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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.

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)

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FUNDACIO INSTITUT MAR D INVESTIGACIONS MEDIQUES IMIM

Spain

EU Contribution

€ 150 157

UNIVERSITY OF YORK

United Kingdom

EU Contribution

€ 415 255

HELMHOLTZ-ZENTRUM FUR UMWELTFORSCHUNG GMBH - UFZ

Germany

EU Contribution

€ 262 862

ECT Oekotoxikologie GmbH

Germany

EU Contribution

€ 332 459

STICHTING KATHOLIEKE UNIVERSITEIT

Netherlands

EU Contribution

€ 339 400

UMWELTBUNDESAMT

Germany

EU Contribution

€ 186 677

THE UNIVERSITY OF EXETER

United Kingdom

EU Contribution

€ 258 566

SYNAPSE RESEARCH MANAGEMENT PARTNERS SL

Spain

EU Contribution

€ 224 866

UNIVERSIDAD POMPEU FABRA

Spain

EU Contribution

€ 125 583

LHASA LIMITED

United Kingdom

EU Contribution

€ 288 640

MOLECULAR NETWORKS GMBH COMPUTERCHEMIE

Germany

EU Contribution

€ 258 475

LIVERPOOL JOHN MOORES UNIVERSITY

United Kingdom

EU Contribution

€ 157 060

BRISTOL-MYERS SQUIBB COMPANY CORP

United States

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.

United Kingdom

JANSSEN PHARMACEUTICA NV

Belgium

Eli Lilly and Company Limited

United Kingdom

MERCK SHARP & DOHME CORP

United States

F. HOFFMANN-LA ROCHE AG

Switzerland

ASTRAZENECA AB

Sweden

SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT

France

PFIZER LIMITED

United Kingdom

NOVARTIS PHARMA AG

Switzerland

BOEHRINGER INGELHEIM INTERNATIONALGMBH

Germany

TEVA PHARMACEUTICALS EUROPE B.V.

Netherlands

Project information

Grant agreement ID: 115735

Status

Closed project

  • Start date

    1 January 2015

  • End date

    31 December 2018

Funded under:

FP7-JTI

  • Overall budget:

    € 9 754 350

  • EU contribution

    € 3 000 000

Coordinated by:

Bayer Pharma AG

Germany