Home | Organization | Members | News and Info. | Publications | Products | Interesting Links librarySecure Contact Us


ACTIP Bulletin 21

August 2000

In this issue:

 

Abstracts vaccine projects

1350 Biotech companies

Germany leading in patents

Public perception

On the web

Regulatory Affairs

Short research news

Short news

Commission news

Publications


Available: Abstracts vacccine projects

The book of abstracts of projects on vaccine development is available. It covers the projects selected for funding following the 1st call for proposals in Key Action 2, Control of Infectious Diseases.
If you are interested in one or more projects: first look up the project titles through the CORDIS database:

http://dbs.cordis.lu/EN-GLOBALsearch.html

and use as search terms the project numbers, i.e. QLK2. You will then get a list of project titles, and can click on for more info. Select the project(s) you are interested in from this list and ask the ACTIP Secretariat to send you the corresponding abstracts. You may also request the ACTIP Secretariat for a full copy of the entire book of abstracts.

 

EU: more than 1, 350 biotech companies

The rate at which new biotech companies are being created in Europe is astounding. In 1999, the number of biotech companies in Europe increased by 15% to 1,351. Much of the recent increase has been focused on Germany, where the number of biotech companies has risen by over 150%, demonstrating the impact of the German government's initiatives to promote biotech. Germany has now surpassed the UK as the country with the most biotech companies, but UK is still leading in the product pipeline, reflecting the maturity of its biotech industry. Some figures will demonstrate the vigour of today's European biotech companies:

Number of biotech companies:
* Germany: 280
* UK: 270
* France: 180
* Sweden: 140
* Switzerland: 98
* Netherlands, Finland, Belgium, Denmark: 60-70 each

Product pipeline of European public companies:
* Total Preclinical (45), Phase I (42), Phase II (49), Phase III (11);
* UK: Preclinical (29), Phase I (28), Phase II (36), Phase III (11);
* Germany: Preclinical (2);
* France: Preclinical (4), Phase I (5), Phase II (4);
* Sweden: Preclinical (5), Phase I (7), Phase II (2);
* Denmark: Preclinical (5), Phase I (1), Phase II (6);
* Netherlands: Phase I (1), Phase II (1).

Source: Ernst & Young, from thought to finish. European Life Sciences Report 2000.
A copy is available from the ACTIP Secretariat or from one of the EU offices of Ernst & Young.

 

...and Germany also leading in patents

According to new research from Derwent Information, Germany is streets ahead of the UK and other countries in biotechnology innovation. The study addresses patent applications in 1998 and 1999 in a number of EU countries. For example, in 1999, the total percentage of biotechnology patent applications from researchers from the UK was 22%, while the percentage for German researchers was 40%. Researchers from France and the Netherlands scored 11 and 8 %, respectively.
This is another indication that Germany's biotech sector is catching up rapidly. The country's patenting activity increased by 11% over 1998's figure of 36%.

The research looked at the number of patent documents in Derwent's Biotechnology Abstracts database. Patent applications to the European Patent Office, World Patent Office Patent Co-operation Treaty (PCT) and Regional Patent Offices are included.

Source: Bioforum International 2, 2000

 

Public perception

The public and genomics

Levels of public understanding of genomics and genome-related issues in the UK are fairly low. The most important features of public attitudes towards these areas of research are:
* the public is relatively supportive of explicitly medical applications of molecular genetics, with the important exceptions of transgenic animal research and xenotransplantation;
* people tend to distinguish clearly between morally acceptable apllications (i.e. screening for serious genetic diseases) and morally unacceptable applications (i.e. eugenic attempts to improve human nature). At present, the British public has provisionally classified all forms of human cloning in the 'morally unacceptable' category.

On a global level, the following emerges:
* support for genetic testing: 50% in the EU, 51% in the USA and 48% in Canada;
* support for biotechnological food: 22% in the EU, 37% in the USA and 38% in Canada;
* support for xenotransplantation: 16% in the EU, 23% in the USA and 29% in Canada.

Source: European Biopharmaceutical Review, March 2000, pp 8-12

 

EU support for biotech decreases - the New Eurobarometer 2000 study

The previous Eurobarometer study dated from 1996. Since then, much has happened: Dolly, the first cloned sheep and discussions about human cloning, xenotransplantation, failed trials with gene therapy and even deaths, still raging controversies about genetically modified ('Frankenstein') foods. The most recent Eurobarometer 2000 study shows that all these issues have influenced the thinking of Europeans about biotechnology and its applications: support for biotechnological applications has fallen even further.

