Presentations

SESSION 1

State of the Art: IBD Therapy and Clinical Trials in IBD
Chairs: Ed Loftus, David Rubin

Epidemiology of IBD
Ed Loftus

Evidence-based Medicine: Treatment of Ulcerative Colitis
Hans Herfarth

Evidence-based Medicine: Treatment of Crohn’s Disease
Ray Cross

Treatment in Pediatric IBD: What is Different?
Mike Kappelman

SESSION 2

Understanding the Drug Development Process
Chairs: Brian Feagan, Peter Higgins

The Big Picture: The Overall Environment of Drug Development & Life Cycle of a Drug
Asit Parikh, MD (Takeda)

The Role of the FDA in Drug Development
Kerry Jo Lee

What is the Future of NIH-funded Clinical Research in IBD?
Steve James

Patient Involvement in the Drug Development Process
Dan Sharp

SESSION 3

Ethical Issues, Safety, Data Integrity and Trial Design
Chairs: Kim Isaacs, Jim Lewis

Ethics and Conflict of Interest — Concepts and Case Studies
David Rubin

Good Clinical Practices: Concepts and Case Studies
Kim Isaacs

Adverse Events in Clinical Trials: Recognition and Reporting — Case studies
Kay Sauder (Michigan)

Classic Studies and Prototypical Study Designs in IBD
Brian Feagan

Post-Marketing Surveillance Studies in IBD: How Meaningful Are They and Are They Prone to Bias?
Bruce Sands

Structuring for Data Integrity Success (Concepts and Cases)
Kristen Anton

Data Disasters and How to Prevent Them
Colleen Marano (JNJ) and Anne Robinson (AbbVie)

FDA GREAT Clinical Trial Endpoints in IBD
Andrew Mulberg

Saturday, January 14th 2017

BREAKOUT 1

How to Plan and Start a Clinical Trial
Chair: Peter Higgins

Funding and Grantsmanship in Clinical Research
Peter Higgins

How (and Why) to Get Started: Academic Perspective
Jim Lewis

BREAKOUT 2

Organizational Strategies for Clinical Trials
Chair: Alandra Weaver

SOPs: What Are They, and Why Do We Need Them?
Susan Jackson (UNC)

Research Personnel and Research Space: A Place for Everything
Kay Sauder, Michigan

Recruitment, Retention and Monitoring of Study Subjects
Barbara Schliebe and Susan Jackson

MAIN SESSION

Measurement of Outcomes in IBD Clinical Trials
Chairs: Hans Herfarth, Ray Cross

Activity and Endoscopic Measures: Crohn’s Disease
Jean-Fred Colombel

Activity and Biomarker Measures: Ulcerative Colitis
Mark Osterman

Patient Reported Outcomes in IBD
Peter Higgins

Controversies in Patient Populations, Phenotyping
Miguel Regueiro

Children in IBD Studies: Critical Design Issues, Activity Measures and Markers
Jeffrey Hyams

How Patients Feel about the Endpoints
Sara Ringer

Factors affecting Clinical Trial Interest and Enrollment in IBD Patients
Alandra Weaver



SESSION 4

Challenges, Pitfalls and the Future of IBD Trials
Chairs: Balfour Sartor, Jean-Fred Colombel

Challenges and Pitfalls in Clinical Trials: Lessons Learned
Brian Feagan

Challenges in Investigator-Initiated Clinical Trials: Lessons Learned
Jim Lewis and Hans Herfarth

The Future (Near and Far) of IBD Therapeutic Research
Balfour Sartor and Jean-Fred Colombel