VasoGenix Pharmaceuticals presents data related to CGRP (Calcitonin Gene Related Peptide) for heart failure patients

VasoGenix Pharmaceuticals Inc. (www.vasogenix.net) recently announced the results of collaborative research that the Company conducted with the Cleveland Clinic’s Lerner Research Institute related to VasoGenix’s first drug, Calcitonin Gene Related Peptide (‘CGRP’), for the treatment of heart failure. The data was presented earlier this month at the Annual Meeting of the American Heart Association in Orlando, Florida. The presentation was entitled: Calcitonin Gene Related Peptide Receptor Regulation in Human Heart Failure. The research was conducted in the laboratory of Sathyamangla V. Naga Prasad, Ph.D., at Cleveland Clinic’s Lerner Research Institute.

Study results demonstrated that CGRP receptors in heart tissue of heart failure patients are upregulated 38% compared to heart tissue taken from patients without heart failure. Furthermore, the study elucidated the regulation of CGRP receptor components in human heart failure and evaluated the signaling mechanisms involved in CGRP receptor activation.

“CGRP has demonstrated favorable clinical effects on parameters affecting heart failure patients and may be beneficial in multiple ways. It also appears that the blood plasma levels of CGRP may be raised in heart failure patients. Taken together with the upregulation of the CGRP receptor sites in the failing hearts, these data suggest that a human failing heart may desire CGRP to help it function better,” said Lee Southard, Ph.D., CEO of VasoGenix. “Consequently, we have a heightened expectation that our clinical assessment of CGRP in heart failure will produce positive results and significantly impact this disease. This is important because heart failure is the most costly hospital diagnosis and is responsible for more deaths of people over 65 than any other disease."

CGRP is distributed in neural tissue throughout the human body but concentrated in the heart, where nerves secrete it following a heart attack, in an apparent attempt to reduce the infarct size and keep heart cells alive. Unfortunately, an insufficient amount is produced to have a meaningful effect on heart failure (HF) or myocardial infarction (MI). While current drugs for treating HF and MI have a single mechanism of action, CGRP appears to work on several levels: for example, it (1) increases local blood flow enhancing hemodynamic proficiency; (2) protects heart muscle cells from the damage due to lack of oxygen (ischemia); and, (3) modulates the immune system by boosting anti-inflammatory cytokine expression while suppressing pro-inflammatory cytokines, which reduces the inflammatory response to provide a cardioprotective effect. All these actions are meant to minimize heart muscle damage and subsequent scar tissue formation, while promoting the healing process.

VasoGenix Pharmaceuticals Inc. is a preclinical-stage company capitalizing on the hemodynamic and immunomodulation properties of Calcitonin Gene Related Peptide (CGRP) and analogs. It is focused initially on the treatment of heart failure with future products targeted at myocardial infarction and kidney failure. The VasoGenix business strategy is cost-affective and is geared to maximizing ROI and a three-year exit strategy.

Renewable Fuels, Environmental Concerns Drive Rapid Advances in Biotechnology

Rapid advances in biofuel research and development are being driven by concerns about the environment and the need for renewable fuels, according to top industry and government officials from China, Canada, the United States and Hawaii attending the second annual Pacific Rim Summit on Industrial Biotechnology and Bionergy.

The second annual Summit gathered 340 biotechnology and bioenergy business executives, scientists, academics, and government officials in Honolulu to review progress in developing the bioenergy industry. The conference was hosted by the Biotechnology Industry Organization (BIO), the American Chemical Society and the State of Hawaii.

“Building new business partnerships within the bioenergy industry, particularly along the Pacific Rim, was a primary objective of the Summit,” said Erickson. “As we heard from our plenary speakers, government policies that support development of the industry, which are being driven by concerns about the environment and future economic growth, have been vital in attracting the private investment needed to make this industry successful. Pacific Rim countries have been in the lead in implementing these policies.”

The Summit featured more than 100 presentations from researchers and scientists, discussing biotechnology applications in energy, marine biotechnology, fine chemicals, and biobased products. The Summit also facilitated more than 45 meetings between companies seeking partnerships for the commercialization of new bioenergy research and applications.

“The Pacific Rim Summit showcased the latest biotech advances in feedstocks, production processes and novel biobased products,” said Brent Erickson, executive vice president of BIO’s Industrial and Environmental Section. “Attendees learned about new areas being explored for bioenergy applications, including marine biotechnology, nanotechnology and synthetic genomics.”

Keynote speakers at the summit included Jiayang Li, vice president of the Chinese Academy of Sciences, and James Spaeth, manager of biomass research at the U.S. Department of Energy (DOE), who outlined their respective governments’ programs to support development of the biofuel industry in the opening session, titled “The Status of Biofuels Development in the Pacific Rim.”

Plankton Recruiting to stop Global Warming

Could plankton save the planet? In an effort to ameliorate the effects of global warming, several groups are working on ventures to grow vast floating fields of plankton intended to absorb carbon dioxide from the atmosphere and carry it to the depths of the ocean. It is an idea, debated by experts for years, that still sounds like science fiction — and some scholars think that is where it belongs.

But even though many questions remain unanswered, the first commercial project is scheduled to get under way this month when the WeatherBird II, a 115-foot research vessel, heads out from its dock in Florida to the Galápagos and the South Pacific.

The ship plans to dissolve tons of iron, an essential plankton nutrient, over a 10,000-square-kilometer patch. That’s equivalent to 2.47 million acres (3,861 square miles on land or 2,912 square nautical miles). When the trace iron prompts growth and reproduction of the tiny organism, scientists on the WeatherBird II plan to measure how much carbon dioxide the plankton ingests.

Their efforts underscore a growing effort to pull carbon from the atmosphere. Solutions include planting or restoring forests and — once many economic and technical obstacles are overcome — capturing tons of carbon from coal burning for electricity and oil refineries, piping it back underground or burying it under the ocean.

