Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease

Liver Forum Pediatric Working Group

doi:10.1053/j.gastro.2019.08.048

Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease

Liver Forum Pediatric Working Group

School of Medicine

Research output: Contribution to journal › Editorial › peer-review

6 Scopus citations

Original language	English (US)
Pages (from-to)	1448-1456.e1
Journal	Gastroenterology
Volume	157
Issue number	6
DOIs	https://doi.org/10.1053/j.gastro.2019.08.048
State	Published - Dec 2019

ASJC Scopus subject areas

Hepatology
Gastroenterology

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10.1053/j.gastro.2019.08.048

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@article{dc6aa6f34073483d8a3e2920ee6cbcc2,

title = "Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease",

author = "{Liver Forum Pediatric Working Group} and Vos, {Miriam B.} and Lara Dimick-Santos and Ruby Mehta and Omokaro, {Stephanie O.} and Johannes Taminiau and Elmer Schabel and Kleiner, {David E.} and Peter Szitanyi and Piotr Socha and Schwimmer, {Jeffrey B.} and Stephanie Noviello and Silberg, {Debra G.} and Richard Torstenson and Veronica Miller and Lavine, {Joel E.} and Nathalie Adda and William Baldyga and Rajarshi Banerjee and Cynthia Behling and Sherif Boulos and Gary Burgess and Dania Calboli and Edgar Charles and Rose Christian and Claude Cohen-Bacrie and Doina Cosma-Roman and Danzer, {Claus Peter} and Ingrid Delaet and Mark Delegge and Nicholas DiProspero and Kathleen Donohue and Laurent Fischer and Emer Fitzpatrick and Michael Fried and David Hagerty and Paula Hale and Keri Hildick and Dean Hum and Khurram Jamil and Lijuan Jiang and Saul Karpen and Matt Kelly and Rohit Kohli and Kattayoun Kordy and Nancy Krieger and Joel Lavine and Lois Lee and Eric Lefebvre and Patricia Lopez and Kathleen Schwarz",

