News in June 2012
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The Biosafety Scanner

Biosafety Scanner - searchable database on global biotech crops and regulations with nice infographs and maps - CSP

Biosafety Scanner provides a range of useful information for the planning and management of GMO control activity in crop production, with particular reference to international commerce.

Data processing gives a concise picture of whether or not, in the country of interest, conditions exist which can favour GMO contamination of crop production or the import of products not conforming to European standards with regard to traceability and labelling requirements.

It will be possible, however, to evaluate the following by means of the information displayed and on the basis of the user's needs

Epigenetic Screening Trends 2012
Published: June 2012

Executive Summary and Table of Contents

This market report summarizes the results of HTStec's 2nd industry-wide global web-based benchmarking survey on epigenetic screening assays carried out in May 2012. The survey was initiated by HTStec as part of its tracking of this emerging life science marketplace and to update HTStec's previous report (June 2010). The questionnaire was compiled to meet the needs, requirements and interests of the epigenetic vendor community.

The objective was to comprehensively document current practices and preferences in epigenetic enzyme screening assays, to understand future user requirements, and interest in outsourcing. Equal emphasis was given to soliciting opinion from Pharma, Biotech and Academic Research market segments in both North America and Europe.

Purchase Report at
Price: $2,500

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Biotechgate can be used as an outsourcing service by economic development agencies and medtech and biotech associations as a regional/national directory. Having relevant statistics at your fingertips can prove to be a very valuable and effective tool.

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Down Under Doesn’t Want to be Left Behind When it Comes to Biotechnology

Editorials, Guest Commentary — By Heather Baldock on June 21, 2012

The ban on GM crops in South Australia, through a moratorium that’s been in place for almost a decade, is stifling the opportunity to meet the challenge of food production. This is a huge mistake. Around the world, biotechnology is transforming agriculture for the better, helping farmers grow more food on less land and in sustainable ways. Australia should place itself on the cutting edge of this development. In South Australia, we have amazing facilities like the Australian Centre for Plant Functional Genomics and a state of the art Plant Accelerator that can help us do this–and yet we’re failing to keep up, as countries from Brazil to Canada to the Philippines accept biotechnology and discover its incredible benefits.

In South Australia, we’d make good use of biotechnology right away, especially with the planting of canola. Over time, the innovation we’d most welcome is drought-resistant wheat. This crop would be a great addition to the cropping program in low-rainfall regions such as ours. The technology is not yet widely available, though it’s near. And with the rate of productivity growth slowing over the last decade in Australia according to the “At a Glance 2010” publication released by the Australian Department of Agriculture, Fisheries and Forestry, it is certainly time for the next round of innovation on our farm. The one thing most responsible for holding it back is politics, not science.


Biospain 2012
Biospain 2012, the main international biotechnology meeting in the south of Europe, celebrates its sixth edition in Bilbao (September, 19-21). Biospain ( brings together the main stakeholders in biotechnology and life sciences, with a program which includes partnering, plenary and parallel sessions, and an investor forum, among others. More than 1.300 delegates from more than 25 different countries are expected to meet, network and exploit business opportunities.

More: Emma Zubia

SPRI office in the Czech Republic and Slovakia,;

Upcoming Events in 2012:
Bioprocessing & Stem Cells Europe 27-28 June, London, England
Genomics Research Europe 4-5 September, Frankfurt, Germany
Systems Biology Europe 16-17 October, Madrid, Spain
Genomics Research Asia 13-14 November, Daejeon, South Korea
Genomics Research Europe & Asia Training Courses
03 - 07 September 2012, Frankfurt, Germany; 12 - 16 November 2012, Daejeon, South Korea

Europe - EU

EFSA on France ban of MON810

Panel on Genetically Modified Organisms (EFSA GMO Panel) evaluated the documentation submitted by France in support of its request for the prohibition of the placing on the market of the genetically modified maize MON 810 according to Article 34 of Regulation (EC) No 1829/2003. The EFSA GMO Panel notes that some publications referred to by France were already part of the submission package by France for its safeguard clause and emergency measure on maize MON 810 in 2008. Those publications were addressed previously by the EFSA GMO Panel in its 2008 Scientific Opinion on the safeguard clause and emergency measure notified by France on maize MON 810. In the remaining documentation provided by France in support of the current emergency measure on maize MON 810, the EFSA GMO Panel could not identify any new science-based evidence indicating that maize MON 810 cultivation in the EU poses a significant and imminent risk to the human and animal health or the environment. With regard to issues related to management and monitoring of maize MON 810, the EFSA GMOPanel refers to its recent recommendations for management and monitoring measures of maize MON 810. In conclusion, the EFSA GMO Panel considers that, based on the documentation submitted by France, there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of an emergency measure under Article 34 of Regulation (EC) No 1829/2003 and that would invalidate its previous risk assessments of maize MON 810.

