In this issue:

Results first call for proposals

Next deadlines

Cell Factory meeting in Graz

Medical Biotechnology Section of EFB

Technology Transfer US style

On the web

Top 500 companies

Short News

Voice against antibiotics ban

Fear for change

Publications

Results First Calls for Proposals

Quality of Life Programme

Some 1790 proposals were received in June following the first closing dates for the Quality of Life and Management of Living Resources Programme. The average project had almost 8 partners, and 50% of the projects had at least one industrial partner. Average budgetary request was 1.8 million Euro.

Key action 3: Cell Factory

For Key Action 3, the Cell Factory, 399 proposals were received:

* 219 for area 3.1, new and innovative health-related products and processes;
* 39 for area 3.2, bioremediation;
* 135 for area 3.3, new biological processes and products from cell factories.

In total, 2,978 different laboratories were involved in the 399 proposals, bringing the average number of participants to 7.6. The average EU contribution requested was 1.99 million EURO. Industrial penetration (at least 1 industrial partner) was 72.5%. The ratio of funds requested versus available funds was only 10.1%.

This reflected in the number of proposals that could be funded. Out of more than 80 shortlisted proposals that had come through the first evaluation round with very high marks (at least a 4 or 5 for science and management), only 37 have been selected for contract negotiations. The problems is clearly a financial one, since the quality of proposals was very high. A success rate of slightly more than 10% is very disappointing for the almost 3,000 laboratories who worked hard on a proposal.

On December 15, 1999, the External Advisory Group (EAG) of the Cell Factory Area will publish the new guidelines for the year 2000 Work Programme.

Source: Dr. Alfredo Aguilar, during the Graz conference

Next deadlines

The next deadlines for submission of project proposals for the Life Sciences Programme of the 5th Framework Programme have been changed and are now:

Key actions:
1. Food, nutrition and health: March 2000
2. Control of Infectious Diseases: November 15 1999 and October 2000
3. Cell Factory: March 2000 and October 2000
6. Ageing population: March 2000

Generic RTD activities: November 15, 1999; October 2000

Support for research infrastructures: November 15, 1999; March 15, 2000 and October 11, 2000

Individual Training Fellowships: April 12, 2000; October 11, 2000

Marie Curie Host Fellowships: February 1, 2000

Technology Stimulation: January 12, 2000; September 13, 2000

SME support: April 26, 2000

Accompanying measures: February 10, 2000; October 11, 2000

Proposals must nowadays be sent to:
European Commission, followed by programme name
Research Proposals Office (ORBAN 8)
Square Frère Orban 8, B-1000 Brussels

Cell Factory meeting in Graz

From October 27-30, 1999, the European Commission sponsored a meeting, the 'grand finale', where results of 70 projects funded under the Cell Factory area of the 4th Framework Programme were presented. At the Brussels meeting, ACTIP members will hear a report on the projects funded under the biopharmaceuticals and animal cell section. Here I will review some of the highlights of the other sectors.

Highlight report

A highlight report prepared by the Commission services was handed out to the press. The report demonstrates the versatility of the cell factory area and makes good reading. It covers the following topics:

enzymes to produce pure chemicals;

lactic acid bacteria as oral vaccines;

extremophiles as cell factories;

stem cells to produce human tissue engineered organs;

using fungi to fight fungal diseases in agriculture;

new methods of vaccine production.

Copies of these reports can be requested from the ACTIP secretariat. They can also be found, including nice pictures, on:

http://europa.eu.int/comm/dg12/biotech/graz.html

Importance of the Cell Factory

During the Graz conference, Dr. Alfredo Aguilar presented some interesting data and statement on the area of the Cell Factory. He gave the following key data on the life sciences in the EU versus the USA:

	EU	USA
R&D expenses in million EURO's	2,334	8,398
Number of companies	1,178	1,283
Employment	45,823	153,000

Thus, in the USA, much more is spent on research and many more people are employed in approximately the same number of companies. Coupled to the emergence of a biosociety, in which food, health, environment and employment determine quality of life, the message is that European research in the bioscience has to become much more relevant. The relevance of research is important in the evaluation of research proposals for the 5th Framework Programme, and scientists should make a mind-switch: the money is not there to fund your research but the money is there if you can offer research that addresses societal needs. Thus, there is no longer a science-driven approach but a problem-solving approach, in which we have to link the ability to discover to the ability to exploit.

