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Purpose​

The purpose of Prepare-NS is to develop and validate publicly available clinical outcome assessments (COAs) of fluid overload (FO) fit for drug development for a range of nephrotic syndrome (NS) inducing rare chronic kidney disorders.​

Purpose
Core Team

Core Team

Stakeholders & Consultants

The External Technical Advisory Committee (ETAC) 

The External Technical Advisory Committee (ETAC) represents the foremost experts on Core Outcomes Assessment (COA) development and evaluation for regulatory use.  They play an active role in guiding scientific aspects of the project, guiding logistical and programmatic elements, and participate in Planning, Evaluation/Validation, and Dissemination project phases.

  • Robyn Bent, MS, RN -- FDA

  • Melanie Calvert, PhD -- University of Birmingham

  • David Cella, PhD -- Northwestern University

  • Sonya Eremenco, MA -- Critical Path Institute; PRO Consortium

  • Allison Jaure, PhD -- Sydney Medical School; PI, Standardised Outcomes in Nephrology (SONG)

  • Kathleen Wyrwich, PhD -- Bristol Myers Squibb

Committees

The Clinical Expert Panel (CEP)

​The Clinical Expert Panel (CEP) participates in scheduled meetings and provides clinician perspectives to inform the Prepare-NS study.

  • David Selewski, MD, MS (co-chair) -- Medical University of South Carolina

  • Richard Lafayette, MD (co-chair) -- Stanford University School of Medicine

  • Keisha Gibson, MD, MPH -- University of North Carolina School of Medicine

  • Kristen Hood, EdD, MSN, RN -- Travere Therapeutics

  • Matthias Kretzler, MD -- University of Michigan Medical School

  • Laura Mariani, MD, MSCE -- University of Michigan Medical School

  • Susan Massengill, MD -- Levine Children's Hospital, Carolinas Medical Center

  • Jun Oh, MD -- University Medical Center, Hamburg

  • Louse Oni, PhD -- University of Liverpool, England

  • Brad Rovin, MD -- The Ohio State University

  • Howard Trachtman, MD -- New York University Langone Medical Center

  • Shikha Wadhwani, MD -- University of Texas Medical Branch

The Stakeholder Engagement Group (SEG) 

​The Stakeholder Engagement Group (SEG) is composed of patients and caregivers, as well as representatives with drug development, patient-centered science, patient advocacy and engagement, payer, and clinical expertise. The group participates in meetings and contributes perspectives essential to developing meaningful outcome measures.

  • Patrick Nachman, MD (co-chair) -- University of Minnesota

  • Brittney Parris (co-chair) -- NephCure

  • Anupam Chugh -- care partner

  • Theodore Danoff, MD, PhD -- Pathalys Pharma

  • David Feldman, PhD -- National Kidney Foundation

  • Folke Folkvaljon, MSc -- AstraZeneca

  • Jay Garg, MD -- Genentech

  • Houston Gilbert, PhD -- Hi-Bio

  • Barbara Gillespie, MMS, MD -- Fortera

  • Christine Gwinn -- patient

  • John Letterman -- patient

  • Meg Modes -- care partner

  • Dr. Nima Soleymanlou -- Boehringer Ingelheim

  • Melissa West, MA -- American Society of Nephrology

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