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Public comment invited on application of new animal drug provisions of the Federal Food Drug and Cosmetic Act The U.S. Food and Drug Administration, part of the Department of Health and Human Services, released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals. The 25-page document is available online at http://www.fda.gov/cvm/GEAnimals.htm. The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18, 2008. "Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation," said Randall Lutter, Ph.D., deputy commissioner for policy. "Our guidance provides a framework for both GE animals and products made from them to reach the market." Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it's called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits. GE animals can be divided into several classes, based on their intended use. They include animals that produce human or animal pharmaceuticals (biopharm animals); animals that serve as models for human diseases; animals that produce high-value industrial or consumer products, such as fibers; and food-use animals with new traits such as improved nutrition, faster growth or lower emission levels of environmentally harmful substances (such as phosphate in their manure). Genetic engineering already is widely used in agriculture to make crops resistant to pests or herbicides. In medicine, genetic engineering is used to develop microbes that produce drugs and other therapeutic products for use in humans. In food, genetic engineering is used to produce microorganisms that aid in baking, brewing, and cheese-making. Using the animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA's Center for Veterinary Medicine (CVM) has been working with developers of GE animals to make them aware of their responsibilities to ensure that food from these animals does not enter the The FD&C Act classifies "articles (other than food) intended to affect the structure or any function of the body of man or other animals" as drugs. An rDNA construct that is in a GE animal and intended to affect the animal's structure or function meets the definition of a new animal drug, whether the animal is intended for food, or used to produce another substance. Developers of these animals must demonstrate that the construct and/or any new products expressed from the inserted construct are safe for the health of the GE animal. Under the draft guidance, in those cases in which the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. The FDA will review this information as part of its food safety assessment, consistent with that recommended in the recently adopted Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals. Codex is a worldwide food safety organization sponsored by the United Nations. The draft guidance also describes a sponsor's responsibility in meeting the requirements for environmental assessment under the National Environmental Policy Act. Depending on the species of animal and its intended use, the FDA will coordinate with agencies in the U.S. Department of Agriculture (USDA) and with other federal departments and agencies, such as the Environmental Protection Agency, in regulating GE animals. The draft guidance indicates the areas in which the FDA will be working with those agencies to develop a coherent policy under the Coordinated Framework for the Regulation of Biotechnology. USDA has published in the same issue of the Federal Register a "Request for Information" that seeks input on what types of actions and approaches it should consider under the Animal Health Protection Act (AHPA) that would complement FDA's guidance. The AHPA gives the Secretary of Agriculture authority to take specific actions to prevent the spread of diseases and pests of livestock. "This is a cutting-edge technology that has significant implications, including real benefits, not just for human health, but also for animal health, such as developing disease-resistant animals," said CVM Director Bernadette Dunham, D.V.M., Ph.D. "We look forward to the public comments to help refine our thinking and approach." The draft guidance describes how the FDA may exercise enforcement discretion, that is, not require premarket approval, for some GE animals depending on potential risk, as we did after reviewing information about Zebra danio, aquarium fish genetically engineered to glow in the dark. For example, the draft guidance states the FDA's intent to exercise enforcement discretion for laboratory animals used for research and kept in confined conditions. The agency does not expect to exercise enforcement discretion for animal species traditionally consumed as food and expects to require approval of all GE animals intended to go into the human food supply. The draft guidance describes how the FDA regulates heritable rDNA constructs, that is, constructs inherited from one generation to the next. Non-heritable constructs, such as those used for gene therapy to treat individual animals, may be the subject of a subsequent guidance. For more information, see http://www.fda.gov/cvm/GEAnimals.htm. Source: FDA Press Release |
DNA Barcodes: Standardized Genetic Tags --How accurate are they? Study questions reliability of some results-- August 25, 2008-DNA barcoding is a movement to catalog all life on earth by a simple standardized genetic tag, similar to stores labeling products with unique barcodes. The effort promises foolproof food inspection, improved border security and better defenses against disease-causing insects, among many other applications. But the approach as currently practiced churns out some results as inaccurately as a supermarket checker scanning an apple and ringing it up as an orange, according to a new Brigham Young University (BYU) study. The results are published online this week in the journal Proceedings of the National Academy of Sciences (PNAS). The researchers recommend specific quality control procedures to ensure that correct genes are captured. "It's important to test any scientific tool because all have limits--some situations are more suited than others for barcode use," said Rick McCourt, program director in the National Science Foundation (NSF)'s Division of Environmental Biology, which funded the work. "This research could help clarify the answer to that question." Organisms can be identified no matter what stage of life they are in. For example, larvae of malaria-carrying mosquitoes contain the same DNA as the adult version of the insect targeted for eradication. The portion of the gene selected as the universal marker by the barcoding movement is part of the genome found in an organism's mitochondria. But the BYU study showed the current techniques can mistakenly record instead the "broken" copy of the gene found in the nucleus of the organism's cells. This non-functional copy can be similar enough for the barcoding technique to capture, but different enough to call it a unique species, which would be a mistake. With the International Barcode of Life project seeking to build on the 400,000 species that have been "barcoded" to date, this goal warrants more careful execution, the BYU team says. "To have that kind of data is hugely valuable, and the list of applications is endless and spans all of biology," said PNAS paper co-author Keith Crandall, a biologist at BYU. "But it all hinges on building an accurate database. Our study is a cautionary tale--if we're going to do it, let's do it right." Proponents of DNA barcoding seek to establish a short genetic sequence as a way of identifying species in addition to traditional approaches based on external physical features. Their aim is to create a giant library full of these sequences. Scientists foresee a future handheld device like a supermarket scanner--a machine that would sequence a DNA marker from an organism, then compare it with the known encyclopedia of life and spit out the species' name. This new approach requires only part of a sample. A feather left behind by a bird struck by an airliner, for example, would be enough to indicate its species and clue officials how to prevent future collisions. "Building a genetic library of all life is a great goal," said Song, "but we need to pay careful attention to the data that go into that library to make sure they are accurate." "Scientists have been so preoccupied with creating a barcode of life, that they have not been careful in monitoring the accuracy of the underlying data," BYU scientist Michael Whiting said. -NSF- The National Science Foundation (NSF) is an independent federal agency that supports fundamental research and education across all fields of science and engineering, with an annual budget of $6.06 billion. NSF funds reach all 50 states through grants to over 1,900 universities and institutions. Each year, NSF receives about 45,000 competitive requests for funding, and makes over 11,500 new funding awards. NSF also awards over $400 million in professional and service contracts yearly. Useful NSF Web Sites: NSF Home Page: http://www.nsf.gov NSF News: http://www.nsf.gov/news/ |
