Our Consortium

The GANNET53 consortium consists of 22 partners from 5 European countries (Austria, Belgium, France, Germany and Italy). We are a group of passionate collaborates and an interdisciplineary team that has one common goal: improve the life of patients suffering from ovarian cancer.

The GANNET53 consortium consists of

  • 14 patient-recruiting clinical centres
  • 4 so-called national trial groups
  • 1 coordinating centre for clinical trials
  • 3 research organisations involved in translational research
  • 1 software and database company with focus on medical IT solutions

Here you find a detailed description of all GANNET53 Project Partners


Management Structure

The project coordinator is the intermediary for the communication between European Commission and the participants. The project management team (PMT) includes the project coordinator, a medical clinical trial manager, the clinical trial administrator (AAGO trial centre: legal sponsor) and an administrative manager. The PMT takes the responsibility of day-to-day management of the project. There are 22 participants in the GANNET53 consortium; each contributes to various tasks defined in eight work packages (WP). Each work package is led by a work package leader (WP leader). The two core work packages, WP3 (Phase I) and WP4 (Phase II), respectively, are organised with an additional management layer between participant and WP leader, namely the national trial groups. The WP leaders, the national trial group leaders and the PMT make up the Managerial Board (MB). A Steering Committee (SC) includes all participants in the consortium (except for the national trial groups; see below) and is the decision-making organ of the project. In addition, an External Advisory Board (EAB) is established including five eminent experts from different areas relevant to the project. For clinical trial safety monitoring a Data and Safety Monitoring Committee (DSMC) is established.

Coordinator

The Coordinator (Nicole Concin) is the intermediary for the communication between the European Commission and the contractors. In this function the coordinator may be considered the “head of the project” and is responsible for the overall scientific, financial, gender and ethical coordination of the project and for being carried out in a timely manner.

Profile Nicole Concin

Managerial Board (MB)

The Project Management Team, the Work Package (WP) Leaders, and the National Trial Group Leaders make up the MB. The MB is responsible for monitoring the project progress towards the objectives (deliverables, milestones), ensuring collaboration within and between the WP, coordinating future activities and decision-making/problem-solving in case of unforeseen difficulties. The MB will in particular monitor the strategy for use and dissemination of the project results. The MB will generally decide by majority vote. The MB will get advice from the External Advisory Board (EAB).

Project Management Team (PMT)

As suitable for the complexity and scale of the project, the project management will be performed by a team. The project management team (PMT) is responsible for the day-to-day scientific, ethical, gender, financial, administrative, and contractual management of the project. The PMT consists of the Coordinator, the Project Manager, the Medical Clinical Trial Manager and the Clinical Trial Administrator (Austrian-AGO trial centre at Innsbruck Medical University: legal sponsor of the GANNET53 trial; BOGO at KU Leuven, Belgium: legal sponsor of the EUDARIO trial).

Project Manager

The Project Manager (Gabriele Klaming) is responsible for the overall administrative management of the project. She is responsible for all organisational task regarding EU requirements.

Profile Gabriele Klaming

Medical Clinical Trial Manager

The Medical Clinical Trial Manager (Alain Zeimet) is responsible for the executive medical management of the clinical trials.

Profile Alain Zeimet

Clinical Trial Administrator

The Clinical Trial Administrator (Regina Berger) is responsible for the overall administrative clinical trial coordination.

Clinical Trial Administrator in the GANNET53 trial:

Profile Regina Berger

Clinical Trial Administrator in the EUDARIO trial:

Profile Joke De Roover

National Trial Groups

The two core work packages, i.e. WP3 and WP4 (Phase I and II clinical trials), are organised with an additional management layer between participants, i.e. patient-recruiting centre, and WP leader, namely the national trial groups. National trial groups are responsible for the administrative coordination of the clinical trial on the level of their assigned national centres.

National Trial Group Leaders:

Profile Christian Marth

Profile Eric Pujade-Lauraine

Profile Ignace Vergote

Profile Jalid Sehouli

Profile Sven Mahner

Steering Committee (SC)

The Steering Committee (SC) is the decision-making organ of the GANNET53 consortium and will decide all issues not covered by the consortium agreement. To ensure a fair cooperation of all participants, this board follows the matrix organisation structure: members responsible for specific tasks only report and advice, the group leaders of the consortium have voting power (including the coordinator), but have decision power only as a whole body. The SC will meet at least once a year to monitor the progress and will get advice form the External Advisory Board (EAB).

