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Newsletter - Year 2007 - Volume 01
Looking back |
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| Biotechnology
When the first genetically modified crops were introduced to the world ten years ago, the advancement was seen as the beginning of a new time that could help struggling farmers, the environment, and reduce hunger around the world, according to reports. Today, genetically modified crops are driving profits at major players in the industry. However, as the biotechnology industry celebrated its 10th Anniversary, the early promises of genetically modified foods remain largely unrealized (Biotech Crops mark First Decade with Wins, Losses, CNETNews.com, 12/29/05).
Genetically modified products have not lived up to their early expectations.
According to Joel Cohen, senior research fellow at the International Food Policy Research Institute, there are series of dependable, reliable crops using this technology, but there is still a large precautionary perspective.
In late 2005, cereal giant Kellogg’s announced that it would start using a healthy low linolenic oil derived only from Monsanto’s biotech soybean in its cookies, crackers and other food products. Less than two weeks later, however, Kraft Foods said it would stop supplying all genetically engineered food products, including additives, to China due to a lack of market acceptance. PepsiCo and Coca-Cola have made similar pledges.
The author writes of other recent setbacks, including a decision in November 2005 by Swiss voters to ban planting of biotech crops for five years and the recent revelation in Australia that a biotech pea caused health problems in research mice, forcing the cancellation of that project. Also, Monsanto was forced to withdraw a biotech wheat it planned to sell in the United States and Canada in 2004 because of strong market opposition.
Margaret Mellon, director of the Agriculture and Biotechnology Program at the Union of Concerned Scientists in her article stated that backers of biotechnology say the crops are good for the environment because they can reduce the amount of chemicals needed to grow healthy crops, but opponents say chemical use many times increases because of weed resistance and other problems. Critics also say that farmer profits tied to better yields get eaten up by the higher prices they pay for biotech seeds and that biotechnology has not eased hunger because many poor countries are unable or are unwilling to adopt the technology.
Still, according to the article, more growth and acceptance of the technology is on the horizon. The author states that an industry report due in January 2006 is expected to show good growth not only in the United States, but in many other countries and barriers in Europe are slowly lowering and new products in the pipelines should help to improve acceptance.
The author writes that according to Michael Fernandez, executive director of the Pew Initiative on Food and Biotechnology, there is currently an “enormous investment” in agricultural biotechnology in China, Argentina, Chile, and other countries, and genetically modified rice was likely to gain approval in China in the near future, a move that could shift acceptance globally in favor of biotech food.
Despite opposition, biotechnology and the acceptance of genetically modified foods is certainly moving in the right direction. Here’s to more advancement and breakthroughs in the industry in 2006 and the next ten years.
(Extract from: Posted by acbaumer on January 1, 2006 01:12 PM | Permalink - http://www.gmofoodforthought.com/2006/01/looking_back_on_biotechnologys.htm). |
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Pharmaceutical |
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Industry Update on Plant-Made Pharmaceutical
| “Using plants as factories to produce recombinant protein products is emerging as a cost-effective, high capability solution to the issue of production capacity.” |
Phil Webster, research analyst
Frost & Sullivan |
Pharmaceuticals produced from biotech plants are a new application of biotechnology that turn plants into “factories” that produce therapeutic proteins used in biopharmaceuticals. Medicines produced from plants represent one of the brightest new hopes in medicine. While great strides have been made through biotechnology in the search for treatments and cures to the most formidable diseases, research and development of biotech drugs may be cut short due to capacity and cost issues. Plants may offer a cost effective, sustainable, and faster source of medicines for patients, and provide access to new treatments which would otherwise be out of reach.
In the last year, progress in the plant-made pharmaceutical industry has advanced significantly – from the first regulatory approval of a plant-made animal vaccine to successful clinical trial results in developing countries, to identifying the potential of producing insulin from biotech safflower. Several companies have shown the effectiveness of plant-made pharmaceuticals in addressing the medical needs of large and growing patient populations. In January 2005, market research firm Frost & Sullivan predicted that the plant-made pharmaceutical market could realize revenues of $98.2 billion by 2011
| First Federally Approved Plant-Made Vaccine |
| In January 2006, the U.S. Department of Agriculture’s (USDA) Center for Veterinary Biologics (CVB) gave regulatory approval for the first plant-made vaccine to Dow AgroSciences’ Animal Health division and their Concert™ product, a vaccine to improve animal health. This first U.S. regulatory approval of a plant-made vaccine demonstrates the safety and efficacy of plant-made vaccines. |
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| Child Health Study of Plant-Made Proteins in Electrolyte Replacement Solutions Demonstrates Success |
Every year, two million children die of complications from diarrhea, making it the second largest infectious killer of children under age five. With children in the United States, there are more than 1.5 million outpatient visits, 200,000 hospitalizations and 300 deaths per year due to acute diarrhea. It has been estimated that this is a multi-billion dollar burden for the healthcare system in the United States. In the 1960s, health professionals found that rehydration using electrolyte solutions reduced annual deaths from greater than five million to two million. Modern research has demonstrated that breast-fed children have a significantly lower incidence of diarrhea and infections, leading Ventria Bioscience to begin research into the development of an electrolyte solution that contained the protective proteins found in breast milk. Ventria has developed an electrolyte solution that includes Lactiva™ (lactoferrin) and Lysomin™ (lysozyme), two proteins naturally found in breast milk, which are produced in rice. The University of California at Davis worked with leading international institutions to conduct a Child Health Study using this product.
