New drugs trail many old ones in effectiveness against disease. Unpatentable Drugs and the Standards of Patentability by Benjamin N. Roin. Harvard Law School February 2009 Texas Law Review, Vol. 87, pp. 503-570, 2009 Abstract: The role of the patent system in promoting pharmaceutical innovation is widely seen as a tremendous success story. This view overlooks a serious shortcoming in the drug patent system: the standards by which drugs are deemed unpatentable under the novelty and non-obviousness requirement bear little relationship to the social value of those drugs or the need for a patent to motivate their development. If the idea for a drug is not novel or is obvious, perhaps because it was disclosed in an earlier publication or made to look obvious by recent scientific advances, then it cannot be patented. Yet the mere idea for a drug alone is generally of little value to the public. Without clinical trials proving the drug's safety and efficacy, a prerequisite for FDA approval and acceptance by the medical community, it is unlikely to benefit the public.
Number of Pages in PDF File: 68 Accepted Paper Series. Real-Life True Blood: Synthetic Blood Is Coming — And So Are a Host of Potential Complications | Underwire. Image: HBO Season 6 of HBO’s vampire drama True Blood premieres on Sunday night, presumably following up on last year’s cliffhanger where the factory that produces Tru-Blood — the bottled synthetic blood that allows vampires go “vegetarian” — was burned to the ground, destroying the product that made it possible for vampires to non-violently co-exist with people. But out here in the real world, the future of synthetic blood is just beginning. After decades of global research, controversies, and failed approval petitions, the UK’s Medical and Healthcare products Regulatory Agency finally gave researchers at the Scottish Centre for Regenerative Medicine the go-ahead late last month to start developing synthetic blood with adult stem cells.
And according to Ruha Benjamin, a sociologist at Boston University, the arrival of synthetic blood is also likely to come with some serious socioeconomic and ethical issues, including ones that have complicated many medical advances before it. Organ-on-a-chip. An Organ-on-a-Chip (OC) is a multi-channel 3-D microfluidic cell culture chip that simulates the activities, mechanics and physiological response of entire organs and organ systems. It constitutes the subject matter of significant biomedical engineering research, more precisely in bio-MEMS. The convergence of Lab-on-Chips (LOCs) and cell biology has permitted the study of human physiology in an organ-specific context, introducing a novel model of in vitro multicellular human organisms. One day, they will perhaps abolish the need for animals in drug development and toxin testing. Although multiple publications claim to have translated organ functions onto this interface, the movement towards this microfluidic application is still in its infancy.
Organs-on-chips will vary in design and approach between different researchers. As such, validation and optimization of these systems will likely be a long process. Brief Overview of Lab-on-Chips (LOCs) Organs Lung-on-a-Chip Nina Tandon: Could tissue engineering mean personalized medicine? Engineering 3D-printed stem cells. Inside the stem cell printer. While much has been said on the topic of 3D printing within the context of the maker movement, it is in the medical world where arguably the most important advances are being made.
Scientists at the Heriot-Watt University in Scotland have recently proven they can print human embryonic stem cells, a breakthrough which has the potential to revolutionise organ replacement in the coming years. The printer is able to print clusters of the embryonic stem cells delicately enough that they don’t get harmed in the process – this is done by using a series of microvalves. Valve based printing Dr. The cells maintained their important biological function of pluripotency Maintaining the pluripotency of each cell is key because this will allow for stem cells to make any type of organ or tissue and while 3D printing cells has been achieved previously, Dr. Dr. Ending drug testing on animals For a lot of human diseases it is best to use human tissue to test drugs Dr. Of Mice and Man | Science & Society. Editing the genome with high precision. Researchers at MIT, the Broad Institute and Rockefeller University have developed a new technique for precisely altering the genomes of living cells by adding or deleting genes.