Trial Statistician

The Trial Statistican (Hanno Ulmer) is responsible for all statistical issues of the clinical trial.

Profile Hanno Ulmer

External Advisory Board (EAB)

In order to strengthen the power of the consortium, to update the plans according to 1) developments and changes in clinical, scientific and technologically relevant areas, and to 2) significant changes or problems arising within the consortium, we will establish an EAB with four members, whose world renowned expertise cover very important areas relevant to the GANNET53 trial. EAB will advise the MB and the SC. At least the EAB chair will be invited to all meetings of the SC.

Members

Data and Safety Monitoring Committee (DSMC)

The Data and Safety Monitoring Committee (DSMC) will be responsible for independently evaluating the safety of the patients participating in the trial. All captured adverse events and safety reports will be reported to the DSMC for assessment. The DSMC will meet (e.g. via teleconference) on a regular basis over the course of the study and may also meet on an unscheduled basis if any unexpected safety concerns arise.

Members

Patient Self-Help Groups

Selbsthilfegruppe für Frauen mit Unterleibskrebs, Linz

Contact

Selbsthilfegruppe Eierstock- und Gebärmutterkrebs; Berlin

Contact

Selbsthilfegruppe Ovarialkazinom OVARCOME, Wien

Contact

Deutsche Stiftung Eierstockkrebs, Berlin

Contact


Work Packages (WP)

In order to achieve the objectives of this project, the GANNET53 trial is structured into eight work packages (WP):

WP1 comprises all management activities in connection with the EU FP7 project.

WP2 organisse all legal, ethical, and administrative prerequisites necessary for Phase I and Phase II clinical trials, i.e the GANNET53 and the EUDARIO trials.

WP3 and WP4 are the centrepieces of the GANNET53 project, i.e. Phase I and Phase II clinical trials based on the use of the HSP90 inhibitor Ganetespib, respectively. WP3 is the Phase I GANNET53 dose escalation/de-escalation study aiming to define the safety of the experimental drug Ganetespib given in a new combination with Paclitaxel in Pt-R ovarian cancer patients with Type II tumours. WP3 will provide the Ganetespib combination dose to be used in the Phase II GANNET53 trial (takes 10 months: M9-18).

WP4 comprises two randomised, open label, Ganetespib-based Phase II trials (begins 1.5 years after project start), in which the efficacy of Ganetespib combinations versus standard chemotherapy will be determined in ovarian cancer patients. It will also include the collection of biomaterials.

WP5 will organise the retrospective (archival) and prospective collection, handling, processing and barcoded storage of biomaterials by developing SOPs. Moreover, WP5 provides central histopathological review (CHR) of archival ovarian cancer tissues in all Phase II patients. CHR will also provide the quality control of all biosamples to be used in experimental work. Another core task of WP5 is the development of four dedicated data handling systems, i.e. three web-based systems for the documentation of clinical data (eCRFs) in Phase I and Phase II GANNET53 trial and in the EUDARIO trial, respectively, and a fourth system providing a virtual biobank and enabling tracking of biosamples.

The core task in WP6 is the exact determination of p53 mutational status in all Phase II GANNET53 patients in archival and prospectively collected biosamples. WP6 includes the processing of collected biomaterials by patient-recruiting centres. *WP6 will perform molecular efficacy testing of Ganetespib in collected biomaterials and correlate findings with clinical outcome in the GANNET53 and EUDARIO trials, e.g. a functional molecular test to predict responsiveness to Ganetespib will be developed and evaluated.

WP7 will lift the underlying scientific concept of the clinical trials to the highest level of preclinical evidence by Genetic and Pharmacologic Proof-of-Principle experiments in vivo in engineered mice and human xenografts. Furthermore, this WP will perform a stringent causality proof for Ganetespib-mediated drug action leading to preferential killing of mutp53 cancer cells in human ovarian cancer models using cell cultures and xenografts.

WP8 is dedicated to dissemination.

Work Package Leaders

To ensure clear responsibilities and smooth decision making, the next layer in the management structure has the classical line-and-staff structure: Each WP has a WP leader who is responsible for the timely implementation of the work plan, for continuously monitoring and reporting progress, for identifying the needs for Intellectual Property (IP) management at the WP level.

Work Package Leaders:

Profile Nicole Concin (WP 1 & 8)

Profile Regina Berger (WP 2)

Profile Isabelle Ray-Coquard (WP 3)

Profile Ignace Vergote (WP 4)

Profile Ioana Braicu (WP 5)

Profile Robert Zeillinger (WP 6)

Profile Ute Moll (WP 7)