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ACTIP Bulletin 33

March 2003

 

Next meeting

Please note that the next ACTIP meeting will take place in

Toulouse, France on

April 24-25, 2003

Central topics of this meeting are:
biomanufacturing variations
stem cells as research/screening tools

Please contact the actip@wirehub.nl ACTIP Secretariat if you would like to receive an invitation and accompanying documentation

In this issue

2002 European Innovation Scoreboard
The chipping forecast
stormy weather ahead
Higher biology teaching standards
Innovative medicines used erratically
Stem Cell news
Research news
Business News
On the web
Publications
Training courses
Agenda

 

2002 European Innovation Scoreboard

Last year we reported on the results in Europe regarding key factors determining Europe's innovation scores. Here are the main findings for the year 2002.

As in 2001, smaller Member States are in the top slots for many factors:
Sweden is in the top 3 11 times, Finland 9 times, the Netherlands 5 times, Denmark 4 times; This shows that the EUs innovative leaders are found in the Nordic countries plus the Netherlands.
For 7 out of 10 indicators, the leading EU countries are better placed than the USA and Japan. For example, Finland and Sweden lead in business R&D expenditure, and Luxembourg, Spain and the Netherlands in new capital raised. The EUs only significant lead over Japan is in home Internet access.
Some relative strengths:
Denmark: lifelong learning, US patents, venture capital;
Germany: patenting, business R&D, medium/high tech manufacturing employment;
France: science graduates, home internet access;
Ireland: science graduates, manufacturing high tech value added, home internet access;
UK: education, high tech manufacturing value added;
Sweden: patents, finance, lifelong learning;
Netherlands: new capital raised, patents, lifelong learning
Spain: new capital raised, US patents, home internet access

The full report (2002 European Innovation Scoreboard SEC 2002 1349 of Dec 9 2002) can be requested from innovation@cec.eu.int or downloaded from www.cordis.lu/focus/en/src/supplements.htm . There is also a dedicated website: http://trendchart.cordis.lu/Scoreboard2002/index.html
Source: Innovation and Technology Transfer, Special Edition, February 2003

 

The chipping forecast

In December 2002, Nature Genetics published 'The Chipping Forecast II'. Part I was published in January 1999 and focused on the 'nuts and bolts' of micro-array technology. However, 3 years later, the biggest concern is no longer how to make and use arrays, but how to design experiments, weed out noise, analyze data and validate results. Therefore, part II, published in December 2002, contains a number of articles focusing on just these issues. Here an example of some of the reviews:


Fundamentals of experimental design for cDNA microarrays
Microarray data normalization and transformation
From patterns to pathways: gene expression data analysis comes of age
Post-analysis follow up and validation of microarray experiments
Characterizing the physical genome
The genetics of variations in gene expression
Protein microarrays and proteomics
Molecular portraits and the family tree of cancer
Functional exploration of the C.elegans genome using DNA microarrays
Better therapeutics through microarrays
Source: Nature Genetics, Supplement, Vol 32, December 2002

 

.......stormy weather ahead

The 10th Annual BioPartnering Europe Conference 2002 was attended by over 1,500 delegates. There were several BioPartnering Leadership sessions, among which a 'Forecaster of the Future'. The latter featured a keynote address by Dr. Stuart Henderson, partner at Deloitte & Touche, who quoted from that firm's Life & Health Sciences Report. His 10 predictions for the future of the Life Sciences session are the following, and they do not make easy reading:


The general economic conditions are likely to worsen in the near term;
The capital markets are likely to remain shut for at least the next four to six quarters, possibly even until 2005/2006;
Venture capital funds are likely to remain defensive (= protect their existing portfolios and remain cautious with respect to new investments);
The long-awaited and much-heralded M&A activity (merging and acquisition) will begin;
There will be a slow down of company formation, but more collaboration between academic and licensing groups;
There will be an increase in recycling of venture capital funds;
Product focus will dominate for investments in the sector;
Extended enterprise will take centre stage in the most successful companies going forward (includes more recognition of mutual co-dependency);
The pharmaceutical industry will need to take a pivotal role in stabilizing the industry;
There need to be new EU initiatives to fill equity gaps (assisting companies to proceed financially past the seed stage phase).

