Virtual | Virtual

Event Title

FDA Workshop on the Role of Phytosterols in PNALD/IFALD

May 6, 2022

Date:: May 6, 2022

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Topics & Presentations	Speakers
FDA Workshop on the Role of Phytosterols in PNALD/IFALD – Session 1
FDA Introduction	Judy Racoosin, MD, MPH Deputy Director for Safety Division of Hepatology and Nutrition (DHN) CDER
Neonates and Infants	Camilia R. Martin, MD MS Associate Professor of Pediatrics Chief, Division of Newborn Medicine New York-Presbyterian/Weill Cornell Medical Center
Older Pediatric Patients	Samuel A. Kocoshis, MD Professor, University of Cincinnati Department of Pediatrics Medical Director, Small Bowel TransplantationProgram Medical Director, Intestinal Care Center
Adults	Alan Buchman, MD, MSPH Professor of Clinical Surgery and Medical Director Intestinal Rehabilitation and Transplant Center University of Illinois at Chicago
Panel Discussion	Camilia R. Martin, MD Samuel A. Kocoshis, MD Alan Buchman, MD, MSPH David F. Mercer MD, PhD Professor of Surgery Director of Intestinal Rehabilitation Program University of Nebraska Medical Center M. Petrea Cober, PharmD Professor, Pharmacy Practice Director of Professional Development Northeast Ohio Medical University (NEOMED) College of Pharmacy
FDA Workshop on the Role of Phytosterols in PNALD/IFALD – Session 2
Metabolism of Phytosterols Non-clinical (Animal) Evidence Supporting the Association Between Plant-based ILEs and PNALD/IFALD	Douglas Burrin, Ph.D. Research Physiologist United States Department of Agriculture Agricultural Research Service Children's Nutrition Research Center Department Pediatrics, Baylor College of Medicine
Clinical Evidence Supporting the Association Between Plant-based ILEs and PNALD/IFALD	Kishore R Iyer, MBBS Director, Intestinal Rehab & Transplant Program Program Director, Transplant Surgery Fellowship Professor of Surgery & Pediatrics Mount Sinai Medical Center Icahn School of Medicine at Mount Sinai
Scientific Challenges to Producing an ILE with Reduced Phytosterol Content	David F. Driscoll, Ph.D. Vice President of Stable Solutions, LLC Associate Professor of Medicine, UMASS Medical School
Industry Perspective - Fresenius Kabi	Martin Westphal, MD, MBA Chief Medical Officer and Executive VP Medical, Clinical & Regulatory Affairs, BU Nutrition Fresenius Kabi

Industry Perspective - Baxter International Inc.	Baptiste Bodet, M. Sc. Chemical Engineering Baxter International Inc. Technical Leader \| Clinical Nutrition BU
Panel Questions and Discussion	Douglas Burrin, PhD Kishore R Iyer, MBBS David Driscoll, PhD Valeria C. Cohran, MD, MS Medical Director, Intestinal Rehabilitation and Transplant Associate Professor of Pediatrics Feinberg School of Medicine Northwestern University Muralidhar H. Premkumar, MBBS Associate Professor, Pediatrics and Neonatology Baylor College of Medicine

ABOUT THIS WORKSHOP

Parenteral nutrition-associated liver disease (PNALD)/ intestinal failure-associated liver disease (IFALD) can occur in patients who require parenteral nutrition for more than two weeks, and the incidence increases with longer duration of treatment. PNALD/IFALD can result in permanent liver injury, and sometimes results in liver transplant or death. Although PNALD/IFALD has many risk factors, the phytosterol content of intravenous lipid emulsions (ILEs) used as part of total parenteral nutrition is a modifiable risk factor. In the last six years, FDA approved ILEs with lower or no phytosterol content.

This scientific workshop will discuss:

The changing epidemiology of PNALD/IFALD over the last decade
Strategies for managing PNALD/IFALD
The role of phytosterols in the disease process
Potential next steps for mitigating the risk of PNALD/IFALD

INTENDED AUDIENCE

Neonatologists, pediatric gastroenterologists and hepatologists, pediatric surgeons, adult gastroenterologists and hepatologists, PharmDs with a nutrition focus, nutritionists
Manufacturers of intravenous lipid emulsions
Researchers working on parenteral nutrition-associated liver disease/ intestinal failure-associated liver disease
Foreign regulators

FDA RESOURCES

FDA-approved product labeling for the marketed intravenous lipid emulsions: