Science Weekly: Obama pulls the plug on Nasa’s moon ambitions

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Future of human spaceflight; reaction speeds in gunfights; plus, is the MMR controversy really over?

American Academy of Dermatology Annual Meeting

Target Health is pleased to announce that Dr. Jules Mitchel will be attending the annual meeting of the American Academy in Miami, March 7-8. Please let us know if you will be attending.

For more information about Target Health and our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com

Physicists Kill Cancer With Nanobubbles

Using lasers and nanoparticles, scientists at Rice University have discovered a new technique for singling out individual diseased cells and destroying them with tiny explosions. The scientists used 1) ___ to make “nanobubbles” by zapping gold nanoparticles inside cells. In tests on cancer cells, they found they could tune the lasers to create either small, bright bubbles that were visible but harmless or large bubbles that burst the 2) ___. “Single-cell targeting is one of the most touted advantages of nanomedicine, and our approach delivers on that promise with a localized effect inside an individual cell,” said Rice physicist Dmitri Lapotko, the lead researcher on the project. “The idea is to spot and treat unhealthy cells early, before a disease progresses to the point of making people extremely ill.” The research is available online in the journal Nanotechnology. Nanobubbles are created when 3) ___ nanoparticles are struck by short laser pulses. The short-lived bubbles are very bright and can be made smaller or larger by varying the power of the laser. Because they are visible under a microscope, nanobubbles can be used to either diagnose sick cells or to track the explosions that are destroying them. In laboratory studies published last year, Lapotko and colleagues at the Laboratory for Laser Cytotechnologies at the A.V. Lykov Heat and Mass Transfer Institute in Minsk, Belarus, applied nanobubbles to arterial plaque. They found that they could blast right through the deposits that block 4) ___. The bubbles work like a jackhammer. In the current study, Lapotko and Rice colleague Jason Hafner, associate professor of physics and astronomy and of chemistry, tested the approach on leukemia cells and cells from head and neck cancers. They attached antibodies to the nanoparticles so they would target only the cancer cells, and they found the technique was effective at locating and killing the 5) ___ cells. Lapotko said the nanobubble technology could be used for “theranostics,” a single process that combines diagnosis and therapy. In addition, because the cell-bursting nanobubbles also show up on 6) ___ in real time, Lapotko said the technique can be use for post-therapeutic assessment, or what physicians often refer to as “guidance.” Hafner said, “The mechanical and optical properties of the 7) ___ offer unique advantages in localizing the biomedical applications to the individual cell level, or perhaps even to work within cells.” The research resulted from collaboration between Rice and the Lykov Institute of the Academy of Science of Belarus, which recently established the US-Belarus Research Lab of Fundamental and Biomedical Nanophotonics.

ANSWERS: lasers; 2) cells; 3) gold; 4) arteries; 5) cancer; 6) microscopes; 7) bubbles

Mutation In Brain Cells Of Descendants Of Abraham Lincoln Suggest He Suffered From Movement Disorder

Researchers at Johns Hopkins and the University of Minnesota discovered a gene mutation in the descendants of Abraham Lincoln’s grandparents that suggests the Civil War president himself might have also suffered from a disease that destroys nerve cells in the cerebellum – the part of the brain that controls movement. The joint finding of the SCA5 mutation comes over a decade after initial speculation that Lincoln might have suffered from Marfan disease. People with this inherited disorder are often tall and thin and can commonly have slender, tapering fingers. The identification of the Marfan gene at Hopkins sparked debate concerning testing of President Lincoln’s DNA to determine whether his tall stature could have been caused by that disease. The discovery in Lincoln’s descendants of the gene that causes a movement disorder called spinocerebellar ataxia type 5 (SCA5), however, appears to offer much stronger evidence that the past president himself might have had SCA5. SCAs are neurodegenerative disorders that cause loss of coordination of limbs and eye movements, slurred speech and swallowing difficulties. The finding also has wider implications because similar mutations might also be associated with other neurodegenerative diseases. The study discovered that SCA5 is caused by a mutation of the ?-III spectrin gene SPTBN2, which disrupts the ability of certain nerves in the cerebellum to respond normally to incoming chemical signals. Eventually, these nerves – called Purkinje cells – degenerate, and the person loses fine control of the leg and arm muscles. This would explain historical descriptions of Lincoln’s uneven gait – an early sign of ataxia. Ataxia is an inability to coordinate muscle activity in the arms and legs. The study, published in Nature, found the mutation in all 90 affected individuals (ages 7 to 80 at time of exam) and in 35 descendants of Lincoln who had not yet started to show symptoms of SCA5 (ages 13 to 67 at time of exam). The study also found two other types of mutations in ?-III spectrin 2 in a French and German family, respectively. The mutations found in the American, French and German families each affected a different part of the SPTBN2 gene, and thus knocked out a different part of the ?-III spectrin protein. Adapted from materials provided by Johns Hopkins Medical Institutions.