In all, 16,000 Europeans were interviewed. Below we give the responses, and we compare the 2000 responses with the ones given in 1996.

* modern biotech and food: useful 55% in 1996, 42% in 2000;
* genetically modified plants for insect resistance: useful 68% in 1996, 55% in 2000;
* human genes in bacteria for vaccine production: useful 80% in 1996, 68% in 2000;
* genetic tests for detection genetic diseases: useful 80% in 1996, 73% in 2000;
* improvements in quality of life: yes 43% in 1996, 37% in 2000;
* trust in information sources: most trust in consumer organisations and medical professionals (25% in 2000, an increase). Trust in universities (7% in 2000) and environmental organisations (14%) decreased.

Source: Bionieuws 10, May 20, 2000

See also:
www.europa.eu.int/comm/research/press/2000/pr2704en-ann2.html

 

Worldwide attitude to biotechnology

Recently, results were published from a worldwide study on public attitudes towards biotechnology. The study was performed by the Angus Reid Group and interviewed 2,000 respondents in the USA and Canada, and 3,000 people in Australia, UK, France, Germany, Brasil and Japan. The study was conducted in 1998 and in 2000. Results have been published in the report 'New Thoughts for Food: Consumer Reaction to Biotechnology in Foods'.
Aversion against genetically modified foods increased from 45% to 51% in the USA, and in Canada from 45% to 59%. Percentages for the UK, France, Germany and Japan are respectively 58%, 73%, 73% and 82% negative.

Source: Angus Reid Press Release, June 8, 2000. See also:
www.angusreid.com/media/content/displaypr.cfm?id_to_view=1040


On the web

 

European voice on web

 

European Voice, the weekly journal for news on the Commission, Council and EP, is now available online:

www.European-Voice.com

 

New website DG Research:

 

http://europa.eu.int/comm/dgs/research

http://europa.eu.int/comm/research

 

Submission of project proposals

 

The following websites are handy when submitting a project proposal to the European Commission:

Workprogrammes FP5:
www.cordis.lu/fp5/home.html

Latest calls for proposals FP5:
www.cordis.lu/fp5/src/calls.htm

FP5 proposal submission forms:
www.cordis.lu/fp5/src/forms_a.htm

FP5 infodesk addresses:
www.cordis.lu/fp5/src/cont-cec.htm

Evaluation manual FP5:
www.cordis.lu/fp5/src/evalman.htm

Peer review evaluation process:
www.cordis.lu/life/src/library.htm

Intellectual Property Rights model contract:
www.ipr-helpdesk.org/en/booka1.htm

External advisory groups Quality of Life programme:
europa.eu.int/comm/dg12/fp5/advice/hleg-1.html

 

 

Job listings on the web

 

The ACTIP website now features a link to BioView, a website with thousands of job listings in all disciplines, including research, development, regulatory affairs, validation, manufacturing/production etc. The sites also features an area where candidates can leave a resume for review by industry professionals. See:

http://www.bioview.com

 

 

Companies involved in stem cell research

 

(for a full table with a description of the activity, please contact the ACTIP Secretariat):

Aastrom Biosciences (USA):
www.aastrom.com

Advanced Cell Technology Inc (USA):
www.advancedcell.com

Advanced Tissue Sciences (USA):
www.advancedtissue.com

BresaGen Ltd
www.bresagen.com.au

Cell Based Delivery Inc. (USA):
www.cbd-biotech.com

CytoTherapeutics Inc (USA):
www.cyto.com

Geron Corp (USA):
www.geron.com

Ixion Biotechnology Inc. (USA):
www.ixion-biotech.com

Layton Biosciences Inc (USA):
www.laytonbio.com

NeuralStem BioPharmaceuticals Ltd (USA):
www.neuralstem.com

NeuroNova AB (Sweden):
www.neuronova.com

Nexell Therapeutics Inc (USA):
www.stemcellselection.com

Osiris Therapeutics Inc. (USA):
www.osiristx.com

Stem Cell Sciences Pty Ltd (Australia)
no web address found

 

Regulatory Affairs

 

New vaccine guidelines approved

In May 2000, a group of experts representing member states and the EMEA met to discuss key issues concerning the procedure of batch release of vaccines in Europe. These guidelines have been prepared by the Official Medicines Control Laboratory network (OMCL). The following guidelines have been adopted or approved for consultation:

Adopted guidelines for:
* Hepatitis A vaccine;
* Hepatitis B vaccine;
* combined Hepatitis A and B vaccine.

