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Accelerating medical product development in kidney transplantation through a public-private partnership

Start Date: 9/22/22
Start Time: 8:00 AM ET

AbOUT:

This public workshop will be focusing on 1) qualifying a composite surrogate for long-term graft loss after kidney transplantation 2) real-world evidence (RWE) use in transplant clinical trials and 3) potential future endpoints in kidney transplantation

The Transplant Therapeutics Consortium (TTC) aims to accelerate the medical product development process for transplantation by identifying challenges, prioritizing solutions, and developing tools to advance new product development to meet the most pressing needs of transplant recipients.

AGENDA:

Welcoming remarks Amanda Klein and Ozlem Belen
Session 1: Qualifying a composite surrogate for long-term graft loss after kidney transplantation
  • 1A - Regulatory qualification procedures and qualification status of the iBox Scoring System as a reasonably likely surrogate endpoint with FDA
  • 1B - Graphical user interface for sample size calculation using iBox scores
  • Panel discussion
Speakers: Amanda Klein and Luke Kosinski

 

Moderator: William E. Fitzsimmons
Session 2: Real-world evidence (RWE) use in transplant clinical trials
  • 2A - Sample size calculation and need for RWE supplemental external controls for the 5-year survival analyses
  • 2B - Pilot study for external control using the cyclosporine arm of the BENEFIT RCT versus UNOS/OPTN registry data
  • 2C - Regulatory and design considerations for RWE supplementation in transplant clinical trials
  • Panel discussion
Speakers: Luke Kosinski, Alice Toll, and John Concato

Moderator: Amanda Klein
Session 3: Future endpoints in kidney transplantation
  • 3A - Efficacy endpoints
  • 3B - Safety endpoints
  • 3C - Regulatory qualification procedures for clinical outcome assessments
  • 3D - Patient-reported outcome measures for transplantation
  • Panel discussion
Speakers: Peter Nickerson, William E. Fitzsimmons Rebecca Speck, and Dave Taber

 

Moderator: Mark Stegall
Closing Remarks Amanda Klein, Kenneth Newell, and Ulf Meier-Kriesche


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Critical Path Institute is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government source(s), totaling $11,196,634. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.

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