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

Author

Uc, Aliye, Andersen, Dana K, Borowitz, Drucy, Glesby, Marshall J, Mayerle, Julia, Sutton, Robert, and Pandol, Stephen J

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Nutrition, Orphan Drug, Diabetes, Rare Diseases, Kidney Disease, Digestive Diseases, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Oral and gastrointestinal, Good Health and Well Being, Acute Disease, Biomedical Research, Drug Development, Humans, National Institute of Diabetes and Digestive and Kidney Diseases (U.S.), Pancreatitis, Pancreatitis, Chronic, Pharmaceutical Preparations, United States, clinic trial, drug development, pancreatitis, patient-reported outcomes, study design, Clinical Sciences, Gastroenterology & Hepatology, Clinical sciences
Abstract

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.

Published
2018

18. CFTR modulator theratyping: Current status, gaps and future directions

Author

Clancy, John Paul, Cotton, Calvin U., Donaldson, Scott H., Solomon, George M., VanDevanter, Donald R., Boyle, Michael P., Gentzsch, Martina, Nick, Jerry A., Illek, Beate, Wallenburg, John C., Sorscher, Eric J., Amaral, Margarida D., Beekman, Jeffrey M., Naren, Anjaparavanda P., Bridges, Robert J., Thomas, Philip J., Cutting, Garry, Rowe, Steven, Durmowicz, Anthony G., Mense, Martin, Boeck, Kris D., Skach, William, Penland, Christopher, Joseloff, Elizabeth, Bihler, Hermann, Mahoney, John, Borowitz, Drucy, and Tuggle, Katherine L.

Published
2019
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24. Forced Expiratory Volume in 1 Second Variability Helps Identify Patients with Cystic Fibrosis at Risk of Greater Loss of Lung Function

