ABDD HABP/VABP

ABDD HABP/VABP Pilot Study Workshop

FEBRUARY 24, 2015

CTTI Project: HABP/VABP Studies

Meeting Goal

To determine the study design for the CTTI Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) pilot study. The study will test the principles and recommendations identified in the CTTI Program on Antibacterial Drug Development (ABDD).

Meeting Location:

Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Rd, Bethesda, Maryland 20852

Meeting Materials:

Meeting Agenda

List of meeting attendees

Meeting Presentations:

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.

CTTI’s #DIA2014 Posters Available Online

Posted on by Lorri Bingham

On June 15-19, the DIA hosted their 50th Annual Meeting (also known as #DIA2014) in San Diego, CA. Several CTTI members and staff attended the conference, and were involved with panels, workshops and poster presentations. We are now pleased to share the posters from this event on our website:

  1. A Collaboration to Facilitate the Development of Antibacterial Agents for Unmet Need: Streamlining Clinical Trial Protocols
    Abstract Summary: This collaboration includes the participation of a multi-disciplinary working group led by CTTI. Several meetings and workshops were held to gain a wider understanding of issues, several solutions using a Quality by Design approach were proposed.
    Presenter: Gary Noel, MD, Senior Director for Janssen Research and Development
  2. Good Clinical Practice (GCP) Training: Identifying Key Elements and Strategies for Increasing Training Efficiency
    Abstract Summary: CTTI convened a multidisciplinary working group involving partners from academia, industry, and government to develop recommendations for streamlining current GCP training efforts.
    Presenter: Jonathan Seltzer, MD, MA, MBA, FACC, President and CEO for Applied Clinical Intelligence, LLC

We would like to thank our colleagues in attendance at #DIA2014 who contributed to this successful conference, and we look forward to seeing you at #DIA2015.

Invent the Future with CTTI at DIA 2014 50th Annual Meeting

Posted on by Lorri Bingham

On June 15-19, the DIA is hosting their 50th Annual Meeting in San Diego, CA. The tagline for this year’s event, Celebrate the Past – Invent the Future, resonates closely with one of CTTI’s own strategic approaches: helping to shape the clinical trials enterprise of the future.

During this week of forward-thinking discussions, we look forward to connecting with many of you. Several CTTI representatives will be presenting, and CTTI will also host a pre-conference tutorial. Specifically, we look forward to sharing our work on quality by design, patient recruitment, antibacterial drug development, and good clinical practice. Below is a schedule of opportunities to hear more about these topics at the conference.

Sunday June 15, 2014

9:00 AM – 5:00 PM – Quality by Design, from Theory to Practice

  • Event Information: Pre-Conference Tutorial TUT44 (*Advanced Registration Required)
  • Presenters: Ann Meeker-O’Connell, Jean Mulinde, John Alexander
Tuesday June 17, 2014

7:15 AM – 4:00 PM – A Collaboration to Facilitate the Development of Antibacterial Agents for Unmet Need: Streamlining Clinical Trial Protocols

  • Event Information: Poster – W30 located in the Sails Pavilion
  • Presenter: Charles Knirsch

8:00 AM – 9:30 AM – Updated Strategies for Effective Recruitment of Patients in Clinical Trials

  • Event Information: Panelist Session #201 located in Room 1B
  • Presenters: Elizabeth Mahon (Chairperson); Margo Michaels, Jonca Bull (Panelists)

1:30 PM – 3:00 PM – Collaborating to Streamline Drug Development: Case Studies of What Works (and What Doesn’t)

  • Event Information: Panelist Session #259 located in Room 2
  • Presenters: Douglas Peddicord (Chairperson); Dalvir Gill, Christine Pierre, Pamela Tenaerts, Ann Meeker-O’Connell (Panelists)
Wednesday June 18, 2014

7:15 AM – 4:00 PM – Good Clinical Practice (GCP) Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

  • Event Information: Poster – T03 located in the Sails Pavilion
  • Presenter: Jonathan Seltzer

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