Cranberry Juice Creates Energy Barrier that Prevents Bacteria from Adhering to Cells, and Prevents Urinary Tract Infections--Cranberries may prevent urinary tract infections by changing the thermodynamic properties of bacteria, creating an energy barrier that keeps them away from cells in the urinary tract—
The study, published in the journal Colloids and Surfaces: B, was conducted by Terri Camesano, associate professor of chemical engineering at WPI, and a team of graduate students, including PhD candidate Yatao Liu. They exposed two varieties of E. coli bacteria, one with hair-like projections known as fimbriae and one without, to different concentrations of cranberry juice. Fimbriae are present on a number of virulent bacteria, including those that cause urinary tract infections, and are believed to be used by bacteria to form strong bonds with cells. For the fimbriaed bacteria, they found that even at low concentrations, cranberry juice altered two properties that serve as indicators of the ability of bacteria to attach to cells. The first factor is called Gibbs free energy of attachment, which is a measure of the amount of energy that must be expended before a bacterium can attach to a cell. Without cranberry juice, this value was a negative number, indicating that energy would be released and attachment was highly likely. With cranberry juice the number was positive and it grew steadily as the concentration of juice increased, making attachment to urinary tract cells increasingly unlikely. Surface free energy also rose, suggesting that the presence of cranberry juice creates an energy barrier that repels the bacteria. The researchers also placed the bacteria and urinary tract cells together in solution. Without cranberry juice, the fimbriaed bacteria attached readily to the cells. As increasing concentrations of cranberry juice were added to the solution, fewer and fewer attachments were observed. Cranberry juice had no discernible effect on E. coli bacteria without fimbriae, suggesting that compounds in the juice may act directly on the molecular structure of the fimbriae themselves. This reinforces previous work by the WPI team that showed that exposure to cranberry juice alters the shape of the fimbriae, causing them to become compressed. Using an atomic force microscope as a minute strain gauge, the team also showed that the adhesive force exerted by bacteria on urinary tract cells declined in direct proportion to the concentration of cranberry juice in the solution. "Our results show that, at least for urinary tract infections, cranberry juice targets the right bacteria—those that cause disease—but has no effect on non-pathogenic organisms, suggesting that cranberry juice will not disrupt bacteria that are part of the normal flora in the gut," Camesano says. "We have also shown that this effect occurs at concentrations of cranberry juice that are comparable to levels we would expect to find in the urinary tract." Camesano notes that unpublished work has shown that while cranberry juice has potent effects on disease-causing bacteria, those effects are transitory. "When we take E. coli. bacteria that have been treated with cranberry juice and place them in normal growth media, they regain the ability to adhere to urinary tract cells," she says. "This suggests that to realize the antibacterial benefits of cranberry, one must consume cranberry juice regularly—perhaps daily." For those watching calories, Camesano says other recent work in her lab has shown that the effects of regular cranberry juice cocktail and diet (sugar-free) cranberry juice are identical. "That's good news for people who do not like to consume a lot of sugary juice," she says. About Worcester Polytechnic Institute Founded in 1865 in |
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A Low Dose of Dietary Resveratrol Partially Mimics Caloric Restriction and Retards Aging Parameters in Mice Citation: Barger JL, Kayo T, Vann JM, Arias EB, Wang J, et al. (2008) A Low Dose of Dietary Resveratrol Partially Mimics Caloric Restriction and Retards Aging Parameters in Mice. PLoS ONE 3(6): e2264. doi:10.1371/journal.pone.0002264 Abstract Resveratrol in high doses has been shown to extend lifespan in some studies in invertebrates and to prevent early mortality in mice fed a high-fat diet. We fed mice from middle age (14-months) to old age (30-months) either a control diet, a low dose of resveratrol (4.9 mg kg−1 day−1), or a calorie restricted (CR) diet and examined genome-wide transcriptional profiles. We report a striking transcriptional overlap of CR and resveratrol in heart, skeletal muscle and brain. Both dietary interventions inhibit gene expression profiles associated with cardiac and skeletal muscle aging, and prevent age-related cardiac dysfunction. Dietary resveratrol also mimics the effects of CR in insulin mediated glucose uptake in muscle. Gene expression profiling suggests that both CR and resveratrol may retard some aspects of aging through alterations in chromatin structure and transcription. Resveratrol, at doses that can be readily achieved in humans, fulfills the definition of a dietary compound that mimics some aspects of CR. Read the full-length article at: http://www.plosone.org/article/fetchArticle.action?articleURI=info:doi/10.1371/journal.pone.0002264 Published: June 4, 2008 Copyright: © 2008 Barger et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
Bacteria "Feed" on Earth's Ocean-Bottom Crust --Rocks on and under seafloor offer feast for microbes-- Seafloor bacteria on ocean-bottom rocks are more abundant and diverse than previously thought, appearing to "feed" on the planet's oceanic crust, according to results of a study reported in this week's issue of the journal Nature. The findings pose intriguing questions about ocean chemistry and the co-evolution of Earth and life. Once considered a barren plain dotted with hydrothermal vents, the seafloor's rocky regions appear to be teeming with microbial life, say scientists from the Woods Hole Oceanographic Institution (WHOI) in Woods Hole, While seafloor microbes have been detected before, this is the first time they have been quantified. Using genetic analyses, Cara Santelli of WHOI, Katrina Edwards of USC, and colleagues found three to four times more bacteria living on exposed rock than in the waters above. Surprised by this diversity, the scientists tested more than one site and arrived at consistent results, making it likely, according to Santelli and Edwards, that rich microbial life extends across the ocean floor. "This may represent the largest surface area on Earth for microbes to colonize," said Edwards. "These scientists used modern molecular methods to quantify the microbial biomass and estimate the diversity of microbes in deep-sea environments," said David Garrison, director of the National Science Foundation (NSF)'s Biological Oceanography Program. NSF's Ridge 2000 program funded the research. "We now know that this remote region is teeming with microbes, more so than anyone had guessed." Santelli and Edwards also found that the higher microbial diversity on ocean-bottom rocks compared favorably with other life-rich places in the oceans, such as hydrothermal vents. These findings raise the question of where these bacteria find their energy, Santelli said. "We scratched our heads about what was supporting this high level of growth," Edwards said. With evidence that the oceanic crust supports more bacteria than overlying water, the scientists hypothesized that reactions with the rocks themselves might offer fuel for life. In the lab, they calculated how much biomass could be supported by chemical reactions with the rocky basalt. They then compared this figure to the actual biomass measured. "It was completely consistent," Edwards said. This discovery lends support to the idea that bacteria survive on energy from Earth's crust, a process that could add to our knowledge about the deep-sea carbon cycle and the evolution of life. Many scientists believe that shallow water, not deep water, is better suited for cradling the planet's first life forms. Up until now, dark, carbon-poor ocean depths appeared to offer little energy, and rich environments like hydrothermal vents were thought to be relatively sparse. But the newfound abundance of seafloor microbes makes it possible that early life thrived--and perhaps began--on the seafloor. "If we can really nail down what's going on, there are significant implications," Edwards said. "I hope that people turn their heads and notice: there's life down there." In addition to Santelli and Edwards, the paper's co-authors are: Beth Orcutt of USC; Erin Banning of WHOI; Wolfgang Bach of WHOI and Universität Bremen; Craig Moyer of Western Washington University; Mitchell Sogin of the Marine Biological Laboratory; and Hubert Staudigel of the Scripps Institution of Oceanography. The research was also funded by the NASA Astrobiology Institute and Source: Credit NSF Press Release http://www.nsf.gov |
