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Intelligent Assessment of Pharmaceutical in the Environment

Objective

Active pharmaceutical ingredients (APIs) can be released to the natural environment during the manufacturing process, following use by patients or when unused medicines are disposed of. As APIs are biologically active compounds concerns have been raised about the potential effects of APIs in the environment on human and environmental health. Over the past 15 years, a substantial amount of work has been done to determine the occurrence, fate, effects, and resulting risks of APIs in the environment and regulatory schemes have been developed requiring environmental risk assessments of all new APIs. However for most APIs currently in use, limited data are available on environmental risks and for new APIs, the testing regimes may not always be optimum. The aim of this project therefore is to develop frameworks that utilise information from toxicological studies, pharmacological mode of action and in silico models to support more intelligent environmental testing of pharmaceuticals in development and to prioritise legacy pharmaceuticals for full environmental risk assessment and/or environmental (bio) monitoring. The aim will be delivered through a number of specific objectives: 1) to review existing approaches for prioritisation and mode of action based intelligent testing of APIs and develop improved frameworks; 2) to establish a high quality database on the properties, environmental fate characteristics and ecotoxicity of APIs; 3) to develop methods for estimating external and internal exposure to APIs for different scenarios; 4) to develop methods and models for predicting ecotoxicological responses to APIs; 5) to validate the developed models, concepts and frameworks using targeted experiments; and 6) to develop a software system to support intelligent testing and prioritisation of APIs in the environment. These objectives will be delivered by a world leading consortium comprising experts in data management and computational modelling, pharmacology, ecotoxicology, environmental chemistry, predictive (eco)toxicology, prioritisation and intelligent testing methodologies and environmental risk assessment.

Field of science

  • /natural sciences/computer and information sciences/software/system software
  • /natural sciences/computer and information sciences/software
  • /medical and health sciences/basic medicine/pharmacology and pharmacy
  • /medical and health sciences/basic medicine/toxicology

Call for proposal

IMI-JU-11-2013
See other projects for this call

Funding Scheme

JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)

Coordinator

Bayer Pharma AG
Address
Muellerstrasse 178
13353 Berlin
Germany
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
Reinhard Laenge (Dr.)
Administrative Contact
Petra Freitag (Ms)

Participants (24)

FUNDACIO INSTITUT MAR D INVESTIGACIONS MEDIQUES IMIM
Spain
EU contribution
€ 150 157
Address
Doctor Aiguader 88
08003 Barcelona
Activity type
Research Organisations
Administrative Contact
Andreu Fort (Mr.)
UNIVERSITY OF YORK
United Kingdom
EU contribution
€ 415 255
Address
Heslington
YO10 5DD York North Yorkshire
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Caroline Moore (Ms)
HELMHOLTZ-ZENTRUM FUR UMWELTFORSCHUNG GMBH - UFZ
Germany
EU contribution
€ 262 862
Address
Permoserstrasse 15
04318 Leipzig
Activity type
Other
Administrative Contact
Annette Schmidt (Ms)
ECT OEKOTOXIKOLOGIE GMBH
Germany
EU contribution
€ 332 459
Address
Bottgerstrasse 2-14
65439 Florsheim
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Anja Coors (Dr)
STICHTING KATHOLIEKE UNIVERSITEIT
Netherlands
EU contribution
€ 339 400
Address
Geert Grooteplein Noord 9
6525 EZ Nijmegen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
E. Davina (Ms.)
UMWELTBUNDESAMT
Germany
EU contribution
€ 186 677
Address
Woerlitzer Platz 1
06844 Dessau-rosslau
Activity type
Research Organisations
Administrative Contact
Sören Schladitz (Mr.)
THE UNIVERSITY OF EXETER
United Kingdom
EU contribution
€ 258 566
Address
The Queen's Drive Northcote House
EX4 4QJ Exeter
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gurney Pam (Mrs)
SYNAPSE RESEARCH MANAGEMENT PARTNERS SL
Spain
EU contribution
€ 224 866
Address
Calle Velazquez 94 Planta 1
28006 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Elena del Rey (Mrs.)
UNIVERSIDAD POMPEU FABRA
Spain
EU contribution
€ 125 583
Address
Placa De La Merce, 10-12
08002 Barcelona
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eva Martin (Ms)
LHASA LIMITED
United Kingdom
EU contribution
€ 288 640
Address
Granary Wharf House, 2 Canal Wharf
LS11 5PS Leeds
Activity type
Research Organisations
Administrative Contact
Katharine Briggs (Ms)
MOLECULAR NETWORKS GMBH COMPUTERCHEMIE
Germany
EU contribution
€ 258 475
Address
Neumeyerstr 28-34
90411 Nurnberg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Christof H. Schwab (Dr)
LIVERPOOL JOHN MOORES UNIVERSITY
United Kingdom
EU contribution
€ 157 060
Address
Rodney Street 2 Egerton Court
L3 5UX Liverpool
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ian Pennington (Mr)
BRISTOL-MYERS SQUIBB COMPANY CORP
United States
Address
Park Avenue 345
10154 New York
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Todd Davidson (Manager)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
Address
Great West Road 980
TW89GS Brentford
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Graham Somers (Dr)
JANSSEN PHARMACEUTICA NV
Belgium
Address
Turnhoutseweg 30
2340 Beerse
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Koen Meeussen (Mr)
Eli Lilly and Company Limited
United Kingdom
Address
Lilly House, Priestley Road
RG24 9NL Basingstoke
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Birgit Steckel-Hamann (Dr.)
MERCK SHARP & DOHME CORP
United States
Address
One Merck Drive
08889 Whitehouse Station Nj
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Joan Tell (-)
F. HOFFMANN-LA ROCHE AG
Switzerland
Address
Grenzacherstrasse 124
4070 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jason Hannon (Dr)
ASTRAZENECA AB
Sweden
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Eva Lindgren (-)
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
France
Address
Pierre Brossolette 1
91380 Chilly Mazarin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Laurence Mazuranok (Ms)
PFIZER LIMITED
United Kingdom
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Max Mirza (-)
NOVARTIS PHARMA AG
Switzerland
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Stephan Korte (Dr.)
BOEHRINGER INGELHEIM INTERNATIONALGMBH
Germany
Address
Binger Strasse
55218 Ingelheim
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Rolf Göggel (Dr)
TEVA PHARMACEUTICALS EUROPE B.V.
Netherlands
Address
Piet Heinkade 107
1019 GM Amsterdam
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Oded Yaari (Senior Counsel)