February 2016 Semi-Annual Update
In This Newsletter
The IQ Working Group Directory is a compilation of working group progress reports created to promote awareness of ongoing activities, participation, and collaboration opportunities. It contains information about working group objectives, participants, activities, and accomplishments. The report is posted in the members’ section of the IQ website, under “News” (you must log into the website to view the report).
CMC Leaders Meet with FDA
IQ’s CMC Leadership met with FDA in October to discuss a range of CMC activities within the Consortium, including continuous manufacturing, the Pediatric Working Group’s efforts, the Novel Excipients Working Group, process capability, and recent interactions related to co-crystals. Minutes of the meeting are available on the members’ section of the IQ website, under “News” (you must log into the website to view the minutes).
The ICH E14 Implementation Working Group has revised the Questions and Answers document for the ICH E14 Guideline, "The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential For Non-Antiarrhythmic Drugs." The Q&A document now contains a revision to question 5.1, "Use of Concentration Response Modeling of QTc Data," which now provides a basis for regulators to waive the thorough QT (TQT) studies based on data from early phase 1 studies (see Darpo et al, 2015). This important revision provides a data-based, streamlined approach for QT assessment, and is based on the studies conducted and published via the IQ-CSRC collaboration.
The production version of the IQ database framework has been launched to provide support for complex data sharing projects. To accommodate less complex data sharing projects, IQ is currently extending the framework with a “flat database” extension. Once complete, the framework will be able to support accelerated creation of flat databases utilizing the automated blinding, validation, and export functionalities of the framework.
IQ Welcomes New Member Companies
In the past several months, Concert Pharmaceuticals, Pierre Fabre, Seattle Genetics, Theravance, and UCB all joined IQ. The Consortium welcomes these companies, and the new perspectives they will contribute to the organization’s ongoing activities.
Recent Publications & Comments
All IQ publications and comments, as well as presentations from IQ events, are available through the IQ Publications Directory.
Registration for all IQ-wide events may be completed via the IQ website.
IQ has several webinars scheduled, and more may be added. Each is deemed a members only event, unless otherwise noted. Registration is open to all individuals from IQ member companies, and registration may be accessed via the IQ website. After registering, individuals will receive a confirmation email with information about joining the webinar.
IQ maintains a directory of meetings and webinars on its website. Events are added as planned, and listings are updated with information about location (as applicable) and registration when that information is available.