NEUBLASTIN VIRTUALLY RESTORES COMPLETE LONG-TERM SENSORY MOTOR FUNCTION IN PRECLINICAL STUDIES--Findings by Biogen Idec, Cambridge, MA -- March 24, 2008 -- Biogen Idec, in collaboration with scientists at the University of Arizona and Tufts University reported in the April issue of the journal Nature Neuroscience that in preclinical studies, injections of the protein neublastin (also known as artemin) promoted the regeneration of damaged sensory nerve cells and produced virtually complete, long-term restoration of sensory and motor function. These studies suggest neublastin has potential for further development as a treatment for traumatic nerve injury. Neublastin, also known as artemin, belongs to a family of proteins, called glial-derived neurotrophic factors (GDNF), which promote nerve cell survival. The protein is unique because it acts selectively on sensory neurons. In previous preclinical studies, neublastin reversed a number of features of chronic pain associated with peripheral nerve injury. Specifically in the studies, six neublastin injections were administered over 11 days following injury to the dorsal root, a bundle of peripheral nerve fibers adjacent to the spinal cord that transmit sensory information to the central nervous system. The injections promoted nerve growth into the spinal cord and restored the ability to respond normally to a variety of sensory stimuli and perform complex motor activities such as grasping an object on contact. The functional recovery occurred even after a two-day delay in administering neublastin and lasted for more than six months. "Sensory nerves entering the spinal cord have minimal capacity to regenerate and severe injury often results in permanent loss of sensory functions," said Frank Porreca, PhD, Professor of Pharmacology at the In a series of biochemical, molecular and electrophysiology studies, the researchers also demonstrated that neublastin promoted the regeneration of multiple classes of nerve cells back into the spinal cord and the re-establishment of functional connections with their spinal targets. "These exciting results support further research, as the data suggest that neublastin may have the potential to promote sensory neuronal regeneration and functional recovery following injury," said Ken Rhodes, PhD, Vice President, Discovery Neurobiology, Biogen Idec. "The neublastin program is part of Biogen Idec's commitment to innovative neurological science and discovery." Biogen Idec is developing neublastin for use in treating peripheral nervous system diseases under an exclusive license from NsGene. Scientists at NsGene discovered neublastin in 1998. About Biogen Idec Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Source: Biogen Idec Press Release
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X-treme Microbes They’re called extremophiles and they live in hellish places once thought uninhabitable. Now, they’re revealing their secrets to science … Credit: National Science Foundation Report View Special Flash Report at: http://www.nsf.gov/news/special_reports/microbes/index.jsp RADIATION EATERS AMAZING SURVIVORS Radiation Eaters Overview But in the 1960s, scientists began discovering exotic organisms that play by astonishingly different rules, such as microbes living in near-boiling water or high-acidity environments. Now, a team searching deep in a South African gold mine has found one that redefines the very limits of life: Bacteria that subsist in rock at huge pressure for thousands of years by ’eating‘ by-products of radioactivity, completely isolated from any organic matter or effects of photosynthesis. Tullis Onstott of Princeton University, Lisa Pratt of Indiana University and colleagues think the microbes may have first trickled down there between three and 25 million years ago. The microbes were forced to survive on the leftovers that result when radioactivity from uranium, thorium and potassium in the native rock breaks down molecules of water, prompting a sequence of chemical reactions that produce hydrogen peroxide, break down pyrite, and form sulfates. They developed a way of taking metabolic advantage of these reactions that is very different from the processes used by their conventional topside cousins. These rock-dwellers may be some of above-ground life’s oldest relatives. Pratt and Onstott suspect that they’re probably not much different now than when they were separated from the surface, because they grow very slowly to conserve scarce nutrients. In fact, ’very slowly‘ is an understatement: Whereas E. coli, like those found in the intestines of mammals, divide every day or so, the subsurface microbes reproduce once a year at most, and possibly only every 300 years … or more! So far, researchers haven’t been able to grow them in the lab under the microbes’ natural conditions. But they are working on genomic sequencing to evaluate how closely related the newly discovered bacteria are to other extremophiles and surface organisms. In the future, those studies may change the way instruments look for life on Mars. And they may even begin to answer the question: Did life on Earth begin underground? ---- Amazing Survivors Overview They’re at home in some of the most forbidding pockets of the planet, where scientists are studying their survival mechanisms—and probing the outermost boundaries of life. Life can’t exist without any water. But research is showing how shockingly little is necessary. Even in the planet’s driest places—such as the Atacama high desert in Other organisms found in Atacama and elsewhere can enter a seemingly lifeless, freeze-dried state, reviving only if and when some water appears. In the ultra-arid That’s just one of many creatures specially adapted to extremely frigid venues. Researchers uncovered microbes in an ice core extracted from just above Laboratory studies have shown that many cold-surviving life-forms (collectively known as psychrophiles) have remarkable cellular ingredients that prevent the formation of ice crystals. Others have evolved a talent for huddling together into mats called biofilms. Many can’t live at all above 50 F. It’s just too hot. Miles below the ocean surface on the lightless seafloor, giant cracks in the Earth’s crust create sites where mineral-dense water—heated to 600 F—spews forth in roiling clouds. It’s as forbidding an environment as one could imagine. Yet scientists have found hosts of organisms that have learned to thrive there. In those circumstances, of course, photosynthesis simply isn’t possible. But certain kinds of single-celled archaea have developed a unique alternative called chemosynthesis: a means of converting inorganic hydrogen sulfide dissolved from rocks into food. Archaea living on or under the seafloor make up vast microbial mats and other configurations that provide the foundation for a bizarre and abundant community of towering tube worms, gigantic clams and mussels, and strange fish and crabs that can withstand the titanic pressure and utter dark. When it comes to acidity versus alkalinity, most mammals are wimps. On the pH scale, 7 is neutral. The lower the number, the more acidic; the higher, the more alkaline. Human blood has to stay between 6.8 and 7.8 to support life. But nature is replete with creatures that thrive on the extreme ends of the pH scale. In On the double-digit side of the scale, soda lakes in Lab studies of both acidophiles and alkalophiles continue to show the remarkable—and often unexpected—range of conditions to which life can adapt. |
Results from Study of Brain Electrical Activity Using Cyberkinetics' NeuroPort(TM) System at the American Epilepsy Society Meeting --Neural monitoring technology shown to identify micro-seizure activity that precedes significant epileptic seizures-- --Advanced brain activity monitoring could help to improve treatment of epilepsy and other neurological disorders- FOXBOROUGH, Mass---Researchers from Cyberkinetics Inc. were successfully able to record and monitor brain electrical activity with improved precision and detect micro-seizure activity in advance of larger epileptic seizures among patients implanted with the NeuroPort(TM) Neural Monitoring System (NeuroPort(TM) System) developed by Cyberkinetics Neurotechnology Systems, Inc. Results from an ongoing study at Columbia University Medical Center were presented on Saturday, December 1, 2007, at the 61st Annual Meeting of the American Epilepsy Society in Philadelphia, Pennsylvania. Led by Ronald G. Emerson, M.D., and Catherine Schevon, M.D., Ph.D., the research team reported results from patients who had the NeuroPort(TM) sensor implanted, along with standard intracranial electroencephalography sensors. Using the NeuroPort(TM) System, researchers were able to: -- successfully record and monitor brain electrical activity with higher fidelity than is possible with other recording technologies; -- detect micro-seizures and micro-discharges in patients with epilepsy that may play a role in the genesis of their seizures, but that are not detectible by scalp or standard electrodes placed directly on the brain; and -- correlate this micro-activity to the onset of significant epileptic seizure activity. "With this sensor, we were able for the first time to observe micro-seizure activity in the brain that appears to precede epileptic seizures in some patients," stated