Approved for consultation:
* tick-borne encephalitis;
* virosomal Hepatitis A vaccine;
* live, oral typhoid vaccine;
* combined haemophilus type B conjugate and Hepatitis B vaccine;
* revised guideline for pneumococcal polysaccharide vaccine;
* revised haemophilus type B conjugate vaccine.

All the adopted guidelines are published on the website of the European Directorate for the Quality of Medicines (EDQM) of the European Council:
http://www.pheur.org

 

Alternatives to potency testing tetanus vaccines

On June 27, 2000, the EDQM, together with WHO, organized a scientific symposium on tetanus vaccines for human use to survey the recent developments in the quality control of tetanus vaccines and to examine the progress made for their potency determination.

Current European Pharmacopeia and WHO potency tests involve tests in animals and a more acceptable method for routine testing of tetanus vaccines has long been sought. At the symposium, serological potency models using ELISA and TOBI techniques were the centre of interest. Data was presented to show the usefulness of these methods either alone or in conjunction with methods that are now used. Discussion on common approaches on how to perform quality controls of these vaccines in the future based on alternative methods for demonstration of batch consistency were held.

Source: press release EDQM, June 27, 2000. See also www.pheur.org

 

Short research news

 

Listeria genome sequenced

On April 18, a press release announced the successful completion of a BIOTECH project to sequence the Listeria genome. See: europa.eu.int/comm/research/quality-of-life.html

 

Insect cells interesting for vaccines

Company Intervet in the Netherlands (subsidiary of Akzo Nobel Pharma) has chosen for the baculovirus expression system in insect cells to produce an animal vaccine against swine fever (hog cholera). Reason: the baculovirus expression system allows a 100-fold higher production of protein compared to a system based on animal cells. Current production is in 1,000 litre bioreactors.
Glycosylation in insect cells is slightly different from glycosylation in mammalian cells, but the small differences do not seem to have an adverse effect on immunogenicity.

Baculoviruses are also used to produce virus-like particles. US company Medimmune is currently conducting clinical tests with a human parvovirus vaccine.

A major advantage is the speed with which a production system based on the baculovirus expression system can be developed (within 8 weeks). This speed could be a major advantage in the developed of anti-flu vaccines. UK company Protein Sciences is conducting clinical tests with human flu vaccines produced in insect cells. It is impossible to reach a similar development speed using mammalian cells, since selection of recombinant mammalian cells is quite a lengthy procedure.

Source: Bionieuws 9, May 6, 2000. For more info, see:

www.proteinsciences.com

www.medimmune.com

www.intervet.com

 

Pharming abandons rabbits for alpha-glucosidase

Dutch company Pharming is well known for its use of genetically modified cattle or rabbits for the production of biopharmaceutical proteins, intended for orphan diseases.
For 5 years, Pharming has been pioneering a production method in rabbits of the protein alpha-glucosidase to treat patients with Pompe's disease. Phase II clinical trials, conducted together with partner Genzyme, were successful. However, just before the start of phase III clinical trials, it became evident that researchers of the US Duke University, together with company Synpac, would be able to beat Pharming with the presentation of a dossier to the authorities. Synpac's method is based on the use of CHO cells. Instead of competing with Synpac, Pharming decided to acquire the rights to the CHO-based production method from Synpac. Pharming will continue to develop alpha-glucosidase against Pompe's disease, but will switch to the CHO-cell based method. Pharming's newly built Belgium facility for 3,000 genetically modified rabbits will remain empty for the time being.

Source: Volkskrant April 4, 2000

 

Short News

 

New Secretary-General for EuropaBio

The Board and membership of EuropaBio have appointed Hugo Schepens as new Secretary-General. He will join the association in October as the successor to Anthony Arke. Hugo Schepens has considerable experience in the pharmaceutical industry and in health economics.

Source: press release EuropaBio, August 8, 2000

 

Tightening TSE prevention rules

On May 17, 2000, the European Parliament adopted a proposal for a Regulation creating rules for controlling and preventing Transmissable Spongiform Encephalopathies (TSEs). The EP want to urge member states to routinely slaughter all the animals in a cattle herd when one of them has been infected by mad cow disease. They also call for wide scale introduction of BSE screening tests. The rapporteur also wants to extend the scope to include products so far excluded, such as cosmetics, pharmaceuticals and other medicinal products. Specified Risk Material (SRM) is to be dealt with according to special treatment arrangements, i.e. feeding prohibition, mandatory removal and incineration of SRMs from live cattle, goats and sheep.