Other panel members cited Europe's problems of 'ack of depth' and 'lack of quality in senior management teams'. Furthermore, there was consensus to plan sensibly, refocus businesses and build what is needed within existing companies. Quote: "it is our opportunity to do the right thing that will deliver the value in the industry in the next 3-4 years".

Source: European Biopharmaceutical Review, winter 2002, pp 35. See also www.techvision.com/bpe

 

Higher biology teaching standards

The European Commission is funding a two-year initiative to create an ongoing training programme for biology teachers and scientists, and to develop, archive and distribute the best available teaching resources throughout Europe. The project is entitled 'Continuing Education for European Biology Teachers', and will be coordinated by the European molecular biology organization (EMBO), working in collaboration with the European molecular biology laboratory and the European Federation of Biotechnology. The initiative will receive 710,000 euros under the quality of life and management of living resources section of the Fifth Framework Programme.

A key feature of the project is the organization of one international and eight national teacher workshops - aimed at increasing European cooperation and exchange - during which training materials and teaching resources will be developed and disseminated. The national workshops will take place in Hamburg, Copenhagen, Madrid, Prague, Hinxton, Warsaw, Szeged and Jerusalem, with the international event being held in Heidelberg.

The aim of the collaboration is to create a training programme that will bring teachers into laboratories for hands-on activities with qualified students in order to develop new assets for biology teaching. A dedicated facility will be established at the EMBL in Heidelberg for this purpose. The project will also result in an online resource centre and archive that offers practical classroom materials to teachers and students. In addition, the resource centre will address current ethical and social issues connected with the impact on society of advances in science, and suggest how best to introduce these topics into a classroom setting.

Source: EMBO at http://www.embo.org .

 

Innovative medicines used erratically

According to a recent study, the development and improved application of innovative medicine is essential to attempts to improve health care systems throughout Europe. The study, carried out by Professor Schoffski on behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), also revealed a current lack of recognition and erratic use of innovative medicines among Member States' health care systems.

The findings of the study showed that while there are innovative medicines available for the 20 diseases studied, patients are in many cases receiving medicines that are proving less effective or having severe side effects. In some cases, patients were not given any treatment at all. Such findings not only suggest worrying trends in current health systems in Europe, but also imply a lack of understanding and interest in the value of innovative medicines, which could, in turn, have repercussions on the further funding of research and development in the area of innovative pharmaceuticals.

The study suggests that by developing and implementing innovative medicines, health care systems can become more cost effective, with higher investment compensated by improved life expectancy of patients. Professor Schoffski believes that to stimulate the application of such medicines, patients and health professionals should be made more aware of all the treatments available, and that the pharmaceutical industry has to address the price differences between new medicines and older treatments which inevitably lead to the use of older therapeutic principles for a longer time.

Source: EFPIA at http://www.efpia.org .

 

Stem Cell News

Commercializing cell therapies

The commercialization of cell therapy has yet to take off. While some skin and bone products are leading the way, only a fraction of the potential of cell therapy has been realized. A number of companies have started autologous cell therapy services and are generating revenues. However, as the barriers to enter these markets are low, the investment return is unlikely to excite. Products based on allogenic cell therapy are a much better commercial proposition: they are scaleable and can be patent protected, making them a more desirable goal for companies. Key hurdles associated with supply, function and control are being addressed, with technologies like inducible apoptosis likely to make a real impact. Real advances are being made on the manufacturing aspect of product delivery, for instance with the generation of sophisticated serum-free media.
Cell therapy will start to fulfill its potential when human cells of defined function for each specific need can be grown easily in the laboratory and can be controlled once implanted in the patients. True stem cell products may still be a long way off (some even estimate 10 years or more), whereas those based on more controllable, partially differentiated cells are likely to become a reality much sooner. These products have the potential to displace traditional pharmaceutical and health care approaches.