Risk assessment of GM animal

The European Food Safety Authority (EFSA) has launched a public consultation on its draft guidance for the environmental risk assessment (ERA) of GM animals. The document, which focuses on GM fish, insects, mammals and birds, outlines the specific data requirements and methodology for the ERA of GM animals should applications be submitted for market authorisation in the European Union (EU) in the future. The risk assessment is based on a comparative approach between GM and non-GM animals. All stakeholders and interested parties are invited to provide their comments on the guidance through an online public consultation that runs until 31 August 2012.

The basic assumption of the comparative assessment, which is the risk assessment approach for all GMOs laid down in EU legislation, is that non-GM animals serve as a baseline with respect to environmental safety. Thus the ERA of GM animals involves collecting, assessing and, where appropriate, generating information about the GM animal to determine, on a case-by case basis, its impact on the environment in comparison with non-GM animals.

New EU project AMIGA: Coordinating European research on GM plants and their impacts

How can environmental risk assessments of GM plants be standardised within Europe whilst making allowances for the diversity of Europe’s agro-ecosystems? A consortium of research institutions from all over Europe has been considering this matter since December 2011. Two teams from Germany are involved and are focusing on bees and soil micro-organisms, continuing the biosafety research in these areas funded by Germany’s Federal Ministry of Education and Research.

Barbara Löchte, - GMO Safety editorial team

Genius GmbH, Darmstadt; i-bio Information Biowissenschaften, Aachen

EFSA on RR soybean

Parma/Munich – For the first time, the European Food Safety Authority (EFSA) has approved the cultivation of genetically modified (GM) soy. So far, the GM soy "roundup-ready" by US-industry leader Monsanto can only be imported to the EU. The Scientific Opinion published by the EFSA’s GMO panel now paves the way for EU Commissioner John Dalli. The Commission can give Monsanto the green light for cultivating the crop on European soils if the EU member states will not achieve a qualified majority on the issue.

However, there might be a fierce head wind blowing. German anti-GMO association Testbiotech e.V. points out that there's a legal minefield in the way. A study done on behalf of Testbiotech (see says that an expected admittance might violate EU law. Matter of concern: the EFSA opinion itself. According to the study, the EFSA should have also tested if the residues of pesticides to be used (in this case glyphosate) could have negative effects on human health. Not implementing this concern in the risk assessment could be equivalent to a breach of EU laws. The crop in question is soybean 40-3-2. It carries a gene that makes it tolerant to glyphosate (brand name: Roundup). That is why the soybean is also dubbed "roundup-ready soy". The EFSA opinion clearly regulates the use of this pesticide: "It should result in similar or reduced environmental impacts compared with conventional soybean cultivation." The panel also recommends that case-specific monitoring of (1) changes in weed community diversity; and (2) the evolution of resistance to glyphosate in weeds should be deployed.

New Eorobarometer:
Innovation in the public sector: its perception in and impact on business

This study reports on the abilities of companies to innovate and to interact with public services. The survey shows which levels of government are regarded as the most innovative and the quality of the service they provide. The report also gives information about the role of innovation in public procurement.


Fanatics were stopped - Police prevent destruction of trial plot

An open field trial with GM wheat in Harpenden near London can go ahead thanks to the police, who prevented a planned destruction of the trial on 27th May. In the run-up to the protest action there was a broad public debate throughout the UK in which the scientists engaged proactively with the GM opponents. The protest group argued that the research project was unnecessary and would pose risks to the environment. The scientists explained in a video and blog and on Twitter that they are attempting to contribute to a more environmentally friendly form of agriculture. An online petition against the trial destruction received over 6000 signatures.

