Event Details
Agenda
Event Details
Background
Acute and chronic pancreatitis account for 300,000+ hospital admissions per year, effect large healthcare expenditures for inpatient and outpatient treatment, and result in a high risk of metabolic and neoplastic diseases.
No effective drugs are currently available to halt progression or effect the reversal of acute and chronic pancreatitis.
Meeting Objectives
- To identify the requirements, obstacles and opportunities to enhance the development and clinical testing of potential therapeutic agents for the treatment of acute pancreatitis, recurrent acute pancreatitis and chronic pancreatitis
- To identify research gaps which are needed to facilitate drug development and clinical testing
- To engage representatives from the Food and Drug Administration to assist with the development of guidance documents which will assist investigators in studies of the treatment of these diseases
Co-Sponors
Additional support from the National Pancreas Foundation
Registration Deadline
July 11, 2018
Agenda
July 25, 2018
- 7:30 a.m. – 8:00 a.m.
- Registration
- 8:00 a.m. – 8:10 a.m.
- Welcome
Co-chairs—
Aliye Uc, University of Iowa Stead Family Children’s Hospital
Stephen Pandol, Cedars-Sinai Medical Center
- 8:10 a.m. – 9:50 a.m.
- Session 1: Introduction—Overcoming Obstacles in Clinical Trials
Aliye Uc and Stephen Pandol, Moderators
- 8:10 a.m. – 8:35 a.m.
- RAPID-I: The Infliximab Trial in Acute Pancreatitis
Robert Sutton, University of Liverpool
- 8:35 a.m. – 9:00 a.m.
- Lessons from the Development of Cystic Fibrosis Drugs
Drucy Borowitz, Cystic Fibrosis Foundation
- 9:00 a.m. – 9:25 p.m.
- Considerations for Clinical Trial Design
Julia Mayerle, Klinikum der Ludwig-Maximilians-Universität München
- 9:25 a.m. – 9:50 a.m.
- Overview of FDA Considerations for Clinical Trials
Wen-Hung Chen and Juli Tomaino, U.S. Food and Drug Administration (FDA)
- 9:50 a.m. – 10:15 a.m.
- Break
- 10:15 a.m. – 12:00 p.m.
- Session 2: Drug Development and Trials in Acute Pancreatitis
Moderators—
Bechien Wu, Kaiser Permanente Los Angeles Medical Center
Anna Gukovskaya, University of California, Los Angeles
Maisam Abu-El-Haija, Cincinnati Children’s Hospital Medical Center
- 10:15 a.m. – 10:35 a.m.
- Natural History and Current Management of Acute Pancreatitis
Peter Hegyi, University of Pécs
- 10:35 a.m. – 10:50 a.m.
- Pre-clinical Models of Acute Pancreatitis
Ashok Saluja, University of Miami Miller School of Medicine
- 10:50 a.m. – 11:05 a.m.
- Potential Molecular Targets in Acute Pancreatitis
Anna Gukovskaya, University of California, Los Angeles
- 11:05 a.m. – 11:25 a.m.
- Risk Stratification and Subject Selection
Tim Gardner, Dartmouth-Hitchcock Medical Center
- 11:30 a.m. – 12:00 p.m.
- Discussion
- 12:00 p.m. – 1:00 p.m.
- Lunch
- 1:00 p.m. – 3:00 p.m.
- Session 3: Drug Development and Trials in Recurrent
Acute Pancreatitis
Moderators—
Mark Lowe, Washington University School of Medicine in St. Louis
David Whitcomb, University of Pittsburgh
- 1:00 p.m. – 1:20 p.m.
- Definition and Natural History of Recurrent Acute Pancreatitis
David Whitcomb, University of Pittsburgh
- 1:20 p.m. – 1:40 p.m.
- Genetics of Recurrent Acute Pancreatitis and Gene Intervention Targets
Mark Haupt, Ariel Precision Medicine
- 1:40 p.m. – 2:10 p.m.
- Selection of Outcome Measures for Recurrent Acute Pancreatitis
Patient-reported Outcomes
Marshall Glesby, Weill Cornell Medical College
Physician-reported Outcomes
Greg Coté, Medical University of South Carolina
Marc Goodman, Cedars-Sinai Medical Center
- 2:10 p.m. – 2:30 p.m.
- N=1 Studies
Nicholas Schork, Translational Genomics Research Institute
- 2:30 p.m. – 3:00 p.m.
- Discussion
- 3:00 p.m. – 3:15 p.m.
- Break
- 3:15 p.m. – 5:00 p.m.
- Session 4: Drug Development and Trials in Chronic Pancreatitis
Moderators—
Christopher Forsmark, University of Florida
Dhiraj Yadav, University of Pittsburgh Medical Center
- 3:15 p.m. – 3:40 p.m.
- Patient Perspective and Patient-centered Outcomes
Patient-focused Drug Development for Chronic Pancreatitis
Megan Golden, Mission: Cure
Patient and Family Experiences
Amy Jensen, Mission: Cure
Karen Smakosz, Parent
Lauren Smakosz, Patient
- 3:35 p.m. – 3:55 p.m.
- Outcome Selection Informed by Previous Trials: Pain and Progression of Disease
Pain-related Outcomes
Chris Forsmark, University of Florida
Chronic Pancreatitis Progression-related Outcomes
Julia Mayerle, Klinikum der Ludwig-Maximilians-Universität München
- 3:55 p.m. – 4:15 p.m.
- Considerations for Pain-centered Outcomes
John Farrar, University of Pennsylvania
Liang Li, The University of Texas MD Anderson Cancer Center
- 4:15 p.m. – 4:35 p.m.
- Considerations for Natural History–centered Outcomes
Liang Li, The University of Texas MD Anderson Cancer Center
Dhiraj Yadav, University of Pittsburgh Medical Center
- 5:00 p.m. – 5:30 p.m.
- Session 5: Group Discussion and Recommendations
Moderators—
Aliye Uc, University of Iowa Stead Family Children’s Hospital
Stephen Pandol, Cedars-Sinai Medical Center
- 5:30 p.m.
- Adjournment