The randomized, double-blind study enrolled 140 children under 5 years of age who were suffering from acute diarrhea. Children who took the electrolyte solution which contained Lactiva™ and Lysomin™:
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Were sick for less time – on average, they were sick for 3.67 days, as compared to 5.21 days for children who consumed conventional electrolyte solution. |
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Reached complete resolution of their diarrhea with much higher frequency than children receiving the electrolyte solution alone. 85.1 percent of children who consumed Lactiva™ and Lysomin™ electrolyte solution recovered, while only 69.2 percent of the control group recovered. |
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Were less likely to relapse into another episode of diarrhea. The percentage of children who relapsed was lower in the Lactiva™ and Lysomin™ electrolyte solution group versus the control group. |
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| Using Plants to Combat the Diabetes Epidemic |
In July 2006, Calgary-based SemBioSys announced that it can produce over one kilogram of insulin per acre of protein-producing biotech safflower. This is enough to supply 2,500 patients for one year of treatment each. With insulin demand projected to be 16,000 kilograms by 2012, SemBioSys’ biotech safflower may be the only way to ensure adequate supply of insulin to continue to treat a growing diabetic patient population. Affecting millions of people worldwide, diabetes has been growing at a disturbing and epidemic rate over the past decade. If left untreated, diabetes can lead to life-threatening complications, such as blindness, kidney disease, nerve disease, heart disease, amputations, and stroke. It is projected to affect over 370
million individuals by 2030. The increasing incidence of diabetes, combined with the adoption of alternative delivery technologies with low bioavailability will drive insulin demand from current levels (about 5,500 kilograms) to over an estimated 16,000 kilograms by 2012. In addition to meeting patient supply needs, producing insulin in biotech safflower can reduce capital costs compared to existing insulin manufacturing by 70 percent and products costs by 40 percent. |
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| Biotech Plants Address Drug Abuse |
Abuse of PCP and methamphetamine is increasing and there are currently no therapies available for treatment. According to the National Institute on Drug Abuse (NIDA), there are more than 400,000 people considered to be “hardcore” PCP and methamphetamine-users. California-based InterveXion Therapeutics is developing two forms of products for the treatment of PCP abuse, as well as in overcoming methamphetamine addiction. More than a decade of research has concluded that monoclonal antibodies (MABs), which can be found in both of InterveXion Therpeutic’s products, absorb the toxins in the bloodstream to reduce the acute effects of overdose and can also be used in the chronic setting to help drug abusers overcome dependency. |
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| PMP Research Continues |
For the millions of patients who suffer from cystic fibrosis, cancer, multiple sclerosis, AIDS, diabetes, and heart disease, plants that produce therapeutic proteins may be the only chance to obtain needed treatments. In addition to the companies above, other groups working on plant-made pharmaceuticals
include: cystic fibrosis treatment from biotech corn (Meristem); treatment for ovarian cancer from biotech tobacco (Chlorogen); biotech tobacco to address dental caries, as well as the common cold, and hair loss (Planet Biotechnology); and the production of monoclonal antibodies from biotech duckweed (Biolex).