Source: Will West, CellFactors, European Biopharmaceutical Review, Winter 2002, pp 56-60

 

The UK National Stem Cell Initiative

The UK has adopted a pragmatic approach combining public acceptance, government recognition of potential scientific and commercial value with a clear and open regulation of stem cell research. This approach has resulted in the UK National Stem Cell Initiative.
The National Initiative not only provides additional funding for stem cell projects. As part of this initiative, the UK Medical Research Council and the Biotechnology and Biological Sciences Research Council are jointly funding the establishment of a National Stem Cell Bank. This bank will curate existing and newly developed human embryonic stem cell lines as well as human stem cell lines derived from fetal and adult tissues. Cell lines will be available to UK academics and industry and to overseas academics. It is intended to eventually follow both a cGMP and a non-GMP track. Ownership of the cell lines deposited remains with the depositor, and issues of lines and materials from the bank to 3rd parties will be under materials transfer agreements. The presence of a UK Stem Cell Bank clearly represents a major opportunity for coordinated UK research on existing and newly developed cell lines. This should make the UK an attractive environment for stem cell research.

Source: Dr. John Sinden, ReNeuron, European Biopharmaceutical Review, Winter 2002, pp 62-63

 

Sweden: New Stem Cell Institute

Swedish stem cell researchers in Lund are building a new interdisciplinary 'Center for Stem Cell Biology and Cell Therapy' through the establishment of a Stem Cell Institute (SCI). Sweden is one of the few countries to allow stem cell research and the use of therapeutic cloning. For the next 6 years 10 million EURO is available to build up the centre. The centre will comprise 11 major research groups.

 

Stem Cell bank in China, Stem cell Institute in USA

The Chinese government has approved the establishment of a stem cell bank in Tianjin, near Peking. The stem cell bank will be coupled to a transplant centre, capable of treating 200 patients annually. Also in other life sciences fields China is particularly active. Three years ago, the Chinese Genome Centre was established, and this played a key role in the elucidation of the genome of rice. Furthermore, the Chinese are pioneering human-animal cell hybrids for the production of tissues.
Also in Europe and the USA work is in progress to use human stem cells for transplantation purposes. Stanford University announced in December the establishment of a stem cell research institute.

Sources:
China approves stem cell bank, BBC News, 11 December, 2002:

http://news.bbc.co.uk/1/hi/sci/tech/2567757.stm
New Institute Targets Stem Cells, Washington Post, December 11, 2002:
http://www.washingtonpost.com/wp-dyn/articles/A37453-2002Dec10.html

 

Research News

Human therapeutic proteins from silkworms

Recombinant protein production remains a bottleneck in the biotechnology industry. Significant progress has been made with all available expression technologies, but production yields are still insufficient for a large number of proteins. For example, 1,2 tons of human serum albumin are needed annually in a country as small as Switzerland. Other proteins needed in large quantities include collagen, thrombin and antibodies or antibody-like molecules. But a novel production system might be in the pipeline. In January 2003, Japanese researchers (Tomita et al) showed for the first time that stable, long-term expression of a human recombinant protein (procollagen) is possible in the silk glands of the Bombyx mori larvae (the ordinary silkworm).
It is obvious that the protein production capacity of silkworms exceeds that of any other industrial system in use today. In addition, the glands of these animals produce an almost pure product. Purification of recombinant protein from cocoons seems to be a rather simple process despite silk-fibroin synthesis being maintained in the insect. The authors indicated that even with 'low' yields being reported, 5 kg of pure collagen was produced on a surface area of 300 m2 with five workers caring for 1.5 million silkworms. The only remaining issue is protein quality, but recent papers have shown that expression of mammalian glycosyltransferase genes in insect cells can broaden their capacity for glycosylation.

