CORDIS alert service

CORDIS is a service of the European Commission, operated by external contractors, which collects and publishes information on all aspects of European Research and Development. At the CORDIS website, you may find basic information on EU funding programmes, partner finding and contacts, and dissemination of research results. All EU co-financed projects are recorded on CORDIS. Thereby, CORDIS is the only central place where research across all the Commission programmes can be seen/found. In addition, it contains many projects from national or other programmes.

You may find the CORDIS website at:

http://www.cordis.lu

Summary of project results

Now, CORDIS is experimenting with a new service: the CORDIS automatic alerting service. By subscribing (free) to this service, you will automatically receive well-written results of projects (written by the project coordinator). The results are accompanied by key data of the project. I tried it out myself and it worked very fine, with good project information. The only problem I have is selecting keywords so that I receive information on projects I am interested in.

The service is currently under development. If, in the future, you want to be included in this CORDIS service, they would like to receive some background information on your business, such as products/services you offer, processes you use, markets you serve, and any technologies that are of special interest to you. Please send this information by fax to + 32 2 238 1798 or email to:

etis@cordis.lu

Alternatively, you may set up your own automatic email alerting service (RAPIDUS) by going to:

http://www.cordis.lu/src/t_005_en.htm

If you want to see more detail before contacting the project contractor, go to
http://www.cordis.lu, click on 'search databases' or 'map based search', then click on results, and enter the title or keywords and click on 'search'. That should do it!

Research News in short

EU proposals on orphan drugs

EU proposals as they stand at present would designate products as orphan drugs where they are used to treat illnesses affecting no more than 5 of every 10,000 individuals in the EU. Estimates suggest there are some 5,000 rare illnesses worldwide.
Medicines can also be designated as orphan drugs where greater numbers are involved, but the disease is transmissable and life threatening or seriously debilitating. In such cases, it must be demonstrated that the therapy would not be developed without the incentive offered by orphan drug status.

For manufacturers, incentives include 10 year exclusive distribution rights throughout the EU, help with research costs, and full or partial waiver of the costs of designation.
Rights may be withdrawn if the holder is unable to supply sufficient quantities of the drug, or if other applicants can prove they have developed a safer, more effective product.
Members states can also request a reduction to 6 years if they can show that a designation criterion is no longer met (the number of patients affected has risen, for example), or if the distributor's price is deemed excessive.
Manufacturers can consult EMEA for advice and practical help in planning the requisite clinical trials and in cross-border recruitment of sufficient patients.

Source: Pharmaceutical Visions 88-89.

2nd orphan drug for Pharming

The FDA has recently granted Leiden-based company Pharming a double Orphan Drug Designation for recombinant human C1 esterase inhibitor. The special status holds for both the prophylactic and the acute treatment of heritable angio-edema (HAE), of which there are worldwide approximately 10,00-50,000 patients. After human alpha-glucosidase, this is Pharming's second drug with an Orphan Drug Designation. As for the first, this drug will also be produced in the milk of transgenic rabbits. It is expected that human clinical trials may start next year. An FDA Orphan Drug Designation guarantees 7 year market exclusivity after drug approval. The Orphan Drug Act in the USA has been very successful: since its inception in 1983, more than 170 drugs and biologicals for rare diseases have been introduced on the market. The preceding decennium, less than 10 orphan drugs had been developed.

Hormone vaccine

A hormone suppressant that promises to control certain sex-related cancers in humans has been developed by Biostar Inc of Saskatoon, Canada. The product, Norelin, is a therapeutic vaccine that stimulates an immune response to suppress testosteron, the hormone which contributes to the growth of prostate cancer. The patented Norelin technology might also be applicable to female hormone-dependent diseases, such as breast, ovarian and uterine cancers. Small scale clinical trials are now underway.

Source: Agbiotech bulletin Vol 7, issue 4, April 1999. Contact: Dr. Stephen Acres, president of Biostar. (306) 931 7500.

Research in Europe

Access to Funding Sources

Organization Promservices offers, free of charge, access to a new European Funding Sources On Line Service. The programmes covered in the free service include:

* JOP (companies, eastern Europe)
* Leonardo (training)
* Socrates (education)
* Public Health (hospitals)
* Falcone (justice)
* Recite II (regions)
* Impoving Human Potential (researchers)
* Democracy (associations)
* Information Society Technologies (research)
* EU-China (cooperation)

Also free information on 61 infosheets of the 5th Framework Programme.

Visit:

http://www.promservices.com/eurofunding

Education and Training in the EU

The European Union attaches much importance to a Europe in which scientific knowledge, skills and personnel can move freely and efficiently. Training and education play an important role in this. The EU supports the following education and training activities:

* the programmes managed by DG XXII include:

- Leonardo Da Vinci (vocational training). F Gutmann, DG XXII. Email: leonardo@dg22.cec.be

- Socrates (cooperation in education)
- 2 Youth Programmes

* Of the Human Potential programmes managed by DG XII:

- Research Training Networks. C. Dirscherl, email: cyril.dirscherl@ dg12.cec.be
Marie Curie Fellowships. P. Floreen. Email: patrik.floreen@dg12.cec.be

Of the Commission's Joint Research Centre:

- own training grant scheme, providing fellowships for young researchers to train within its institutes. M. Cundy. Email: m.cundy@jrc.nl

Of the Innovation Programme:

- pilot projects to promote and spread good practice in entrepreneurship training for researchers. J-C Venchiarutti. Fax: + 352 4301 321 00

