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September 30, 2019 PRINT PDF

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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