Source: Nature Biotechnology Jan 2003, vol 21, pp 34-35, 52-56

 

Glycosylation in E.coli

Researchers in Switzerland and the UK recently reported a way of engineering E.coli to carry out oligosaccharide modifications similar to mammalian cells, providing a system that is not only applicable to mammalian protein expression, but also robust and relatively low cost. The authors introduced a Campylobacter jejuni gene (pgIB) with high sequence homology to a protein essential in the process of N-linked glycosylation into E.coli. That resulted in a mutant able to glycosylate proteins in a way similar to eukaryotic cells. However, at present the protein-linked oligosaccharide structure in E.coli differs significantly from the eukaryotic modifications, but there is good hope that it will be possible in the future to generate E.coli strains that attach the specific desired glycan to proteins.

Source: Science 2002, vol 298, pp 1790

 

Business News

Rapid HIV test obtains FDA approval

OraSure Technologies (USA) has received FDA approval to manufacture and markets its OraQuick Rapid HIV-1 antibody test. This is a point-of-care dipstick test to detect HIV antibodies in whole blood samples within 20 minutes. The test has a sensiticity of 99.6% and specificity of 100% on clinical studies performed with blood specimens.

Source: IVD Technology Jan/February 2003

 

Rapid test for West Nile Virus

Manufacturers are scrambling to develop rapid and effective nucleic acid tests to screen donated blood for West Nile Vitrus (WNV) before the onset of the modsquito season this summer. In 2003, the FDA will require WNV screening of the entire blood supply. In 2002, the US WNV-epidemic escalated to a total count of 3873 confirmed cases and 246 deaths. 80% of infected people are asymptomatic. The WNV test development process will serve as the example for rapid response in the future. It is a test of flexibility and agility for the blood industry, for the diagnostics industry and for the FDA.
See also:
www.devicelink.com/ivdt

Source: IVD Technology Jan/February 2003


Japanese and British databases for genetic research

This year the Japanese government will establish a database with the DNA and lifestyle data of 300,000 Japanese citizens. The objective is to link diseases that will be found in the coming years in this group to genetic data.
In other countries similar projects are being contemplated. Also this year, the British medical Research Council will start a large-scale investigatuion into the genetic cause of disease. Medical and genetic data of 500,000 British citizens between 45 and 69 years old will be collected and studied over a period of 10-20 years. This study, dubbed the UK Biobank, is the largest of its kind sofar.

Sources:
Asahi Shimbun, 01-01-03: http://www.asahi.com/english/national/K2003010100139.html
Biobank UK:
http://www.biobank.ac.uk/Welcome.htm

 

Swedish Biotechnology Industry Organization

The first Swedish Biotech Industry Organization has been launched under the name SwedenBIO. It aims to campaign for a national investment programme as well as for more foreign investment in the sector. Chairman is Bjorn Nilsson, president of Karo Bio.

 

Dolly is dead

On February 14, 2003, the Roslin Institute announced the death of Dolly, the world's first cloned sheep made from a mamma cell from an adult animal. While Dolly seemed healthy in the first few years of her life (she gave birth to 6 lambs), she became ill when only 5 years old. It started with arthritis, and last year a viral infection that resulted in a lung tumour. Both diseases are ageing diseases. A normal sheep lives 10-12 years. Also other cloned animals (goats, cows, pigs, mice, rabbits, cats) show a variety of diseases, such as defect of the immune system, miscarriages, obesity, pulmonary and circulatory problems, kidney and brain disorders, diabetes, malformations, early death due to lungproblems, cancer and liver diseases.