Results and outlook for cell factories

The last day featured a plenary discussion, where session chairmen shortly presented results of their area. They concluded the following:

* in fungi, the knowledge base has increased and there is now a better use of biodiversity. Outlook: address low expression levels; increase in collections of thermostable enzymes;

* in lactic acid bacteria, a lot of new knowledge has been generated very fast. Apart from improved food production, the big question is what to do with all this new knowledge. Outlook: foods with inbuilt design structures; manipulation of metabolism to improve health properties;

* in process optimization, work focuses on special cell factories and is very multidisciplinary, requiring the European dimension. Some results are nearing the market;

* in other cell factories, secretion of products is the key question. The patent situation forces diversion to many different host systems. Outlook: systems with more efficient secretion;

* in antibiotics, the research potential has been increased and the position in basic research to generate new lead compounds has been strengthened. Outlook: intensification research, new anti-infectives plus new mechanisms; education public & physicians.

* in yeasts, Europe's strong position has been maintained, with improved production of proteins, alcohol, product shelf life, and heterologous proteins. Companies are hesitant to use GMO's because of negative public perception. Outlook: societal benefits, use of yeasts as a powerful production system;

* in biopharmaceuticals, scientists are really mission oriented. Most projects were very innovative and 3 have led to new therapies;

* in chirotechnology, the EU's position has been further strengthened, knowledge increased and in 4 projects really new biocatalytic processes have been realized;

* in animal cells, knowledge has increased but is still far behind lactic acid bacteria. Pojects can be divided in those contributing to more understanding, more tools, new strategies and new candidate products. Outlook: more prophylactics and cell/gene therapy; faster results because of good basis.

Message for FP 6

The final message of the grand finale of the 4th FP is that:

* the future of the cell factory will look different because of exploitation of new tools;
* the innovation potential must be strengthened;
* companies are focusing more on core competencies, meaning that new science has to come from scientists;
* institutions and networks must be further strengthened;
* SMEs play an important role as the link between basic research and established industry;
* scientists should get involved in communication and optimize it;
* basic research must be the basis for Framework Programme 6.

Medical Biotechnology Section of EFB

In July 1999, ESACT proposed to the EFB, the European Federation of Biotechnology, to establish a Medical Biotechnology Section. The proposal was received favourably and the Section will be started.

The Medical Biotechnology Section aims to enhance the beneficial use of biotechnology in healthcare in Europe, focusing in particular on such issues as:

* therapeutic and diagnostic proteins;
* vaccines and immunologicals;
* organs and tissues;
* gene therapy;
* clinical microbiology and antibiotics.

It wants to achieve this by stimulating interactions between relevant research groups, pharmaceutical R&D, clinical practitioners and public policy makers.

For the first 3 years, the Medical Biotechnology Section will attempt to:
* characterise existing players;
* prepare position papers on need for R&D and education;
* work on improving public perception;
* proposals to improve Framework Programmes;
* link with relevant Commission bodies and Industrial Platforms.

Membership is open to representatives of industry, universities, research institutes, national governments and non-governmental organisations.

For more information, see the ESACT Newsletter of September 1999 or contact the ESACT Secretariat, John Griffiths, at Tel + 44 1980 610 405; fax + 44 1980 610 405.

The ESACT membership list 1999/2000 has been published. You may request a copy of the ESACT secretariat or, alternatively, from the ACTIP secretariat.

Technology Transfer US style

A recent two-day workshop highlighted examples of best practice and set out to demonstrate the relevance of the US approach to the EU's 5th Framework Programme.

Federal funding has a strong influence on research in the US. The 1980 Bayh-Doyle patent and trademark act created a uniform policy for federal research agencies, enabling small businesses and non-profit organisations to retain the rights to innovations resulting from federal funding. It also encourages universities to collaborate with industry to promote the application of their inventions. Results have been overwhelming:

* since 1980, more than 2,200 academic start-up companies have ben formed;

* by 1997, gross university income from licenses had risen to US $ 700 million;

* most American universities now have their own technolgy transfer and licensing offices to co-ordinate the exploitation of intellectual property rights.

In Europe, the legal situation is not the same and fragmented, with universities having different traditions and employees' rights as inventors vary widely. For example, German university professors retain the rights to any invention, irrespective of external funding.

But these differences do no mean that Europe is not inventive - Europe does not like to boast and underplays its successes. Some examples:
* over the past 20 years, the Max Planck Institute has earned 500 million EURO from patents;
* the Catholic University of Leuven in Belgium is making 4,5 million EURO/year from a single drug.

Yet, patent awareness in Europe is increasing, with many clients for the Quick Scan Novelty Search Service (to screen applications for EU research funding on novelty aspects) and the IPR Helpdesk. (see previous ACTIP Bulletin no. 9, Oct 1998 for Quick Scan (contact DG XIII, odilia.knap@inbistau.lu) and for the IPR Helpdesk (contact + 352 47 77 77)

But instead of national patents, Europe needs Community patents, providing immediate coverage for the whole EU. Such patents need to be cheap, defensible and practicable. The current proposals forn an EU patent would perfectly fit these demands, but might take another 5 years before implemented.

