B-Tech Update

Vol. 9, No. 1

Thomas is the B-Tech Update columnist for The SciTech Lawyer. He can be reached at CRT@bionano.com.

This column is devoted to developments in legislative, judicial, and public policy matters concerning the science and technology areas of biotechnology, pharmacy, life sciences, and related arts.

Will That Be Paper, Plastic, Or Protein to Hold Your Medicine?

Biotech researchers have been spending lots and lots of time looking for ways to deliver drugs to specific targets inside the body. Typically the drugs cannot be allowed to spread throughout the body in concentrations high enough to affect the target because of toxic side effects, so the researchers often have attempted to encapsulate the drug materials. Unfortunately, the capsules introduce all kinds of complications given their varying biochemical makeup and properties. A consensus may be developing around using proteins for biocompatibility, but the fact that we are mostly water and that proteins dissolve in water presents a difficult problem for their use as encapsulating materials. Now researchers lead by Joseph DeSimone of the University of North Carolina at Chapel Hill have tweaked protein particles so that they are insoluble outside of a cell, but become soluble once they reach the inside of a cell. Then they release their cargo—in this case a nucleic-acid based small interfering RNA (J. Am. Chem. Soc., DOI: 10.1021/ja302363r).

The “secret sauce” is a compound called dithio-bis(ethyl 1H-imidazole-1-carboxylate) (DIC), which cross-links proteins via their amine groups and makes them no longer soluble in water. However, DIC contains a disulfide bond that breaks in the environment inside a cell, thus allowing the protein capsule to release its cargo. Also, the remaining halves of the DIC molecule fall off the proteins when the disulfide bonds break and restore the proteins to their original state. This new technique gets high praise from a Stanford University researcher, who described it as “beautiful” and suggests that this opens up the possibility of using the protein matrix itself as a medication. See http://cen.acs.org/articles/90/web/2012/05/Drug-Carrier-Dissolves-Cells.html.

What’s for Dinner Tonight? Something Bio?

The International Food Information Council (http://www.IFIC.us) has been communicating science-based information about food safety and nutrition to health professionals, government officials, educators, journalists, and consumers for almost 20 years. Recently they surveyed consumer perceptions on various food technology issues. The survey found that 74 percent of respondents had read or heard at least “a little” about the concept of food biotechnology. With respect to plant biotechnology in general, respondents who had favorable opinions concerning plant biotechnology (38%) almost doubled those who had unfavorable opinions (20%). Even more respondents (49%) had favorable opinions concerning the use of biotechnology by farmers to grow more crops in order to help meet food demand. An amazing 98 percent said they would prefer biotech crops to shoe leather [according to data B-Tech Update just made up—we now return you to your regularly scheduled words and numbers]. A majority of respondents noted that they were likely to purchase foods produced through biotechnology in order to provide more healthful fats (71%), avoid saturated fat (68%), or make foods taste better or stay fresher (69%). Given the choice between increased pesticide use or biotechnology, 77 percent of respondents said they would be likely to purchase foods that had been biotechnologically engineered for their ability to reduce pesticide use. (A surprising 10% said they would miss the taste of DDT). With respect to animal biotechnology in general, respondents who had favorable opinions concerning animal biotechnology (33%) outnumbered those who had unfavorable opinions (26%). However, the difference in these groups was less pronounced than it was for biotechnologically engineered plants. A majority of respondents (66%) also indicated that they supported the FDA’s current food labeling policy for foods produced through biotechnology. Only 24 percent of respondents believed additional information should be required on food labels, with only 3 percent suggesting that the additional information that was needed on labels related to biotechnology. (One percent has demanded a picture of Frankenstein on the labels, or maybe B-Tech Update just dreamed that). See Patent Docs at http://goo.gl/FEfjj.

It Looks So Easy With Trick Photography

Lee Majors had a robotic arm in The Six Million Dollar Man. Will Smith had one in I, Robot. A report recently published in Nature describes an ongoing clinical trial where a paralyzed woman was able to reach for and sip from a drink on her own—for the first time in nearly 15 years—by using her thoughts to direct a robotic arm. Progress in the real world (sans trick photography) takes lots of time and money. The first $6 million was spent ages ago, but researchers keep advancing brain-computer interface (BCI) functionality. The reported trial is evaluating the safety and feasibility of an investigational device called the BrainGate neural interface system. Two individuals paralyzed by strokes are learned to use the BrainGate system to make reach-and-grasp movements with a robotic arm, as part of the BrainGate2 clinical trial. The report highlights the potential for long-term use and durability of the BrainGate system, part of which is implanted in the brain to capture the signals underlying intentional movement. The BrainGate neural interface system consists of a sensor to monitor brain signals and computer software and hardware that turns these signals into digital commands for external devices. The sensor is a baby-aspirin-sized square of silicon containing 100 hair-thin electrodes, which can record the activity of small groups of brain cells. It is implanted into the motor cortex, a part of the brain that directs movement. The report also describes the most complex functions to date that anyone has been able to perform using a brain-computer interface. As the trial continues, the research team needs to test the technology in more individuals, they said. For more information, visit http://www.braingate2.org or http://www.clinicaltrials.gov/ct2/show/NCT00912041. Hochberg L.R. et al., “Reach and Grasp by People With Tetraplegia Using a Neurally Controlled Robotic Arm,” Nature, May 17, 2012, Vol. 485, pp. 372–75.

What Doesn’t Belong in This Picture (But Should)?

The Smithsonian: the words conjure up images of dinosaur fossils, decades-old airplanes, and ancient Egyptian jewelry. Genomics? Not so much. But next year the Smithsonian and the National Human Genome Research Institute (NHGRI), with $3.5 million in funding from the Life Technologies Foundation and others, will open an exhibit to highlight human genomics. The planned exhibit will celebrate the tenth anniversary of the completion of the Human Genome Project and the 60th anniversary of the discovery of the DNA double helix by James Watson and Francis Crick. The people behind the effort understand how important it is for the public to understand and to appreciate the applications genomics has for society and for individuals and medical care. It is interesting that one of the planned themes is “The Genome and You” and that one of the other funders is the Brin Wojcicki Foundation (as in 23andMe). As the Smithsonian museum aims to engage and educate visitors about the impact of genomics in the twenty-first century, one cannot help but wonder about subjects for possible other “museum” exhibits, such as ones on quantum computers and invisibility cloaking technologies. All kidding aside, Smithsonian visitors should learn to recognize that DNA is the universal code that connects all life on earth, past and present, and that the exhibit will highlight how genomics helps us better understand the natural world. At some future point the Smithsonian building may become “the largest and densest collection of genomes on Earth,” and that harnessing the information in that repository for genomics research is part of the museum’s five-year plan. In the words of one of the people making this exhibit happen, this will be “way cool.” See http://www.genomeweb.com//node/1077366.

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