Source: Bionieuws February 28, 2003

 

The promise of pharmacogenomics and pharmacogenetics

Pharmacogenomics as applied to medical practice offers the promise of reduction in adverse drug events (ADEs), enhanced drug efficacy and selection of patients able to respond to specific agents. The estimated annual cost of drug-induced illness in the US is 136 billion USD, and ADEs were estimated to be the 4th to 6th leading cause of death in the US. Pharmacogenomics offers the promise of improving medical care through selection of patients who will respond more effectively to drug therapy, optimizing efficacy and decreasing the frequency of ADEs. Many ADEs have underlying identifiable genetic components. Pharmacogenetics is now poised to move into the clinic from a strong base of support built upon research studies on polymorphic drug metabolism. To successfully reduce the frequency of ADEs, pharmacogenetics and pharmacogenomics must broaden its focus to include not just a consideration of polymorphic drug metabolizing enzymes, but also additional pathways that contribute to polymorphic drug disposition such as drug-transporter and receptor polymorphisms and drug-drug interactions. A new level of complexity involving management of many bits of information is essential to move the prediction of phenotype from genotypic analyses into patient care.

Source: Pharmacogenomics (2003) 4(1), 1-4

 

On the web

Free medical publications

Thousands of medical publications, free on-line at:
http://www.ncbi.nlm.nih.gov/PubMed/

Biotech abbreviations

The Pharma Lexicon search box gives free access to theÝworld's largest online database of medical, pharmaceutical and biotech abbreviations. &endash; more than 70,000
Visit:
http://www.pharma-lexicon.com

Weekly summary R&D and innovation

The European Commssion has launched a new electronic information service termed CORDIS Express digest. Every Friday the weekly electronic bulletin summarizes the latest European research and innovation developments. Visit: http://www.cordis.lu/express"

Overview Italian Biotech

A new public database now offers a complete overview of Italy's biotechnology industry sector. It provides instant access to over 150 companies and research organizations.
Visit:
http://www.biotechwithitaly.com/companies.asp

Nanotechnology

Are you interested in micro/nanotechnologies, information technology and neuro/biotechnologies? You then might want to check out the APTE Association, a knowledge and co-operation network particularly active in Europe. Please visit: http://apte.net" http://apte.net

Human tissue and cell products & transplants

If you are interested in position papers on human tissue and cell products & transplants, you might want to check out the following documents and position papers:
Proposal for a Directive on setting clear safety and quality standards on donation, testing and procurement for human tissues and cells regardless of final use, including transplantation and related medical applications.
http://europa.eu.int/comm/health/ph/others/human_tissues/index_en.htm

3/12/02 &endash; EuropaBio's Human Cell and Tissue Working Group publishes position paper on DG Sanco proposed directive. The final version of EuropaBio position paper was addressed to Commission (DG Sanco, DG Entreprise) and MEP, Dr P Liese http://www.europabio.org/xtranet/wo_contents.asp?do_id=482

3/12/02 &endash; EuropaBio explanatory document re: proposals and queries on the Tissue Banks and Clinical Trials sections of DG Sanco Directive; The paper was sent to P Liese and D Bouis (DG Enterprise) http://www.europabio.org/xtranet/wo_contents.asp?do_id=500

Review of pharmaceutical legislation

The Commission modified proposal on the Review of Pharmaceutical legislation is available at the following website: http://dg3.eudra.org/F2/pharmacos/docs.htm

 

Publications

New magazine: European Biotechnology Science & Industry News

This new magazine will offer a multinational forum for opportunities and developments throughout Europe focused on the biotechnology sector. It features a new forum for current economic affairs, qualified political background information from Brussels and the latest highlights from science and technology. The magazine is published by BIOCOM AG (Berlin) in association with the European Federation of Biotechnology.