ONCOLOGY

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Antibodies Against Abnormal Glycoproteins Are Possible Biomarkers For Cancer Detection

An antibody is a type of protein that the body’s immune system produces when it detects harmful substances called antigens. Antigens include microorganisms such as bacteria, fungi, parasites, and viruses. Antibodies are also produced when the immune system mistakenly considers healthy tissue a harmful substance. These antibodies, called autoantibodies, target a person’s own molecules and tissues. Research has shown that cancer patients sometimes make autoantibodies against their own malignant cells and tissues, as part of an immune response against their cancers. It is unclear why some cancer cells evade immune defenses. According to an article published in Cancer Research (15 February 2010), it was found that cancer patients produce antibodies that target abnormal glycoproteins (proteins with sugar molecules attached) made by their tumors. The result of this work suggests that antitumor antibodies in the blood may provide a fruitful source of sensitive biomarkers for cancer detection. The glycoproteins that were the focus of this study are called mucins. Mucins comprise a family of glycoproteins, called O-glycoproteins, which are on the outer surface of cells and play an important role in cell-to-cell interactions. Tumors have been found to produce different types and amounts of mucins compared with normal cells and these mucins have been shown to have altered sugar groups. The study hypothesis was that the abnormal molecular structures of the O-glycoproteins manufactured by cancer cells might cause patients to develop autoantibodies to them. To test this theory, the study had to overcome a number of challenges to develop a tool that could successfully identify autoantibodies to abnormal O-glycoproteins. Previously, the authors used this approach to screen blood specimens from breast, ovarian and prostate cancer patients. Results showed distinct abnormal mucin-type O-glycopeptide epitopes (parts of molecules that antibodies will recognize and bind to) that were targeted by autoantibodies in cancer patients. In contrast, these antibodies were absent in healthy controls. Although larger sets of specimens will have to be analyzed to fully appreciate the clinical value of this technology, the preliminary results are very promising. The study was an international collaboration that was funded in part by NCI through the trans-NIH Alliance of Glycobiologists for Detection of Cancer and Cancer Risk. The alliance is a consortium of NCI-supported tumor glycomics laboratories that are working to reveal the cancer-related dynamics of complex carbohydrates and develop biomarkers for early cancer detection and risk assessment.

Willful Modulation of Brain Activity in Disorders of Consciousness

The differential diagnosis of disorders of consciousness is challenging and the rate of misdiagnosis is approximately 40%. Therefore, new methods are required to complement bedside testing, particularly if the patient’s capacity to show behavioral signs of awareness is diminished. A study, reported in the New England Journal of Medicine (www.nejm.org February 3, 2010;10.1056/NEJMoa0905370), was performed involving 54 patients with disorders of consciousness. The study used functional magnetic resonance imaging (MRI) to assess each patient’s ability to generate willful, neuroanatomically specific, blood-oxygenation-level-dependent responses during two established mental-imagery tasks. A technique was then developed to determine whether such tasks could be used to communicate yes-or-no answers to simple questions. Results showed that of the 54 patients enrolled in the study, 5 were able to willfully modulate their brain activity. In three of these patients, additional bedside testing revealed some sign of awareness, but in the other two patients, no voluntary behavior could be detected by means of clinical assessment. One patient was able to use the technique to answer yes or no to questions during functional MRI; however, it remained impossible to establish any form of communication at the bedside. The authors concluded that the results show that a small proportion of patients in a vegetative or minimally conscious state have brain activation reflecting some awareness and cognition. The authors added that careful clinical examination will result in reclassification of the state of consciousness in some of these patients, and that this technique may be useful in establishing basic communication with patients who appear to be unresponsive.