Turning point in the GM debate
James Randerson,, 30 May 2012

The failure to vandalise the plants at Rothamsted Research in Hertfordshire is the important turning point in the GM debate that this trial has revealed. Media reporting and comment has been mostly neutral and positive about the experiments, or actively hostile to the protesters - a far cry from the days of "Frankenfood" headlines. What has changed? First, instead of hiding, the scientists have been out in the open.

Also vital to the researchers' argument is that they are not Monsanto. The research is publicly funded, and the scientists have promised that the results will not be patented. So familiar jibes that the scientists are only in it for the money have missed their mark.

Another important ingredient has been the researchers' ability to tap into a diverse, science-friendly army. An online "Don't destroy research" petition, hosted by Sense About Science, has attracted more than 6,000 signatures.

Something else which has changed is that genetic modification is no longer new. GM crops have been grown commercially around the world for more than a decade, and have been eaten by millions. Scary health effects that were always the most potent fears for average consumers (though perhaps also the least credible) have failed to materialise. And while the impact of GM crops has been far from benign in all instances, the logic that every case of manipulating plant genes is bad and dangerous is now demonstrably false.

'Risk research on GM crops is a dead parrot
Torbjörn Fagerström et al, EMBO reports advance online publication 11 May 2012; EMBO Open.

Ever since the Asilomar Conference on 'Recombinant DNA' in February 1975, regulatory policies relating to recombinant DNA technology have focused on the idea that this technology implies threats to human health and the environment [1]. As a consequence, the explicit goal of these policies is to protect society and nature from an assumed hazard, or, if protection is not possible, at least to delay the implementation of the technology until scientific evidence shows it to be harmless.

These policies were widely accepted at the time, as public concerns were, and still are, important. As time has gone by, the evidence for negative impacts of genetically modified (GM) crops has become weaker. However, the regulatory policies within the EU are still rigid enough to prevent most GM crops from leaving the confined laboratory setting; should some candidate occasionally overcome the hurdles posed by these policies, the precautionary principle is invoked in order to ensure further delaying in its use in the field. The reason for this over-cautious approach is widespread public resistance to GM crops, caused and amplified by interested groups that are opposed to the technology and invest heavily into lobbying against it.

New notification; - B/DE/10/210

Project title:

Evaluation of pollen spread of plastid located genes for the model plant Nicotiana tabacum "Petit Havanna" under field conditions


Embargo On Bt Brinjal A Great Disservice to India Says Academician

Delivering a 19th Dr. B.P. Pal Memorial Lecture on "Research Priorities for Application of GM Technology to Indian Agriculture", Prof. G. Padmanaban said the embargo on Bt brinjal a great disservice to the country in terms of turning away researchers from the field of biotechnology. He further cautioned that even industry is reluctant to invest in transgenic crop research due to prevailing political and regulatory uncertainty on crop biotech in the country. "It is suicidal for a country to deny itself a technology option," he added.


Gene-Modified Cotton Aids Pest-Killing Insects
From Bloomberg Businessweek
By Jack Kaskey on June 13, 2012

Cotton genetically modified to resist crop-damaging insects also protects beneficial bugs, according to a Chinese study that suggests the positive effect may extend into neighboring farms.

Chinese cotton growers were able to cut their use of insecticides that control bollworms after they began planting a crop engineered to make a toxin derived from Bacillus thuringiensis, or Bt, according to a study reported in the journal Nature. The use of fewer chemical sprays allowed the proliferation of insects that feed on crop-damaging aphids, the study said.

The research found the Bt crops also controlled bugs on neighboring farms as more aphid-eating insects such as spiders and ladybugs survived in soybean, peanut and corn fields. The study, based on 20 years of data from northern China, was led by the Chinese Academy of Agricultural Sciences in Beijing.

“The widespread adoption of Bt cotton, as a sustainable measure to reduce insecticide use, has indirectly promoted generalist predator abundance in Bt cotton fields but also to a smaller extent in three common adjacent crops,” according to the study. “Bt crops therefore might enhance biocontrol.”

Bt cotton, approved in 1997, is China’s only engineered crop authorized for commercial planting. As of last year, about 95 percent of the cotton grown in northern China was genetically modified, according to the report.


