3.3 Total kidney volume as a prognostic biomarker / reasonably likely surrogate endpoint for use in clinical trials for Polycystic Kidney disease
Dr. Vijay Modur (Sanofi)
Presentations on approaches to regulatory acceptance of current projects
3.4 Islet autoantibodies as susceptibility/risk biomarkers for T1D diagnosis in at risk subjects
Dr. Joe Hedrick (Janssen)
3.5 Novel biomarkers for Crohn’s disease drug development programs
Dr. Jiri Aubrecht (Takeda)
3.6 Developing and validating an in silico model for proarrhythmia risk assessment under the CiPA Initiative
Dr. Zhihua Li (US FDA)
Keynote Address
Dr. Peter Stein (US FDA)
Session 4. Addressing Drug Development Gaps through Data Sharing: Converting Data into Knowledge
Moderators: Dr. Klaus Romero (C-Path) and Ms. Amanda Borens (C-Path)
4.1 Introduction and notes on data sharing and acquisition
Dr. Klaus Romero (C-Path)
4.2 Data-driven models for drug development
Dr. Jackson Burton (C-Path)
4.3 Bridging the gap
Ms. Amanda Borens (C-Path)
4.4 NIH Strategic Data Initiative
Dr. Ken Wilkins (NIDDK)
4.5 CREATE: Children’s REgistry for the Advancement of ThErapeutics
Dr. Eric Zuckerman (Pediatric IBD Foundation)
4.6 C-Path Biomarker Data Repository
Dr. Jennifer Burkey (C-Path)
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