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Career Opportunities in Biotechnology and Drug Development (Hardcover)

Career Opportunities in Biotechnology and Drug Development (Hardcover)by Toby Friedman (Author).

As the world of biotechnology has grown in leaps and bounds, so too have the career opportunities. But the choices can be daunting. What types of jobs are available? How do you get your foot in the door? What will your job entail if you become a "Preclinical Project Manager" or a "Process Scientist"? What s the difference between biotech and pharma?

Career Opportunities in Biotechnology and Drug Development provides a comprehensive and systematic overview of careers in the life science industry, with all their ups and downs. The author, Toby Freedman, Ph.D., has conducted interviews with hundreds of key players in the industry, who provide first hand explanations of their day to day roles and responsibilities, and offer key insights into how they landed those jobs in the first place. Careers in everything from discovery research to venture capital are covered in detail.

Each chapter includes valuable sections on preparing yourself for a prospective career: educational requirements and personality characteristics needed; recommendations of books, magazines, and Web site resources; and issues to consider regarding salary and compensation. The book also includes interviewing and job searching tips, as well as suggestions on writing a resume specifically for industry.

Career Opportunities in Biotechnology and Drug Development is an essential guide for science graduates and medical, business, legal, high tech or engineering professionals. With discussions of job security, future trends, and potential career paths, even those already working in industry will find helpful information on how to take advantage of opportunities available within their own companies and elsewhere. This book will help you make wiser and more informed decisions about what role you would like to play in the biotechnology and drug development industry.

The Nanotech Future: A Conversation with Mihail Roco

Nanotechnology refers to the emerging science of manufacturing materials that are measured in nanometers, usually at the 1-100 nanometers scale. The head of a pin is 1 million nanometers wide. By 2014, Lux Research estimates that $2.6 trillion in manufactured goods will incorporate nanotechnology, or about 15 percent of global output.

What was Dr. Rocos vision in 2000 at the start of the NNI? What are his expectations for nanotechnologys many promises-in medicine, sustainable energy, and electronics? What challenges does nanotechnology pose for the future, particularly as it reaches toward third and fourth generation development-in guided molecular assembly, 3D networking, robotics, supra-molecules, molecules by design, and evolutionary systems?

Robert Service, nanotechnology reporter at Science magazine, will interview Dr. Roco about nanotechnology at a Friday, November 9th, 2007, 12:30 p.m. event and live webcast at the Woodrow Wilson International Center for Scholars.

The event is sponsored by the Project on Emerging Nanotechnologies ( http://www.nanotechproject.org ), a joint initiative of the Wilson Center and The Pew Charitable Trusts. Project director David Rejeski will introduce the program.

Prior to joining the National Science Foundation, Dr. Roco was Professor of Mechanical Engineering at the University of Kentucky ((1981-1995), and held visiting professorships at the California Institute of Technology (1988-89), Johns Hopkins University (1993-1995), Tohoku University (1989) and Delft University of Technology (1997-1998). He is credited with 13 inventions, and has authored and co-authored numerous articles, publications and books.

Dr. Roco will receive the National Materials Advancement Award from the Federation of Materials Societies at the National Press Club in Washington, DC on December 5, 2007.

He is Corresponding Member of the Swiss Academy of Sciences, Fellow of the American Institute of Chemical Engineering, Fellow of the Institute of Physics and Fellow of the American Society of Mechanical Engineering. Dr. Roco initiated work on converging technologies, and on societal implications of nanotechnology since the beginning of the NNI.

FDA Clears Genetic Lab Test for Warfarin Sensitivity

The U.S. Food and Drug Administration today cleared for marketing a new genetic test that will help physicians assess whether a patient may be especially sensitive to the blood-thinning drug warfarin (Coumadin), which is used to prevent potentially fatal clots in blood vessels.

One-third of patients receiving warfarin metabolize it quite differently than expected and experience a higher risk of bleeding. Research has shown that some of the unexpected response to warfarin depends on variants of two genes, CYP2C9 and VKORC1. The Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test detects some variants of both genes.

"Today’s action offers physicians the first FDA cleared genetic test for warfarin sensitivity, which is another step in our commitment to personalized medicine,” said Daniel Schultz, M.D., director, FDA’s Center for Devices and Radiological Health. “With this test, physicians may be able to use genetic information along with other clinical information to treat their patients.”

Warfarin can be a difficult drug to use because the optimal dose varies depending on many risk factors, including a patient's diet, age, and the use of other medications. Rapidly achieving the correct dose is important. Patients who receive doses that are higher than needed to correctly thin the blood are at risk of life-threatening bleeding. Those who receive doses that are too low may remain at risk of life-threatening blood clots.

Warfarin is the second most common drug, after insulin, implicated in emergency room visits for adverse drug events.

In August, FDA approved updated labeling for Coumadin, the brand name version of warfarin, explaining that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug. Manufacturers of generic warfarin are adding similar information to their products' labeling.

Physicians and other health care professionals who prescribe warfarin regularly check to see if the drug is working properly by ordering a test called the PT or prothrombin time that evaluates the blood's ability to clot properly. The results are measured in seconds and compared with the expected value in healthy people, known as the International Normalized Ratio or INR.

The Nanosphere test is not intended to be a stand-alone tool to determine optimum drug dosage, but should be used along with clinical evaluation and other tools, including INR, to determine the best treatment for patients.

FDA cleared the test based on results of a study conducted by the manufacturer of hundreds of DNA samples as well as on a broad range of published literature. In a three site study, the test was accurate in all cases where the test yielded a result; 8 percent of the tests could not identify which genetic variants were present.