note = "Funding Information: The content of this paper represents the considerations and reflections of the authors, and not the views of the U.S. Food and Drug Administration, Bundesinstitut fuer Arnzeimittel und Medizinprodukte, the European Medicines Agency, or the National Institutes of Health. Appendix Funding Information: Funding This work was supported in part by the Intramural Research Program of the NIH, National Cancer Institute and by The Liver Forum. Conflicts of interest The authors disclose the following: Dr Vos reports personal fees from AMRA, Bristol Myers Squibb, Boehringer Ingelheim, Intercept, Shire, Mallinrockdt, Novo Nordisk, Target Pharmasolutions and grants from Gemphire, Immuron, Target Pharmasolutions and Resonance Health Ltd. Dr Schwimmer reports ad hoc consulting fees from NovoNordisk and grants from Galmed and Intercept. Stephanie Noviello is a former employee and current stockholder of Bristol-Myers Squibb, and a stockholder of Merck and Johnson & Johnson. Debra G. Silberg is a full-time employee of Takeda Pharmaceutical Company (previously Shire). Richard Torstenson is a former employee of Novo Nordisk A/S Denmark and currently a full-time employee and stockholder of Allergan, UK. Dr Miller is an employee of the Forum for Collaborative Research, which receives contributions from the following companies: AbbVie, Afimmune, Aligos Therapeutics, Allergan, AMRA, AstraZeneca, BMS, Boehringer Ingelheim, Celera (Quest), Celgene, Cirius Therapeutics, Conatus, ConSynance Therapeutics, Covance Owned by LabCorp, CTI Clinical Trial and Consulting Services, Cymabay, Deuterx (Poxel), DiaPharma, Echosens, Eli Lilly, Enanta Pharmaceuticals, ENYO Pharma, Exalenz, Ferring Pharmaceuticals, Fractyl, Genentech, Genfit, Gilead, GSK, HepQuant, HistoIndex Pte Ltd, Humedics GmbH, ICON, Immuron, Intercept Pharmaceuticals, Inventiva Pharma, Janssen, Madrigal Pharmaceuticals, Mallinckrodt Pharmaceuticals, MEDIAN Technologies, MediciNova, Morphic Therapeutic, NGM Biopharmaceuticals, Nordic Bioscience, NorthSea Therapeutics, Novartis, Novo Nordisk, NuSirt, Perspectum Diagnostics, Pfizer, Pliant Therapeutics, ProSciento, Resonance Health, Resoundant, Shire, Syneos Health, Takeda, TARGET PharmaSolutions, VLVBio, Zafgen, and Zealand. Dr Lavine reports ad hoc consulting fees from Merck, Pfizer, Janssen, Allergan, Novartis, NovoNordisk, Viking, Madrigal, Horizon, and Target PharmaSolutions. Funding Information: Nathalie Adda, Enanta Pharmaceuticals, Inc. William Baldyga, Patient Representative Rajarshi Banerjee, Perspectum Diagnostics Ltd. Cynthia Behling, University of California, San Diego Sherif Boulos, Resonance Health Gary Burgess, Vectura Limited Dania Calboli, Novartis Pharma AG Edgar Charles, Bristol-Myers Squibb Rose Christian, Bristol-Myers Squibb Claude Cohen-Bacrie, SuperSonic Imagine Doina Cosma-Roman, Teva Pharmaceuticals Claus-Peter Danzer, Novartis Pharma AG Ingrid Delaet, Intercept Pharmaceuticals, Inc. Mark Delegge, QuintilesIMS Lara Dimick-Santos, U.S. Food and Drug Administration Nicholas DiProspero, Janssen Research and Development Kathleen Donohue, U.S. Food and Drug Administration Laurent Fischer, Allergan Emer Fitzpatrick, King's College London School of Medicine at King's College Hospital Michael Fried, University of North Carolina David Hagerty, Conatus Pharmaceuticals, Inc. Paula Hale, Novo Nordisk Keri Hildick, Perspectum Diagnostics Ltd. Dean Hum, GENFIT SA Khurram Jamil, Mallinckrodt Pharmaceuticals Lijuan Jiang, Enanta Pharmaceuticals, Inc. Saul Karpen, Emory University Matt Kelly, Perspectum Diagnostics Ltd. David E. Kleiner, National Cancer Institute Rohit Kohli, Children's Hospital Los Angeles Kattayoun Kordy, Novartis Pharmaceuticals Nancy Krieger, Novartis Pharma AG Joel Lavine, Columbia University Lois Lee, Intercept Pharmaceuticals Eric Lefebvre, Allergan Patricia Lopez, Novartis Pharma AG Erica Lyons, U.S. Food and Drug Administration Laura Malahias, TARGET PharmaSolutions Sophie Megnien, GENFIT SA Ruby Mehta, U.S. Food and Drug Administration Peter Mesenbrink, Novartis Pharmaceuticals Veronica Miller, Forum for Collaborative Research Pansy Minnick, Janssen Research and Development Christine Murray, Raptor Pharmaceuticals Tien Nghiem, Afimmune Limited Nikki Nicholson, TARGET PharmaSolutions Stephanie Noviello, Bristol-Myers Squibb Stephanie O. Omokaro, U.S. Food and Drug Administration Wenjie Pang, Resonance Health Ltd Lisa Percival, Bristol-Myers Squibb Dan Peres, Immuron Limited Margaret Powell, TARGET PharmaSolutions Dragos Roman, U.S. Food and Drug Administration Mark Root, Novo Nordisk Claire Sampson, Novo Nordisk Arun Sanyal, Virginia Commonwealth University Elmer Schabel, Bundesinstitut f{\"u}r Arzneimittel und Medizinprodukte Kathleen Schwarz, Johns Hopkins University School of Medicine Jeffrey B. Schwimmer, University of California, San Diego and Rady Children{\textquoteright}s Hospital San Diego Star Seyedkazemi, Allergan David Shapiro, Intercept Pharmaceuticals, Inc. Reshma Shringarpure, Intercept Pharmaceuticals Debra Silberg, Takeda Pharmaceuticals Edward Smith, Conatus Pharmaceuticals Inc Piotr Socha, The Children' s Memorial Health Institute Robert Squires, Children's Hospital of Pittsburgh of UPMC Peter Szitanyi, General University Hospital, First Faculty of Medicine, Charles University in Prague Johannes Taminiau, European Medicines Agency Richard Torstenson, Novo Nordisk A/S Denmark William Treem, Takeda Pharmaceuticals Pamela Vig, Allergan Miriam Vos, Emory University Mason Yamashita, Conatus Pharmaceuticals, Inc. Michael Zemel, NuSirt Biopharma ",

year = "2019",

month = dec,

doi = "10.1053/j.gastro.2019.08.048",

language = "English (US)",

volume = "157",

pages = "1448--1456.e1",

journal = "Gastroenterology",

issn = "0016-5085",

publisher = "W.B. Saunders Ltd",

number = "6",

}

TY - JOUR

T1 - Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease

AU - Liver Forum Pediatric Working Group

AU - Vos, Miriam B.

