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  4. FDA Workshop on the Role of Phytosterols in PNALD/IFALD - 05/06/2022
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Virtual | Virtual

Event Title
FDA Workshop on the Role of Phytosterols in PNALD/IFALD
May 6, 2022

May 6, 2022

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Topics & Presentations



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)




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



Alan Buchman, MD, MSPH

Professor of Clinical Surgery and Medical


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


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



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


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

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