The new test was cleared for use on the Verigene System, a clinical laboratory test system. Both products are manufactured by Nanosphere Inc., Northbrook, Ill.

Biotech investment on the rise

Author: Liu King-pong

Taiwan's biotechnology and pharmaceutical industry received a boost in September from MediVas LLC, a drug and biological delivery system developer based in San Diego, California. The U.S. firm announced Sept. 20 that it has selected Taiwan as the site for its Asian operations.

"Taiwan has probably the most dynamic economy in Asia and its way of doing business is very similar to that in the United States," said Kenneth Carpenter, president and chief executive officer of MediVas. "But, most importantly, the Taiwan government has committed to making the biotech and pharmaceutical industry a trillion dollar business," he added, referring to the government's strong support for the development of biotechnology. The remarks came at the Sept. 20 grand opening ceremony of MediVas Asia Corp.

Carpenter's optimistic statement is the result of the close cooperation between the government and the local biotechnology industry. This trend was recently highlighted with a statement made by Ho Mei-yueh, chairwoman of the Council for Economic Planning and Development. She announced Sept. 14 that the state-owned National Development Fund would invest US$20 million in TaiMed Biologics Co., a new biotech firm focusing on AIDS drugs.

TaiMed Biologics' competitive advantage lies in that it has acquired the patent from the U.S.-based Genentech Inc. for its lead clinical product, TNX-355. The drug shows promise as an effective treatment for AIDS patients and those infected with HIV. The patent rights to a product with such potential no doubt prompted Ho to indicate that the establishment of TaiMed Biologics marked a breakthrough in Taiwan's biotech industry.

MediVas' business, unlike most biotech and pharmaceutical firms, focuses mainly on changing the way pharmaceuticals are delivered. Its technology platform uses protein-like polymeric biomaterials to make drug and biological delivery more effective.

What makes the new investment in Taiwan more significant is that MediVas Asia's facility on the island will focus on the development of so-called "super-generic" drugs, Huang Bor-fuei, director of the industry promotion and marketing department at the Development Center for Biotechnology, stated Sept. 22.

Self-described as the matchmaker between MediVas and Taiwan, Huang pointed out that the firm defines super-generics as drugs whose original patents have expired but would be re-patented by MediVas Asia. "This re-patenting is a result of improving or modifying the delivery of the drug. Such modification has several advantages, including longer duration of drug effectiveness, less undesirable side effects and changes in the method of administration," he said.

"For example, you might take the drug once a week instead of once a day, or you can stop taking a drug by injection and start to take it orally," he explained.

MediVas Asia had talked to local pharmaceutical firms about joint development of super-generics. Local pharmaceutical companies typically focus on production of low-margin generic drugs, however, and did not embrace MediVas' plans.

"Although local firms showed interest, they were slow to act, perhaps due to a risk-aversion mindset and an overly conservative culture of avoiding change," said Huang.

According to Huang, China and India are usually seen as the only new emerging biotech markets in Asia. Taiwan is not associated with advances in biotechnology and is often overlooked. Huang took a different view, however. "I believe a sustainable technology is important in making biotech and pharmaceuticals our twin-star industries for our future economy," he stated. "A powerful platform technology can enable the improvement or even the creation of a variety of new products that can help the whole industry, and that is where our true niche lies."

Using the analogy of a fishing pole and a fish, Huang explained the value of a powerful platform technology. "MediVas' drug-delivery system can deliver more than one successful product, in the same way a fishing pole can deliver a continuous supply of fish. In the long run, more than being a successful company, MediVas will have positive economic impact on Taiwan's biotech industry."

MediVas Asia would set up its own research-and-development center in Taiwan and the company would establish its manufacturing facilities for super-generic production within a year, Huang revealed.

Write to Liu King-pong at kpliu@mail.gio.gov.tw

New research into plant colours sheds light on antioxidants

Scientists have made an important advance in understanding the genetic processes that give flowers, leaves and plants their bright colours. The knowledge could lead to a range of benefits, including better understanding of the cancer-fighting properties of plant pigments and new, natural food colourings. The research is highlighted in the new issue of Business from the Biotechnology and Biological Sciences Research Council (BBSRC).

The scientists, at the John Innes Centre and Institute of Food Research in Norwich, have pinpointed a key group of enzymes involved in the production of plant pigments. The pigments, called anthocyanins, are what give some plants the vivid colours that they use to attract insects and foraging animals. They also give plants protection against environmental stresses and disease. Hundreds of different anthocyanins exist in nature, all with slightly different chemical compositions. The international research team, supported by BBSRC, identified the genes responsible for the enzymes which chemically modify anthocyanins to alter their properties.

Prof Cathie Martin at the John Innes Centre who co-led the project explains: “Using a new strategy, we conducted biochemical studies on the brassica plant Arabidopsis. We found that a small number of genes responsible for the enzymes that chemically modify anthocyanins were ‘switched on’ when the plants were making anthocyanins in response to stress.

“When we transferred these genes to a tobacco plant, the colour of the tobacco flowers changed slightly, confirming that these genes, and the enzymes that they produce, were indeed responsible for modifying anthocyanins.

“What’s more, these anthocyanins that had been modified by the enzymes were more stable than those that hadn’t. This is significant because stabilised anthocyanins could be used as natural food colourants to replace many artificial colours used in various foods. This improved understanding of the genetics of anthocyanins also provides a better platform for studying their antioxidant properties, important in the fight against cancer, cardiovascular disease and age-related degeneration.”

Crucell grants Merck access to vaccine technology

Leiden, The Netherlands, September 10 2007 - Dutch biotechnology company Crucell N.V. announced today that Merck & Co., Inc. (Whitehouse Station, NJ) has exercised an option for the exclusive use of Crucell's PER.C6® technology and an option for access to Crucell's AdVac® vaccine technology in two infectious disease areas.

