FDA Workshop on the Role of Phytosterols in PNALD/IFALD – Session 2

Показать описание

This scientific workshop discusses the changing epidemiology of Parenteral nutrition-associated liver disease (PNALD)/ intestinal failure-associated liver disease (IFALD), strategies for managing PNALD/IFALD, the role of phytosterols in the disease process, and potential next steps for mitigating the risk of PNALD/IFALD.

0:01 FDA Introduction
0:28 Metabolism of Phytosterols; Non-clinical (Animal) Evidence Supporting the Association Between Plant-based ILEs and PNALD/IFALD
29:04 Clinical Evidence Supporting the Association Between Plant-based ILEs and PNALD/IFALD
50:51 Scientific Challenges to Producing an ILE with Reduced Phytosterol Content
1:11:28 Industry Perspective – Baxter International Inc. Martin Westpal
1:27:19 Industry Perspective – Fresenius Kabi
1:42:52 Panel Questions and Discussion

Presenters and Panel:

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

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
David F. Driscoll, Ph.D.
Vice President of Stable Solutions, LLC
Associate Professor of Medicine,
UMASS Medical School

Baptiste Bodet, M. Sc. Chemical Engineering
Baxter International Inc.
Technical Leader | Clinical Nutrition BU

Martin Westphal, MD, MBA
Chief Medical Officer and Executive VP
Medical, Clinical & Regulatory Affairs, BU Nutrition
Fresenius Kabi
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

-------------------- 
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.   

Phone - (301) 796-6707 I (866) 405-5367

Рекомендации по теме

FDA Workshop on the Role of Phytosterols in PNALD/IFALD – Session 2

FDA Workshop on the Role of Phytosterols in PNALD/IFALD – Session 1

FDA Workshop on the Role of Phytosterols in PNALD/IFALD – Session 2

FDA Public Workshop on Opioid Prescriber Education Day 1

2021 T1D Workshop- FDA Perspective: Clinical endpoints and validated surrogates

2021 T1D Workshop- FDA perspective | Kristen Pluchino

FDA-ASH Sickle Cell Disease Endpoints Workshop: Welcome Address by Brett P. Giroir, MD

2022 PRO Consortium Workshop: Session 1: FDA Update

Margolis-FDA Workshop: Identifying Key Competencies for Opioid Prescriber Education: Day 1

FDA’s Role in Foreign Drug Manufacturing (November 2017)

FDA Webinar on the Guidance for Industry on Infant Formula Enforcement Discretion Policy

FDA Webinar: Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance

FDA Public Workshop | AI in Imaging | Development & Validation of Breakthrough AI-Guided Echo Sy...

FDA Public Workshop on Opioid Prescriber Education Day 2

FDA’s International Office and the Pharmaceutical Quality Mission (12/15) Global Quality

FDA Roundtable

FDA-AACR Workshop: Non-clinical Models for Safety Assessment of Immuno-oncology Products

FDA D.I.S.C.O.: First Tissue/Site Agnostic Approval Transcript

2021 PRO Consortium Workshop - FDA Update

UMDF Power Surge 2020: FDA Workshop and Other Regulatory Learnings

AMA Webinar: FDA Review Process for COVID-19 Vaccine Candidates (Episode 1 of a series)

FDA Workshop 'Next-Gen vaccines without the right platform limit pandemic effectiveness'

Xtalks eCademy - FDA Inspections - Simulated Environment of a Clinical Response Team

Perspectives from FDA's Leadership - Sentinel Initiative Public Workshop

2021 FDA Science Forum – Session #1- Improving Clinical and Post-Market Evaluation