(Extracts from: Industry Update of Plant-Made Pharmaceuticals (177 KB PDF, December 2006), http://www.bio.org/healthcare/pmp/ ) |
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Looking forward |
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The opportunity for biotech is on the selling side
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Given these factors, and that we are on the verge of economic and social change, what are the outcomes from these global events and how they impact the development of biotechnology? |
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lant biotech industry in North America is about where computer science was in 1983; there are many parallels between the two industries; we need the foresight to see how we can use plant biotechnology for the future |
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There is a "wellness" demand bubble ahead of us health, nutrition, information, genetics are all going to converge; because aging population is also quite computer literate, they will take control of their wellness major change in the medical community |
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We will end up with two classes of food: pharmafoods (supplements, regulated similarly as they are now) and "lifestyleoriented" designed or functional food products) |
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What impact will this "wellness" have on the health care system? Currently 60% of health care costs are in the last 6 months of life - this change and focus will create tremendous opportunities |
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Other prediction: one of the most resistant areas to change is health care; next to them is the pharmaceutical companies the food/farm industry may change the pharmaceutical companies biotechnological changes can also be done on animals (and humans) |
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Two other areas for value creation and growth from biotechnology in the agricultural area: 1) if we look at emerging industrial nations and demand for animal protein, those nations are reducing their ability to produce food, they want to eat more animal protein (limitation: less land to produce feed grains to feed the animals) |
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To meet these challenges, we have to apply biotechnology as safely and as widely as we can |
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Our land prices will likely double, therefore our food prices will increase unless we apply technology and use finite land resources and water |
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We can also change how and where crops are grown i.e., adapt plants to be more frosttolerant so you can plant them in different climates |
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$35 billion in new value creation from animal and plant biotechnology innovations in the near future, the question of whether we use the land for food versus feed stocks will need to be addressed |
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By globalizing trade we've opened up the world as a market, but with the Internet (increased communication), we've "tribalized" the world with each tribe looking at the world a certain way; for example, the U.S. is actionoriented; in Canada, the driving factor is all the space we have ("the Great White North"), so we tend to take stronger, longer, caring, weighing processes to make decisions; this attitude will likely stand us in good stead when it comes to biotechnological issues, but we have to make a decision |
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The "Titanic" has sailed, it will hit the iceberg, the issue of food security is real and we're going to have to deal with it; what is happening in Asia is an economic shakeout, but China is still growing economically, they will get it sorted out, but it hasn't changed the direction of the "ship" |
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Risk &benefit have to be weighed together |
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Benefit is the other side of risk and if we take the opportunities presented by biotechnology, we can miss the "Titanic" and get the "Loveboat |
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| Q. |
Relates to biotechnology and technology use agreements (TUA)? How does it affect TUA's? |
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The dominant design usually comes in after the industry gets going that has not happened in agricultural biotechnology. We are at the early stage to patent. Human biopharma industry has developed, on a scale of 1 to 10 it's a 7; plant biotechnology is about a 4 (out of 10). The next wave will be from human biopharma. |
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Every speaker has talked about educating the public whose job is it to get the word out about biotech? |
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We all have a stake in it and have to be part of the solution. This whole area of education, we have a hard time dealing with it. The effective time sequence of getting information out is about 10 seconds on national television. I was at Eli Lilly when we developed insulin (produced by genetically altered bacteria E coli). To date, there hasn't been a "saleable" product that we can bring to market, e.g., you take this product and it'll drop your cholesterol 15 points, we'll be able to sell it. |
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(Extracts from: Biotechnological Impacts by Mr. John Oliver, Maple Leaf BioConcepts –
http://www.cfbmc.com/riskman/Biotech_Impacts/body_biotech_impacts.html#5c) |
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Major breakthrough |
Scientists crack the code for DNA organisation in nucleus - By Wai Lang Chu
The discovery of a genetic code for DNA organisation within a cell’s nucleus has significant implications in future drug discovery processes as cracking the genetic code that determines nucleosome location on the DNA strand will aid identification of drug targets.
Pharmaceutical companies are targeting DNA for different therapies, and they need to identify DNA or small molecules that selectively bind to DNA to turn on or off the gene expression related to a particular disease.
By identifying this specific sequence, not only can drugs be made more effective, it might also be possible to predict a patient's response to a particular type of drug therapy.
At the Weizmann Institute of Science in Rehovot, Israel, researchers proved that DNA sequence also encodes “zoning” information on where to place nucleosomes.
They characterised this code and then, using the DNA sequence alone, were able to accurately predict a large number of nucleosome positions in yeast cells.
The researchers examined around 200 different nucleosome sites on the DNA and asking whether their sequences have something in common. Mathematical analysis revealed similarities between the nucleosome-bound sequences and eventually uncovered a specific “code word.”
This “code word” consists of a periodic signal that appears every 10 bases on the sequence. The regular repetition of this signal helps the DNA segment to bend sharply into the spherical shape required to form a nucleosome.
To identify this nucleosome positioning code, the research team used probabilistic models to characterise the sequences bound by nucleosomes, and they then developed a computer algorithm to predict the encoded organisation of nucleosomes along an entire chromosome.
This latest discovery bodes well for gene expression control exhibited by DNA-binding drugs, which has become of great interest in molecular biology and biotechnology.
The ability of some drugs to switch on or off the gene expression brings the possibility to develop treatments for genetic diseases, infection by antibiotic-resistant bacteria, and especially cancer, which is typically accompanied or caused by mutations in the DNA and the way it organises into chromosomes.
The analysis of the DNA sequence-dependent conformational energy gives hints for the design of DNA-binding drugs that modify the DNA conformational state.
Dr. Eran Segal and research student Yair Field of the Computer Science and Applied Mathematics Department at the Weizmann Institute of Science said that since the proteins that form the core of the nucleosome are among the most evolutionarily conserved in nature, the scientists believe the genetic code they identified should also be conserved in many organisms, including humans.
Such mutational processes may be influenced by the relative accessibility of the DNA to various proteins and by the organisation of the DNA in the cell nucleus.
Therefore, the scientists believe that the nucleosome positioning code they discovered may aid scientists in the future in understanding the mechanisms underlying many diseases. |
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