Mr. Jaap Goudsmit, Crucell's Chief Scientific Officer said: "We are excited about this technology agreement which represents a further expansion of the relationship between our company and Merck. Crucell's vaccine technologies, PER.C6® and AdVac®, are increasingly used by the vaccine industry to develop important novel vaccines for infectious diseases. This agreement further broadens the number of disease areas in which our technologies are used."

Under the terms of the agreement, Crucell acquires rights to certain cell-line technology developed by Merck for the manufacturing of recombinant proteins. The option and the related rights to certain technology developed by Merck originate from the cross-license agreement executed in December 2006 between Crucell and Merck. Specifics concerning the infectious disease indications remain undisclosed.

About Crucell
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a biotechnology company focused on research, development and worldwide marketing of vaccines and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases, and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminium-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several Crucell products based on its unique PER.C6® production technology. The Company licenses this and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi aventis, GSK and Merck & Co. Crucell is headquartered in Leiden (the Netherlands), with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the US. The Company employs over a 1000 people. For more information, please visit www.crucell.com.

Prana to Raise A$7.0 million from Institutional and Professional Investors

Prana Biotechnology Limited (NASDAQ: PRAN / ASX: PBT), a biopharmaceutical company focused on the research and development of treatments for neurodegenerative disorders, today announced, subject to shareholder approval, a private placement of approximately 24.56 million new shares at a subscription price of A$0.285 (28.5 cents) per share, with a 2 for 6 free attaching option.

Prana will receive approximately A$7.0 million before allowing for issue costs from institutional and professional investors in Australia and the United States. The funds will be predominantly used for the ongoing development of its lead compound, PBT2, currently in a Phase IIa trial in patients with Alzheimer’s disease.

This trial, scheduled for completion in December 2007, is designed to advance the commercialization of Prana’s programs to develop novel treatments for neurodegenerative disorders.

“We are especially pleased to receive support from this group of investors, a number of whom have been strong supporters of the Company since inception,” commented Prana Chairman and Chief Executive Officer, Geoffrey Kempler. "This commitment reflects confidence in Prana and the potential of PBT2 as a disease modifying therapy for Alzheimer’s disease patients.”

The Phase IIa trial of PBT2 is a double-blind, placebo-controlled safety and tolerability study in patients with Alzheimer’s disease. PBT2 is Prana’s proprietary lead compound. The trial is well advanced, over 70% of study patients have been dosed and almost half of the target 80 patients have already completed the trial. “Given this progress, we are particularly pleased with the positive safety and tolerability demonstrated by PBT2 to date. We are on track to complete the trial by the end of the year and report results in the first quarter of 2008” said Mr Kempler.

New York based Brimberg & Co assisted with this transaction. The placement is subject to shareholder approval at an Extraordinary General Meeting, which is expected to occur on or about October 15, 2007. The Company will be seeking shareholder approval for the right to allot up to 35,087,700 shares with 2 for 6 attaching options which would raise up to $10 million if fully subscribed. The Company currently has firm commitments in place for $7.0 million of this total. The 2 attaching options, which will expire on 31 October and 30 November 2010 respectively, will be exercisable at A$0.37 cents and A$0.43 cents respectively.



About Prana Biotechnology Limited
Prana Biotechnology was established to commercialise research into Alzheimer's disease and other major age-related neurodegenerative disorders. The company was incorporated in 1997 and listed on the Australian Stock Exchange in March 2000 and listed on NASDAQ in September 2002. Researchers at prominent international institutions including The University of Melbourne, The Mental Health Research Institute (Melbourne) and Massachusetts General Hospital, a teaching hospital of Harvard Medical School, contributed to the discovery of Prana’s technology.

For further information, please visit the web site at www.pranabio.com.

Plants and stress; key players on the thin line between life and death revealed

Our crops are not doing well these days: too much water, too little sunlight... In short, they are suffering from stress. Scientists from VIB, associated with the Katholieke Universiteit Leuven (K.U.Leuven), have revealed a new mechanism demonstrating the intricate ways in which plants deal with stress. The newly discovered control system has a remarkable way of orchestrating the activity of hundreds of genes, forcing the plant into ‘safety mode’; the consumption of energy is contained while the organism is stimulated to mobilize reserves. This may have a negative impact on growth, but it allows the plant to temporarily safeguard itself against pernicious stress conditions. These findings also may prove to be useful beyond the case of plants, for the results are likely to be valuable in understanding disorders such as cancer and diabetes.

Life thanks to plants
Plants catch sunlight and use it as an energy source to produce sugars from CO2 and water. In doing so, they are at the very basis of the food chain. Ultimately, all life on earth depends upon this biochemical process: photosynthesis. Without plants, life as we know it today would simply not be possible. But what if things go wrong? When there is too little sunlight, for example? And what with other stressful conditions for plants? Environmental changes can compromise photosynthesis and exhaust energy supplies.

Plants control their own energy balance
Fortunately, plants have developed different mechanisms to detect and cope with 'stress’. Together with his American colleagues at Harvard Medical School (Boston, USA), VIB scientist Filip Rolland, associated with the Katholieke Universiteit Leuven, is uncovering a new system of detection and control. It is driven by KIN10 and KIN11. These ‘kinases’ – which are also found in human beings – react to energy shortages, when, for example, there is too little sunlight or too little sugar production. They control the activity of a broad network of genes, promoting the release of energy (catabolism) from alternative sources and blocking its assimilation (anabolism). In this way, the plant protects itself against stress conditions; like a really bad summer.

The key players: KIN10 & KIN11
The model organism for this study was Arabidopsis thaliana or thale cress. For decades, this small weed has been used as a model in molecular and genetic plant research. The scientists have tested numerous stress conditions that affect photosynthesis and energy production, such as darkness, herbicide treatment and flooding (lack of oxygen). By overexpressing the KIN10 gene, causing the plant to produce more of this protein, stress tolerance is increased and plants survive longer. By switching off these genes, their control function is eliminated.

