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Analyst Research Laboratories Ltd

  Name of Israeli SMEs:

1.       Analyst Research Laboratories Ltd  - coordinator - Israel

2.       OSM-DAN Ltd – Administrative manager - Israel

3.       Factline Webservices GmbH - Austris

 

 

Title:

Pharmaceutical products in the environment:

Development and employment of novel methods for assessing their origin, fate and effects on human fecundity

 

Acronym: F&F

Submitted February 2004 for SUB-PRIORITY 5.4.6 Environmental health risks

STREP

 

Subject and Context of the project:

Over recent years there has been growing interest in the significance of reported declines in a number of markers of human fecundity in both men and women. Since many chemicals have been shown experimentally to mimic the activities of estrogen and other hormones, the potential exists for environmental exposure to chemicals to influence a wide range of human reproductive endpoints, including those relating to reproductive competence through disturbance of the endocrine system or other mechanisms. A particular aspect that has received relatively sparse attention is the possible impact of chemical exposure on the fecundity (ability to reproduce) of human populations. In particular, the extent to which food as a medium for exposure to synthetic endocrine disrupters impacts on fecundity is unknown, as is its importance relative to other potential modifiers of fecundity, such as lifestyle.

During the past three decades, studies focused almost exclusively on the conventional “priority” endocrine disruptors: pesticides, heavy metals and toxic environmental contaminants of industrial origin that display persistence in the environment. One large class of chemical that received relatively little attention is that of pharmaceutical products (PPs), which are used in large amounts throughout the world in quantities that are comparable to those of agrochemicals.

Currently, very little is known of the occurrence and effects of PPs in the environment (only a very small percentage of commercially used PPs have been investigated for their occurrence in the environment: about 50 out of the thousands in current use). Similarly, there is no information on the fate of most PPs especially their bio-transformation and photo-transformation. Our understanding of the possible transmission of PPs into the food chain is also very scarce and even less is known of if and how such food, once consumed, affects human fecundity. Part of the problem results from the scarcity of methods for simple and efficient clean-up and pre-concentration of PPs from environmental and food samples, and from the lack of highly specific sensitive and reproducible diagnostic assays (at the ppt level) that can handle large numbers of such samples for monitoring purposes at high rates of analysis at low costs.

 

 

The solution proposed by this project:

The strategic approach for solving this problem and providing answers to the above questions is to develop and employ validated methods for the screening and testing PPs (mainly fecundity hormones such as: estrogen, androgen and thyroid hormone-like compounds) and their metabolites, to identify potential endocrine disruptors, determine their adverse effects, origin and fate, as well as their mechanisms of action, assess their risk and propose risk management policies. These methods and assays, once developed and validated should identify and characterize the endocrine activity of PPs, enable to point at high priority PP compounds (i.e., high risk) and help to establish policies to prevent or minimize these effects and risks. 

 

The subject of the project is to asses and validate Pharmaceutical Products (PPs) in the environment and study their influence on human fecundity. In order to achieve this objective the F&F project will develop and employ validated methods for the screening and testing of PPs (mainly fecundity hormones) and their metabolites, determine their adverse effects, origin and fate, study their mechanism of action and assess their risk on men and women fecundity (ability to reproduce) in various geographical locations in Europe.

 

The main aspects that will be addressed with respect to this general topic are:

·                Identification of the environmental factors (PPs) that affect fecundity.

·                Understanding the mechanisms involved in their fecundity disrupting activity

·                Determination of environmental, food and population exposure to priority PPs and their metabolites

·                Determination of methods to prevent or minimize these effects and risks

. 

Based on the above F&F will concentrate on the following scientific objectives:

 

 

Consortium Composition:

 

 

Partner

Short name

CC

Type

  1.  

Analyst Research Laboratories Ltd.

ARL

IL

IND

  1.  

The Volcani Center, ARO

ARO

IL

RES

  1.  

MRC Institute for Environment and Health

University of Leicester

 

IEH

UK

RES

  1.  

Aarhus University Hospital -

 

AUH

DK

RES

  1.  

INRA-CNRS -
Physiologie de la Reproduction & des Comportements

INRA

F

RES

  1.  

Centre Universitaire-UFR Biomédicale

 

UFR

F

HE

  1.  

Factline Webservices GmbH

FW

AU

IND-SME

  1.  

Wessex Institute of Technology

WIT

UK

RES

  1.  

OSM-DAN

OSM

IL

OTH

 

 
The Budget:

 

2218600€

 

The Work programme:

 

WP

Subject

1.0

Pilot study-Proof of Concept:

Identification of high priority PPs and development of diagnostic and clean up methods

2.0

Risk assessment  of PPs based on regional, socio-economic and gender

 

3.0

R&D of diagnostic assays and validation of assays

 

4.0

Studies of  the mechanism of action of PPs

5.0

Clinical epidemiology

6.0

Monitoring PPs in human, food & environmental samples

7.0

Exploitation and data dissemination

8.0

Project management and Coordination

 
The SME:

1. Analyst  Research Laboratories Ltd. – ARL - ISRAEL

Analyst Research Laboratories is a GLP (good laboratory practice) accredited analytical contract  organization with more than 20 years of experience in analytical method development, environmental and pharmaceutical testing and trace analysis of pharmaceuticals. Analytical and chemical R&D is one of the main activities at Analyst.

