Thinktank Meeting on QT Assessment in Early Clinical Development

7:30-8:00am     Registration and Continental Breakfast

8:00-8:30am

 

8:30-10:00am     Session I: Role of Concentration Effect Modeling in Assessing a Drug’s Effect on the QTc Interval (Session Chair and Moderator: Christine Garnett)

  • FDA Perspective on using concentration-QTc relationship in regulatory decisions: Christine Garnett
  • FDA Statistical Perspective: Joanne Zhang
  • Industry experience of the concentration-QTc relationship in phase 1 studies:
  • Pfizer Experience: Steve Riley
  • AstraZeneca Experience: Corina Dota
  • Statistical properties (type 1 error, power) of concentration-QTc analysis: Geunter Heimann
  • Data-based simulation studies to assess the power of detecting moxifloxacin QTc response using concentration-QTc in small phase-1 studies: Georg Ferber
  • Round Table Discussion: Chair, Speakers, and Krishna Prasad

 

10:00-10:10am     Break

 

10:10-11:20am     Session II: How Can Assay Sensitivity be Established in Early Clinical Trials without the use of Moxifloxacin? (Session Chair and Moderator: Charles Benson)

  • FDA View: What is needed to demonstrate that a QT Study is sufficiently sensitive to detect a small change in QT without the use of a positive conrtol?: Norman Stockbridge
  • Quality criteria as evidence of assay sensitivity for studies assessing QT effects: Marek Mailk
  • Autonomic maneuvers and food effect as examples of alternative approaches to demonstate assay sensitivity: Anthony Fossa
  • Statistical Approaches to Assay Sensitivity: Stanley Young
  • Round Table Discussion: Chair, Speakers, Philip Sager, and Colette Strnadova

 

11:20-12:20pm     Session III: Can an approach integrating non-clinical and early clinical QT assessment replace the thorough QT study? (Session Chair and Moderator: Borje Darpo)

  • How can early phase studies produce QT data with the same validity of TQT study? Design considerations and measurement techniques of early studies: Borje Darpo
  • The role of non-clinical assays in determining the level of clinical QT assessment: Rob Wallis
  • What aspects of the non-clinical data increase confidence in this data in an integrated approah of QT data?: John Koerner
  • Round Table Discussion: Chair, Speakers, and Christine Garnett

 

12:20-12:50pm     Lunch

 

12:50-1:40pm    Session IV: What will it take to convince a regulator? (Session Chair and Moderator: Krishna Prasad)

  • Industry View: Integration of non-clinical and clinical data to replace the TQT study: Charles Benson
  • What will it take to convince a regulator that the TQT study can be replaced by combining non-clinical and early clinical data:

Personal View from Regulators:

 

1:40-1:50pm     Introduction to Break-Out Sessions: Philip Sager

 

1:50-3:00pm     Break-out Sessions

  • Effort #1: Role of Concentration Effect Modeling in Assessing a Drug’s Effect on the QTc Interval (Moderators: Christine Garnett and Steve Riley)
  • Effort #2: How Can Assay Sensitivity be Established in Early Clinical Trials without the use of Moxifloxacin? (Moderators: Charles Benson and Philip Sager)
  • Effort #3: Can an approach integrating non-clinical and early clinical QT assessment replace the thorough QT study? (Moderators: Borje Darpo and Krishna Prasad)

 

3:00-5:00pm     Roundtable Discussion and Reports from Break-out Sessions (Facilitators: Borje Darpo, Christine Garnett, and Philip Sager)

 

5:00-5:30pm     Meeting Summary and Wrap-up

  • Wrap-up and Future Directions: Meeting Co-Chair: Christine Garnett
  • Conclusions and Meeting Outcome: Philip Sager

Click here for a draft agenda.

   

TRANSPORTATION

Hotel Shuttle Service:

Thursday morning shuttle transportation will be available on a first-come, first-served basis from the Crowne Plaza Hotel. The shuttle will arrive at the hotel at 7:05 a.m. with a prompt departure of 7:15 a.m.

If the shuttle reaches maximum capacity before you have been seated, you will be responsible for your own transportation to the White Oak Facility.

 

Thursday Afternoon Departure Information:

Each participant is responsible for their own departure transportation from the White Oak Facility once the meeting adjourns. Two transportation services to consider are Barwood Taxi 301-984-1900 or AAA limousine service 703-575-9560.

All meeting participants will enter through Building 1.

 

Driving Directions:

White Oak FDA Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993

Participants driving to the White Oak Facility should follow the directions and parking instructions provided on the map (below). Again, all attendees must enter through Building 1.

 

Metro Station Shuttle:

The shuttle will take you directly to the White Oak Facility from various metro stations. All attendees must enter through Building 1.

 

IMPORTANT SECURITY INFORMATION

Cameras, recordable devices, sharp objects, etc., will not be allowed to pass through FDA security. Laptops, cell phones and jump drives are permitted.

The host hotel for this meeting is the Crowne Plaza. Rooms are currently available for booking until January 18th, 2012. We advise you to register for the program and reserve your lodging as soon as possible. Please reference “CSRC Conference.” Hotel contact information can be found below:


Crowne Plaza

8777 Georgia Avenue

Silver Spring, Maryland 20910

1-800-972-3159

Objective of Meeting:

The objective of the meeting is to identify key knowledge gaps and propose research areas in regard to future replacement of the ICH E14 ‘thorough QT/QTc study’ with QT assessment in early clinical trials using alternative analysis techniques and refined methodologies. While improved non-clnical assessment of proarrhythmic risk may constitute an important part of this strategy, the meeting will focus on clinical QT assessment.

Expected Outcome:

The expected outcome is the formation of collaborative CSRC research groups with members from regulators, sponsors, and academia with the goal to perform, promote, and compile research in areas addressing identified key knowledge gaps.

 

The host hotel for this meeting is the Crowne Plaza. Rooms are currently available for booking until January 18th, 2012. We advise you to register for the program and reserve your lodging as soon as possible. Please reference “CSRC Conference.” Hotel contact information can be found below:


Crowne Plaza

8777 Georgia Avenue

Silver Spring, Maryland 20910

1-800-972-3159

 

Click here for online booking: http://www.ichotelsgroup.com/crowneplaza/hotels/us/en/silver-spring/wasss/hoteldetail?ratePreference=6CBARC&groupCode=CSR