PUBLIC RELEASE DATE:

23-Jan-2014

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, January 23, 2013-The U.S. Food and Drug Administration (FDA) mandates adequate enrollment of women in post-approval studies (PAS) of medical devices to ensure that any sex differences in device safety and effectiveness are not overlooked. A group of authors from the FDA report the results of a study evaluating the participation of women and analysis of sex differences in PAS in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the Journal of Women's Health website.

Women may respond differently to medical devices due to factors such as genetics, body size, hormones, or other intrinsic sex-specific or extrinsic societal or environmental factors. They may face greater or lesser risk of adverse events or derive more or less benefit. "Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews," state the authors in their article "Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration."

"It is critically important that we have adequate participation of women in clinical trials, and that we analyze sex differences in study outcomes and adverse events," says Editor-in-Chief Susan G. Kornstein, MD, Executive Director of the Virginia Commonwealth University Institute for Women's Health, Richmond, VA, and President of the Academy of Women's Health.

###

About the Journal

Journal of Women's Health, published monthly, is a core multidisciplinary journal dedicated to the diseases and conditions that hold greater risk for or are more prevalent among women, as well as diseases that present differently in women. The Journal covers the latest advances and clinical applications of new diagnostic procedures and therapeutic protocols for the prevention and management of women's healthcare issues. Complete tables of content and a sample issue may be viewed on the Journal of Women's Health website. Journal of Women's Health is the Official Journal of the Academy of Women's Health and the Society for Women's Health Research.

About the Academy

View post:
Are enough women included in medical device studies, as required by the FDA?

Montral (PRWEB) January 23, 2014

Today, with the addition of members in Antarctica, Synbiota Inc. connects synthetic biology researchers across all 7 continents, just 3 months after the company's launch. Also announced today is $300,000 in available funding for Synbiota members and their biological solutions.

"Genetic engineering is our best bet to save the world," says Bill Liao, Founder of CoderDojo, a global network of hackerspaces and partner at SOSVentures. "That's why we're offering Synbiota's global network of researchers and biohackers $300,000 in available funding to accelerate the development of sustainable biological solutions via the SynBio axlr8r program." Learn more, and sign up at synbiota.com/axlr8r.

Synbiota is satisfying a global need for advanced virtual lab technology with its free web-based software. Previously limited to large corporations such as Monsanto, genetic engineering is touted by experts as one of humanity's best tools to combat global challenges in climate, access to food, fuel, materials, and the development of effective, low-cost medicine.

"Biotech is advancing much faster than computer technology, and Synbiota is at the heart of this revolution" says Rob Carlson, principal at Biodesic, and synthetic biology advisor to corporations and governments around the world. "Bringing together a global cadre of independent researchers, and pairing them with real funding opportunities is just the sort of thing that ignites revolutions. This is an incredible opportunity for the iGEM, DIYBio, and entrepreneurial communities to fund their work."

About Synbiota:

Synbiota Inc. was founded in April 2013 with the mission to streamline life science R&D and to make it universally accessible. Synbiota was a Fellow of Mozilla Labs WebFWD, winner of Hacking Healths Most Transformative Technology award, recipient of grants from FedDev and the Eastern Ontario Development Program, and creator of the S PRIZE global biotech contest. Synbiota Inc. has offices at the Digital Media Zone at Ryerson University (DMZ) in Toronto, and Maison Notman in Montral.

View post:
Synbiota Expands Into Antarctica, Attracts Investors

PUBLIC RELEASE DATE:

23-Jan-2014

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, January 23, 2014The search for extraterrestrial life extends far beyond Earth's solar system, looking for planets or moons outside the "stellar habitable zone" that may have environments even more favorable to supporting life than here on Earth. These superhabitable worlds have unique characteristics and are ideal targets for extrasolar exploration, as described in a provocative Hypothesis Article in Astrobiology, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the Astrobiology website.

In "Superhabitable Worlds" Ren Heller, McMaster University (Hamilton, Ontario, Canada) and John Armstrong, Weber State University (Ogden, UT), propose how tidal heating can create conditions in which life could emerge on an icy or terrestrial planet or moon once thought to be uninhabitable.

"A great place for hydrothermal microorganisms and a volcanic eruption in the weather forecast every morning and evening," says Norman Sleep, Senior Editor for Astrobiology and Professor in the School of Earth Sciences at Stanford University, "a tidally heated planet would be unpleasant though spectacular to visit."