 

·           Previous R&D projects:

a.          Participated in an R&D project, with the Volcani center (Ministry of Agriculture). Purification

         and identification of biological active compounds in seeds.

b.          Participating in an international survey of environmental contamination by military industries.

c.          Participating in a national project of trace analysis of PCB’s.

d.          Participating in more than 25 clinical trials as analytical coordinator.

e.          Analytical consultancy and coordination.

“Analyst “ staff includes Seven  Ph.D’s  in chemistry or related areas.

The   laboratories are equipped with:

 

ü    The latest model of LC-MS-MS (Quattro Ultima - Pt  high performance Tandem- quadrupole,  Micromass-Waters UK. )

ü    Agilent 1100 LC-MSD.

ü    15  chromatographic systems of HPLC & GC

ü    Sample preparation equipment  for residue analysis.

ü    Supporting  equipment and utilities for sensitive &  quantitative analysis.

.

2. OSM-DAN Ltd. - OSM

It is a consultancy company that provides its services to Israeli and European customers:

The company assists and supports insuatriess and universities to set up high level R&D projects proposals  and  to obtain funding for new technology generation. The sources of funding are the European Framework Programs and bi-national cooperative agreements between Israel and European countries.

The company specielizes also in managing R&D project during their impelementation.

OSM-DAN gained a high level of expertise in,.

·                 Project planning and consortium building

·                 Professional Writing of all proposal Parts

·                 Leading  contracts negotiation phase

·                 Managing and administrative coordinating the projects

The staff of OSM-DAN is comprised of highly professional consultants in most technological areas: advanced industrial practices, advanced materials, biotechnology, energy, information technology, and water treatment.

In addition, OSM-DAN employs highly professional business development consultants, with rich experience in international business in Europe and other areas of the World.

Dr. Pnina Dan is continuously involved in the EU Framework Programmes from FP4, in  projects :

Some Projects managed by OSM

NanoBatt – STREP (Energy FP4); U-BROAD - STREP (IST-FP6); F&F – STREP (Food FP6)

SELECTNANO – STREP (NMP 2005); CHILL ON – IP (Food FP6 under negotiation)

 

3. Business Development Factline Webservices GmbH  - FW

Factline was founded in 4/1999 and is a Vienna-based SME with a staff of 8 full time people. Factline offers content & community management systems for web based knowledge communities: factline community server (FCS) allows groups of users to exchange and publish information, and to communicate directly with each other, independent of time/space. FCS is used for project collaboration, learning communities and public knowledge platforms. In addition to technology, factline offers services for community building (analysis, content, consulting). Expertise is focused on innovative chat-technology for collaboration purposes and issues addressing the future of hyper-linked network publishing.

 

M.A. Lotte Krisper-Ullyett

Was born on in Steyr. After the Study in the Institute for “Business management” at the WU (University of economics), Vienna, and a year of Scientific Generics in Cambridge, she has worked for 5 years for Reuters. In the beginning she has worked in Vienna in the field of business information products for sales and marketing. In 1996, because of her good knowledge of the Russian language, she has moved for half a year to Moscow. Her task there was to get contracts the former Soviet Union, i.e. to win the local and regional newspapers, and/or news agencies as data suppliers for the “Reuters Business Briefing” database. After she has return, she has continued this task in the whole central and Eastern Europe, especially Poland, Hungary, Czech republic and Slovakia.

 

M.A. Max Harnonocourt

Was born in Graz. He has studied “Business Administration” in the WU-Vienna (University of Economics), where he has specialized in “Information management and informatics” and has finished this study in 1995. During, and after finishing his study he has worked for the news agency Reuters, meanwhile in 1997 founding the structure of an agency for sustainable development (“proCourage”).

 

In the context of a project about setting up of an information and a discussion platform for renewable energy in the internet, an idea about developing a standard product for knowledge communities occurred, this standard product being web-based: the company factline was founded.

 

How did the SME get involved in the project:

 

OSM-DAN Ltd., a consultancy company, works in collaboration with ISERD.

ISERD- the Israel Europe R&D directorate, and a SFF partner, works to encourage Israeli SMEs to participate in the European Framework programme in general, and as a SFF partner, in projects in Priority 5 in particular. ISERD accompanied this project from its very beginning. ISERD’s role was assisting in finding more partners, disseminating Partner searches among Priority 5 NCPs across Europe, inputs during the consolidation of the project, and similar functions.

 

 

SME Budget:

700000 Euro

 

 Link to the project website: http://foodandfecundity.factlink.net/180095.1/



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