Labelling GMO?
Richard Cornett, Western Farm Press, June 1, 2012

The initiative known as the California Right to Know Genetically Engineered Food Act is currently being evaluated to determine if the adequate amount of voter signatures has been collected to place it on November's ballot. No other state in the union requires these types of labels on food.

Figures compiled from the U.S. Department of Agriculture reported that 88 percent of the corn, 94 percent of the soybeans and 90 percent of the cotton planted in the U.S. last year were biotech varieties. Other biotech crops grown in the U.S. include alfalfa, canola, sugar beets, squash and papaya. 80 percent of the processed food sold in U.S. grocery stores is reported to contain biotech products, so unless food processors want to label all their products, they will need California-only packaging.

The right to know nothing
Dan Murphy. Drovers CattleNetwork; June 13, 2012

The problem starts with nomenclature. Instead of discussing bioengineering, which is the application of our most sophisticated scientific prowess to the challenge of food production, the activist community has managed to label the technique of using precise insertion of genetic materials as Frankenfoods.

Even “genetic modification” sounds scary.

Now, the same partisans who helped demonize the science are launching a ballot initiative in California that would require the vast majority of food products sold in the Golden State to carry warning labels announcing its connection to genetic engineering.

Titled the California Right to Know Genetically Engineered Food Act, the initiative is currently under evaluation by state officials to determine if sufficient voter signatures have been collected to place the measure on the state’s November’s ballot.

Here’s what it says:

“Commencing on July 1, 2014, any food offered for retail sale in California is misbranded if it is or may have been entirely or partially produced with genetic engineering and that fact is not disclosed . . . with the clear and conspicuous words Genetically Engineered on the front of the package.”

Given that an estimated 165 million acres of biotech crops were planted last season in the United States and that USDA data show that more than 88% of corn, and 94% of soybeans were biotech varieties, practically any processed food product using soy-derived vegetable protein (the darling of anti-industry vegetarians) or corn products would require special labeling.

That’s not all.

Consider the language that would likely appear on the voter’s guide distributed prior to the election:

bullet“Genetic engineering of plants and animals often causes unintended consequences. Manipulating genes and inserting them into organisms is an imprecise process. The results are not always predictable or controllable, and they can lead to adverse health or environmental consequences.” (Actually, biotechnology is an incredibly precise process, unlike conventional cross-breeding and hybridization, which proceeds on a hit-or-miss, trial-and-error basis until favorable traits spontaneously appear).
bullet“Government scientists have stated that the artificial insertion of DNA into plants can cause a variety of significant problems. Such genetic engineering can increase the levels of known toxicants in foods and introduce new toxicants and health concerns.” (Actually, the Food and Drug Administration has consistently stated that GM labeling is unnecessary because there is no nutritional or chemical difference between biotech and conventional food crops—not to mention that after a generation of eating biotech foods, there’s not a shred of evidence that anyone has been made ill or suffered any adverse effects from biotech foods).
bullet“The cultivation of genetically engineered crops designed to withstand weed-killing pesticides known as herbicides [result in] hundreds of millions of pounds of additional herbicides used on U.S. farms.” (Actually, ag biotech lowered pesticide use globally from 1996 to 2010 by nearly a billion pounds, an 18% reduction, according to PG Economics, a UK-based agricultural consultancy—not to mention significantly less greenhouse gas emissions from reduced fossil fuel use and added soil-based carbon storage from the no-till cultivation possible with GM crops).
bullet“The California Right to Know Genetically Engineered Food Act is intended to have no cost for consumers or food producers. It simply requires that foods produced with genetic engineering must disclose this fact on food packaging or labels on store shelves.” (Actually, the segregation of ingredient and the recordkeeping required to process and package “California Only” foods would generate horrendous additional costs. The California Right To Know group behind the initiative is clearly taking advantage of the public’s ignorance of manufacturing and distribution logistics).
GMO foods don’t need special label, American Medical Assn. says
The Los Angeles Times, June 21, 2012

Should foods containing genetically modified ingredients be specially labeled as such? The American Medical Assn. doesn’t think so, according to a policy statement adopted Tuesday at its annual meeting in Chicago.

