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Accelerating the Drug Delivery Pipeline for Acute and Chronic Pancreatitis—Knowledge Gaps and Research Opportunities

Overview Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop

Uc, Aliye, MD*; Andersen, Dana K., MD; Borowitz, Drucy, MD; Glesby, Marshall J., MD, PhD§; Mayerle, Julia, MD; Sutton, Robert, DPhil; Pandol, Stephen J., MD#

doi: 10.1097/MPA.0000000000001176
Conference Reports

A workshop was sponsored by the Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, on July 25, 2018, in Pittsburgh, Penn. The workshop was designed to bring together a multidisciplinary group of experts to accelerate the development of therapeutics for clinical application in inflammatory diseases of the exocrine pancreas. Three separate working groups (acute pancreatitis, recurrent acute pancreatitis, and chronic pancreatitis) were formed to address the needs, gaps, and opportunities. The working groups included patients with pancreatic diseases, pharmaceutical company leaders, basic scientists, clinical researchers, and representatives from the US Food and Drug Administration to assist with regulatory considerations and to identify the unmet needs, research targets, and opportunities to provide direction for successful development of therapeutic agents in these diseases. This article represents the summary of the overview presentations at the National Institute of Diabetes and Digestive and Kidney Diseases workshop including an ongoing drug trial in acute pancreatitis; a successful drug development network developed by the Cystic Fibrosis Foundation; and considerations for subject selection in drug trials, incorporating Food and Drug Administration guidelines on clinical trial design and clinical outcome measures. The summaries of each working group follow separately in accompanying articles.

From the *Division of Gastroenterology, Hepatology, Pancreatology, and Nutrition, Stead Family Department of Pediatrics, University of Iowa Carver College of Medicine, Iowa City, IA;

Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health; and

Cystic Fibrosis Foundation, Bethesda, MD;

§Division of Infectious Diseases, Department of Medicine, Weill Cornell School of Medicine, New York, NY;

Department of Medicine II, Ludwig Maxmilian University and Polyklinik, Munich, Germany;

Royal Liverpool University Hospital and Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom; and

#Division of Digestive and Liver Diseases, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA.

Received for publication August 1, 2018; accepted August 28, 2018.

Address correspondence to: Aliye Uc, MD, Stead Family Department of Pediatrics, The University of Iowa Carver College of Medicine, BT1120-C, 200 Hawkins Dr, Iowa City, IA 52242 (e-mail: aliye-uc@uiowa.edu).

Research reported in this publication was supported by National Institute of Diabetes and Digestive and Kidney Diseases under award numbers R21 DK096327, U01 DK108334, R01 DK097820, DK108314, PePPP Center of Excellence MV ESF/14-BM-A55-0045/16; ESF MV V-630-S-150-2012/132/133); and DFG RTG 1947/A3. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

A.U. is a member of American Board of Pediatrics, Subboard of Pediatric Gastroenterology. R.S. is a consultant for AbbVie, CalciMedica, Cypralis, EA Pharma, GlaxoSmithKline, Lilly, and Novartis; R.S. has received research funding from Cypralis, GSK, and Merck; all resources and/or funds for the above have been gifted/paid to the University of Liverpool and/or Royal Liverpool and Broadgreen University Hospitals NHS Trust. The other authors declare no conflict of interest.

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