AU - Dimick-Santos, Lara

AU - Mehta, Ruby

AU - Omokaro, Stephanie O.

AU - Taminiau, Johannes

AU - Schabel, Elmer

AU - Kleiner, David E.

AU - Szitanyi, Peter

AU - Socha, Piotr

AU - Schwimmer, Jeffrey B.

AU - Noviello, Stephanie

AU - Silberg, Debra G.

AU - Torstenson, Richard

AU - Miller, Veronica

AU - Lavine, Joel E.

AU - Adda, Nathalie

AU - Baldyga, William

AU - Banerjee, Rajarshi

AU - Behling, Cynthia

AU - Boulos, Sherif

AU - Burgess, Gary

AU - Calboli, Dania

AU - Charles, Edgar

AU - Christian, Rose

AU - Cohen-Bacrie, Claude

AU - Cosma-Roman, Doina

AU - Danzer, Claus Peter

AU - Delaet, Ingrid

AU - Delegge, Mark

AU - DiProspero, Nicholas

AU - Donohue, Kathleen

AU - Fischer, Laurent

AU - Fitzpatrick, Emer

AU - Fried, Michael

AU - Hagerty, David

AU - Hale, Paula

AU - Hildick, Keri

AU - Hum, Dean

AU - Jamil, Khurram

AU - Jiang, Lijuan

AU - Karpen, Saul

AU - Kelly, Matt

AU - Kohli, Rohit

AU - Kordy, Kattayoun

AU - Krieger, Nancy

AU - Lavine, Joel

AU - Lee, Lois

AU - Lefebvre, Eric

AU - Lopez, Patricia

AU - Schwarz, Kathleen

N1 - Funding Information: The content of this paper represents the considerations and reflections of the authors, and not the views of the U.S. Food and Drug Administration, Bundesinstitut fuer Arnzeimittel und Medizinprodukte, the European Medicines Agency, or the National Institutes of Health. Appendix Funding Information: Funding This work was supported in part by the Intramural Research Program of the NIH, National Cancer Institute and by The Liver Forum. Conflicts of interest The authors disclose the following: Dr Vos reports personal fees from AMRA, Bristol Myers Squibb, Boehringer Ingelheim, Intercept, Shire, Mallinrockdt, Novo Nordisk, Target Pharmasolutions and grants from Gemphire, Immuron, Target Pharmasolutions and Resonance Health Ltd. Dr Schwimmer reports ad hoc consulting fees from NovoNordisk and grants from Galmed and Intercept. Stephanie Noviello is a former employee and current stockholder of Bristol-Myers Squibb, and a stockholder of Merck and Johnson & Johnson. Debra G. Silberg is a full-time employee of Takeda Pharmaceutical Company (previously Shire). Richard Torstenson is a former employee of Novo Nordisk A/S Denmark and currently a full-time employee and stockholder of Allergan, UK. Dr Miller is an employee of the Forum for Collaborative Research, which receives contributions from the following companies: AbbVie, Afimmune, Aligos Therapeutics, Allergan, AMRA, AstraZeneca, BMS, Boehringer Ingelheim, Celera (Quest), Celgene, Cirius Therapeutics, Conatus, ConSynance Therapeutics, Covance Owned by LabCorp, CTI Clinical Trial and Consulting Services, Cymabay, Deuterx (Poxel), DiaPharma, Echosens, Eli Lilly, Enanta Pharmaceuticals, ENYO Pharma, Exalenz, Ferring Pharmaceuticals, Fractyl, Genentech, Genfit, Gilead, GSK, HepQuant, HistoIndex Pte Ltd, Humedics GmbH, ICON, Immuron, Intercept Pharmaceuticals, Inventiva Pharma, Janssen, Madrigal Pharmaceuticals, Mallinckrodt Pharmaceuticals, MEDIAN Technologies, MediciNova, Morphic Therapeutic, NGM Biopharmaceuticals, Nordic Bioscience, NorthSea Therapeutics, Novartis, Novo Nordisk, NuSirt, Perspectum Diagnostics, Pfizer, Pliant Therapeutics, ProSciento, Resonance Health, Resoundant, Shire, Syneos Health, Takeda, TARGET PharmaSolutions, VLVBio, Zafgen, and Zealand. Dr Lavine reports ad hoc consulting fees from Merck, Pfizer, Janssen, Allergan, Novartis, NovoNordisk, Viking, Madrigal, Horizon, and Target PharmaSolutions. Funding Information: Nathalie Adda, Enanta Pharmaceuticals, Inc. William Baldyga, Patient