The 500-ish-word statement, which is not yet up at the medical association’s website, says among other things that as of this month, “there is no scientific justification for special labeling of bioengineered foods, as a class, and that voluntary labeling is without value unless it is accompanied by focused consumer education.”

Federal oversight in agriculture, the statement also says, “should continue to be science-based and guided by the characteristics of the plant or animal, its intended use, and the environment into which it is to be introduced, not by the method used to produce it, in order to facilitate comprehensive, efficient regulatory review of new bioengineered crops and foods.”

In other words, it’s less important whether a plant or animal was altered by conventional breeding or genetic engineering, say, than what the potential for a problem might be.

The AMA does want each new genetically modified organism, or GMO, product to be carefully assessed for consumption safety and potential environmental risks such as spread of insect-resistance or herbicide-resistance to a crop’s wild relatives. And the AMA would like to see better technologies developed for assessing health risks, such as the potential for eliciting allergic reactions.

Common Sense Labeling
Board Commentary, Editorials — By Terry Wanzek on June 28, 2012

Senator Bernie Sanders of Vermont–an “independent” who calls himself a socialist--offered an amendment to the farm bill.

On the face of it, the Sanders amendment sounded reasonable: It would have granted states the right to establish their own rules for labeling food that contains biotech ingredients. In the last year, legislators in 19 states have offered three dozen bills on this matter, according to Packaging Digest. This November, California voters will weigh a ballot initiative to require labels on food that may contain GM ingredients.

In the Senate, the Sanders amendment lost by a wide margin: 26 in favor, 73 opposed. If a new version comes up in the House, let’s hope that it loses again.

No European dependence for ag exports
Columbus Telegram (Ohio), By Alan Guebert. June 11, 2012;

U.S. ag exports are forecast to reach $134.5 billion in Fiscal Year 2012.

That estimate, released by the U.S. Department of Agriculture May 31, is $3.5 billion higher than USDA’s February guess and only $3 billion under FY 2011’s record-smashing foreign ag sales.

More impressive than these two years of high altitude flying is the steep uptrend they cap. U.S. ag exports in FY 2007 were a then-fabulous $82.2 billion. This year’s number is a staggering $50 billion-and-change higher. What a run.
Lost in the thin air, however, are higher ag imports. While their rocket ride has been slower — U.S. ag imports are up $37 billion between 2007 and 2012 — they are climbing, too, and will total an estimated $107.5 billion by Sept. 30, the end of the government’s fiscal year.

Still, given the economic jitters rattling Asia, Europe and North America now, any growth in ag exports is a minor miracle, and an estimated growth of 3.4 percent, USDA’s number for 2012 is major miracle.

As usual, the big boys of the American exporting past are the (forecasted) big boys of today’s export market: 1 billion bushels of wheat for $8.5 billion, 1.7 billion bushels of corn for $12.5 billion, 1.3 billion bushels of soybeans for $18.1 billion.

Also, 2012 livestock, poultry and dairy exports will total $29.6 billion and, nearly as large, are sales of fresh and processed fruits, vegetables and nuts; they are forecast to hit $28.5 billion.
Charting where American food goes should draw you an economic map of the world today, right? (Link to the USDA report at I mean China on top, maybe Japan next, then Europe.

No, nope and not even close.

America’s number one food customer in 2012 will be Canada, at $20 billion, then Mexico at $19 billion, then (finally) China at $18.5 billion.

Regionally, however, Asia easily tops the list; 43 percent of all American food exports headed west to the East in 2011 whereas our NAFTA partners gobbled up 26.4 percent. That won’t change this year.

By comparison, the European Union’s 27 members had a small U.S. shopping cart last year. Just 7.4 percent of all American ag exports — valued at $10.2 billion — went east to the West.

The striking difference between those numbers carries two potent suggestions. First, the EU’s economic stumbles have sent few ripples across America’s fruited plain and, in all likelihood, won’t unless their money flu infects our bigger, better customers.

Second, those bigger, better customers are far bigger and far better and so should be our worries because they buy groceries, literally, by the boatload.

For example, Japan, with $14 billion food purchases in 2011 and 2012, was and will remain a far bigger U.S ag export market than all of Europe combined. China, while dropping its estimated U.S. food buys to $18.5 billion in 2012 from $19.9 billion last year, is still your dream customer — a billion mouths, rising incomes, a growing economy and expanding Western tastes.