Source: Europe Environment, no. 569, May 30, 2000

 

US and EU establish mutual forum

Biotechnology holds great promises for the future of mankind, but it has also created unease due to concerns about possible unknown effects and food safety.
To help address these concerns and to study the benefits and risks of biotechnology, the USA and the EU agreed at their May 31 summit meeting to establish a Biotechnology Consultative Forum. The Forum includes a carefully selected group of eminent scientists, ethicists, environmentalists, farmers, businessmen, consumer representatives and development experts. A report of their findings will be available at the December 2000 summit.

If you would like to know the names of the US or EU forum members, please ask the ACTIP Secretariat for a list of members.

 

Programme ESACT meeting

Sessions ot the 17th ESACT meeting, to be held from June 10-14, 2001 in Tylosand, Sweden, will include:
* identification of drugs and drug targets;
* expression systems for target and drug production;
* cell physiology and metabolism;
* production technology;
* changes in the regulatory environment;
* novel technologies for administration of cell derived proteins;
* novel prophylactic and therapeutic approaches based on animal cells or nucleic acids;
* biotech in the new millennium

Source: ESACT Newsletter July 2000

 

Biological Weapons Convention - joint industry position

The global pharmaceutical, chemical and biotechnology industry, as represented by EFPIA, FEBC and PHRMA, has issued a joint industry position paper on the Compliance Protocol to the Biological Weapons Convention. Major points are:

* industry is actively supporting efforts to strengthen the Convention by the inclusion of effective measures to help enhance compliance with its objectives and to reduce the threat of biological warfare;
* industry seeks to ensure that an appropriate balance is achieved between the objectives of the compliance protocol and the legitimate rights of private industry facilities, including the protection of intellectual property and confidential business information.
* industry's concerns with the compliance protocol include the scope of declarations and on-site activities and the degree to which the burden of the protocol on legitimate activities is balanced by its value for arms control purposes.

The full text of the position paper is available on the ACTIP website, as well as on the EFPIA website:
www.efpia.org


Commission News

 

New Research Director General

DG Research Director-General Jorma Routti has stepped down. The DG portfolio is now managed by Deputy DG Hendrik Tent.

 

Technical assistants

In 2000, the EC will seek Project Technical Assistants (PTAs) to help with the implementation of FP 5 for a number of programmes, including the Quality of Life, Information Society, SME, INCO and Human Potential Programmes. For more information, look regularly at:
www.cordis.lu

 

New EU Health Strategy

On May 16, 2000, the European Commission, by David Byrne, Commissioner for Health and Consumer Protection, presented its proposals for the future strategy on health in the Community. A key part is the new public health programme, which will run for six years and will cost 300 million EURO. Focus will be on:
(1) improved health information;
(2) improved capacity to address health threats;
(3) key determinants of health (and disease).

 

Busquin to 'think big' on new R&D funding

This autumn, Research Commissioner Philippe Busquin will unveil plans to focus EU funding for R&D on large-scale strategic projects, in a bid to help the Union catch up with its US and Japanese rivals. In his paper, he will argue that the EU money currently is spread far too thinly on a raft of small-scale projects. Instead, the Commission should be prepared to think big with FP6 with priority given to fewer, bigger projects worth millions of EURO apiece. The projects should add value to the EU.
The list of key priorities will most likely include:
* genomics;
* nano technology;
* medical research covering the human brain;
* fuel cell research;
* aeronautics;
* information society.

His plans will be closely linked to separate proposals to build a 'European research area'. The latter aims to improve coordination of national and Union-level R&D programmes.

The Commisioner is also examining ways to encourage R&D through tax breaks for research.

Source: European Voice, Vol 6, nr 30, July 27 2000.

 

Scientific big shots to advice Busquin

On April 27, Commissioner Busquin announced the establishment of a High Level Group on Biosciences. The group is composed of 11 eminent scientists in the life sciences and will advice about current and future developments in biotechnology. Members of the group have been selected on the basis of both their scientific merits as well as their ability to communicate with the lay public. Well known names are Derek Burt, chairman of the British Committtee for the environmental introduction of GMOs, and Marc van Montagu, professor in Gent. For more details, see

http://www.europa.eu.int/comm/research/press/2000/pr2704en-ann1.html


Exploitation responsibility of specific research programmes

Since 1989, the European Commission has supported demonstration and dissemination projects as a follow up to research projects. Often, these innovation projects had their own funding, and specific innovation programmes existed.

In FP 5, however, the role of facilitating subsequent exploitation of Community-based research has been passed to the specific research programmes themselves. It is now the responsibility of each of the four thematic programmes to ensure that every FP 5 research project makes concrete plans for eventual commercialization, and follows these through tthe licensing of intellectual property in foreign markets.

