplasia. Other areas of interest include liver/small bowel transplantation, sessile serrated polyps and molecular diagnostics of colorectal cancer.

Marc Goldfinger, PhD
Product Specialist, Perspectum

Dr. Goldfinger has worked in the field of diagnostic pathology for over 9 years, in both neuroscience and gastrointestinal disease. Dr. Goldfinger has recently focused on integrating artificial intelligence into MR applications and digitized histopathology to better understand hepatobiliary disease and bowel disease in order to identify novel biomarkers that may better stratify and monitor bowel disorders.

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