On the web

Network of Innovation Relay Centres

The Innovation and SMEs programme's network of 53 Innovation Relay Centres (IRCs) spans the EU, Iceland, Norway, Switzerland and Israel, with twinning arrangements to some Central and Eastern European countries.
Each IRC is its region's window on European innovation, helping companies and research organisations to transfer technologies to and from the rest of Europe. For more information, visit:

http://www.cordis.lu/irc/home.html

Access to clinical trials

Clinical trials information center of the US National Cancer Institute. Information on 1,600 open clinical trials, best source to locate clinical trials in the USA:

http://cancernet.nci.nih.gov/

Comprehensive listing of Internet clinical trial resources, and a searchable database of all open UPCC clinical trials, frequently asked questions and news:

http://cancer.med.upenn.edu/clinical_trials/

General database of clinical trials, with listings of more than 7,500 clinical trials, newly approved drug therapies, research center and industry provider profile:

http://www.centerwatch.com/

European cancer research and treatment, host to register of cancer clinical trials:

http://telescan.nki.nl

Explanation of the clinical trial system for the layperson:

http://www.cancerguide.org/clinical_trials.html

Source: Internet Resources, M. Francisco. Nature Biotechnology Vol 17, Feb 1999

Available

For your comments: Development pharmaceutics

Development pharmaceutics for Biotechnological and Biological products (CPMP/BWP/328/99) - Annex to note for guidance on the development of pharmaceutics (CPMP/QWP/155/96). Recently released for consultation. The deadline for comments is September 1999. Source: CPMP (Committee for Proprietary Medicinal Products). Available from the ACTIP Secretariat.

For comments and drafting: New Points to Consider for somatic cell therapy

The rapid developments in cell biology and biotechnology have opened new possibilities to use somatic cells for therapeutic purposes. The present guideline issued by the CPMP relating to gene therapy (Gene Therapy Product Quality Aspects in the production of vectors and genetically modified somatic cells) does not fully cover all aspects of somatic cell therapy. Hence, the guideline is under revision. In July 1998 the CPMP adopted the concept paper for the revision of the Gene Therapy guideline. Because there are special considerations specific to somatic cell therapy, a separate guideline is warranted. This Points to Consider Document should be developed, containing a clear definition of cell therapy and cell therapy products, addressing solely human somatic cell therapy and adhere to the spirit of Good Manufacturing Practice. Please contact Berthold Bodeker for more information or if you want to get involved in the drafting of this document.

New EMEA fees

Since December 1998, the EMEA (European Medicines and Evaluation Agency) has implemented new rules for fees and payments to national authorities. The information available shows the difference between the current fees according to Council Regulation no 2743/98 of December 14, 1998 and the previous fees according to Council regulation 297/95 of February 10, 1995.
Main changes are the addition of an annual fee of 60,000 EURO (for each medicinal product already authorised), a fee for scientific advice (advice before submitting an application, maximum 60,000 EURO), and an administrative fee (for supplying documents or certificates, maximum 5,000 EURO).
Full information is available from the ACTIP Secretariat.

Patent Application trends in Europe

An interesting article appeared, comparing biotechnology patent applications in France, the UK and Germany. The authors concluded that:

* France is characterized by strong participation of public sector laboratories in patent applications;
* the UK is characterized by the strong presence of foreign companies in patent applications, and leads in genomics and pharmaceuticals;
* Germany is characterized by a large number and variety of organizations participating in patent applications, and leads in key technologies.
The article contains a table with numbers of patent applications by European companies.
Available from the ACTIP Secretariat, or try the source: Nature Biotechnology, Vol 17, Jan 1999, page 83-85.

Biosafety Protocol halted

At the end of February, negotiators assembled in Cartagena, Colombia, were unable to adopt the Biosafety Protocol to regulate the testing of and trade in genetically modified organisms (GMOs). This is good news insofar as the draft regulation was unscientific, anti-innovative and anti-competitive. The bad news is that the proposal was not rejected on these arguments, but on arguments relating to trade considerations. The talks will be resumed probably in September, and although a compromise will surely be found one day, it might leave us with international regulation that focuses on the 'inherent danger' of biotechnology and is devoid of scientific and common sense.
Source: Henry Miller, Science Viewpoint, March 1999.

Publications

Looking at the biotechnology consumer. Views on the introduction of genetically modified foods and food ingredients to the European market, expressed in 1997 by the food industry, government departments, consumer associations, environmental organisations and some others. EUR 18492 EN. Available from DG XII (fax + 32 2 299 18 60) or the ACTIP Secretariat.

Cultural and social attitudes to biotechnology: analysis of the arguments, with special reference to the views of young people. EUR 18491 EN. For a summary, see also A 99/19. Available from DG XII (fax + 32 2 299 18 60) or the ACTIP Secretariat.

Acelluvax: social acceptance and economic impact of a recombinant vaccine (against pertussis). A study within the framework of the socio-economic impact of biotechnology. EUR 18311 EN. Available from DG XII (fax + 32 2 299 18 60) or the ACTIP Secretariat.

Contribution to the analysis of the position of trade unions and employers regarding genetic pre-employment tests. With extended bibliography. Available from DG XII (fax + 32 2 299 18 60) or the ACTIP Secretariat.

Catalogue of social economic impact studies in the field of biotechnology (1994-1998). Very useful publication, giving abstracts of social-economic studies, names and contact details of contractors, and a list of socalled ELSA projects (projects studying ethical, legal and social aspects). Available from DG XII (fax + 32 2 299 18 60) or the ACTIP Secretariat.

Animal Cell Technology. Report of the EC-Biotech Meeting, Oulu, Finland, May 29-30, 1998, with project overviews. Highly recommended. Available from DG XII (fax + 32 2 299 18 60) or the ACTIP Secretariat.

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