Ronald G. Emerson, M.D., a lead investigator on the study and professor of clinical neurology in the Columbia Comprehensive Epilepsy Center at Columbia University College of Physicians & Surgeons and a member of the hospital staff at the New York-Presbyterian Hospital. "The ability to monitor brain activity with this level of precision could help us to identify the onset and progression of seizures in the years ahead. It may also help us more accurately identify brain tissue to be removed during surgical treatment of epilepsy." Up to three percent of people in the "From a small sample area of the brain, this new monitoring system provides us with high quality information about the genesis and evolution of seizure activity," added Catherine Schevon, M.D., Ph.D., co-lead investigator and assistant professor of clinical neurology in the Columbia Comprehensive Epilepsy Center at Columbia University College of Physicians & Surgeons and a member of the hospital staff at the NewYork-Presbyterian Hospital. "These results expand our understanding of brain seizure activity and we hope it will someday enable us to develop more effective ways to detect and treat seizure disorders." Cyberkinetics' NeuroPort(TM) System is a medical device indicated for the temporary (less than 30 days) recording and monitoring of brain electrical activity. It consists of a 4 x 4 mm, 100-microelectrode array and a signal processor. The array is implanted on the surface of the brain where the electrodes sense electrical activity from individual and groups of neurons. Cleared to market in the "The medical, productivity and personal costs associated with the treatment of epilepsy represent a significant burden to the healthcare system and to society," added Timothy R. Surgenor, President and Chief Executive Officer of Cyberkinetics. "We believe that our NeuroPort(TM) technology could one day enable physicians to better locate seizure activity and treat epilepsy to help more patients adequately control this condition." In March 2006, Cyberkinetics and About Cyberkinetics Neurotechnology Systems, Inc. Cyberkinetics Neurotechnology Systems, Inc., a leader in the neurotechnology industry, is developing neural stimulation, sensing and processing technology to improve the lives of those with severe paralysis resulting from spinal cord injuries, neurological disorders and other conditions of the nervous system. Cyberkinetics' product development pipeline includes: the Andara(TM) Oscillating Field Stimulator (OFS(TM)) Device, an investigative device designed to stimulate regeneration of the neural tissue surrounding the spinal cord and to restore sensation and motor function; the BrainGate System, an investigative device designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement; and the NeuroPort(TM) System, which is cleared to market in the United States, a neural monitor designed for acute inpatient applications and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity. Additional Information is available at Cyberkinetics' website at www.cyberkinetics.com . |
MEDICINEANDBIOTECH.COM LISTS PIVOTAL BIOTECH AND MEDICAL TECHNOLOGIES OF THE FUTUREe-published on MedicineandBiotech.com Jan 1st, 2007
1. Biochips for Improved Drug, DNA and Chemical testing - A better, cheaper alternative to animal testing in drug development- Biochips or MetaChips or DataChips are glass slides with nanoliter droplets of proteins or human enzymes or cells. For example a biochip with human liver enzymes can determine the toxicity results of a drug when exposed to human liver enzymes. A DataChip is similar but contains cell culture droplets from various human organs like liver, kidney, etc. and can examine the toxic effect of a compound on these cells. MetaChip and DataChip are now a reality because scientists are able to isolate and generate p450 liver enzymes as well as make three-dimensional cell cultures in droplets.
These Biochips can enable much cheaper pharmacological and toxicity studies of drug compounds of interest without the use of animals, plus these studies can be initiated much earlier in the R&D phase. Demand for biochip technology will definitely increase soon in response to a European Union ban on testing on animals set to take effect in March 2009.
2. Neurotechnologies Technologies aimed at improving damaged nervous systems and neural functions will be key in the future. Neurotechnologies for neural stimulation, sensing and processing technology to improve the lives of those with severe paralysis resulting from spinal cord injuries, neurological disorders and other conditions of the nervous system will be in demand. An example is Cyberkinetics' product development pipeline that includes: Andara(TM) OFS(TM) Therapy for acute spinal cord injury, an investigative device designed to stimulate nerve repair and restore sensation and motor function; the BrainGate System, an investigative device designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement; and a pilot program in the detection and prediction of seizures due to epilepsy.
The Andara(TM) OFS(TM) System is intended as a treatment option for people with acute spinal cord injuries. The device is designed to be implanted in patients within 18 days following a spinal cord injury to stimulate nerves to grow across the area of injury. Though the device is removed after 15 weeks of treatment, improvement in both sensory and motor function may continue for months, even years, as nerves form new connections to transmit information to and from the brain.
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3. i-Snake -The future of surgery is in smart devices like i-Snake.
Experts are developing a flexible surgical robot, known as the i-Snake, which they say could revolutionize keyhole surgery. It could enable surgeons to do complex procedures previously possible only through more invasive techniques. A team at Imperial College London has been granted £2.1 million for the work. They envisage using the i-Snake - a long tube housing special motors, sensors and imaging tools - for heart bypass surgery. But it could also be used to diagnose problems in the gut and bowel by acting as the surgeon's hands and eyes in hard to reach places inside the body. The KEYHOLE SURGERY MILESTONES 1900s - Mirrors, lights and lenses attached to endoscopic tubes are used to examine bodies' interiors 1930s - Fibre-optics offer an essential light source; endoscopes now thinner and more flexible 1970s - Cameras attached to endoscopes mean that surgeons can operate from images on a screen. Lasers developed which can perform surgery Minimally invasive surgery has obvious advantages - it can mean smaller scars, reduced hospital stays and shorter recovery times. Surgeons are also looking at ways to avoid skin incisions altogether. One approach is Natural Orifice Translumenal Endoscopic Surgery or Notes. This means operating in the peritoneal space through natural orifices or cavities, such as the bowel. The unrivalled imaging and sensing capabilities coupled with the accessibility and sensitivity of i-Snake will enable more complex diagnostic and therapeutic procedures than are currently possible. The cost benefits that i-Snake will introduce include earlier, cheaper and less invasive treatment, faster recovery and procedure times and intangible benefits through an increase in patient care and quality of life. 4. Molecular Methods for Early Diagnosis of Cancer in Circulating Blood, Serum or Cells Researchers have now discovered molecular signposts pointing to the presence of cancer, and those signs can provide physicians with early and, in some cases, more specific cancer detection opportunities. The goal of screening and early detection is to identify primary tumors at initial stages of development when they can be successfully controlled or cured with local therapy. Most cancer deaths are caused by metastatic disease, later stage tumors that spread to other sites in the patient. Clinical monitoring of molecular markers of primary tumors and metastasis allows for early response strategies in the treatment to control or cure the disease. LCDetect is a serum test for lung cancer screening. It works by measuring the serum levels of Human Aspartyl (Asparaginyl) β-Hydroxylase (HAAH). LC Detectsm is recommended for men and women, 50 years of age or older, who have smoked cigarettes extensively in the past, regardless of whether they currently smoke. HAAH levels in the serum of individuals with lung cancer are three-fold higher when compared to individuals who are cancer-free. LC Detectsm provides useful information about the likelihood of lung cancer in those at highest risk for the disease, such as current or former smokers. * Another Example is FDA approved CellSearch™ - advanced test for monitoring metastatic colorectal cancer. The CellSearch™ System by Veridex LLC, a Johnson & Johnson company, identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic colorectal or breast cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch™ System, in conjunction with other clinical methods for monitoring, can help physicians assess disease progression, thereby guiding more informed care decisions earlier. 5. Stem Cell Technologies The technology centers on human stem cells. These are the "master" cells which have the potential to become any of the body's many different types of tissue. Scientists believe that if they can grow these cells in the laboratory and then control the way they develop, they are able to grow any type of tissue needed for transplant. New ways of growing human embryonic stem cells in the laboratory without animal protein contaminations will reduce the risk that their use in therapy could go wrong. It is essential that stem cells are cultured in a safe way to avoid immune reactions in transplantation, and to prevent genetic changes during long-term culture. Stem cells have remarkable potential to treat a range of diseases, including cardiovascular conditions, spinal cord injuries, Parkinson's and diabetes. Transplantation experiments in animal models have shown remarkable therapeutic effects for various chronic diseases, including spinal cord injuries. Share your Favorite articles on the following Social Networks: Share on Facebook 