Author

Morgan, Wayne, Konstan, Michael, Liou, Ted, McColley, Susanna, McMullen, Ann, Quittner, Alexandra, Regelmann, Warren, Ren, Clement, Rosenfeld, Margaret, Sawicki, Greg, Schechter, Michael, VanDevanter, Donald, Wagener, Jeffrey, Woo, Marlyn, Brasfield, Dana, Lyrene, Raymond, Sindel, Lawrence, Roberts, Dion, Carroll, John, Warren, Robert, Nassri, Louay, Anderson, Paula, Brown, Mark, Silverthorn, Amy, Radford, Peggy, Gong, Gerald, Legris, Gregory, Greene, Gerald, Sudhakar, Reddivalam, Platzker, Arnold, Nickerson, Bruce, Hardy, Karen, Harwood, Ivan, Shay, Gregory, Quick, Bryon, Lieberthal, Allan, Moss, Richard, Landon, Chris, Fanous, Yvonne, Lieberman, Jay, Spiritus, Eugene, Chipps, Bradley, McDonald, Ruth, Pian, Mark, Cropp, Gerd, Lewis, Nancy, Nielson, Dennis, Shapiro, Bertrand, Wagener, Jeff, Accurso, Frank, Saavedra, Milene, Daigle, Karen, Hen, Jacob, Palazzo, Regina, Dodds, Kathryn, Pad-man, Raj, Goodill, John, Winnie, Glenna, Davies, Lea, Kriseman, Tony, Sallent, Jorge, Chiaro, Joseph, Kubiet, Martin, Goldfinger, Sue, Schwartzman, Morton, Diaz, Carlosenrique, Maupin, Kevin, Riff, Eduardo, Geller, David, Livingston, Floyd, Mavunda, Kunjana, Birriel, Jose, Jr., Faverio, Luis, Rosenberg, David, Schaeffer, David, Sherman, James, Wagner, Mary, Light, Michael, Schnapf, Bruce, Montgomery, Gary, Kirchner, Kevin, Weatherly, Mark, Caplan, Daniel, Guill, Margaret, Hudson, Valera, Akhter, Javeed, Davison, Donald, Boas, Steven, Chung, Youngran, Latner, Rennee, Aljadeff, Gabriel, Chan, Youngran, Kraut, Jerome, Stone, Arvey, Still, John Lloyd, Sharma, Girish, Eagleton, Lanie, Hopkins, Patricia, Chatrath, Umesh, Lester, Lucille, Kim, Young-Jee, Anthony, Veena, Eigan, Howard, Howenstine, Michelle, James, Pushpom, Gergesha, Edward, Harris, James, Plant, Robert, Zivkovich, Veljko, Collins, Angela, Nassif, Edward, Ahrens, Richard, Doornbos, Daniel, Kanarek, Joseph, Leff, Richard, Shaw, Pamela, Demoss, Elanor, Riva, Maria, Sullivan, Leonard, Anstead, Michael, Kanga, Jamshed, Eid, Nemr, Morton, Ron, Hilman, Bettina, Jones, Kim, Davis, Scott, Harder, Ralph, Lever, Tom, Cairns, Anne Marie, Caldwell, Edgar, Zuckerman, Jonathan, Mogayzel, Peter, Rosenstein, Beryl, McQuestion, John, Perry, Donna, Rosenberg, Samuel, Gerstle, Robert, Colin, Andrew, Wohl, Mary Ellen, Lapey, Allan, Yee, William, O'Sullivan, Brian, Zwerdling, Robert, Abdulhamid, Ibrahim, O'Hagan, Adrian, Schuen, John, Kurlandsky, Lawrence, Honicky, Richard, Homnick, Douglas, Marks, John, Pichurko, Bohdan, Maxvold, Norma, Nasr, Samya, Simon, Richard, Tsai, Wan, Kissner, Dana, McNamara, John, Henry, Nancy, Marker, Stephen, Pryor, Michael, Walker, Lynn, Woodward, Jim, Mizell, Louis, Miller, Suzanne, Rosenbluth, Daniel, Black, Philip, McCubbin, Michael, Cohen, Alan, Ferkol, Thomas, Mallory, George, Rejent, Anthony, Rubin, Bruce, Graff, Gavin, Konig, Peter, Colombo, John, Murphy, Peter, Boyle, William, Parker, Worth, Patton, Chandler, Zanni, Robert, Atlas, Arthur, Turcios, Nelson, Laraya-Cuasay, Lourdes, Bisberg, Dorothy, Aguila, Helen, Allen, Sarah, James, David, Perkett, Elizabeth, Thompson, Marsha, Budhecha, Sonia, Diaz, Ruben, Rosen, Jonathan, Kaslovsky, Robert, Percciacante, Ronald, Borowitz, Drucy, Cronin, Joseph, McMahon, Colin, Quittell, Lynne, Giusti, Robert, Cohen, Rubin, DeCelie-Germana, Joan, Gorvoy, Jack, Patel, Kalpan, Kattan, Meyer, Dozor, Allen, DiMango, Emily, Berdella, Maria, Anbar, Ran, Ianuzzi, Debra, Sexton, James, Tayag-Kier, Catherine, McBride, John, Voter, Karen, Dimaio, Mary, Georgitis, John, Majure, Joseph Marc, Martinez, Maria, McIntosh, Clarke, Leigh, Margaret, Black, Hugh, Hughes, James, Kantak, Anand, Wilmott, Robert, Omlor, Gregory, Stone, Robert, McCoy, Karen, Acton, James, Doershuk, Carl, Fink, Robert, Steffan, Michael, Vauthy, Pierre, Joseph, Patricia, Reyes, Santiago, Kramer, John, Royall, James, Eisenberg, Jay, Wall, Michael, Fiel, Stanley, Scanlin, Thomas, Phadke, Shroti, Weinberg, Joel, Sexauer, William, Wolf, Stephen, Holsclaw, Douglas, Klein, Debra, Warren, Stuart, Kinsey, Robert, Perez, Carlos, Ganeshanathan, Muttiah, Shinnick, James, Panitch, Howard, Varlotta, Laurie, Robinson, Cynthia, Santana, Jose Rodriguez, Passero, Mary Ann, Gwinn, Jane, Baker, Robert, Bowman, Michael, Flume, Patrick, Brown, Daniel, Marville, Roxanne, Wallace, James, Parry, Rodney, Ellenburg, Don, Rogers, John, Mohon, Ricky, Ledbetter, Joel, Hanissian, Aram, Schoumacher, Robert, Campbell, Preston, Harris, Christopher, Slovis, Bonnie, Stokes, Dennis, Hale, Kathryn, Katz, Marcia, Seilheimer, Dan, Sockrider, Marianne, Frank, Allan, Daniel, James, Cunningham, James, Browning, Iley, Bray, John, Dove, Amanda, Mandujano, Fernando, Tremper, Larry, Morse, Martha, Willey-Courand, Donna, Copenhaver, Steven, Pohl, John, McWilliams, Bennie, Martine-Logvinoff, Marie, Wallace, Marsh, Klein, Robert, Amaro, Rodolfo, Couch, Leslie, Brown, Michael, Prestidge, Claude, Inscore, Stephen, Lipton, Andrew, Chatfield, Barbara, Liou, Theodore, Marshall, Bruce, Lahiri, Thomas, Swartz, Donald, Whittaker, Laurie, Karlson, Karl, Ropoll, Ignacio, Rubio, Thomas, Schmidt, Joel, Thomas, David, Osborn, John, Froh, Deborah, Gaston, Benjamin, Elliott, Greg, Gibson, Ronald, Ramsey, Bonnie, McCarthy, Michael, Larson, Lawrence, Ricker, David, Robbins, Mark, Aitken, Moira, Emerson, Julia, Aronoff, Stephen, Moffett, Kathryn, Biller, Julie, Splaingard, Mark, Sullivan, Bradley, Pritchard, Paul, Adair, Stu, Holzwarth, Peter, Dopico, Guillermo, Meyer, Keith, Green, Christopher, Rock, Michael, Morgan, Wayne J., VanDevanter, Donald R., Pasta, David J., Foreman, Aimee J., Wagener, Jeffrey S., and Konstan, Michael W.

