Pre-Conference Seminar Day

Monday | November 1, 2021

9.55 - 17.30 EST | 6.55 - 14.30 PST

Understanding the Drug Development Progress & Opportunity to Address Intestinal Fibrosis in GI Complications such as IBD

9:55 am Chair’s Opening Remarks

  • Florian Rieder Director, Head of Co-Section & Inflammatory Bowel Diseases Specialist, Cleveland Clinic

10:00 am Preclinical Discovery, Validation & Clinical Development Programs in IBD Associated Fibrosis

  • Florian Rieder Director, Head of Co-Section & Inflammatory Bowel Diseases Specialist, Cleveland Clinic

Synopsis

• Overview of preclinical human and animal models driving discovery and reverse translation
• Discussing a clinical development program based on novel clinical trial endpoints in stricturing Crohn’s disease
• Outlining remaining unmet needs in the space of intestinal fibrosis

10:30 am Targeting IL-36R Pathway In IBD- Opening New Doors for Novel Therapies

  • Meera Ramanujam Director, Disease Insights Accelerator & Biomarker Discovery, Boehringer Ingelheim

Synopsis

• Overview of IL-36 pathway and recent advances in understanding this pathway
• Exploring the Immune-stromal cross-talk in IBD
• Discovering the of IL-36 in IBD and the recent appreciation of the role of these family members in driving inflammation and fibrosis in the gut

11:00 am Bringing the Bench Closer to the Bedside: Advanced in-vitro Validation Models to Study Mechanisms Driving Intestinal Fibrosis

Synopsis

• Assessing the development of physiological in vitro primary human cellular assays to model stromal and immune crosstalk
• Characterizing endpoints with high translational value
• Utilizing these pre-clinical models to inform target selection for antifibrotic agents

11:30 am Morning Break & Networking

12:30 pm Understanding the Role of the Gut Microbiome in Intestinal Fibrosis

  • Nobuhiko Kamada Associate Professor of Internal Medicine, University of Michigan

Synopsis

• Analyzing the interplay between the gut microbiome and fibrosis
• Understanding the interaction between gut microbes and host epithelial and immune cells
• Applying insight of the gut microbiome to the design of targeted interventions to clinically manipulate these processes

1:00 pm Examining the Process of Creeping Fat in Humans

  • Britta Siegmund Director Medical Center for Gastroenterology, Infectiology & Rheumatology, Charité Universitätsmedizin Berlin

Synopsis

• What do we know about creeping fat- Analysing single-cell RNA sequencing
• Identifying the impact of microbial translocation
• Analyzing the role of mesenteric fat hyperplasia in intestinal fibrosis
• What is the contribution/ role of the immune system?

1:30 pm Networking Lunch

2:30 pm Similarities & Differences Between Intestinal Fibrosis & Other Fibrotic Diseases

  • Bryan Fuchs Research Therapeutic Area Head - Gastroenterology & Hepatology, Ferring Pharmaceuticals

Synopsis

• What has single-cell sequencing taught us about fibroblast populations in different fibrotic diseases?
• What aspects of intestinal fibrosis are unique to the gut?
• Are there lessons with respect to biomarkers and endpoints from trials in other fibrotic indications that can be applied to intestinal fibrosis?

3:00 pm Analyzing Developments in Non-Invasive Biomarkers to Predict or Detect Intestinal Fibrosis

  • Peter Higgins Director of Inflammatory Bowel Disease (IBD) Program, University of Michigan

Synopsis

• Reviewing existing and experimental technologies for imaging intestinal fibrosis
• Analyzing updates in deep learning approaches to evaluate intestinal fibrosis in magnetic resonance imaging models
• Assessing tissue perfusion characteristics by ultrasound

3:30 pm Afternoon Break & Networking

4:30 pm Addressing Unmet Medical Needs in Intestinal Strictures: Developing a Path for Approved Therapies in Fibrostenotic Crohn’s Disease

  • KT Park Principal Medical Director in IBD, Genentech

Synopsis

• Reviewing the traditional path of drug development in Crohn’s disease
• Defining highest unmet medical needs in fibrostenotic Crohn’s disease and potential endpoints for trials
• Evaluating strategies to accelerate development of anti-stricture therapies

5:00 pm Panel Discussion: Clinical Trial Endpoint Development: Establishing a Pathway for Approving Anti-Stricture Therapies in IBD to Drive Clinical Progress

  • Florian Rieder Director, Head of Co-Section & Inflammatory Bowel Diseases Specialist, Cleveland Clinic
  • Bryan Fuchs Research Therapeutic Area Head - Gastroenterology & Hepatology, Ferring Pharmaceuticals
  • KT Park Principal Medical Director in IBD, Genentech
  • Bertram Bleck Principal Scientist, Takeda
  • Peter Higgins Director of Inflammatory Bowel Disease (IBD) Program, University of Michigan

Synopsis

• Discussing how to work collaboratively with regulatory authorities to develop clinical endpoints
• Exploring strategies for study design to optimize clinical outcomes
• Analyzing clinical trial data and future implications

5:30 pm Chair’s Closing Remarks

  • Florian Rieder Director, Head of Co-Section & Inflammatory Bowel Diseases Specialist, Cleveland Clinic