iBox Derived Sample Size Calculator: https://cpath.shinyapps.io/sample_size_ibox_V2/

About the Transplant Therapeutics Consortium (TTC): https://c-path.org/programs/ttc/

Overview: The TTC, in collaboration with leaders from industry, academia, clinical practice, and the US Food and Drug Administration (FDA), hosted this event for stakeholders to discuss pursuing qualification of the iBox Scoring System as a reasonably likely surrogate endpoint with the FDA. The TTC has an accepted Letter of Intent in the FDA Biomarker Qualification Program. In addition, to support the implementation of the iBox Scoring System in future kidney transplant clinical trial design, the TTC developed a graphical user interface for sample size calculation using iBox scores presented in the webinar.

Topics included:

• Pursuing qualification of the iBox Scoring System as a reasonably likely surrogate endpoint
• Clinically meaningful differences in iBox parameters
• Graphical user interface for sample size calculation using iBox scores

Moderator:

• William E. Fitzsimmons, Senior Advisor, Transplant Therapeutics Consortium

Presenters:

• Amanda Klein, Executive Director, Transplant Therapeutics Consortium
• Luke Kosinski, Quantitative Medicine Scientist

Panelists:

• Jiang Liu, Associate Director for Therapeutic Review, Division of Pharmacometrics, Office of Clinical Pharmacology, FDA
• Ulf Meier-Kriesche, Chief Scientific Officer, Veloxis Pharmaceuticals

FDA Letter of Intent: https://www.fda.gov/media/139301/down...

ABOUT C-PATH: Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.