Published
2016
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38. Gastrointestinal factors associated with hospitalization in infants with cystic fibrosis: Results from the BONUS Study

Author

Sathe, Meghana, Huang, Rong, Heltshe, Sonya, Eng, Alexander, Borenstein, Elhanan, Miller, Samuel I., Hoffman, Lucas, Gelfond, Daniel, Leung, Daniel H., Borowitz, Drucy, Ramsey, Bonnie, and Freeman, A. Jay

Subjects
Cohort Studies, Hospitalization, Neonatal Screening, Cystic Fibrosis, Infant, Newborn, Humans, Infant, Enzyme Replacement Therapy, Article
Abstract

OBJECTIVES: To identify factors that increase risk of gastrointestinal-related (GI-related) hospitalization of infants with cystic fibrosis (CF) during the first year of life. METHODS: The Baby Observational and Nutrition Study was a longitudinal, observational cohort of 231 infants diagnosed with CF by newborn screening. We performed a post-hoc assessment of the frequency and indications for GI-related admissions during the first year of life. RESULTS: Sixty-five participants had at least one admission in the first 12 months of life. High pancreatic enzyme replacement therapy (PERT) dosing (>2000 LU/kg/meal) (hazard ratio, HR=14.75, p=0.0005) and use of acid suppressive medications (HR=4.94, p=0.01) during the study period were positively associated with subsequent GI-related admissions. High levels of fecal calprotectin (fCP) (>200 μg/g) and higher relative abundance of fecal Klebsiella pneumoniae were also positively associated with subsequent GI-related admissions (HR=2.64, p=0.033 and HR=4.49, p=0.002, respectively). During the first 12 months of life, participants with any admission had lower weight-for-length z-scores (WLZ) (p=0.01). The impact of admission on WLZ was particularly evident in participants with a GI-related admission (p

Published
2021

49. Clinical Effectiveness of Lumacaftor/Ivacaftor in Patients with Cystic Fibrosis Homozygous for F508del-CFTR. A Clinical Trial

Author

Sagel, Scott D., primary, Khan, Umer, additional, Heltshe, Sonya L., additional, Clancy, John P., additional, Borowitz, Drucy, additional, Gelfond, Daniel, additional, Donaldson, Scott H., additional, Moran, Antoinette, additional, Ratjen, Felix, additional, VanDalfsen, Jill M., additional, and Rowe, Steven M., additional

Published
2021
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