On the web

Cell lines

The catalogue of the American Type Culture Collection is accessible from:

http://www.atcc.org/catalogs.html

Information on hybridomas and other cloned cell lines is available from the International Hybridoma data Bank (HDB):

http://www.atcc.org/hdb/hdb.html

Cell lines from dozens specialised collections and cell banks are available at one address:

http://www.biotech.ist.unige.it/cldb/indexes.html

If you would like to know what is currently financed by either the US Department of Agriculture or the US Public Health Service, contact:

http://cristel.nal.usda.gov:8080/

or

http://www-commons.dcrt.nih.gov/

Toxicity data for over 120,000 chemicals and pharmaceutical compounds can be found at:

http://ulisse.etoit.eudra.org/Ecdin/Ecdin.html

One of the world's major databases on biomedicine, covering 9 million records, is produced by the US National Library of Medicine: Medline. Downloadable from:

http://www.nlm.nih.gov

Available to registered users of BioMedNet (registration is free and immediate) is the BioMedNet:

http://www.biomednet.com

A comprehensive listing of national self-help groups and other reputable UK web sites that provide patient information can be found at:

http://www.patient.co.uk

News items

(source: BIA Neswcast)

GM pig cells could save human spinal cords and brains'. Source: Daily Telegraph

http://www.telegraph.co.uk:80/t?ac=001829912314602&rtmo=wQ0nsMlb&atmo=ttttttyd&pg=/et/99/10/26/ncells26.html

Human gene patents defended. Source: BBC On-Line

http://news.bbc.co.uk/hi/english/sci/tech/newsid_487000/487773.stm

Top 500 companies

If you want to learn about the fastest-growing technology companies, their programmes, timelines nd press information, visit the Technology Fast 500 site of Deloitte & Touche. Also features links to other technology company sites. Making the Fast 500 list is a significant achievement and is becoming a competitive benchmark within the technology community. The US Fast 500 by industry segment has the following characteristics: 41% software, 15% communications, 9% biotech, 7% medical and scientific, 5% internet. The medical sciences are having a growing influence on the technology economy, with 2 biotech firms (ICOS and Incyte Pharmaceuticals) among the top 5 companies. Visit:

http://www.fast50.com

Short News

Hungary joins Pharmacopoeia

Hungary will accede to the Convention on the Elaboration of a European Pharmacopoeia on September 9, 1999. This will mean that Hungary will elaborate with other member states and the European Union a common 'European Pharmacopoeia, and will take the necessary measures to ensure that the texts adopted in Strasbourg which constitute the European Pharmacopoeia become the official standards applicable on its territory, replacing any pre-existing national standard.

No offspring and lifelong monitoring for xenotransplant patients

A British Commission on Xenotransplantation has issued the 'Consultation document on the monitoring and surveillance of potential
infections associated with xenotransplantation.' It will be discussed in December in the UK Xenotransplantation Interim Regulatory Authority.
To reduce the risk that a patient who has received a transplant with a pig organ or pig cells becomes of source of a dangerous, pig-borne viral infection, the Committee has recommended rather severe measures: a ban to produce offspring following the transplantation, use of contraceptives that prevent the transmission of viruses, and life-time monitoring of the transplant patients and his/her sexual partner(s).

Source: BBC online, 25/10/99;
http://www.doh.gov.uk/surveil.htm http://www.doh.gov.uk/surveil.htm

Voice against antibiotics ban

Europe's drug manufacturers are stepping up pressure on the European Commission not to ban the use of four more antibiotics in animal feed until it has definitive scientific evidence to justify such a move.

Antibiotics are added to feed to ensure that animals gain weight in a shorter amount of time, trimming farmer's production costs. But in May a group of European scientists found that the use of these drugs in animal feed could make similar drugs in humans less effective. That panel, however, did not study individual products.

Now, Commissioner David Byrne (Consumer Protection) warns that he is considering outlawing the use of the antibiotic avilamycin and phasing out three other antibiotics, following an advice of the Scientific Steering Committee to ban the use of antibiotic growth promoters in animal feed.

Source: European Voice, Oct 28-Nov 3, 1999

Fear for change

During the Graz meeting, Stephane Hogan of DG12 gave me a copy of a Newspaper article, unfortunately without a reference (but apparently a column appearing under the name PosteScript by George Poste). Under the title 'the new risks to scientific progress', the unknown author (it only says, chief science and technology officer at SmithKline Beecham) analyses the public debate about the safety of biotechnology. It makes very interesting reading, and you can request a copy from the ACTIP secretariat. Below I will quote some of the author's most striking remarks (it might wet your appetite to read the entire article):

* the public debate about the safety of biotechnology is being driven by an irrational retreat from reason and an unattainable desire for complete freedom from risk;

* truth and reason keep little companion together nowadays (Shakespeare, A Midsummer Night's Dream);

* history will not kindly judge any participant in the biotechnology safety debate:
- single issue activist offer over-simplified and distorted warnings about impending disaster;
- the media are uncritical, eager to trumpet half truths and creating the appearance of controversy, conflict and unchecked commercialism;
- politicians are trapped by populism and give in to obfuscation in the hope the issue will disappear;
- scientists have lost credibility during the BSE debate and are unwilling to engage in the cut and thrust of public debate, reflecting misplaced arrogance, genuine unease and sterotypic betrayal;
- the biotechnology industry has mishandled the GM food debate and lost all credibility.

* two pernicious principles contaminate all aspects of the public debate about risk: the polarising principle (applied routinely in so-called sophisticated debates) and the precautionary principle (any activity should not be undertaken unless its outcome can be predicted fully in advance);

* unpredictability and ambiguity will always be fellow travellers with technical innovation;

* our doubts are traitors, and make us lose the good we oft might win by fearing to attempt (Shakespeare, Measure for Measure).

Publications

The promise of tissue engineering

In April, Scientific American published a special 30-page report on tissue engineering. The report features very readable articles by leading scientists on
* growing new organs;
* embryonic (stem) cells (including the ethics debate)
* cell therapy (encapsulated);
* organogenesis of the skin;
* tissue engineering.
With many useful and clear diagrams, sketches etc. Recommended.

Reference: Scientific American, special report, April 1999, volume 280, nr 4, pp 37-65. A copy can also be requested from the ACTIP secretariat.

EC publications

Report BSE diagnostics available

In the previous Newsletter, we reported on a statement from DG XXIV regarding the evaluation of diagnostic tests for BSE. It was then reported that 3 tests had scored 100% effectiveness. Now, the full (albeit called preliminary) report is available. It can be downloaded from the website of DG XXIV in PDF format. Go to:

http://europe.eu.int/comm/dg24/health/bse/index_en.html

As soon as the password protected area of the ACTIP website is up and running, it will also be available from the ACTIP website for ACTIP members and observors.

Linking Biovalleys

On May 27, 1999, the workshop 'Entrepreneurship: networking of biovalleys in Europe' was held in Brussels. This workshop was an initiative of the External Advisory Group (EAG) of the Cell Factory Key Action and invited were managers of biovalleys, which is a novel word to indicate bioregions, biopoles, entreprise incubators etc. The biovalleys in Europe create a nurturing environment for a new generation of European entrepreneurs to start up and flourish.

Attributes for success in biotech entrepreneurship are:
* an outstanding science base;
* a committed national governmental context;
* a flexible financial structure;
* a market niche;
* positive public perception;
* an experienced management.

Linking biovalleys would provide added value through exchange of information, complementarity and critical mass.

Source: Report 'Entrepreneurship - networking of biovalleys in Europe'. A copy can be requested from the ACTIP Secretariat or from Philippe de Taxis du Poet at the Commision (email: Philippe.de-Taxi-du-Poet@dg12.cec.be

Publications of DG12 studies/projects

The industrial use of genome resources in Europe. Result of a socio-economic study funded under the 4th FP. Authors S. Thomas, N. Simmonds and Pierre-Benoit Joly. The study involved background research, the construction of a new database for company alliances, the use of patent and bibliometric indicators and interviews. With information on:

* 83 genomic related alliances in industry. Of the 83 studied, 42% were in screening, 1% in DNA probes, 22% in gene sequencing, 25% in recombinant DNA, 3% in transgenics and 7% in transcription factors.
* distribution of patents and publications for 74 SME's;
* company R&D programmes in genomics;
* national and international programmes in genomics research, with a complete listing of EU genome research activities;
* listings of HGS patents (by name and number) on cytokines/chemokines, enzymes/proteins, G-protein coupled receptors etc;
* status of genome sequencing projects (complete, almost public etc.).

If you're into genomics, a very useful publication.

Reference: The industrial use of genome resources in Europe, EUR 18850 (100 pages)

Other useful publications are:

Survey on the current status of Genomes research in the EU (479 pages), Reference EUR 18593

Survey on the current status of research into ageing in Europe (257 pages), Reference 185 94

You can request a copy of these DG12 publications from the ACTIP secretariat or order one directly from the Commission: fax + 32 2 299 1860; email: life@dg12.cec.be.

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