With this research, the Flemish and American scientists have succeeded for the first time in attributing KIN10 and KIN11 a key role in the control of the plant energy budget and metabolism and thus the fragile balance between growth and survival; in short, the choice between life and death.

Are humans similar to plants?
The new insights gained by this study are not limited to the functioning of plants; they may also be important for human beings. KIN10 and KIN11, as ’fuel gauges’ controlling the expression of a whole set of genes, are also found in mammals. The results with plants, therefore, may play a pioneering role in discovering new functions of these proteins in disorders such as diabetes, cancer, obesitas, and aging.

Relevant scientific publication
The research findings are published in the leading scientific journal Nature (Baena-González et al., A central integrator of transcription networks in plant stress and energy signalling, Nature, 2007).

EU Court Rejects Austrian Biotech Ban

Yesterday, the European Court of Justice confirmed that statutory GMO-free regions are illegal. The Court dismissed the appeals of Upper Austria and the Austrian Government against their ban on the use of biotech crops in the region of Upper Austria.

“This is great news for farmers, for the scientific based risk assessment of the EFSA and for the EU biotech regulatory framework which the Member States put in place. Industry now calls on the region of Upper Austria to drop its illegal and unscientific opposition to approved biotech crops and allow Austrian farmers the choice to grow GMOs if they so wish.” said Johan Vanhemelrijck, Secretary General EuropaBio – the EU association for bioindustries. “Attempts to create so called “GMO-free regions” should be seen for what they are: a denial of the
freedom of choice for farmers and consumers.”

The Judgement says that practices like organic agriculture and small scale farming cannot be used as an argument to ban cultivation of approved biotech crops. Both the Commission and the Commissioner for Agriculture, Mariann Fischer Boel have stated in the past that “farmers should be able to produce in a traditional way, be it conventional or organic, according to the high quality and safety standards in the EU. And they should as well have the choice to produce
GM-crops, if they see advantages in doing so and find a market for them.” (1) Farmers can take official action against their region if it tries to stop them from cultivating EU approved biotech crops, while freedom of choice guarantees that individual or groups of farmers are free to cultivate conventional, organic or biotech crops. Today’s decision confirms that it is illegal for regional or national governments to impose bans and deprive individual farmers of the choice to grow biotech crops which have been approved for commercial cultivation in the EU.

Assesment of Cloned Animal Products

Recent articles (December 2006 and January 2007) in the Washington Post dealt with the U.S. Food and Drug Administration (FDA) assessment that products from cloned animals including meat and milk do not present a risk to food safety. Editorials in the same paper applauded the FDAs reliance on science to come to their conclusions but reminded readers that was not the same as acceptance in the market place.

The FDA made the decision based on its regulatory authorities to perform “a comprehensive risk assessment of the health of animal clones, their progeny, and the food products derived from them”. The approach that FDA used was apparently a cooperative one with the industries that were to be scrutinized for the impact of their products of cloning. The Center for Veterinary Medicine (CVM) of FDA asked that such products be withheld from the food supply. They also asked the National Research Council of the National Academies of Science to characterize “the hazards in animal biotechnology”.

The FDA asserted several principles related to cloned animals that were the underlying basis for their risk assessment: (1) cloning is not a form of genetic engineering; (2) “Animals used for food in the US are inspected without regard to the method by which they are bred”; (3) “The only remaining hazard(s) from cloning are likely to be subtle in nature.”

The presumption by FDA that cloning is not a form of genetic engineering recognizes that it is not an attempt to improve for some purpose the genetic composition of animals. Nonetheless, cloning may be an important part of many current and future approaches to genetic engineering which will be discussed later.

Points 2 and 3 clearly define the scope of the FDA risk assessment and indicate that current food safety procedures and the nature of cloned animals limit science-based concerns about cloning to potential subtle effects of cloning. Based on a voluminous literature review, FDA recognized that the problems most likely associated with cloning would be from the failure of the somatic cells used as nuclear donors in the cloning procedure (SCNT) to completely transform from a pluripotent state to the totipotent state found in germ cells. They acknowledge that the most severe errors in “reprogramming” will result in early death and thus the observed poor efficiency of cloning. This failure to reprogram completely may result in epigenetic variation between clones and the original individual. FDA is concerned that persistent epigenetic differences might result in a “subclinical physiological effect.”

FDA, in their review of the literature and submitted data, found that clones have the same type of health risks as other animals but at a higher frequency. As reported in the literature they recognize that hydroallantois and dystocia are sometimes present in the surrogate dams carrying cloned lambs or calves. They recognized the potential for large offspring syndrome in cows and lambs and some potential for small offspring in pigs. Cattle and sheep neonates were found to need more support for respiration and body temperature control. Reproductive health was found to be normal and they expect the second generation to lose their epigenetic variances. They found that the available literature and submitted data supports the notion that meat and milk from clones was within normal ranges for most compositional analyses. FDA concluded that meat and milk derived from clones is as safe as that “derived from animals produced using contemporary agricultural practices.” They suggest that data on sheep products needs additional data prior to lifting a moratorium on the products from sheep clones.

Source:

Regulation of animal biotechnology: Research needs
Theriogenology, Volume 68, Supplement 1, 1 September 2007, Pages S3-S8
C.E. Rexroad Jr., R.D. Green and R.J. Wall

New light-sensing ability discovered in disease-causing bacteria

The bacteria that cause brucellosis can sense light and use the information to regulate their virulence, according to a study in the August 24 issue of the journal Science. The discovery comes after 120 years of research into the disease, which causes abortions in livestock and fevers in humans. Researchers found that two other bacteria, including a species that attacks plants, sense light using the same type of protein structure, and at least 94 more species possess the code for it in their DNA.

"These bacteria have been very well studied for years, and no one knew they could sense light," said lead author Trevor Swartz, who initiated the study as a research scientist at the University of California, Santa Cruz. "Now it seems like it's a common thing rather than being an anomaly."

The ubiquity of the structure suggests that light may play a much more important role in bacterial life than has previously been recognized. And because the recurrent structure can be paired with a variety of signaling proteins, it gives organisms immense versatility in the ways they use light, Swartz said.

"We have bumped into an entirely new family of light receptors in nature," said coauthor Roberto Bogomolni, professor of chemistry and biochemistry at UCSC.

The receptor molecule contains a light-sensing region known as an LOV domain because it resembles similar units in other proteins that sense light, oxygen, or voltage, said coauthor and longtime collaborator Winslow Briggs, of the Carnegie Institution of Washington. The structure crops up in a variety of proteins, where it lends its light-sensing ability to the whole molecule. The light-sensing structure is very different from either the light-harvesting molecules of photosynthesis or the light-gathering pigments in our own eyes.

Full article here

Cardiocore Acquires Experienced Cardiac Safety Team Formerly with Gentiae

Cardiocore, a premier centralized cardiac safety testing laboratory, announced that it has hired former Gentiae Vice President of Cardiovascular Clinical Services, Polina Voloshko, MD. Cardiocore also acquired key members of Dr. Voloshko’s former staff. This core group includes cardiovascular physicians and technicians as well as project and data managers. Members of the team have worked together for 20 years, originally as part of the esteemed Ischemia Research and Education Foundation.

Dr. Voloshko joins Cardiocore’s scientific consulting team which includes two of the core lab industry’s founding fathers— Chief Medical Officer Lawrence Z. Satin, MD, FACC and Senior Cardiac Safety Consultant, Daniel B. Goodman, MD. With this addition, Cardiocore continues to expand its international scientific leadership, keeping pace with the company’s growing base of pharmaceutical and biotech clients.

Dr. Satin noted, “Cardiocore’s scientific team has overseen roughly a third of all the Thorough QT studies that have been performed to date. By bringing together the thought leadership from three top core labs, we have established a scientific foundation that is uniquely broad. We’ve combined the ‘best of the best’ approaches from across the industry to provide sponsors with unparalleled value.”

“When leading scientists like Polina Voloshko and Daniel Goodman become available in the cardiac testing industry,” added Cardiocore CEO Jennifer Cotteleer, “they are in a position to join any core lab they choose. Therefore, I am proud to see the most prominent experts repeatedly attracted to Cardiocore. They recognize us as the new industry leader, and they’re attracted to the scientific integrity we’ve established.”

“As a recent competitor,” explained Dr. Voloshko, “I can tell you that Cardiocore is setting the standard to which other core labs aspire. This organization delivers the highest quality science and the most thoughtful customer care in the cardiac testing industry. Speaking for myself and my colleagues, we are all delighted to become contributors to this top-quality operation.”

Dr. Voloshko brings 22 years of international experience as a cardiologist and researcher. In her role as Vice President of Medical Operations, she will perform protocol consulting, provide medical leadership and direct the company’s echocardiography services. She will be located in Cardiocore’s San Francisco, California office enabling close collaboration with West Coast life sciences customers.

About Cardiocore Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 14 years. Services include centralized electrocardiographic (ECG) analysis, Holter monitoring, echocardiography, statistical analysis and consulting services such as protocol design. The company is experienced in design and implementation of Thorough QT Trials and cardiac safety and efficacy testing in Phase I, II and III clinical trials. These services are supported by the company’s CardioCorrect® system featuring the proprietary HolterGateway™ and CardioPortal™. Cardiocore’s U.S. headquarters is located in Bethesda, Maryland, its West Coast office is located in San Francisco, California, and its European subsidiary, Cardiocore Limited, is located in London, England.

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Einstein Researchers Use Novel Approach to Uncover Genetic Components of Aging

People who live to 100 or more are known to have just as many—and sometimes even more—harmful gene variants compared with younger people. Now, scientists at the Albert Einstein College of Medicine of Yeshiva University have discovered the secret behind this paradox: favorable “longevity” genes that protect very old people from the bad genes’ harmful effects. The novel method used by the researchers could lead to new drugs to protect against age-related diseases.

“We hypothesized that people living to 100 and beyond must be buffered by genes that interact with disease-causing genes to negate their effects,” says Dr. Aviv Bergman, a professor in the departments of pathology and neuroscience at Einstein and senior author of the study, which appears in the August 31 issue of PLoS Computational Biology.

To test this hypothesis, Dr. Bergman and his colleagues examined individuals enrolled in Einstein’s Longevity Genes Project, initiated in 1998 to investigate longevity genes in a selected population: Ashkenazi (Eastern European) Jews. They are descended from a founder group of just 30,000 or so people. So they are relatively genetically homogenous, which simplifies the challenge of associating traits (in this case, age-related diseases and longevity) with the genes that determine them.

Full story via Fierce Biotech

Biotechnology - Planet's Next Big Opportunity

Asia's influence on the global biotech industry is gathering movement. Asia's foray into biotechnology has generated a huge interest in prospective market players due to the sheer market size that has been unused.

Owing to this government of each Asian country has invested in biotechnology, considered as science of future and they are basically the ones who are driving the biotechnology research. In contrast the role played by Private industry is trivial. This is primarily because biotechnology research requires huge investment in infrastructure as well as the returns is quite low in the early years.

China's foray into biotechnology was with a focus on plant genomics and transgenic technology. It was the Asia's only country, which took part in the human genome project. Similarly,India was among the front-runners in biotech projects and is set to emerge as a strong player in the biopharmaceutical market.

Recent report on "Asia Pacific Biotechnology Market (2007-2010)" by RNCOS' also conveyed similar results, as per which, the biotechnology industry in Asia-Pacific is expected to play a vital role in the global biotechnology market in future. The Asia-Pacific region generated estimated revenues worth US$ 39.16 Billion in 2006.

The report also confirmed the Asian governments efforts in making biotechnology a top priority and agreed that the region is largely dependent on the government with very little private participation in most of the countries.

Likewise the report acknowledged the efforts of China and India (among others) in the field of biotechnology and talked about the China's Beijing Genomics Institute that conducted a number of genome sequencing projects including its well-publicized human genome project. The report also agreed that over US$ 10 Billion worth of biopharmaceuticals were scheduled to go off patent by the end of 2006 andIndia, with its unique pharma and biotech skills, can cash in on this opportunity.

Further, the report also addressed some other interesting issues for today's global business environment such as market trends in the Asia-Pacific Biotechnology industry, the role played by the governments and opportunities that can be leveraged by the industry.

The report provides an extensive research and objective analysis of the biotechnology market in Asia-Pacific and help clients in analyzing the opportunities critical to its growth.

via biotechinbrussels.be

Malacca set to be the next world biotechnology hub

Undertaking this mammoth project at the 113ha site in Malacca is California-based Actis Biologics Inc, a bio-pharmaceutical company which has set up a Malaysian-registered company Actis Biologics Malaysia Sdn Bhd.

Actis co-founder and chairman Sanjeev Saxena said the making of the Bio-City in Malaysia was with the vision to create a competitive, self sufficient Life Sciences industry, create global recognition and ensure investors had good returns.

"Malaysia will also become the hub for the commercialisation of existing research. The biotech hub will also create jobs for thousands of people."

Saxena said his company intends to create Life Science and Life Science-related companies focusing on cardiovascular diseases, anti-cancer, diabetes, respiratory disorders, neurological disorders, regenerative medicines and ophthalmological indications.

The company will also focus on age-related disorders, pain management, new age antibiotics, clinical/molecular diagnostics, process instrumentation and analytical instruments.

Actis Biologics president P.N. Venugopalan said the company would develop therapeutic treatments and would continue its research into vaccines and medications for each of the segments.

Telesto Diagnostics is a medical device company set up by Actis Biologics Malaysia to focus on medical computer-aided diagnosis for breast cancer software.

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Biotechnology Careers in the United States

Author: Biotech Crossing

Biotechnology combines the study of biological sciences with technological advances to find solutions to important societal and scientific issues. Biotechnology is especially useful in research and development related to medicine and pharmaceuticals, agriculture, food production, forensics, wildlife conservation, and biological studies. The field of biotechnology is the ultimate frontier of scientific and technological studies. Biotechnology can aptly be described as a subject that requires a multidisciplinary approach to innovation and development. Those in the industry study the basic elements of matter, such as tissues, cells, and even smaller components of life, to provide solutions to industrial and scientific problems.

Currently, biotechnology is a multidisciplinary domain in the United States. Therefore, diverse educational options exist in the field across the country. There is a growing need to produce skilled graduates who can cater to the career-related demands of the industry. The key aim of biotechnology programs is to ensure core competence in the field of biotechnology. Diverse objectives include preparing researchers, managers, technicians, and other professionals to fuel the surge in the biotechnology industry.

Biotechnology graduates may also elect to pursue higher qualifications in such fields as biophysical science, mechanical engineering, and computing. Educational programs range from certificate and bachelor's degree programs to master's and doctoral degree programs. To cater to the managerial and leadership needs of the biotechnology industry, some universities offer dual degree programs as well. These programs include managerial preparation along with biotechnology training.

Presently, the biotechnology industry offers a variety of career options for biotechnology scientists, agricultural scientists, general practitioners, forensic scientists, laboratory technologists, and veterinarians. More and more career options are opening up in the industry. Biotechnology graduates with some experience can expect to find employment as bioinformaticians, consultants, and industry researchers. Biotechnology graduates with management skills can expect to find employment as biotechnology consultants and biotechnology directors. Although biotechnology has conventionally retained its identity as an academic domain, there is a growing demand for highly educated professionals in biotechnology businesses.

Presently, there are around 1,500 biotechnology companies in the United States. Together, their business totals more than $40 billion. There is a growing need to meet the growing demand for biotechnology professionals and qualified graduates produced by universities in the United States. However, most biotechnology professionals attuned to academic lifestyles are finding the change drastic due to industry expectations with regard to returns on investment. Businesses cannot afford to lose good scientists with sound academic and research credentials. What is required is simply adaptation to the business aspects of biotechnology. Therefore, even if biotechnology scientists do not display entrepreneurial desires, a series of short-term training programs can help fill the gap between academics and business.



Article Source: amazines.com

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Biotechnology and Immortality

Author: Frank Vanderlught

In a very primitive way we are on the road to Immortality.

Within the nucleus of nearly every one of the 100 trillion cells that make up our body is a Computer Program of enormous complexity. This Computer Program is our DNA. We can now for the first time in Man's history read the message this Computer Program produces.

We can read this message by so-called DNA sequencing. What is DNA sequencing? DNA sequencing is the process of determining the exact order of the 3 billion chemical building blocks which make up the DNA of the 24 different human chromosomes. This sequencing revealed the estimated 20,000-25,000 human genes within our DNA as well as the regions controlling them.

What are Genes? Genes are segments of DNA that are the basic functional units of heredity. Genes are determined by an ordered sequence of chemical bases found in a unique position on a specific chromosome. Their "blueprint" guides protein production, which determines how different cells in the body function. Inherited genes also control our unique set of physical traits.

Think of your genes as a blueprint for cell growth and function. Abnormalities in the DNA are like typographical errors. They may provide the wrong set of instructions, leading to faulty cell growth or function.If there is an error in a gene, that same error will appear in all the cells that contain the same gene. This is like having a blueprint in which all the copies have the same typographical error.

So now we have what is basically a blueprint of the Human Body.

What are we going to do with that blueprint? Just because we have the blueprint does not mean we understand it. We are just starting to nibble at the edges. What we would like to do is create personalized health care designed just for us.

Humans have the same DNA sequence except for less than 1% that differs from person to person. The variations in this small percentage are very important because if they do not follow the usual pattern there may be a chance that the body is more or less susceptible to certain diseases.

Our behaviour in most cases can influence to what extent a gene is expressed as a disease. Smoking, drinking, drugs, overeating can all cause a gene or a combination of genes to express as a disease.

There are now tests available using cells collected either from a simple mouth rinse procedure or from a single blood draw that measure selected segments of the genetic code that differ from individual to individual. These are called single nucleotide polymorphisms, or SNPs for short.

So by looking at the exceptions we can now see where we might be at risk in future.

These exceptions are not certainties but possible risk factors which could affect our health if we do not use preventative measures. Historical Medicine treated a person only after he developed the disease.

We now have the ability to not only know to what unique diseases we are at risk, but to know all of them, so we could theoretically protect ourselves against all of them and as healthcare providers become more knowledgeable, better diets, vitamins and exercise programs will be developed that will form the basis of more longevity.

Source: articlesbase

Image: Wikipedia

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What is a Career in Biotechnology Like?

Author: John Daye

Biotechnology is the integration of engineering and technology to the life sciences.

Biotechnologists frequently use microorganisms or biological substances to perform specific processes or for manufacturing. Examples include the production of drugs, hormones, foods and converting waste products.

There are many sub-branches involved in the biotech industry. A few of the more common branches include; molecular biology, genetic engineering, and cell biology.

A new and exciting sub-branch requiring biotechnologists is the field of nanotechnology. Nanotechnology gives us the capability to engineer the tiniest of objects, things at the molecular level. Nano means a billionth of a specific unit in Greek. Nanotechnology includes the study and manipulation of materials between 1 and 100 nanometers.

To give you an idea, DNA is approximately 2.5 nanometers. Red blood cells are 2.5 micrometers (1,000 times larger). And a sheet of paper is about 100,000 nanometers thick! As you can imagine, it is very difficult to scale and mass produce objects within the realm of nanotechnology. Their minute size makes them nearly impossible to manipulate. But scientists and engineers have teamed up to make the seemingly impossible a reality.

Which means those with the proper training will be highly sought after in the future. The National Science Foundation estimates that the U.S. alone will need up to 1 million nanotechnology researchers. It is estimated that the need for nanotechnology workers will reach 2 million by 2015.

Therefore, if you're considering getting into the field of biotech, you may want to gear your background in nanotechnology if your school offers it or seek employment in this exciting new career field after graduating.

No matter what sub-branch you wind up specializing in, biotechnologists often collaborate with others in the laboratory and bounce ideas off one another. This can create a pleasant work environment; one that involves sharing with others and working together to achieve a great goal.

Article Source:
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Biotechnology Careers

Author: Andrew Green

Taking up a job in biotechnology means involving oneself in the development of new products and processes for the good of mankind and quality of life. Before one seriously considers a career in biotechnology, it is imperative to have extensive knowledge in biology, chemistry, and other life sciences.

Biotechnology also has a deep impact on other areas such as human health careers which involves detecting and treating hereditary diseases, cancer, heart disease, AIDS, etc; in Veterinary Medicine, Animal Science, and Livestock Production; and in Agriculture and Plant Science.

A biotechnology company has a number of divisions, each performing different tasks and functions.

• Career in Research and Development: Like any other company, a biotechnology company also needs a qualified team of researchers to represent its future. While some researches may focus on a specific application, some may be carried out for acquiring new knowledge which may not need immediate application. Researchers may also work in academic environments such as universities or within the premises of the company setup. The most important thing is that research and product development form the foundation and basis of any biotechnological setup.


• Career in Production and quality control: People who have extensive knowledge of engineering or industrial-manufacturing technology are required by biotechnological firms in production and manufacturing. In order to make sure the finished products meet specifications, a group or team of quality assurance look after the production process, research and development. This group of experts belongs to the quality control division.


• Career in Management: Biotechnology companies need managers who can supervise the working of the company such as Research and Development, Production, and Quality Control. These people are often Ph.D. level scientists who have worked their way up through special achievements or accomplishments. They may also have business training and experience sometimes.


• Career in Sales and Marketing: Market researchers analyze, assess and estimate the need for a specific product and it would sell. They advertise and promote, and try to find new markets for products already being sold. Salespersons deal directly with consumers by selling, getting feedbacks etc, and are the most visible representatives of the biotechnology company.


• Career in Regulatory Affairs Since all biotechnology companies, especially agricultural and pharmaceutical, are regulated by federal and state agencies such as FDA, EPA, and USDA regarding the safety, ethics etc of manufacturing and products, they need a team of experts and specialists to make sure the company follows all regulations laid down by these agencies.


• Career in Legal Affairs: Any invention or discovery is not safe from copyright infringement without the proper patent. Since biotechnology companies and firms are continually engaged in the search for newer and better products, they need people specializing in law to prepare patent application, or keep track of patent laws.


• Career in Public Relations, Communications, and Training: Biotechnology companies must be able to relay information to the public or other agencies in a language they will understand because biotechnology involves the use of technical terms much of the time. They must also be able to convince others on the credibility and usefulness of their products. As the company grows bigger, the scope of its recruitment also grows along with it. This would imply the need for more training and staff development, and hence more trainers.

Source: articlesbase.com

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