Like Europe now, however, China could falter in the coming two years. Strong evidence suggests that one-half of the nation’s foreign currency reserves are being used to prop up the economy; much of it to build infrastructure — airports, roads, bridges — that have little purpose other than to underwrite continued consumer spending.

Moreover, China’s biggest problem, political reform, awaits. I’ve heard it explained this way: China and its chief regional competitor, India, are two powerful cars roaring down flat, perfect four-lane highways at 200 mph. The road for India, because of its functioning democracy, never ends. The road for China, however, turns into a dirt walking path.

When? As soon as the economy stops growing and China can’t buy enough food — from you — to feed its people.

The Farm and Food File is published weekly in more than 70 newspapers in North America. Contact Alan Guebert at

News in Science

Fungi as serious threats for life

One of the world's largest growing threats to endangered animals and plants is coming from a very small source: fungus. The discovery was made by researchers in the United Kingdom and the United States. Presented in the journal Nature, the study was funded in part by the BIODIVERSA2 (Cooperation and shared strategies for biodiversity research programmes in Europe) project, which received EUR 2 million in funding under the Environment Theme of the EU’s Seventh Framework Programme (FP7). The results suggest that in 70% of instances where an infectious disease caused the extinction of a type of animal or plant, the culprit was a nascent species of fungus.

Commenting on the results, lead author Dr Matthew Fisher from the School of Public Health at Imperial College London said: 'The alarming increase in plant and animal deaths caused by new types of fungal disease shows that we are rapidly heading towards a world where the "rotters" are the winners. We need strive to prevent the emergence of new diseases as we currently lack the means to successfully treat outbreaks of infection in the wild.'

Up to 7%, or 230-580 megatonnes, of atmospheric CO2 are not being absorbed by trees because they have either been killed or are infected by fungi. This impact has caused scientists to believe that fungi may be behind an increase of the greenhouse effect.

Wildlife is not immune from fungal diseases either, according to the researchers. Over 500 species of amphibian species, as well as many endangered species of bees, sea turtles and corals have found themselves under threat as well. Studies suggest that white nose syndrome fungus in the United States has led to a decline in bat populations, and this in turn has led to an increase in the insect crop-pests because the bats are no longer around to keep their numbers down. The cost to agriculture is estimated at more than USD 3.7 billion per year.

Co-author Sarah Gurr, a professor of Molecular Plant Pathology at the University of Oxford, said: 'Crop losses due to fungal attack challenge food security and threaten biodiversity, yet we are woefully inadequate at controlling their emergence and proliferation. We must have better funding channelled into the fight against fungal disease.'

In a worst-case scenario, fungal infection could damage of up to 900 million tonnes of food if disease epidemics were to hit all the top five food crops in the same year, and would leave over 4.2 billion people starving, the researchers said.

As a result of these findings, scientists are calling for solutions to this threat to prevent the proliferation of existing and emerging fungal infections in plants and animals. By tackling this problem now they hope to prevent further loss of biodiversity and food shortages in the future.

Solid-state nanopore sensor

Nanopores are very small holes, usually in synthetic materials like grapheme or silicone, and are used to analyse and sequence single nucleic acid molecules. Nanopore biotechnology offers one of the most promising approaches to single molecule detection and analysis. The ability of solid-state nanopores is enhanced by fitting them with cover plates made of DNA. These nanoscale cover plates, which have had central apertures tailored to various "gatekeeper" functions, are formed by so-called DNA origami. This is the art of making structures from DNA to fold into custom-designed structures with specified chemical properties. This represents a major breakthrough for the industry as a whole with far-reaching effects.

Vaccine for Parkinson disease tested
Vienna, 5 June 2012

The worldwide first clinical trial for the development of a Parkinson´s vaccine has now been started by AFFiRiS AG. The vaccine called PD01A is directed against alpha-Synuclein, a protein considered causing the onset and progression of the disease, and is currently being tested on Parkinson´s patients in a Phase I trial. The vaccine holds out the prospect to deliver a causative treatment of Parkinson´s for the first time. Its potential for success prompted the US-American Michael J. Fox Foundation to generously support the development of PD01A financially. Taking place in Vienna and involving up to 32 patients, the primary endpoints of the trial are safety and tolerability of PD01A.

