Management & Organization

The IMPACTT is a consortium of 10 Partners established in six different countries (Sweden, Germany, Lithuania, Denmark, Italy, and France*). The Partners from Sweden, Germany, Denmark and Lithuania each are in charge of one workpackage (WP). The consortium has a central Coordinator responsible for management of the whole project. The Management Board, is the decision-making forum, which is represented by all of the IMPACTT Partners.

The Consortium management

  1. Coordinator: UU
  2. Project Office: UU
  3. Management Board: IMPACTT WP Leaders
  4. Project Internal Working Groups:
    1. The Clinical Management Committee: Clinical Trial WP Leaders; & Immunsystem
    2. Scientific Board: RTD WP leaders; UU
    3. Business Development Group: Partners Immunsystem, MI, UU
  5. External Advisory Board. A group of Scientific and Clinical Experts

 The Consortium organization

  • The overall coordination of the different project parts is performed by the University of Uppsala , Sweden (UU).
  • The clinical trial Sponsor, Mukoviszidose Institute, Germany, (MI) coordinates the prospective, multicenter clinical trial to evaluate IgY in patients and assumes sponsorship responsibilities. To organize the clinical trial sites in the participating countries, MI acts as the point of contact for European Clinical Trial Network-CF (ECFS-CTN) of the European Cystic Fibrosis Society (ECFS), implementing international CF clinical trials.
  • The ECRIN network (European Clinical Research Infrastructures Network) provides excellence in central quality management, central pharmacovigilance, data management, and biostatistics. Local National partners of the ECRIN network manage the clinical trial in respective countries. The ECRIN member partners in the project include Heinrich-Heine-Universitaet Duesseldorf  (UDUS) , Germany; the Copenhagen Trial Unit, Denmark; Consorzio Italiano per la Ricerca in Medicina (CIRM), Italy; Institut National de la Santé de la Recherche Médicale (INSERM)*, France; Karolinska KTA, Sweden.
  • CF-Europe works in close contact with the clinical trial participants (in particular patient groups and physicians) as well as national, European and worldwide organizations, groups and institutions that represent the CF patient to promote CF healthcare.
  • Primary end point microbiology is  led by Region Hovedstaden, Denmark (RH).
  • Preclinical IgY research, and toxicity and safety data is provided by Partners Valstybinis Moksliniu Tyrimu Institutas Inovatyvios Medicinos Centras, Lithuania (VU); RH, Denmark; and UU, Sweden.
  • The technological advancement is carried out by Immunsystem AB, Sweden.

* The French Partner INSERM is not a IMPACTT Project Partner since July 1st 2012.