8:00 am Registration & Welcome

8:20 am Chair’s Opening Remarks

Designing & Executing Clinical Trials in a Hypercompetitive Market

8:30 am Advancing Precision Medicine in IBD to Deliver Tailored Treatments

Synopsis

  • Highlighting the efforts of the Crohn’s & Colitis Foundation to advance precision medicine, including the identification and validation of predictive and prognostic biomarkers
  • Integrating deep molecular and clinical phenotyping to improve disease prognosis and treatment response predictions

9:00 am Designing Pediatric Studies Towards More Executable Trials for Pediatric IBD Patients

  • Meina Tang Principal Scientist, Clinical Pharmacology, Genentech

Synopsis

  • Accelerating pediatric development timelines using a partial extrapolation approach as outlined by the FDA
  • Maximally leveraging available data (including RWD) when designing pediatric phase III study: considerations in the selection of appropriate dose, sample size, control, and study duration

9:30 am Speed Networking

Synopsis

This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the IBD and anti-inflammatory drug development and establish meaningful business relationships.

10:15 am Morning Break

10:45 am Molecular Profiling of Ulcerative Colitis & Crohn’s Patients

Synopsis

  • Presenting novel pharmacodynamic and clinical efficacy biomarkers uncovered by the TURANDOT and OPERA trials
  • Discussing a mechanistic rationale for a non-monotonic dose response

11:15 am Clinical Development of the TLR-9 Agonist Cobitolimod for Ulcerative Colitis Patients: A Late Stage Drug Candidate with a Novel Mode of Action

Synopsis

  • Discussing cobitolimod as a potential new medication for moderate to severe ulcerative colitis with a novel and unique mechanism of action
  • Sharing compelling efficacy and excellent safety profile of cobitolimod in previous clinical studies
  • Discussing ongoing phase IIb dose optimisation study with cobitolimod with results expected H1 2019

11:45 am Implementing Histologic Endpoints in IBD Clinical Trials

Synopsis

  • Overview of IBD Histology
  • Choosing and implementing a histopathology index
  • Defining histologic endpoints

12:15 pm Lunch & Networking

Patient Profiling & Mucosal Markers: Translational Lessons to Optimize Drug Development

1:15 pm Exploring the Etiology of Inflammatory Bowel Disease

  • Joel Weinstock Chief, Division of Gastroenterology/Hepatology , Tufts University School of Medicine

Synopsis

• Inflammatory bowel diseases are perhaps a number of distinct conditions
• Genetic polymorphisms can affect the expression of IBD
• Environmental exposures probably are most important in influencing susceptibility to IBD

1:45 pm Pharmacogenomics in Ulcerative Colitis

  • Rob Yang Computational Biology Group Leader, I&I TCoE, Celgene

Synopsis

• Analyzing UC patients as heterogeneous by molecular signatures
• Profiling human cohorts and clinical trial cohorts can shed lights to disease stratification and respective responses to therapy
• Discussing why end points matter

2:15 pm Achieving Mucosal Healing as a Target for Therapeutic Efficacy in IBD

  • Carolyn Cuff Senior Director, Translational Immunology Department, AbbVie

Synopsis

• More precisely defining mucosal healing as an endpoint for regulators and patients
• Approaches taken by the field to identify markers of mucosal healing
• Potential Future State

2:45 pm Afternoon Break & Networking

Reducing Toxicity with the Next Generation of Small Molecules

3:30 pm IMU-838 in Clinical Phase 2 – New Selective Oral Treatment for IBD

Synopsis

  • Presenting first in class in IBD
  • Demonstrating selectivity by targeting immune metabolism

4:00 pm FOLH1/GCPII Inhibitors: Novel Small Molecule Therapeutics for the Treatment of IBD

  • Diane Peters Postdoctoral Fellow, John Hopkins Drug Discovery

Synopsis

  • Glutamate carboxypeptidase (GCP) is highly overexpressed in both Crohn’s disease and ulcerative colitis
  • Demonstrating robust anti-IBD efficacy of GCP inhibitors in murine colitis models when administered systemically and orally
  • Presenting inhibition of GCP as a novel therapeutic strategy for IBD management

4:30 pm GI-Targeted ROCK for Crohn’s Disease-Related Fibrosis

Synopsis

  • Demonstrating ROCK as an attractive target for treating fibrosis, but hypotension risks limit development of small molecule inhibitors for systemic application
  • Sharing a series of compounds developed by Redx that target ROCK exclusively in the GI track through intestinal retention and plasma instability
  • Highlighting Redx’s GI targeted ROCK inhibitors as highly potent, selective and able to reverse established fibrosis in murine models of intestinal tissue remodelling

5:00 pm Chair’s Closing Remarks