DNA Repair: How Chromosomes Find Each Other
Published: Wednesday, June 06, 2012; Last Updated: Wednesday, June 06, 2012

Study found that after a double-strand break in DNA, the mobility of both the broken segment and other, unbroken, chromosomes is greatly increased.

Vaccine for grass pollen allergy efficient
Vienna, Austria, 14 June 2012

A novel vaccine for grass pollen allergy has shown significant improvements for patients in a Phase IIa trial. The vaccine BM32 is based on an innovative recombinant peptide carrier technology that allows for fewer injections and shows fewer side effects compared with other immunotherapy treatments for allergy sufferers. BM32 has been developed by Biomay AG, an Austrian biopharmaceutical company specialized in the discovery and development of innovative allergy therapeutics. The company has already initiated a Phase IIb trial for BM32 with 180 allergic patients.

More information Judith Sandberger [].

Anti-HIV drug from GM tobacco

In June 2011, medical regulators gave the go-ahead for trials in humans of a potential new anti-HIV drug. The drug was produced in genetically modified tobacco leaves.

It was the first ever clinical trial of a drug of this type that had been derived from GM plants.

The hope is that the drug will prove effective in preventing HIV infection. But the real significance of the regulatory green light, given by the UK's licensing body, the Medicines and Healthcare products Regulatory Agency (MHRA), went further than that.

It confirmed, for the first time, that molecules known as monoclonal antibodies – the key component of the drug, and of many other highly effective modern pharmaceuticals- could be produced from plants in a form that met the extremely stringent standards required for use in the treatment of humans. As well as bringing hope to the fight against HIV/AIDS, the decision opened the way for trials of other plant-derived medicines to treat a range of diseases.

It was, potentially, an important step towards the transformation of modern drug manufacturing, offering the developing world access to key drugs which have previously been prohibitively costly.

The move to Phase 1 clinical trials was the crowning achievement of PHARMA-PLANTA, a seven-and-a-half year EU-funded project set up in 2004. With € 12 million of funding provided under the EU's 6th Framework Programme of research and development, the PHARMA-PLANTA consortium comprised more than 30 academic and industrial partners from across Europe and South Africa. The consortium's goal was clearly stated: to develop a manufacturing process for recombinant protein drug products derived from GM plants and to take one such product through all the development stages, including clinical trial.

The approval from the MHRA was described by the project's scientific co-ordinator, Professor Julian Ma of St. George's, University of London, as "a red letter day". It was, he said, "an acknowledgement that monoclonal antibodies can be made in plants to the same quality as those made using existing conventional production systems. That is something many people did not believe could be achieved."

The conventional production systems referred to by Professor Ma use sophisticated stainless steel fermentation vats containing bacteria or mammalian cells. The process of deriving antibodies from these cells is high-tech - and highly expensive.

By contrast, the antibodies produced by PHARMA-PLANTA were derived from tobacco plants grown in greenhouses in Germany, harvested after 45 days and shredded. According to Professor Rainer Fischer, Director of the institute where the GM tobacco was grown, this much simpler, more low-tech option is between 10 and 100 times cheaper.

Just as importantly, the simplicity of the process means it could easily be transferred to developing countries, allowing production of drugs "in the region, for the region."

Discovered by one of the four private commercial partners in the project, Austrian biotech company Polymun, the new antibody successfully completed its Phase 1 trial, ascertaining its safety, at the end of 2011. It is now set to move into the next phase of testing, to establish its medical effectiveness.

Meanwhile, other diseases for which it is envisaged that GM plants could provide new drugs include cancer, rheumatoid arthritis and others which, in the words of Professor Ma, are currently "horribly expensive" to treat.

As Professor Fischer explains, the success of PHARMA-PLANTA "is a springboard for European plant biotechnology and will enable many important medical products to be realised".

Project details

Participants The Netherlands, Germany (Coordinator), France, Italy, Belgium, Spain, Sweden, United Kingdom, Austria, Greece, Switzerland, South Africa
FP6 Proj. N° 503565
Total costs: € 17 600 000
EU contribution: € 12 000 000
Duration: from: Feb. 2004 to: Oct. 2011.

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