Antibacterial Drug Development: Developing a Pilot Protocol for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

APRIL 22, 2013 TO APRIL 23, 2013

CTTI Project: Streamlining HABP/VABP Trials

Meeting Background:

The goal of this meeting is to seek solutions for challenges in study design and conduct of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) studies by applying the Quality by Design (QbD) principles.

Meeting Location:

Bethesda, MD

Meeting Materials:

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Introduction and Meeting Goals by Pamela Tenaerts

Session 1: The Challenges of HABP/VABP Trials

Summary of Challenges Identified and Categorized by Brad Spellberg
Operational Challenges in HABP/VABP Trial Conduct by Charles Knirsch
Operational Challenges in HABP/VABP Trial Conduct by David Friedland

Session 2: How can QbD be used to address the challenges in HABP/VABP trials?

Introduction to a QbD Approach to Clinical Trials by Martin Landray
Enhancing Trial Efficiency While Promoting Quality-A Regulatory Perspective by Ann Meeker-O'Connell
Workgroup Instructions

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.