G10 medicines group report

This group was established in March 2001 to look at ways of encouraging innovation and competitiveness in the EUs pharmaceutical industry. The group presented its final report in April 2002. Conclusions:

  • firms offereing innovative products should be given greater opportunity to make profit than those whose products are more traditional;
  • call for the creation of virtual networks of health institues amnd improvements to peocedures for introducing innovative medicines to the mnarketr.
  • member states and the Comjission shoulkd coordinate Europe wide clinical trials and establish a database of trials and clinical research results

Downloadable from:
http://pharmacos.eudra.org/F3/910/g10home.htm

Apoptosis and programmed cell death: molecular mechanisms and applications in biotechnology and agriculture &endash;project report
EUR-OP (Office for Official Publications of the European Communities). See also
http://europa.eu.int/comm/research/pub_rtd.html
Stem cells: therapies for the future? &endash; Conference Report
mailto:
Quality-of-life @cec.eu.int


Training courses


How to use the European Pharmacopoeia, New approaches and media

26-27 June 2003
Training III: Herbals (herbal drugs , extracts , essential oils etc.)
4-5 December 2003
Training IV: General (chemical products )

Information: Caroline Larsen Le Tarnec, Public Relationss , EDQM ,
Fax: +33 (0)3 8841 2771 - Tel: +33 (0)3 8841 2815/2824

AGENDA

A number of interesting conferences and workshops is coming up. Of all the events mentioned here, the detailed programmes and registration/application forms are available from the ACTIP secretariat.

China-EU Colloquium on Functional Genomics and Technology Transfer
April 7, 2003, Lyon, France
More information:
http://www.efbweb.org/activities/efbicintro.htm

BioVision 2003
April 8-11, 2003, Lyon France
Organisation:
http://www.biovision.org" www.biovision.org

The commercialization of tissue engineering and regenerative medicine
9-10 April 2003, London UK
Information: Marcus Evans Life Sciences; mailto:
OlaS@marcusevansuk.com

ACTIP meeting on biomanufacturing variations and stem cells
April 24-25, 2003
Information mailto:
actip@wirehub.nl: ACTIP Secretariat

Linking phenotype to genotype
April 24-25, 2003, Munich, Germany
Information:
http://healthtech.com/conference-info

Clinical Quality Assurance & GCP Compliance;
April 28-29, 2003, UK
Information: Marcus Evans Life Sciences; mailto:
OlaS@marcusevansuk.com

ESACT meeting: animal cell technology meets genomics
May 11-15, 2003, Granada
Organisation: ESACT,
http://www.esact.org
or + 34 932 388 777

Recombinant antibodies
May 14-15, 2003, Cambridge, Massachusetts
Information:
http://healthtech.com/conference-info

Macroresults for microarrays
May 13-14, 2003, World Trade Center, Boston, Massachusetts
Information:
http://healthtech.com/conference-info

Genomic and proteomic sample preparation
May 15-16, 2003, World Trade Center, Boston, Massachusetts
Information:
http://healthtech.com/conference-info

European Science Foundation:
Functional Genomics and Disease 2003

May 14-17, Prague, Czech Republic
Information:
www.functionalgenomics.org.uk/sections/news/programme.htm

Genetics. Genomes, the linkage to life
July 6-12, 2003, Melbourne Australia
Organization:
www.geneticscongress2003.com

11th European Congress on Biotechnology, 25th anniversary of EFB:
Building bridges between biosciences and bioengineering

24-29 August, 2003, Basel, Switzerland
Organisation: ECB11, Tel + 41 61 686 28 28; fax: +41 61 686 21 85; email: mailto:
info@ecb11.ch ; web: www.ecb11.ch" http://www.ecb11.ch

6th Conference on
Protein Expression in Animal Cells

September 7-11, 2003, Montreal, Canada
Information: Amine Kamen, Biotechnology Research Institute, tel + 514 496 0915, fax + 514 496 6785
Email: mailto:
6thPEACe@nrc.ca; www.bri.nrc.ca/6thPEACe

CORDIA-EuropaBio Convention 2003
Dec 2-4, 2003, Vienna, Austria
Information: mailto:
clare.king@reedexpo.co.uk
http://www.cordiaconvention.com

 

ACTIP bulletin no. 33, March 2003

 

 


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