Source: Innovation & Technology Transfer, Vol 3, May 2000. For more info, contact Dr. Archibugi, CNR: archibu@www.isrds.rm.cnr.it

 

Virtual Technology Parks

In 1998, the European Commission approved the European Technology Transfer Initiative (ETTI). Among its recommended elements was a virtual technology park (VTP). Two approaches have been adopted:
(1) a multisectoral hub, structured as a consortium of 15 SME platforms, set up at existing business-support institutions with established client bases. At its core is the ETTN website;
(2) a sectoral hub, modelled on a virtual technology park. It aims to replicate the services of an ordinary technology park but without the bricks and mortar. By now, platforms have been established for the construction, food production and software sectors, each with its own character.

The project is unique and strong interest in joining the project has been voiced in the US and Australia.

Source: Innovation & Technology Transfer, Vol 3, May 2000. For more information, contact Eklen Pedersen at ellen.pedersen@cec.eu.int.
Alternatively, visit:

http://ettn.jrc.it
http://www.connet.org
http://www.nice-food.org
http://www.nsaviking.net

 

Deadlines 2000

The second deadline for the 2nd call for proposals for funding is

October 11, 2000

The following areas will be open for this call for proposals:

Key Action 2, Control of Infectious Diseases:
2.1. Improved or novel vaccines;
2.2. Strategies to identify and control infectious diseases;
2.3. Aspects of public health and care delivery systems;

Key Action 3, the Cell Factory:
3.1.1. Development of new diagnostics;
3.1.2. Therapeutic strategies;
3.2.2. Bioassays and biosensors;
3.2.4. Biodiversity and ecological dynamics;
3.2.5. Safe use of new biomolecules and bioprocesses;
3.3.4. Identification and sustainable use of metabolic and genetic doversity as a source of new valuable products;

RTD activities of a generic nature:
7.1 Pathogenic mechanisms in chronic and degenerative diseases;
8.1. Genome analysis;
8.2. Functional genomics and proteomics;
9.1. Cell communication in Neurosciences;
9.2. Brain theories in neurosciences.

In addition, based on the open call of March 6, 1999, the following areas are still open:
* support for research infrastructures: deadline October 11;
* Marie Curie Host Fellowships: deadine October 11;
* SME Exploratory Awards, deadline September 13;
* Accompanying Measures, deadline
October 11.


Selection projects

Selection rates and funding levels of the first call for proposals FP5, Quality of Life, shows the following:

* Key Action 1 (Food and Health): selection rate 21.5%, average funding per project 1,684,613 million EURO;
* Key Action 2, Infectious Diseases (vaccines): selection rate 33.3%, average funding 1,973,974 EURO;
* Key Action 3, Cell Factory: selection rate 10.4%, average funding 1,945,820 EURO;
* Key Action 4, Environment and Health: selection rate 15.7%, average funding 1,437,871 EURO;
* Key Action 5, Sustainable agriculture etc: selection rate 71%, average funding 1,331,623 EURO;
* Key Action 6, Ageing Population and Disabilities: selection rate 13.7%, average funding 1,387,214 EURO
* Generic projects, selection rate 17%, average funding 1,684,404 EURO;
* Infrastructures, selection rate 33.3%, average funding 913,614 EURO

 

EC publications

The quarterly RTD info magazine informs on the main developments in EU funded research activities. Free:

rtd-info@cec.eu.int
http://europa.eu.int/comm/research/rtdinfo.html

Bimonthly CORDIS focus also provides a review of the EU's research and innovation activities. Free.

innovation@cec.eu.int
http://www.cordis.lu/focus/en/src/focus.htm

Summaries of BIOMED 2 research projects (1994-1998) are available from DG 12:
* vol 1, 713 pp, ISBN 92-828-7426-5
* vol 2, 651 pp, ISBN 92-828-7315-3
Please contact stephane.hogan@cec.eu.int

 

Catalogue of Central and Eastern European projects

Since 1992, the EU has intensified research cooperation with the Central and Eastern European countries and the new independent states of the former Soviet Union under the Copernicus programme.

In 1998, 235 projects were selected (from 1931 proposals) and 1574 teams funded (from 10,236 proposing teams). An amount of 53 million EURO was allocated for projects in environmental protection, health research activities, non-nuclear energy, information technologies, advanced communications and social sciences.

A catalogue of projects is available for 12 EURO (551 pages, reference CG-13-98-322-EN-C).

 


Back To Top. | Home | Organization | Members | News and Info. | Publications | Products | Interesting Links librarySecure Contact Us