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Advancing Personalized Medicine- FDA’s Perspective and Role Credit: FDA Consumer Health Information e-published on MedicineandBiotech.com October 1st, 2007
Each person has a unique set of chemical blueprints that determine how his or her body looks and functions. These blueprints are contained in their own DNA which is made up of two twisting sequences or single strands that are able to be paired with another. Here we discuss the following important topics of interest: * What is Personalized Medicine? * How Does Personalized Medicine Work? * What's Involved? * What are the Benefits of Personalized Medicine? * What are the Challenges? * FDA's Role Medications have been prescribed over the years mostly by trial-and-error to reach the best dose for each patient. Typically, doctors diagnosed a condition and then selected what they believed was the most promising drug for treatment. If one didn't work, they'd try another. Today, as science gives way to the understanding that people and diseases differ at the genetic or molecular level, doctors are learning to tailor treatments—or personalize them—to individuals more effectively. By using "genomics," or the identification of genes and how they relate to drug treatment, doctors will be able to treat patients based on the actual biology of a disease and not just according to symptoms, and as an individual, not just a member of a population. The Food and Drug Administration is especially interested in clearing the pathway for the development of safe and effective, leading-edge products that this burgeoning field of genomics is spawning—multiple tools, technologies, and sciences that will translate into the discovery and safety of drugs and medical products that the agency regulates. By ensuring that new products and technologies are developed and made available to doctors and patients as effectively as possible, FDA believes this can only enhance the health of all Americans. What is Personalized Medicine? Personalized medicine uses information about a person's genetic makeup to tailor products that will detect, treat, or prevent disease in that person. The goal is to get the best medical outcomes by choosing treatments that work well with a person's genetic profile, or with certain characteristics in the person's blood or cells. Scientifically, personalized medicine is known as pharmacogenomics (drugs combined with genes), or how genetic differences in individuals affect the way people respond to drugs. The science of pharmacogenomics tries to answer questions like: Why do some people get cancer and others don't? Why is cancer more aggressive in this person and not in that one? Why does this drug work for him and not for her? Why do some people show toxicity to a drug while others don't? Why does someone need twice the standard dose to be effective? And why do others need only half of the standard dose? How Does Personalized Medicine Work? Someone diagnosed with colon cancer today would receive a treatment based on standard medication and dosing guidelines for that disease. The doctor might factor in weight, age, medical history, and how any blood relatives might have reacted to a certain medication. But the doctor cannot know how that person will respond to the medication, which may help the cancer or have no affect at all. The person could experience terrible side effects or none at all. And, it may be necessary for several revisits to the doctor for adjusting the dosage or to switch medications. This is considered the trial-and-error approach to medicine. With personalized medicine, people may be able to take a genetic test that can help determine which diseases they are likely to develop, and a blood test to help determine which genetic variations they may have—even before they've taken a single dose of medicine. Based on test results, the doctor could tailor a patient's treatment by avoiding using a certain drug, prescribing another, or altering a dose to match the body's genetics. A person's unique genetic profile can help a doctor personalize treatments. What's Involved? New technologies and tools have been developed as a direct result of the nation's effort to understand DNA—deoxyribonucleic acid—the blueprint that determines how each person’s body looks and functions. Those technologies and what they intend to accomplish within personalized medicine include: Functional genomics—measures gene expression under normal and troubled conditions and attempts to predict the gene expression profiles for these conditions. Structural genomics—addresses questions concerning individual genetic differences and the impact that these genetic differences have on the development of disease. Proteomics—seeks to discover all proteins in a living organism, and determine their function and how they affect each other. Metabolomics—studies all the molecules involved in metabolism (metabolites) in a living organism by evaluating tissues and body fluids, such as urine, blood, plasma, and saliva for changes. Genomics and Medical Devices—understands how certain diseases, or increased risks pass from generation to generation. Nanotechnology—uses materials or devices at the level of molecules and atoms too small to be seen with a conventional laboratory microscope. What are the Benefits of Personalized Medicine? * Diagnosing disease or predicting risk of disease. * Determining whether a treatment is working or not. * Monitoring healthy people to detect early signs of disease. * Producing safer drugs by predicting the potential for adverse effects earlier. * Targeting specific groups of people most likely to benefit from a drug, while keeping its use from those who may be harmed by it. * Providing researchers the opportunity to get a global view of the events that are always changing within a cell. * Producing new classes of structural materials that are expected to bring about lighter, stronger, smarter, cheaper, cleaner, and more precise medical products. What are the Challenges of Personalized Medicine? Personalized medicine is new and still in the early stages. Using a pharmacogenomic test to determine who will respond to a treatment or who should not get a treatment may narrow the market for certain drugs—manufacturers may be reluctant to invest time and money. Identifying all of the genetic variations (perhaps millions) that may exist could take years. How a person responds to a medication may not be determined by just one gene, but rather, several genes and their products interacting with each other. This new way of doing things likely will be expensive and time-consuming. FDA's Role Tests that scientists are beginning to use on body fluids and cells to determine the variations of disease were not available in the past. Such tests, coupled with the understanding of the expression of each individual’s genes, will allow scientists to detect differences between patients and diseases much more precisely. FDA's Critical Path Initiative—the scientific process through which a medical product is transformed from discovery to development—is organizing work across 76 science and regulatory areas to improve medical product development, especially for gene-oriented drugs and diagnostic tests. FDA encourages applications for approval of new tools and technologies for a number of reasons: * The ability to bridge data gaps that exist in preclinical studies (animals) and clinical studies (humans) used to assess the safety and effectiveness of products it regulates. * Technologies can be used not only in the discovery phase of potential products, but also in the safety and effectiveness evaluation phase of development and submission to the agency. * Adverse events likely can be predicted prior to the approval and marketing of a product. FDA's role in personalized medicine will be to bring balance to an evolving science in a way that does not inhibit its growth. Thousands of cancer patients are already benefiting from several targeted drugs, such as Tarceva and Gleevec, both known to work better in people with certain genetic profiles. Hope for the future is that personalized medicine will improve the safety, quality and effectiveness of health care for every American. Share your Favorite articles on the following Social Networks: Share on Facebook
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Digitizing Biotechnology and Neurotechnology: Leading the Next Wave into Medicine of the Future By Neerja Sethi, PhD, Managing Editor e- published August 1, 2007 The first iMEME conference, organized by FORTUNE magazine in Prominent scientists and policymakers discussed the technological advancements taking place at the intersection of Biology and Information Technology. Panelists including J. Craig Venter, Founder and President of the J. Craig Venter Institute, John Donoghue, Director, Brain Science Program, Craig Venter is one of the leading scientists and visionaries in the field of genomic research. He is the founder and president of the J. Craig Venter Institute and the J. Craig Venter Science Foundation. The Venter Institute conducts basic research in the field of genomics, metagenomics, sequencing technologies and plays a key role in developing the ethical and policy implications of genomic discoveries. According to Craig Venter, DNA sequence is like a software that creates the hardware or the cell of an organism. And changing species is similar to changing the operating systems. Using combinatorial computational genomics, scientists can mix and match DNA sequences to create synthetic genomes of interest, as recently demonstrated by the results published by Craig Venter Institute in synthetic genomics demonstrating feasibility of genome transplantation. Currently, according to Venter, the limiting factor in analysis and applications of genomics is-slow computers. However, there is hope that the next wave of faster, quantum computers can overcome this limitation. Professor John Donoghue, from the brain Science Program at The main focus of Donoghue’s work is to study if a brain-machine interface will open the door to mind control. John Donoghue has built a brain decoder that could transform the lives of people paralyzed by injury or disease. John Donoghue demonstrated his results from a clinical trial with four patients who had paralyzed limbs in a video clip. Donoghue implanted a chip in these patients that can monitor their brain activity and convert their intentions into computer commands. The chip’s electrodes detects neurons signaling in an area of the brain that controls arm movement and translates neuronal activity into electronic signals. A computer program decodes the brain signals into commands that allow the patient to direct a cursor on a computer screen or the movement of an artificial limb. The results were well demonstrated in the video clip shown at the meeting. According to Donoghue, with such technologies, people with paralyzed limbs and normal brain functions, are capable of leading full and productive lives. In conclusion, the consensus is that digitizing Medicine, whether it is in a hospital setting or developing new therapeutic technologies, is the essential step forward. What’s next in future for the IT-Biotech-Neurotech interface? Can we increase human memory capacity, increase IQ, cure mental diseases through a computer chip or through combinatorial genomics and molecular biology? The race is on between the technologies to achieve these goals!
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FDA Clears CellSearch™ - Advanced Test For Monitoring Metastatic Colorectal Cancer --Capable of detecting minute numbers of circulating cancer cells in 40 billion blood cells, the CellSearch™ test can help guide patient care decisions-- Veridex LLC, a Johnson & Johnson company announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch™ System to be used as an aid in the monitoring of metastatic colorectal cancer. CellSearch™ is currently approved for monitoring metastatic breast cancer. The CellSearch™ System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic colorectal or breast cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch™ System, in conjunction with other clinical methods for monitoring, can help physicians assess disease progression, thereby guiding more informed care decisions earlier. "We are very excited that we can now offer the CellSearch™ test to patients who have metastatic colorectal cancer," said Dr. Ravi Patel of the Comprehensive Blood and The CellSearch™ System is the first diagnostic test to automate the detection and enumeration of CTCs, cancer cells that detach from solid tumors and enter the blood stream, and is the standard in a new class of diagnostic tools. The system's specificity, sensitivity and reproducibility allow for serial assessment of CTCs as early as the first cycle of treatment to help evaluate disease progression sooner. According to the American Cancer Society, colorectal cancer claims approximately 55,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic colorectal cancer occurs when tumor cells spread to other locations in the body and grow. Although there are several options for the treatment of metastatic colorectal cancer, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. The CellSearch™ System helps physicians to predict disease progression and patient survival any time during therapy through its ability to locate minute numbers of circulating tumor cells in the approximately 40 billion cells contained in a 7.5 ml sample of blood – an achievement never before documented in any diagnostic tool. The CellSearch™ System was originally cleared by the FDA in January 2004 as a diagnostic tool for identifying and counting CTCs in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer. A prospective, multi-center clinical trial was conducted to validate the expanded clearance for CellSearch™. The study, which took place in 55 clinical centers in the "Clinical research validates the significance of circulating, cancer tumor cells," said Robert McCormack, Ph.D., Vice President of Medical and Scientific Affairs, Veridex. "Elevated CTCs in the blood stream are associated with lower survival rates. We believe, based on the clinical research, that identifying CTCs as soon as possible can lead to improved patient outcomes." The CellSearch™ test works by using antibodies that are joined to microscopic iron particles, called ferrofluid. These antibody/ferrofluid combinations attach very specifically to CTCs. Powerful magnets then "pull" the CTCs out of the blood sample. They are then stained with additional bio-molecules and chemicals so that they can be positively identified as CTCs. The CellSearch™ test differs from the current standard of care because it can be used much earlier than traditional imaging (e.g., CT scans), and is not subject to the variation observed with other blood tests, called serum tumor markers. In August 2004, a clinical study using the CellSearch™ test in metastatic breast cancer patients was published in The New England Journal of Medicine. The authors of this study concluded "the very short median progression-free survival in patients with elevated circulating tumor cells at the first follow-up visit suggests that these patients are receiving ineffective therapy." In addition, as recently as November 2006, a metastatic breast cancer study was published in Clinical Cancer Research where the authors concluded: "The results reported here indicate that the evaluation of CTCs is an accurate measure of treatment efficacy." Additionally, the authors said: "The ability to serially quantitate and interrogate CTCs in patients with breast cancer makes possible new ways of managing and investigating the disease." About Veridex Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch™ assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch™ assays that use molecular technology to diagnose, stage and more accurately characterize tumors. www.veridex.com. |
FDA Approves Neupro Patch for Treatment of Early Parkinson’s Disease
May 9, 2007. The U.S. Food and Drug Administration (FDA) today announced the approval of Neupro (rotigotine transdermal system), a skin patch designed to treat symptoms of early Parkinson's disease. Rotigotine is a drug not previously approved in the Parkinson's disease, which belongs to a group of conditions called motor system disorders, results from the loss of dopamine-producing brain cells. Rotigotine, a member of the dopamine agonist class of drugs, is delivered continuously through the skin (transdermal) using a silicone-based patch that is replaced every 24 hours. A dopamine agonist works by activating dopamine receptors in the body, mimicking the effect of the neurotransmitter dopamine. The effectiveness of Neupro was demonstrated in one fixed-dose response study and two flexible-dose studies. The parallel group studies were randomized, double-blinded, and placebo-controlled, and involved 1,154 patients with early Parkinson's disease who were not taking other Parkinson's medications. The most common side effects for Neupro included skin reactions at the patch site, dizziness, nausea, vomiting, drowsiness and insomnia, most of which are typical of this class of drugs. Other potential safety concerns include sudden onset of sleep while engaged in routine activities such as driving or operating machinery (sleep attacks), hallucinations, and decreased blood pressure on standing up (postural hypotension). Neupro Patch is manufactured by Schwarz Bioscience of According to the Parkinson's Action Network, more than 1 million Americans live with Parkinson's disease and 60,000 new cases are diagnosed each year. The four primary symptoms of Parkinson's are trembling in hands, arms, legs, jaw, and face (tremor); stiffness of the limbs and trunk (rigidity); slowness of movement (bradykinesia,); and impaired balance and coordination (postural instability). As these symptoms become more pronounced, patients may have difficulty walking, talking, or completing other simple tasks. For more information National Institute of Neurological Disorders and Stroke http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease.htm |
Technique for Converting Blood Types Developed
April 2007. The work, led by the The method, which makes use of newly discovered enzymes, may help relieve shortages of blood for transfusions. Using incompatible blood during a transfusion can put a patient's life in danger. The blood cells of people with group A and B blood contain one of two different sugar molecules - known as antigens - which can trigger an immune system response. People with AB blood have both types of molecule, while those with group O blood have neither. People produce antibodies against the antigens they lack. This means groups A, B and AB can only be given to patients with compatible blood, while O - as long as it is rhesus negative - can be given to anyone. The new technique works by using bacterial enzymes to cut sugar molecules from the surface of red blood cells. After a search of 2,500 fungi and bacteria the researchers discovered two bacteria - Elizabethkingia meningosepticum and Bacterioides fragilis - which contained potentially useful enzymes. They found that enzymes from both bacteria were able to remove both A and B antigens from red blood cells. Trials needed However, they say that patient trials will be needed before the conversion method can be used in hospitals. Writing in the same journal, blood experts Geoff Daniels, of the Bristol Institute for Transfusion Sciences, and Stephen Withers, of the They said the use of enzymes to convert blood group has long been proposed, but has proved to be impractical due to the inefficiency and incompatibility of available enzymes. However, they say the enzymes discovered in the latest study may finally overcome these problems. They write: "Their method may enable manufacture of universal red cells, which would substantially reduce pressure on the blood supply." The new process cannot do anything about another antigen that can trigger an immune response. Blood which carries this antigen is known as rhesus positive. This means that only rhesus negative blood can be used to create the new type of group O supplies |
Medicineandbiotech.com Lists The Most Significant Medical Inventions/Discoveries Of The Past Decade Which Will Propel Medical Technologies Further In The Next Decade
* ARTIFICIAL HEART
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2. RNAi Technology: The Human Genome Project has enabled scientists to identify all human genes. The next stage in unraveling the mysteries of the genetic code is to decipher how these genes function. This has been made possible by the discovery of a process called RNA interference (RNAi) which is used by the body to selectively switch off individual genes. RNAi is a conserved mechanism found in all eukaryotes from yeast to mammals to control gene expression. The process involves small interfering RNA (siRNA) to selectively silence any gene in the genome. The discovery of RNAi has generated a mini revolution in the field of functional genomics and has vast applications in therapeutics design and development. The journal Science recognized RNAi as the “Breakthrough of the Year” in 2002. In 2006, Andrew Z. Fire and Craig C. Mello won the Nobel Prize for Medicine for discovering the “RNA interference mechanism”. RNAi is already being widely used by biotech and pharmaceutical industry as a method to study the function of genes and for developing therapeutics for virus infections, heart diseases, cancer and several metabolic ailments.
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3. Nanotechnology: Nanotechnology involves the manipulation of structures at the molecular scale and can change the behavior of materials. Nanotechnology has been slowly moving into cosmetics, drug delivery and computer disk drives to improve storage. According to a Deloitte research trends report, nanotechnology will soon be a pivotal tool of every manufacturing industry. Nanotechnology has been used to kill cancer cells without harming healthy tissue. The technique works by inserting microscopic synthetic rods called carbon nanotubules into cancer cells. When the rods are exposed to near-infra red light from a laser they heat up, killing the cell, while cells without rods are left unaffected. The future of treatment for life-threatening conditions, including cancer and heart disease, could come from a new breed of microchips. Biological micro-electromechanical devices, known as bioMEMS, could be implanted into the body to deliver specific doses of drugs or carry new cells to damaged tissue. There are various other applications for Nanomedicine which are being commercially developed, e.g., carbon coated Nanomagnets for biomedical applications, anti-cancer therapy using novel gene delivery technology, use of Nanoviricides™ in the treatment of acute and chronic viral illnesses, neuronal regeneration using Nanotope technology, Piezoelectric film technology for diagnostic applications, anti-viral Nanomaterial targeted at Pandemic Viruses, and many more.
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4.Stem Cells: The technology centers on human stem cells. These are the "master" cells which have the potential to become any of the body's many different types of tissue. Scientists believe that if they can grow these cells in the laboratory and then control the way they develop, they are able to grow any type of tissue needed for transplant. New ways of growing human embryonic stem cells in the laboratory without animal protein contaminations will reduce the risk that their use in therapy could go wrong. It is essential that stem cells are cultured in a safe way to avoid immune reactions in transplantation, and to prevent genetic changes during long-term culture. Stem cells have remarkable potential to treat a range of diseases, including cardiovascular conditions, spinal cord injuries, Parkinson's and diabetes. Transplantation experiments in animal models have shown remarkable therapeutic effects for various chronic diseases.
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5. RFID: Radio frequency identification (RFID) technology creates many possibilities to improve the healthcare system by fast, accurate identification and verification in a hospital emergency situation and reducing the number of medical errors. Matching patients to procedures at the bedside with a bar code or RFID wristband is a basic application of this technology. Automatic identification solutions can extend patient protection according to HIPAA regulations to laboratory, phlebotomy, and pharmacy , without burdening healthcare professionals with time-consuming documentation requirements. Bar code and RFID are currently proven tools to accurately match the right patient with the right procedure, medication, and materials. In 2004, The U.S. Food and Drug Administration has approved the first RFID chip that can be implanted in humans. The chips could provide easy access to medical information for individuals with life-threatening diseases, and could be particularly useful during a medical crisis.
NOTE: The above list is based upon independent opinions of scientists and business leaders consulted by MedicineandBiotech.com- Neerja Sethi, PhD, Managing Editor, December 2006. |
New Eczema Treatments on the Horizon
New ways to treat skin conditions which affect millions of people could be on the way after a scientific discovery.
Experts led by the University of Dundee have discovered the gene which causes dry skin, leading to eczema and asthma.
The gene produces the protein filaggrin, which helps the skin form a protective outer barrier. Experts hope to use the discovery for more effective therapies to tackle the root causes of the conditions, rather than simply treating the symptoms.
At the moment the only treatment is through the use of emollients and ointments or anti-inflammatory drugs. The research, to be published in the journal Nature Genetics, was undertaken with collaborators in Glasgow, Dublin, Seattle and Copenhagen.
Filaggrin, abundant in the outermost layers of the skin, keeps bacteria and viruses out while keeping water in to prevent the skin from drying.