The researchers say the technology could offer an easy-to-use, less-expensive way to engineer organisms that produce biofuels; to design animal models to study human disease; and to develop new therapies, among other potential applications. To create their new genome-editing technique, the researchers modified a set of bacterial proteins that normally defend against viral invaders. Using this system, scientists can alter several genome sites simultaneously and can achieve much greater control over where new genes are inserted, says Feng Zhang, an assistant professor of brain and cognitive sciences at MIT and leader of the research team.
Zhang and his colleagues describe the new technique in the Jan. 3 online edition of Science. Lead authors of the paper are graduate students Le Cong and Ann Ran. Early efforts. Light-up tumors show aging in real-time. UNC-CHAPEL HILL (US) — Mice with glowing tissue allow scientists to visualize aging and tumor growth using a gene closely linked to both processes. Researchers have long known that the gene, p16INK4a (p16), plays a role in aging and cancer suppression by activating an important tumor defense mechanism called “cellular senescence.” A team led by Norman Sharpless, Professor of Cancer Research at University of North Carolina, has developed a strain of mice that turns on a gene from fireflies when the normal p16 gene is activated. In cells undergoing senescence, the p16 gene is switched on, activating the firefly gene and causing the affected tissue to glow. Throughout the entire lifespan of these mice, the researchers followed p16 activation by simply tracking the brightness of each animal.
They found that old mice are brighter than young mice, and that sites of cancer formation become extremely bright, allowing for the early identification of developing cancers. Surprising results. Why mice may succeed in research when a single mouse falls short. The New York Times recently produced an article entitled “Mice Fall Short as Test Subjects for Humans’ Deadly Ills” which argued that certain mouse models were flawed.
This post by Mark Wanner was originally posted on The Jackson Laboratory‘s “Genetics and Your Health” blog aimed to clear up some of the misunderstandings that may have come from this article, as well as to explain the benefits that can still be accrued from mice. It is being reproduced here with the full permission of the original author. What would happen if all clothes were made to fit only one person, or at most, that person and his or her identical twin? Whoever it was, this one person wouldn’t represent all people. I hope this is an obvious statement—we all have differences in every measurement possible, and certainly no manufacturer would make a line of clothing tailored only to one person’s size.
But imagine taking this person and testing a new drug in her. Or him. Mark Wanner The Jackson Laboratory Like this: Health Testing on Mice Is Found Misleading in Some Cases. Researchers uncover major source of evolutionary differences among species. University of Toronto Faculty of Medicine researchers have uncovered a genetic basis for fundamental differences between humans and other vertebrates that could also help explain why humans are susceptible to diseases not found in other species. Scientists have wondered why vertebrate species, which look and behave very differently from one another, nevertheless share very similar repertoires of genes. For example, despite obvious physical differences, humans and chimpanzees share a nearly identical set of genes. The team sequenced and compared the composition of hundreds of thousands of genetic messages in equivalent organs, such as brain, heart and liver, from 10 different vertebrate species, ranging from human to frog.
They found that alternative splicing—a process by which a single gene can give rise to multiple proteins—has dramatically changed the structure and complexity of genetic messages during vertebrate evolution. NIH told to retire most research chimpanzees. Tim Mueller/The New York Times/Redux/eyevine Most research chimpanzees would be retired under new recommendations. The US National Institutes of Health (NIH) should dismantle a decades-old colony of 360 chimpanzees, retiring all but 50 or so of the animals to a national sanctuary, the agency was told on 22 January in a long-awaited report. The report, from a working group of external agency advisers, also counsels the NIH to end half of 22 biomedical and behavioural experiments, saying that they do not meet criteria established in a December 2011 Institute of Medicine (IOM) report.
“Clearly there is going to be a reduction in the use of chimpanzees in research,” says working group co-chair Kent Lloyd, associate dean for research at the School of Veterinary Medicine, University of California Davis. Three of nine ongoing invasive experiments — involving immunology and infectious diseases — could continue, the report says, because they meet the IOM criteria.