Mortality Predictors in a 60-Year Follow-Up of Adolescent Males: Exploring Delinquency, Socioeconomic Status, IQ, High-School Drop-Out Status, and Personality

According to an article published in Psychosomatic Medicine (2010;72:46-52), a study was performed to examine whether socioeconomic status (SES), high school (HS) completion, IQ, and personality traits that predict delinquency in adolescence also could explain men’s delinquency-related (Dq-r) mortality risk across the life span. Data for this study was obtained from a sample of the 60-year Social Security Death Index (SSDI) follow-up of 1,812 men from Hathaway’s adolescent normative Minnesota Multiphasic Personality Inventory (MMPI). Mortality risk at various ages and at various levels of prior delinquency severity was examined. The study evaluated SES (using family rent level), HS completion, IQ, and MMPI indicators simultaneously as mortality predictors and tested for SES (rent level) interactions with IQ and personality. Of the 418 decedents, Dq-r mortality peaked between ages 45 years to 64 years and continued through age 75 years, with high delinquency severity showing earlier and higher mortality risk. IQ and rent level failed to explain Dq-r mortality. HS completion robustly conferred mortality protection through ages 55 years and 75 years, explained IQ and rent level-related risk, but did not fully explain Dq-r risk. Dq-r MMPI scales, Psychopathic Deviate, and Social Introversion, respectively, predicted risk for and protection from mortality by age 75 years, explaining mortality risk otherwise attributable to delinquency. Wiggins’ scales also explained Dq-r mortality risk, as Authority Conflict conferred risk for and Social Maladjustment and Hypomania conferred protection from mortality by age 75 years. According to the authors, HS completion robustly predicts mortality by ages 55 years and 75 years. Dq-r personality traits predict mortality by age 75 years, accounting, in part, for Dq-r mortality.

TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.

 

FDA Issues Guidance to Help Streamline Medical Device Clinical Trials

The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies. The Bayesian statistical method applies an algorithm that makes it possible for companies to combine data collected in previous studies with data collected in a current trial. The combined data may provide sufficient justification for smaller or shorter clinical studies. The FDA has substantial experience in the use of Bayesian statistical methods for the design and analysis of scientifically valid clinical studies. The FDA has approved a number of medical devices whose approval applications submitted to the FDA included clinical studies that used these statistical methods. The final guidance, titled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials,“ describes use of Bayesian methods, design and analysis of medical device clinical trials, the benefits and difficulties with the Bayesian approach, and comparisons with standard statistical methods. The guidance also presents ideas for using Bayesian methods in post-market studies. The final document reflects public input gathered in 2006 after release of a draft of the guidance. Health care payers are also contemplating the role Bayesian methods could play in making coverage decisions. In a June 2009 public meeting, the Medicare Evidence Development & Coverage Advisory Committee encouraged Medicare policymakers to consider Bayesian approaches when reviewing trials or technology assessments during the national coverage analysis process. For more information:

Guidance for Use of Bayesian Statistics in Medical Device Clinical Trials

Medicare’s national coverage analysis process (Centers for Medicare and Medicaid Services)

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Target Health (www.targethealth.com) is a full service eCRO with full-time staff dedicated to all aspects of drug and device development. Areas of expertise include Regulatory Affairs, comprising, but not limited to, IND (eCTD), IDE, NDA (eCTD), BLA (eCTD), PMA (eCopy) and 510(k) submissions, Management of Clinical Trials, Biostatistics, Data Management, EDC utilizing Target e*CRF®, Project Management, and Medical Writing. Target Health has developed a full suite of eClinical Trial software including 1) Target e*CRF® (EDC plus randomization and batch edit checks), 2) Target e*CTMS™, 3) Target Document®, 4) Target Encoder®, 5) Target Newsletter®, 6) Target e*CTR™ (electronic medical record for clinical trials). Target Health ‘s Pharmaceutical Advisory Dream Team assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.

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