Reduction or absence of the protein leads to dry and flaky skin. "It was a really tough project, but because we had experience in this type of gene, we managed to crack it where others had failed," said one of the researchers.
"We see this as the dawn of a new era in the understanding and treatment of eczema and the type of asthma that goes with eczema as well.
"If you imagine the disease as a burning building, up until now we've just been throwing buckets of water on the roof.
"But now we know exactly where the fire is underneath and we can put the hoses in there and hopefully tackle the cause of the problem properly."
Experts said new treatments from the discovery could take some time to come to fruition. The study, which also involved Our Lady's Hospital for Sick Children in Dublin, showed that about 10% of Europeans carry a mutation that switches off the filaggrin gene, causing a very common dry, scaly skin condition known as ichthyosis vulgaris.
About five million people in the UK alone make only half of the normal amount of filaggrin protein and have a milder form of the condition, while 120,000 people in the UK have no filaggrin protein and often require specialist treatment.
More than one million people are predicted to have the severe form of the condition worldwide. |
Key to Breast Cancer Metastasis Found
April 2007. Scientists have come closer to working out what makes breast cancer deadly. Four genes have been found to work together to drive the spread of breast cancer to the lungs. Breast cancer cells can spread to other parts of the body. Turning off all four genes at once dramatically reduces the ability of breast tumors to spread - or metastasize - a study in mice showed. Reporting the results in Nature, the Tumors spread when cancer cells break away and travel through the bloodstream to a different site in the body - a process called metastasis. This really nailed the case that if we can inactivate these genes in concert, it will affect metastasis. It is the ability to spread to other tissues and organs that makes cancer potentially deadly and metastases are very common in the late stages of cancer. In a series of experiments, Dr Massague found that four of those genes which produce proteins which combine to enable cancer cells to escape into the bloodstream and get into the lungs. Knocking out each of the genes individually in human cancer cells that had been implanted in mice had a small effect on cancer growth and metastasis. But turning off all four genes at once almost eliminated tumour growth and spread, and the tangle of blood vessels that is normally seen in a tumour was greatly reduced. Injecting cancer cells that had all four genes turned off into the bloodstream of mice also showed that the cells lacked the ability to get into lung tissue. Treatment Two drugs known to inhibit two of the proteins produced by the genes - cetuximab and celecoxib - were also shown to reduce the growth and spread of the breast tumors in mice if used in combination. Discussions are underway for clinical trials in humans. Dr Massague, chair of the cancer biology and genetics program at "This really nailed the case that if we can inactivate these genes in concert, it will affect metastasis." "These genes are used together to attract blood vessels and enter the blood stream and then once they reach the lung they use the same strategy to enter the lungs." Cancer spread Dr Massague is also looking at which genes promote metastasis to other sites in the body, such as brain and bone and whether the same or similar genes are involved in cancer spread in other cancer types, such as colon cancer. Dr Anthea Martin, cancer information officer at Cancer Research "This research has added to our knowledge of the genes that may be involved in the spread of breast cancer to the lungs. "The more we understand about this process, the more likely it is that scientists will be able to design treatments to prevent it from happening. "It is not known if the same genes are involved in the spread of all cancers, but this work is a great starting point for scientists looking at this important area of research." |
Isradipine Treatment Offers Hope for Parkinson's Disease
July 2007. The progression of Parkinson's disease could be slowed or even stopped by a drug commonly used to treat high blood pressure, a study in Nature suggests. Tests on mice at Parkinson’s disease, which mainly affects those aged over 40, leads to tremors and ultimately the inability to walk. The hope is that this drug will protect dopamine neurons, so that if a patient begins by taking it early enough, they won't get Parkinson's disease, even if at risk Researchers at Dopamine is a critical substance which affects the control of movement. When it is lacking, that movement becomes increasingly difficult and uncoordinated. The team found that when people become older, calcium ions start to enter the dopamine neurons and change how they behave. It is thought that isradipine's ability to stop calcium entering the cells is key to the effectiveness of the treatment. The drug could also extend the effectiveness of traditional dopamine-boosting medication, potentially doubling or tripling the length of time it worked. |
Human Gene Therapies: Novel Product Development
Credit: FDA Consumer Health Information e-published on MedicineandBiotech.com November 1st, 2007 Celia M. Witten, Ph.D., M.D., is Director of the Office of Cellular, Tissue and Gene Therapy at FDA's Center for Biologics Evaluation and Research (CBER). She worked for more than 10 years as a practicing physician at the A: Human gene therapy is the use of genetic material to treat, cure, or prevent a disease or medical condition. A: Genetic material can be used to replace defective genes in a person's body that are responsible for a disease or medical problem. It can also be used to treat disease through the expression of a protein that the gene codes for. Currently, all gene therapy is investigational. A: Research in this area has the potential to revolutionize the treatment of diseases that currently are incurable or have inadequate treatments. Gene therapy is being studied to meet unmet medical needs in diverse areas such as genetic diseases, heart disease, cancer, diabetes and stopping the replication of HIV in AIDS patients. A: Since the first human gene transfer in the late 1980s, CBER has provided proactive scientific and regulatory guidance in this area of novel product development. CBER works closely with product sponsors of potential investigational new drug ( A: No. FDA has not yet approved for sale any human gene therapy products. A: The development of gene therapy products is a relatively new field compared to other biologics and to traditional drugs. It takes time and careful evaluation for medical interventions based on the administration of genetic material to modify or manipulate the expression of a gene or to alter the biological properties of living cells to develop and potentially result in licensed products.We continue to see broad interest in the development of a number of different gene therapy vectors used to treat a wide variety of diseases and medical conditions. Gene therapy is highly innovative and poses some unique and potentially unknown risks. However, it also presents unique possibilities and the hope to cure and treat diseases in a manner differently, and in some cases potentially better or more safely, than some currently available treatments. A: No. As a regulatory agency, FDA’s role during the initial review process is to evaluate the information contained in the FDA also works closely with our colleagues at the National Institutes of Health and its Recombinant DNA Advisory Committee, academia, and industry to discuss challenges for conducting gene therapy clinical trials. A: Although gene therapy products present unknown risks, they also have the potential for tremendous patient benefit. FDA’s goal is to minimize those risks. The agency has continually evaluated its review and oversight processes to improve the conduct of clinical trial research. Efforts to ensure better human subject protection, improve investigator compliance, improve the quality of submitted protocols, and provide additional guidance and standards to facilitate preparation of INDs have been done through educational outreach, conferences, meetings and policy development. When developing these new therapies, sponsors of clinical trials must accept responsibility to ensure that participants are not exposed to known unreasonable risks and that the experimental products are as safe as possible. Extensive preclinical studies of safety are typically performed, including in animal models. Measures are built into trials to protect the safety of each volunteer. However, because these are investigational products and are being used to treat significant illnesses, serious adverse events still may occur during the research process. CBER is aware of both the promise of gene therapy and the potential for serious adverse events. Patient protection is our paramount concern, and we are committed to minimizing the risks to volunteers who participate in clinical trials of any type, including gene therapy studies. While the development of promising new experimental therapies presents many challenges, research in this field may lead to the availability of treatments that help save or improve the quality of life for many patients. END Human Gene Therapy and the Role of the Food and Drug Administration |
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