The Project 'Workpackages'

The Project Consortium:

• Partner 1 =  UPPSALA UNIVERSITET  ’’UU’’
• Partner 2 =  Immun System I.M.S. AB  ’’IMS’’
• Partner 3 =  MUKOVISZIDOSE INSTITUT GEMEINNÜTZIGE GESELLSCHAFT FUR FORSCHUNG UND THERAPIEENTWICKLUNG ’’ MI’’
• Partner 4 =  REGION HOVEDSTADEN ’’RH’’
• Partner 5 =  VALSTYBINIS MOKSLINIU TYRIMU INSTITUTAS INOVATYVIOS    MEDICINOS CENTRAS ‘’VU’’ Lithuania
• Partner 6 =  CYSTIC FIBROSIS EUROPE EV CFE ‘’CFE’’
• Partner ‘’7’’  =  HEINRICH-HEINE-UNIVERSITAET DUESSELDORF ‘’UDUS’’
• Partner ’’8’’ = STOCKHOLMS LAENS LANDSTING ’’Karolinska’’
• Partner ’’9’’ =  INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE ''INSRM'' (INSERM is not an active member at the moment)
• Partner 10  = CONSORZIO ITALIANO PER LA RICERCA MEDICA ‘’CIRM’’

WP1 (Pre-clinical IgY studies)

Task 1. To study the in vitro effects of the antibody preparation on adhesion and bacterial growth.
(Partners Immunsystem, UU and RH).
Task 2. To study the reactivity of the formulation towards PA strains in different European countries. (Partners IMS, UU, MI, RH, UDUS).
Task 3. The stability of the solution at various temperatures.
(Partner IMS, UU)

WP 2 (Clinical Studies; Sponsor)

The WP tasks are grouped according to the responsible task leader:
By Partner MI:
Task 1. Sponsor duties MI, (Partners: UDUS, IMS)
Task 2. Transfer of sponsorship duties (Partners: MI, UDUS, RH, Karolinska, INSERM, CIRM , UU)
Task 3. Trial initiation (Partners: UDUS, RH, Karolinska, INSERM, CIRM , MI, UU, CFE)
Task 4. Management of the clinical trial (Partners: MI, UDUS, RH, Karolinska, INSERM, CIRM,)
Task 5. Data management (Partners UDUS, RH, Karolinska, INSERM, CIRM,)By Partner UDUS:
Task 6. Monitoring of the clinical trial (Partners UDUS, RH, Karolinska, INSERM, CIRM)
Task 7. Pharmacovigilance and SAE reporting (Partners UDUS, RH, Karolinska, INSERM, CIRM)
Task 8. Biostatistical analysis ( Partners UDUS, RH, Karolinska, INSERM, CIRM)
Task 9. Quality management (Partners UDUS, RH, Karolinska, INSERM, CIRM, MI)
Task 10. Patient representation (CF)

WP 3 (Pre-clinical studies AND clinical;  clinical trial III sample analysis)

The objectives of this WP are:
1. To measure serum pseudomonas (PA) antibodies (=precipitins) in serum
2. To measure PA and other pathogens in sputum or throat cough swab
3. To confirm that no intermittent or chronic infection has been missed
4. To study the effect of anti-Pseudomonas IgY on biofilm formation.
5. To see if the effect of anti-Pseudomonas IgY can be verified in animal studies.

WP 4 (pre-clinical AND clinical: modes of action of Anti-Pseodomonas antibodies during oral immunotherapy)

Summary of objectives
•To identify modes of action of Anti-Pseudomonas antibodies during oral immunotherapy
•The European Medicines Agency (EMA) granted “Anti-Pseudomonas IgY” an Orphan Drug Designation in September 2008. A primary objective is to provide technical data for an Orphan Drug registration, a requirement for marketing authorization; and for making the treatment available for CF patients within EU.


WP5 (pre-clinical: toxicity studies)

Task 1. Gastrointestinal flora. To study the effect of oral administration of anti-Pseudomonas IgY on the normal faecal flora. To provide information available regarding the effects of oral administration of specific IgY on the normal bacterial flora. (Partners VU, UU and IMS)
Task 2. Gastrointestinal epithelial cells. To study the effects of oral administration of anti-Pseudomonas IgY on the gastrointestinal tract. (Partners VU, UU and IMS)

WP6 ( Anti-Pseudomonas IgY Production)

Task 1. Immunization of hens. Keeping of hens, immunization and collection of eggs from immunized hens as raw materials for the drug formulation. (Partner IMS)
Task 2. Production of anti-Pseudomonas IgY formulations according to MPA and GMP legislation. (Partner Immunsystem)


WP7 (Dissemination, and CF Patient representation)

Task 1. Dissemination, and CF Patient representation(Partners CFE, MI, UU, UDUS, VU and RH)
Task 2. To be the contact point for clinical trial participants
Task 3. The task is led by Partner IMS: Dissemination and Exploitation of project results (includes generated knowledge)


WP8 (IMPACTT Management)

Task 1. Project organisation and management routines (UU)
Task 2. Progress monitoring (UU)Task 3.
Task 3. Coordinator relations with the European Commission (UU)
Task 4. Management of administrative and financial issues (UU)
Task 5. Internal project communication (UU)
Task 6. Project documentation (UU)

Please see to powerpoint on the workpackage breakdown, by clicking here ..