###

About the Journal

Astrobiology, led by Editor-in-Chief Sherry L. Cady, Chief Scientist at the Pacific Northwest National Laboratory, and a prominent international editorial board comprised of esteemed scientists in the field, is the authoritative resource for the most up-to-date information and perspectives on exciting new research findings and discoveries emanating from interplanetary exploration and terrestrial field and laboratory research programs. The Journal is published monthly online with Open Access options and in print, and is the Official Journal of the Astrobiology Society. Complete tables of content and a sample issue may be viewed on the Astrobiology website.

About the Publisher

Read more here:
Looking for a 'superhabitable' world? Try Alpha Centauri B, says Astrobiology Journal

PUBLIC RELEASE DATE:

22-Jan-2014

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, January 22, 2014Metastatic melanoma has a poor prognosis, but treatment with high-dose interleukin-2 (IL2) can extend survival. Now, a combination of IL2 therapy and activation of patients' immune systems using personalized vaccines made from their own tumor cells has been shown to improve survival rates even more than IL2 alone, according to a new article in Cancer Biotherapy and Radiopharmaceuticals, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the Cancer Biotherapy and Radiopharmaceuticals website.

"High-Dose IL2 in Metastatic Melanoma: Better Survival in Patients Immunized with Antigens from Autologous Tumor Cell Lines" describes a statistically significant improvement in survival for patients who received IL2 plus tumor cell-based immunotherapy. Authors Robert Dillman, Carol DePriest and Stephanie McClure, Hoag Institute for Research and Education, Hoag Family Cancer Institute, and Cancer Biotherapy Research Group, Newport Beach, CA, found that administration of immunotherapy after IL2 treatment resulted in longer patient survival than if individuals were vaccinated before receiving IL2.

"This is an important addition to the literature on IL2 treatment for metastatic melanoma demonstrating that personalized vaccine therapy contributed to an increased survival rate," says Co-Editor-in-Chief Donald J. Buchsbaum, PhD, Division of Radiation Biology, Department of Radiation Oncology, University of Alabama at Birmingham.

###

About the Journal

Cancer Biotherapy and Radiopharmaceuticals, published 10 times a year in print and online, is under the editorial leadership of Editors Donald J. Buchsbaum, PhD and Robert K. Oldham, MD, Lower Keys Cancer Center, Key West, FL. Cancer Biotherapy and Radiopharmaceuticals is the only journal with a specific focus on cancer biotherapy, including monoclonal antibodies, cytokine therapy, cancer gene therapy, cell-based therapies, and other forms of immunotherapy. The Journal includes extensive reporting on advancements in radioimmunotherapy and the use of radiopharmaceuticals and radiolabeled peptides for the development of new cancer treatments. Topics include antibody drug conjugates, fusion toxins and immunotoxins, nanoparticle therapy, vascular therapy, and inhibitors of proliferation signaling pathways. Tables of content and a sample issue are available on the Cancer Biotherapy and Radiopharmaceuticals website.

About the Publisher

Read the original post:

Can personalized tumor vaccines improve interleukin-2 treated metastatic melanoma?

AP/January 22, 2014

CONCORD, N.H. (AP) New Hampshires House killed a bill Wednesday that would have required genetically modified foods to be labeled.

The House voted 185-162 to kill the bill, despite supporters arguments it is time for states like New Hampshire to lead on the issue regardless of the federal governments position.

Supporters argued New Hampshire residents have a right to know whether their food is produced with genetic engineering, but critics said the federal Food and Drug Administration has not mandated the labeling because it determined the foods are safe.

The reality is most of us are living every day with the benefits of genetic engineering, said Rep. Linda Lauer, D-Bath. She said insulin has been genetically engineered since 1982. Prior to that insulin was taken from the pancreas of farm animals, she said.

Lauer said the labeling required under the bill would not tell consumers what was in the food, only that it had been genetically engineered. She said the label wouldnt provide accurate information about the foods. For example, genetically engineered beets are used to produce sugar, which is a pure chemical compound. Despite its purity, any foods containing the sugar would have to be labeled, she said.

But Rep. Peter Bixby, D-Dover, said people have a right to know if genetic engineering modified the foods.

People are responsible for their own decisions, but to make those decisions they need information, he said.

But opponents said wary consumers could buy organic foods or foods labeled as not being genetically modified. They said the industry is beginning to respond to consumers wishes for genetically engineered foods to be labeled,

The market will solve this problem. It moves a little slow, but it will solve the problem, said Rep. Robert Haefner, R-Hudson.

Read this article:

House rejects genetically modified foods labeling

PUBLIC RELEASE DATE:

21-Jan-2014

Contact: Sophie Mohin smohin@liebertpub.com 914-740-2100 x2254 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, January 21, 2014 Too much information can be overwhelming, but when it comes to certain types of data that are used to build predictive models to guide decision making there is no such thing as too much data, according to an article in Big Data, the highly innovative, peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available on the Big Data website.

To determine whether more data is really better for predictive modeling, Enric Junqu de Fortuny and David Martens, University of Antwerp, Belgium, and Foster Provost, New York University, NY, tested nine different applications in which they built models using a particular type of data called fine-grained data, such as observing an individual's behavior in a certain setting. In the article "Predictive Modeling with Big Data: Is Bigger Really Better?" the authors state that "certain telling behaviors may not be observed in sufficient numbers without massive data."

"The power of any analytic tool is in using it appropriately," says Founding Editor, Edd Dumbill. "Sweeping assumptions such as 'bigger is better' can be dangerous. This paper significantly advances our knowledge of when massive datasets improve decision-making ability."

###

About the Journal

Big Data, published quarterly in print and online, facilitates and supports the efforts of researchers, analysts, statisticians, business leaders, and policymakers to improve operations, profitability, and communications within their organizations. Spanning a broad array of disciplines focusing on novel big data technologies, policies, and innovations, the Journal brings together the community to address the challenges and discover new breakthroughs and trends living within this information.

About the Publisher

More:

Bigger (data) is better and can improve decision making

Monsantos new veggies are sweeter, crunchier, and more nutritiouswith none of the Frankenfoods ick factor.

In a windowless basement room decorated with photographs of farmers clutching freshly harvested vegetables, three polo-shirt-and-slacks-clad Monsanto executives, all men, wait for a special lunch. A server arrives and sets in front of each a caprese-like saladtomatoes, mozzarella, basil, lettuceand one of the execs, David Stark, rolls his desk chair forward, raises a fork dramatically, and skewers a leaf. He takes a big, showy bite. The other two men, Robb Fraley and Kenny Avery, also tuck in. The room fills with loud, intent, wet chewing sounds.

Eventually, Stark looks up. Nice crisp texture, which people like, and a pretty good taste, he says.

Its probably better than what I get out of Schnucks, Fraley responds. Hes talking about a grocery chain local to St. Louis, where Monsanto is headquartered. Avery seems happy; he just keeps eating.

The men poke, prod, and chew the next course with even more vigor: salmon with a relish of red, yellow, and orange bell pepper and a side of broccoli. The lettuce is my favorite, Stark says afterward. Fraley concludes that the pepper changes the game if you think about fresh produce.

Changing the agricultural game is what Monsanto does. The company whose nameis synonymous with Big Ag has revolutionized the way we grow foodfor better or worse. Activists revile it for such mustache-twirling practices as suing farmers who regrow licensed seeds or filling the world with Roundup-resistant superweeds. Then theres Monsantos reputationscorned by some, celebrated by othersas the foremost purveyor of genetically modified commodity crops like corn and soybeans with DNA edited in from elsewhere, designed to have qualities nature didnt quite think of.

So its not particularly surprising that the company is introducing novel strains of familiar food crops, invented at Monsanto and endowed by their creators with powers and abilities far beyond what you usually see in the produce section. The lettuce is sweeter and crunchier than romaine and has the stay-fresh quality of iceberg. The peppers come in miniature, single-serving sizes to reduce leftovers. The broccoli has three times the usual amount of glucoraphanin, acompound that helps boost antioxidant levels. Starks department, the global trade division, came up with all of them.

Grocery stores are looking in the produce aisle for something that pops, that feels different, Avery says. And consumers are looking for the same thing. If the team is right, theyll know soon enough. Frescada lettuce, BellaFina peppers, and Benefort broccolicheery brand names trademarked to an all-but-anonymous Monsanto subsidiary called Seminisare rolling out at supermarkets across the US.

But heres the twist: The lettuce, peppers, and broccoliplus a melon and an onion, with a watermelon soon to followarent genetically modified at all. Monsanto created all these veggies using good old-fashioned crossbreeding, the same technology that farmers have been using to optimize crops for millennia. That doesnt mean they are low tech, exactly. Starks division is drawing on Monsantos accumulated scientific know-how to create vegetables that have all the advantages of genetically modified organisms without any of the Frankenfoods ick factor.

And thats a serious business advantage. Despite a gaping lack of evidence that genetically modified food crops harm human health, consumers have shown a marked resistance to purchasing GM produce (even as they happily consume products derived from genetically modified commodity crops). Stores like Whole Foods are planning to add GMO disclosures to their labels in a few years. State laws may mandate it even sooner.

Go here to see the original:

What Happens When Monsanto, the Master of Genetic Modification, Decides to Take Nature’s Path?

Jan. 21, 2014 The transition from water to land is one of the most fascinating enigmas of evolution. In particular, the evolution of limbs from ancestral fish fins remains a mystery. Both fish and land animals possess clusters of Hoxa and Hoxd genes, which are necessary for both fin and limb formation during embryonic development.

Denis Duboule's team, at the UNIGE and the EPFL, Switzerland, compared the structure and behavior of these gene clusters in embryos from mice and zebrafish. The researchers discovered similar 3-dimensional DNA organization of the fish and mouse clusters, which indicates that the main mechanism used to pattern tetrapod limbs was already present in fish. However, when inserted into transgenic mouse embryos, the fish Hox genes were only active in the mouse arm but not in the digits, showing that the fish DNA lacks essential genetic elements for digit formation. The study, published in the January 21, 2014 edition of PLoS Biology, thus concludes that, although the digital part of the limbs evolved as a novelty in land animals, this happened by elaborating on an ancestral, pre-existing DNA infrastructure.

Our first four-legged land ancestor came out of the sea some 350 million years ago. Watching a lungfish, our closest living fish relative, crawl on its four pointed fins gives us an idea of what the first evolutionary steps on land probably looked like. However, the transitional path between fin structural elements in fish and limbs in tetrapods remains elusive.

An ancestral regulatory strategy

In animals, the Hox genes, often referred to as 'architect genes', are responsible for organizing the body structures during embryonic development. Both fish and mammals possess clusters of Hoxa and Hoxd genes, which are necessary for fin and limb formation. The team of Denis Duboule, professor at the University of Geneva (UNIGE) and the Ecole polytechnique fdrale de Lausanne (EPFL), Switzerland, had recently shown that, during mammalian development, Hoxd genes depend on a 'bimodal' 3-dimensional DNA structure to direct the development of the characteristic subdivision of the limbs into arm and paw, a division which is absent from fish fins.

'To determine where the genetics behind this subdivision into 'hand' and 'arm' came from during evolution, we decided to closely compare the genetic processes at work in both fin and limb development', says Joost Woltering, researcher at the Department of Genetics and

Evolution of the UNIGE Faculty of Science and lead author of the study. Surprisingly, the researchers found a similar bimodal 3-dimensional chromatin architecture in the Hoxd gene region in zebrafish embryos. These findings indicate that the regulatory mechanism used to pattern tetrapod limbs probably predates the divergence between fish and tetrapods. "In fact this finding was a great surprise as we expected that this 'bimodal' DNA conformation was exactly what would make all the difference in the genetics for making limbs or making fins" adds Joost Woltering.

that just needs to be modernized

Does this imply that digits are homologous to distal fin structures in fish? To answer this question, the geneticists inserted into mice embryos the genomic regions that regulate Hox gene expression in fish fins. 'As another surprise, regulatory regions from fish triggered

Hox gene expression predominantly in the arm and not in the digits. Altogether, this suggests that our digits evolved during the fin to limb transition by modernizing an already existing regulatory mechanism', explains Denis Duboule.

Read more:

How the genetic blueprints for limbs came from fish

Genetic Engineering Project
Science Project.

By: Jackie Tiongco

Read the original:
Genetic Engineering Project - Video

San Jose, California (PRWEB) January 20, 2014

Follow us on LinkedIn Designer babies are defined as babies with artificial genetic makeup selected through a combination of genetic engineering and in vitro fertilization to confirm inclusion or exclusion of specific traits. The term Designer Babies is not a scientific term, but is used by journalists and highlights the fact that parents could choose specific characteristics of their unborn child including physical appearance, character and sex. Advancements in genetic engineering and in vitro fertilization approaches, coupled with the need to lower the occurrence of genetic disorders in offspring, are driving interest in the concept of designer babies. Ethical issues related to commodification of children and genetic manipulation in human offspring, are however projected to present regulatory challenges in the advancement and commercialization of the concept of designer babies in the coming years.

The trend report titled Designer Babies announced by Global Industry Analysts Inc., is a focused research paper which provides cursory insights into the technology concept, its evolution, and future prospects. A part of GIAs new series of short research briefs on emerging technologies, this trend report highlights key enabling technologies including the development of Pre-implantation Genetic Diagnosis (PGD).

For more details about this trend report, please visit http://www.strategyr.com/TrendReport.asp?code=141062

About Global Industry Analysts, Inc. Global Industry Analysts, Inc., (GIA) is a leading publisher of off-the-shelf market research. Founded in 1987, the company currently employs over 800 people worldwide. Annually, GIA publishes more than 1300 full-scale research reports and analyzes 40,000+ market and technology trends while monitoring more than 126,000 Companies worldwide. Serving over 9500 clients in 27 countries, GIA is recognized today, as one of the world's largest and reputed market research firms.

Global Industry Analysts, Inc. Telephone: 408-528-9966 Fax: 408-528-9977 Email: press(at)StrategyR(dot)com Web Site: http://www.StrategyR.com/

###

See original here:

Advancements in Genetic Engineering to Modify Embryos Spur the Concept of Designer Babies, According to a New Trend ...

San Jose, CA (PRWEB) January 20, 2014

Follow us on LinkedIn Genes can be defined as the basic molecular units of heredity in a living organism, holding information on creating and maintaining the cells of an organism and passing genetic traits to its offspring. Radio controlled genes refers to remotely activating genes inside the human body through the use of electromagnetic waves to guide the movement of nanoparticles injected inside the body. As the next frontier of medical science, radio controlled genes is attracting immense R&D interest and investment, given its potential to offer non-invasive and non-pharmacological treatment possibilities. Using radio waves to control gene expression has the advantage of being safe as radio waves, unlike electrical waves, do not damage tissues. Advancements in nanobiotechnology and development of antibody coated metal nanoparticles as carriers to absorb radio frequency energy are expected to help drive growth in the market. Currently, being researched is the possibility of using radiowaves to induce insulin-gene expression and activate insulin production in the body to treat diabetes.

The trend report titled Radio-Controlled Genes announced by Global Industry Analysts Inc., is a focused research paper which provides cursory insights into the technology, its applications, and future prospects.

For more details about this trend report, please visit http://www.strategyr.com/TrendReport.asp?code=141011.

About Global Industry Analysts, Inc.

Global Industry Analysts, Inc., (GIA) is a leading publisher of off-the-shelf market research. Founded in 1987, the company currently employs over 800 people worldwide. Annually, GIA publishes more than 1300 full-scale research reports and analyzes 40,000+ market and technology trends while monitoring more than 126,000 Companies worldwide. Serving over 9500 clients in 27 countries, GIA is recognized today, as one of the world's largest and reputed market research firms.

Global Industry Analysts, Inc. Telephone: 408-528-9966 Fax: 408-528-9977 Email: press(at)StrategyR(dot)com Web Site: http://www.StrategyR.com/

More here:

Developments in Nanobiotechnology Drive the Market for Radio-Controlled Genes, According to a New Trend Report ...

Genetic Engineering: Challenging our perspectives on reproduction by Dr. Gary Fritz

By: Wafeek Wahby

More:
Genetic Engineering: Challenging our perspectives on reproduction by Dr. Gary Fritz - Video

Artificial manipulation, modification, and recombination of DNA or other nucleic-acid molecules in order to modify an organism or population of organisms. The term initially meant any of a wide range of techniques for modifying or manipulating organisms through heredity and reproduction. Now the term denotes the narrower field of recombinant-DNA technology, or gene cloning, in which DNA molecules from two or more sources are combined, either within cells or in test tubes, and then inserted into host organisms in which they are able to reproduce. This technique is used to produce new genetic combinations that are of value to science, medicine, agriculture, or industry. Through recombinant-DNA techniques, bacteria have been created that are capable of synthesizing human insulin, human interferon, human growth hormone, a hepatitis-B vaccine, and other medically useful substances. Recombinant-DNA techniques, combined with the development of a technique for producing antibodies in great quantity, have made an impact on medical diagnosis and cancer research. Plants have been genetically adjusted to perform nitrogen fixation and to produce their own pesticides. Bacteria capable of biodegrading oil have been produced for use in oil-spill cleanups. Genetic engineering also introduces the fear of adverse genetic manipulations and their consequences (e.g., antibiotic-resistant bacteria or new strains of disease). See also biotechnology, molecular biology.

Here is the original post:

Genetic engineering - Definition and More from the Free ...

By Charles Gersbach, Assistant Professor, and Tom Katsouleas, Dean, Duke University's Pratt School of Engineering

Elaborate competitions to build the best robot or design cages to protect falling eggs have been a rite of passage for generations of engineering students. Today, there's a new contest with the same creativity and competitive spirit, but vastly more sophisticated projects--like mixing-and-matching bits of DNA to create new microorganisms that produce biofuels or costly medicines.

The International Genetically Engineered Machines (iGEM) competition challenges student teams to use cutting-edge tools from the new field of synthetic biology to design, build, and test genetically engineered organisms. This fall, 133 teams of students from universities from around the world participated, producing an incredible array of projects. Some engineered microorganisms to produce medicines, clean up environmental contaminants, or act as biosensors for toxins or other chemicals. Others created genetically engineered living board games or transformed otherwise stinky bacteria to smell like wintergreen. Our own Duke University iGEM team focused on engineering gene circuits in yeast to better understand how cells make decisions, such as whether to replicate or respond to an environmental stimulus; the circuits can also be used in biomanufacturing.

If these examples surprise you, you're not alone. As the New York Times observed, "iGEM has been grooming an entire generation of the world's brightest scientific minds to embrace synthetic biology's vision -- without anyone really noticing, before the public debates and regulations that typically place checks on such risky and ethically controversial new technologies have even started." But we think this kind of hands-on experimentation and experience is precisely the way to prepare the next generation of leaders who can help society reap the benefits and manage the risks of synthetic biology--and other fields, for that matter.

At a time when the discussion of the future of college education is largely focused on online teaching and massive open online courses (MOOCs), it is critical to recognize the importance of hands-on education that can only be provided in a dynamic research environment. As Matt Baron, a biomedical engineering student and member of the Duke iGEM team, says: "If I had simply studied synthetic biology but not participated in the iGEM competition, I would not appreciate the practical implementation of the theoretical concepts--or how synthetic biology can be used to solve complex problems across seemingly unrelated fields such as medicine, agriculture, manufacturing and computing. More importantly, I would have lost the opportunity to take ownership over a project along with my team members." By encouraging freedom and independence in project design and exposing students to a new and exciting field as it is developing, the iGEM competition provides a quality of education that clearly cannot be replicated through online teaching, but is critical in educating the next generation of scientists and engineers.

The iGEM competition also teaches participants the importance of considering broader implications of advances in synthetic biology, such as the safety and security of the engineered systems and ethical issues concerning genetic manipulation. All projects are supervised by university faculty mentors, and the iGEM competition stresses environmental and societal responsibility as primary judging criteria. Our iGEM team worked with Duke faculty in the Schools of Law and Public Policy to develop a report on intellectual property and synthetic biology, addressing concerns involving patenting of gene sequences and subsequent effects on basic research and the biotechnology industry. These students are not just learning science and engineering--they're being trained in aspects of philosophy, policy and business.

But synthetic biology is not just an academic exercise. The number of synthetic biology companies has tripled over the last four years, from 61 to 192. The global synthetic biology market was estimated to be worth $2.1 billion in 2012 and is expected to expand to $16.7 billion by 2018. At this rate, the development of this nascent field is rapidly outpacing the release of new textbooks or other conventional educational models--whereas the iGEM competition adapts at the speed of student creativity, providing a new model for training that's already proving its worth. Many successful iGEM projects have been published in peer-reviewed scientific journals, and several iGEM teams have even patented their inventions, creating opportunities to complement their science and engineering training with entrepreneurship experiences.

Educational paradigms must evolve to train the next generation of scientists and engineers, going beyond cultivating creativity and inventiveness to developing social consciousness and the mindset to face the grand challenges for the 21st century. The iGEM competition provides an excellent blueprint for how to achieve these goals by involving students not only in finding the right answers, but asking the right questions.

Link:

Charles Gersbach, Tom Katsouleas: Fun with genetic engineering

POSTED: 01:30 a.m. HST, Jan 12, 2014 LAST UPDATED: 05:59 a.m. HST, Jan 12, 2014

NEW YORK TIMES

KONA From the moment the bill to ban genetically engineered crops on Hawaii island was introduced in May, it garnered more vocal support than any the County Council here had ever considered, even the perennially popular bids to decriminalize marijuana.

Public hearings were dominated by recitations of the ills often attributed to genetically modified organisms, or GMOs: cancer in rats, a rise in childhood allergies, out-of-control superweeds, genetic contamination, overuse of pesticides, the disappearance of butterflies and bees.

Like some others on the nine-member council, Greggor Ilagan was not even sure at the outset of the debate exactly what genetically modified organisms were: living things whose DNA has been altered, often with the addition of a gene from a distant species, to produce a desired trait. But he could see why almost all of his colleagues had been persuaded of the virtue of turning the island into what the bill's proponents called a "GMO-free oasis."

"You just type 'GMO' and everything you see is negative," he told his staff. Opposing the ban also seemed likely to ruin anyone's re-election prospects.

Yet doubts nagged at the councilman, who was serving his first two-year term. The island's papaya farmers said that an engineered variety had saved their fruit from a devastating disease. A study purporting that a diet of GMO corn caused tumors in rats, mentioned often by the ban's supporters, turned out to have been thoroughly debunked.

And University of Hawaii biologists urged the council to consider the global scientific consensus, which holds that existing genetically engineered crops are no riskier than others, and have provided some tangible benefits.

"Are we going to just ignore them?" Ilagan wondered.

Urged on by Margaret Wille, the ban's sponsor, who spoke passionately of the need to "act before it's too late," the council declined to form a task force to look into such questions before its November vote. But Ilagan, 27, sought answers on his own. In the process, he found himself, like so many public and business leaders worldwide, wrestling with a subject in which popular beliefs often do not reflect scientific evidence.

Read more here:

Effort to demystify GMOs was tough

2014 1 3 ZOC Eating Genetic Engineering
Zarrakan Productions is an umbrella group for many YouTube shows, and businesses both inside and outside of Second Life. Please go to http://zarrakan.com/ fo...

By: Zarrakan

View post:

2014 1 3 ZOC Eating Genetic Engineering - Video

Fewer than 250 adults may be left in West Africa, and those big cats are confined to less than 1 percent of their historic range.

The new study, detailed in the journal PLOS ONE, suggests that without dramatic conservation efforts, three of the four West African lion populations could become extinct in the next five years, with further declines in the one remaining population, study co-author Philipp Henschel, the lion program survey coordinator for Panthera, a global wildcat conservation organization, wrote in an email. [In Photos: The Biggest Lions on Earth]

The majestic lion once roamed throughout West Africa, from Nigeria to Senegal.

But as people have converted wild lands to pastureland, hunted the lion's traditional prey antelopes, gazelles, wildebeest, buffalos and zebras and gotten into conflicts with the animals, the big cat population has plummeted in West Africa.

Cash-strapped West African governments have put little money into lion conservation, in part because "wildlife tourism is quasi-absent in West Africa," Henschel said.

And research institutions have similarly neglected the region.

"Like wildlife tourists, most international research institutions and conservation organizations active in Africa also flock to the iconic game parks in East and southern Africa, meaning that lions faced a silent demise in West Africa over the past decades," Henschel told LiveScience.

Massive Survey

To remedy that, Henschel and his colleagues recently completed a massive, six-year survey of West Africa's lions, using remote cameras, interviews with people and counts of lion tracks. The survey, carried out between October 2006 and May 2012, builds on a smaller study done last year, which found shrinking savannas for lions in the region.

About 400 adult and juvenile lions existed in the region. And the wild cats, which were originally thought to have inhabited 21 separate regions, actually exist in just four. Their range is now confined to pockets in Senegal, Nigeria and the borderlands between Benin, Niger and Burkina Faso.

Read the rest here:

Lions Face Extinction in West Africa

Dictionary G Genetic engineering

Definition

noun

The technology entailing all processes of altering the genetic material of a cell to make it capable of performing the desired functions, such as producing novel substances.

Supplement

Genetic engineering covers all various experimental techniques that manipulate the genes of the organism. It uses recombinant DNA, molecular cloning and transformation. At present, it is applied in improving crop technology, manufacturing synthetic human insulin (using modified bacteria), production of erythropoietin (using Chinese hamster ovary cells), and production of new types of experimental mice for research (such as cancer mouse). It also has the potential of being used in humans by changing their appearance, intelligence, character and adaptability; however, there are ethical concerns and controversies it has to resolve before it can be widely accepted.

Related forms: genetic engineer (noun). Synonym: recombinant DNA technology, genetic modification, genetic manipulation (GM), gene splicing. See also: bioethics, biotechnology, cloning, genetic pollution.

Please contribute to this project, if you have more information about this term feel free to edit this page

See entire post

This page was last modified 21:31, 19 June 2008.This page has been accessed 80,191 times. What links here | Related changes | Permanent link

Read the original here:
Genetic engineering - definition from Biology-Online.org

I have frequently pointed out that pharmaceutical companies acknowledge that animal models are not predictive for human response in terms of efficacy or toxicity. More evidence for this position comes from Robert G. Hunter in an article in Genetic Engineering & Biotechnology News.[1] Hunter: Having developed over the past 20 years into a global market recently estimated at $5 billion, in vitro and in silico products and services are now about the same size as the in vivo services (contract research organization) industry. If animal models worked well, there would be no need for industry to look at other options. Pharma does not love bunnies. Pharma loves money.

Matthew Herper addressed the problems in drug development in an article in Forbes.[2] Herper:

Theres one factor that, as much as anything else, determines how many medicines are invented, what diseases they treat, and, to an extent, what price patients must pay for them: the cost of inventing and developing a new drug, a cost driven by the uncomfortable fact than 95% of the experimental medicines that are studied in humans fail to be both effective and safe.

Animal models are relied on for the evaluation of both efficacy and safety.[3-9] Herper continues:

A new analysis conducted at Forbes puts grim numbers on these costs. A company hoping to get a single drug to market can expect to have spent $350 million before the medicine is available for sale. In part because so many drugs fail, large pharmaceutical companies that are working on dozens of drug projects at once spend $5 billion per new medicine. . . . This is crazy. For sure its not sustainable, says Susan Desmond-Hellmann, the chancellor at UCSF and former head of development at industry legend Genentech, where she led the testing of cancer drugs like Herceptin and Avastin. Increasingly, while no one knows quite what to do instead, any businessperson would look at this and say, You cant make a business off this. This is not a good investment. I say that knowing that this has been the engine of wonderful things.

This, in part, is why disease-specific drugs like Kalydeco, a drug for cystic fibrosis (CF) patients that have a specific genetic mutation, costs $294,000 per patient per year.

The reason animal models fail for drug development is that animals and humans are evolved systems that are differently complex. While morphological similarities exist, very small differences in the genetic make-up between species and between individuals of the same species means the predictive value for extrapolation is nil in the real world. (For more on this see Trans-Species Modeling Theory.) Moreover, if the concept of evolved, complex systems invalidates trans-species extrapolation in drug development, it is going to do the same when trans-species extrapolation involves any perturbation that affects higher levels of organization. So just based on the evidence from drug development we can safely say that disease research on mice, monkeys, or dogs is not going to result in knowledge that has predictive value for human patients. The literature confirms this.[10-21][[22]p19-33, 73-77] [23-25]

Compare the above to this recent statement from Michael E. Goldberg published in the Wisconsin State Journal: Nearly every medical advance from the last century is a product of responsible animal research, and animal models will continue to be important to medical progress. . . . Activists who claim animal research does not benefit humans are wrong. Animals are essential to medical progress in all fields of human disease. [26] This illustrates the dichotomy regarding animal models. Dr Goldberg is an animal modeler who does basic research, which he sells as applied research. Not surprisingly, Goldberg thinks animal modeling is great. He does not suffer loss of income or prestige when the knowledge from animal modeling fails to translate to human patients.

Pharma on the other hand, can actually measure the success or lack thereof of animal models in the form of drugs successfully brought to market and Pharma says it doesnt work. Remember, Pharma is a business and they do not care how they develop new drugs they just want to develop new drugs so they can make money. Also remember that there are not two different theories of evolution: one for drug development and another for basic science research or basic research masquerading as applied research. If animal modeling in drug development fails to be consistent with evolutionary biology, then it fails in general as well.

Image courtesy of Wkipedia Common http://en.wikipedia.org/wiki/File:Chromosomes_mutations-en.svg

Continued here:
There is Only One Evolution

PUBLIC RELEASE DATE:

8-Jan-2014

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, January 7, 2014Packaging replacement genes in viruses is an effective method to deliver them to target tissues, but the human body mounts an immune response against the virus. The systemic and local immune reactions induced by an adeno-associated virus (AAV)-based gene therapy to treat lipoprotein lipase deficiency, approved for use in Europe, does not affect the safety of gene therapy or expression of the replacement gene for at least one year after delivery, according to a study published in Human Gene Therapy, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available on the Human Gene Therapy website.

Valeria Ferreira and coauthors, uniQure BV and Academic Medical Center, Amsterdam, the Netherlands, and University of Montreal and Chicoutimi Hospital, Quebec, Canada, evaluated measures of inflammation and adverse clinical events and the expression of a replacement lipoprotein lipase (LPL) gene that was injected intramuscularly into patients with LPL deficiency. The gene was packaged in an AAV vector, as described in the article "Immune responses to intramuscular administration of alipogene tiparvovec (AAV1-LPLS447X) in a phase II clinical trial of Lipoprotein Lipase deficiency (LPLD) gene therapy."

"The clinical data published in this paper were critical to the approval of Glybera," says James Wilson, MD, PhD, Editor-in-Chief of Human Gene Therapy and Director of the Gene Therapy Program, Department of Pathology and Laboratory Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia. "Furthermore, they provide context for laboratory measurements of immune responses which apparently did not impact product performance."

###

About the Journal

Human Gene Therapy, the official journal of the European Society of Gene and Cell Therapy, British Society for Gene and Cell Therapy, French Society of Cell and Gene Therapy, German Society of Gene Therapy, and five other gene therapy societies, is an authoritative peer-reviewed journal published monthly in print and online. Human Gene Therapy presents reports on the transfer and expression of genes in mammals, including humans. Related topics include improvements in vector development, delivery systems, and animal models, particularly in the areas of cancer, heart disease, viral disease, genetic disease, and neurological disease, as well as ethical, legal, and regulatory issues related to the gene transfer in humans. Its sister journals are Human Gene Therapy Methods, published bimonthly and focused on the application of gene therapy to product testing and development, and Human Gene Therapy Clinical Development, published quarterly and featuring data relevant to the regulatory review and commercial development of cell and gene therapy products. Tables of content for all three publications and a sample issue may be viewed on the Human Gene Therapy website.

About the Publisher

Go here to see the original:

Does the body's immune response to viral vector delivery systems affect the safety or efficacy of gene therapy?