Agenda: Day One

Friday, January 13th, 2017

7:00am–9:00am

Attendee Registration

7:30am–8:15am

Breakfast

8:15am–8:40am

Welcome and Remarks from CCFA

SESSION 1

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

8:40am–9:00am

Epidemiology of IBD
Ed Loftus

9:00am–9:20am

Pathogenesis of IBD
Balfour Sartor

9:20am–9:30am

Q & A

9:30am–9:50am

Evidence-based Medicine: Treatment of Ulcerative Colitis
Hans Herfarth

9:50am–10:10am

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

10:10am–10:30am

Treatment in Pediatric IBD: What is Different?
Mike Kappelman

10:30am–10:40am

Q&A

10:40am–11:00am

Refreshment Break

SESSION 2

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

11:00am–11:20am

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

11:20am–11:40am

The Role of the FDA in Drug Development
Kerry Jo Lee

11:40am–12:00pm

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

12:00pm–12:20pm

Patient Involvement in the Drug Development Process
Dan Sharp

12:20pm–12:30pm

Q & A

12:30pm–2:00pm

Lunch

SESSION 3

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

2:00pm–2:20pm

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

2:20pm–2:40pm

Good Clinical Practices: Concepts and Case Studies
Kim Isaacs

2:40pm–3:00pm

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

3:00pm–3:10pm

Q & A

3:10pm–3:20pm

Refreshment Break

3:20pm–3:40pm

Classic Studies and Prototypical Study Designs in IBD
Brian Feagan

3:40pm–4:00pm

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

4:00pm–4:10pm

Q & A

4:10pm–4:30pm

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

4:30pm–4:50pm

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

4:50pm –5:00pm

Q & A

7:00pm–9:30pm

Dinner with Keynote Speaker: FDA GREAT Clinical Trial Endpoints in IBD
Andrew Mulberg