Representative Rajarshi Banerjee, Perspectum Diagnostics Ltd. Cynthia Behling, University of California, San Diego Sherif Boulos, Resonance Health Gary Burgess, Vectura Limited Dania Calboli, Novartis Pharma AG Edgar Charles, Bristol-Myers Squibb Rose Christian, Bristol-Myers Squibb Claude Cohen-Bacrie, SuperSonic Imagine Doina Cosma-Roman, Teva Pharmaceuticals Claus-Peter Danzer, Novartis Pharma AG Ingrid Delaet, Intercept Pharmaceuticals, Inc. Mark Delegge, QuintilesIMS Lara Dimick-Santos, U.S. Food and Drug Administration Nicholas DiProspero, Janssen Research and Development Kathleen Donohue, U.S. Food and Drug Administration Laurent Fischer, Allergan Emer Fitzpatrick, King's College London School of Medicine at King's College Hospital Michael Fried, University of North Carolina David Hagerty, Conatus Pharmaceuticals, Inc. Paula Hale, Novo Nordisk Keri Hildick, Perspectum Diagnostics Ltd. Dean Hum, GENFIT SA Khurram Jamil, Mallinckrodt Pharmaceuticals Lijuan Jiang, Enanta Pharmaceuticals, Inc. Saul Karpen, Emory University Matt Kelly, Perspectum Diagnostics Ltd. David E. Kleiner, National Cancer Institute Rohit Kohli, Children's Hospital Los Angeles Kattayoun Kordy, Novartis Pharmaceuticals Nancy Krieger, Novartis Pharma AG Joel Lavine, Columbia University Lois Lee, Intercept Pharmaceuticals Eric Lefebvre, Allergan Patricia Lopez, Novartis Pharma AG Erica Lyons, U.S. Food and Drug Administration Laura Malahias, TARGET PharmaSolutions Sophie Megnien, GENFIT SA Ruby Mehta, U.S. Food and Drug Administration Peter Mesenbrink, Novartis Pharmaceuticals Veronica Miller, Forum for Collaborative Research Pansy Minnick, Janssen Research and Development Christine Murray, Raptor Pharmaceuticals Tien Nghiem, Afimmune Limited Nikki Nicholson, TARGET PharmaSolutions Stephanie Noviello, Bristol-Myers Squibb Stephanie O. Omokaro, U.S. Food and Drug Administration Wenjie Pang, Resonance Health Ltd Lisa Percival, Bristol-Myers Squibb Dan Peres, Immuron Limited Margaret Powell, TARGET PharmaSolutions Dragos Roman, U.S. Food and Drug Administration Mark Root, Novo Nordisk Claire Sampson, Novo Nordisk Arun Sanyal, Virginia Commonwealth University Elmer Schabel, Bundesinstitut für Arzneimittel und Medizinprodukte Kathleen Schwarz, Johns Hopkins University School of Medicine Jeffrey B. Schwimmer, University of California, San Diego and Rady Children’s Hospital San Diego Star Seyedkazemi, Allergan David Shapiro, Intercept Pharmaceuticals, Inc. Reshma Shringarpure, Intercept Pharmaceuticals Debra Silberg, Takeda Pharmaceuticals Edward Smith, Conatus Pharmaceuticals Inc Piotr Socha, The Children' s Memorial Health Institute Robert Squires, Children's Hospital of Pittsburgh of UPMC Peter Szitanyi, General University Hospital, First Faculty of Medicine, Charles University in Prague Johannes Taminiau, European Medicines Agency Richard Torstenson, Novo Nordisk A/S Denmark William Treem, Takeda Pharmaceuticals Pamela Vig, Allergan Miriam Vos, Emory University Mason Yamashita, Conatus Pharmaceuticals, Inc. Michael Zemel, NuSirt Biopharma

PY - 2019/12

Y1 - 2019/12

UR - http://www.scopus.com/inward/record.url?scp=85075261773&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85075261773&partnerID=8YFLogxK

U2 - 10.1053/j.gastro.2019.08.048

DO - 10.1053/j.gastro.2019.08.048

M3 - Editorial

C2 - 31520612

AN - SCOPUS:85075261773

SN - 0016-5085

VL - 157

SP - 1448-1456.e1

JO - Gastroenterology

JF - Gastroenterology

IS - 6

ER -

Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease

ASJC Scopus subject areas

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