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Solutions to Drug Development Challenges Workshop: Utilizing Quantitative Approaches, Data Sharing, and Novel Biomarkers
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Events
September 30, 2019
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Solutions to Drug Development Challenges Workshop: Utilizing Quantitative Approaches, Data Sharing, and Novel Biomarkers
Title
Presenter
Presentation Link
Introduction
Dr. John-Michael Sauer (C-Path)
Keynote Address
Dr. Joseph Scheeren (C-Path)
Welcoming Remarks
Dr. Janet Woodcock (US FDA)
Session 2: Benefits of DDT progression to regulatory acceptance
Moderators: Dr. Inish O’Doherty (C-Path) and Dr. Ameeta Parekh (US FDA)
2.1 A perspective on the history and evolution of drug development tools at FDA
Dr. Ameeta Parekh (US FDA)
2.2 Overview of Fit-for-Purpose Initiative
Dr. Sharonjit Sagoo (US FDA)
2.3 Overview of Biomarker Qualification Program
Dr. Katherine Hollinger (US FDA)
2.4 Broad perspective on how the paths impact industry
Dr. James Mayne (PhRMA)
Session 3: Approaches to regulatory acceptance of drug development tools
Moderators: Dr. John-Michael Sauer (C-Path) and Dr. Katherine Hollinger (US FDA)
Examples of drug development tool regulatory acceptance covering the unmet need, solution, process, impact, and next steps
3.1 Quantitative solutions for drug development
Dr. Klaus Romero (C-Path)
3.2 Kidney Safety Project Composite Measure of drug-induced kidney injury biomarkers
Dr. Gary Friedman (Pfizer)
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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