Basic and Applied Dermatology Forum – Seminar Series 

Target Health is pleased to announce that it is a Sponsor of the Basic and Applied Dermatology Forum. The next meeting will be held on Tuesday, September, 15, 2009 between 12:30 – 2:30 pm. Dr. Francois Berthiaume, Associate Professor/Biomedical Engineering, Rutgers University will be speaking on the topic of “Metabolic and Tissue Engineering for Skin Wound Healing.” Registration is free. Please let us know if you plan to attend the meeting to be held at:

New Jersey Center for Biomaterials
Life Sciences Building – Busch Campus
Auditorium and Atrium
145 Bevier Road
Piscataway, NJ  08854

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

Metabolic Fingerprints

Scientists are reporting evidence that people have another defining trait that may distinguish each of the 6.7 billion 1) ___ on Earth from one another almost as surely as the arches, loops, and whorls on their fingertips. They report evidence from studies in humans for the existence of unique patterns in metabolism. Metabolism is a complex series of chemical processes. The body uses it to turn food into 2) ___, to grow, repair damage from diseases and injuries, use medicines, and carry out other functions necessary for life. In the new study, Ivano Bertini and colleagues cite growing evidence that each individual has a unique metabolic profile. It’s a biochemical counterpart to 3) ___ that can be detected by analyzing the chemical whorls and grooves that result from metabolism and can be detected in the urine. Doctors have dreamed of using such tests for the early diagnosis of 4) ___ and personalized medical care. They could pick drugs and treatments that are best for each 5) ___, rather than today’s one-size-fits all medicine. To do so, however, doctors need evidence that the metabolic fingerprint remains stable over a period of years, with changes due to disease or medications, for instance, but not advancing age or other factors. The new study provides that evidence, based on the analysis of over 1,800 6) ___ samples from people monitored for 2-3 years. The study was able to identify individual patients from their metabolic profiles with an accuracy of over 99%. The study could pave the way for using metabolic profiling to apply personalized medical care. Source: American Chemical Society 

ANSWERS 

  • 1) humans; 2) energy; 3) fingerprints; 4) disease; 5) individual; 6) urine

What Caused Mozart’s Death?

There have been various theories about the sudden death of Wolfgang Amadeus Mozart, including, poisoning, syphilis, kidney failure, and even Henoch-Sch?nlein purpura. But, in a fascinating article from the Annals of Internal Medicine, a simpler explanation has been suggested: streptococcal infection.  Deaths in Vienna during the winter of 1791 were analyzed, and it was found that, “Tuberculosis and related conditions accounted for the highest number of deaths; cachexia and malnutrition ranked second, and edema was the third most common cause.”  History has noted that Mozart had severe edema upon his death, leading many to speculate that kidney failure was a precipitating cause. But given the sudden nature of his death, along with the fact that he also had a fever, rash, and malaise, an infection like streptococcus becomes plausible.  Untreated streptococcal infection can lead to a kidney condition known as poststreptococcal glomerulonephritis, which can explain many of his described symptoms.

Honey Bee Celestial Navigation and Non-Human Intelligence

Female honey bees are the workers of the hive. First, they learn to babysit, then they learn the construction trade (specializing, of course, in hexagonal wax structures), and eventually take on the daunting task of navigating in the outside world. Honey bees have been known to travel over 10 kilometers away from their hives to find honey – the equivalent of a human flying from San Francisco to Denver to get some pollen. It takes about 6 bees for a lifetime, and thousands of miles flown, to make one teaspoon of honey. Bees are the only other species, to date, that have been shown to communicate with symbolic language-that is, they can talk about details of something that is not present. And what do bees talk about? Mostly astronomy – in particular about the Sun; where it is as compared to where the flowers are. And how do they talk? Mostly they dance! We know of three languages that bees use; it has been postulated that they have several more. The easiest is the Round Dance. Basically when a bee finds a nectar source nearby she comes back to the hive and dances around in a circle giving out samples; (for humans this works well at ice cream stores). The Round Dance tells the other bees to go out and sniff around for the source – it is very close. Another dance is known as the DVAV Dance – basically a kind of bee belly dance. This dialect is reserved for internal hive politics-who is to be the next queen? Is it a good day to swarm? But the most studied language of the bees is the Waggle Dance. When a bee finds a nectar source farther away, she comes into the hive and gets some of the other ladies to gather around. Although it is dark, they can feel how she dances and also taste a bit of the quality of nectar she has brought back. She then starts this special dance over the combs. If more than one bee is dancing, eventually, which source to go to first will be decided democratically; it is discussed until the vote is unanimous. In the waggle dance up is always the direction to the Sun. The bees have little muscles in their necks that can tell which direction is vertical in the dark. The angle from the Sun to the nectar source is then the angle at which the scout bee dances from the vertical, indicating the angle at which the others must navigate. But how far away is the flower? As the scout bee (sometimes called the recruiter bee) dances, the number of waggles she does in the correct angular direction before turning around to begin again is how far the honey source is in bee units. Different types of honeybees have slightly different units of measurement. Finally, the time she takes doing the dance indicates how much of a head wind can be expected. This tells the other bees how much fuel (honey) to tank up on to make their trip there and back. The following is the result of a serendipitous experiment which was performed to evaluate training bees to go farther and farther away for nectar. For the study, nectar was placed close to the hive and then moved 25% farther out every day until, after a while, the nectar source was quite far away. During the experiment, the professor got a call from his graduate student that the student’s car had broken down so he had been unable to re-place the nectar source the extra 25% farther that morning. The professor said he would do it, then, that afternoon. When the professor arrived at the nectar source there were no bees present. But when he arrived at the place where the nectar should have been for that day (but had not been moved there yet), there were all the bees waiting for him! Not only had the bees gotten the math correct (25% farther), but the implication is that they had demonstrated the imagination to be able to picture the future by picturing the nectar-not where it was-but where it was going to be. These bee brains should be greatly respected.

BEHAVIOR

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Imitation Promotes Social Bonding in Primates – Capuchin Monkeys Predisposed Toward Individuals Who Imitate Them

According to an article published in Science (2009:325:880-883) imitation, appears to be an ancient interpersonal mechanism that promotes social bonding and, presumably, sets the stage for relative strangers to coalesce into groups of friends. The study found that capuchin monkeys preferred the company of researchers who imitated them to that of researchers who did not imitate them. The monkeys not only spent more time with their imitators, but also preferred to engage in a simple task with them even when provided with the option of performing the same task with a non-imitator. According to Duane Alexander, M.D., Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, where the NIH portion of the study was conducted. “Observing how imitation promotes bonding in primates may lead to insights in disorders in which imitation and bonding is impaired, such as certain forms of autism.” According to the authors, human beings often will take on body postures, make gestures, and display the mannerisms of people they encounter. For the most part, this behavior is unconscious, with both the imitator and the person being imitated unaware that the behavior is taking place. The authors added that people who are not aware they are being imitated often feel affection and empathy for their imitators. In fact, studies have shown that people are more likely to help their imitators, and under appropriate circumstances, even leave them more generous tips. Such imitation is thought to provide the basis by which human beings ultimately form lasting social groups. Before the current study, however, no one had ever determined if nonhuman primates were also predisposed to bond with individuals who imitated them. The study chose capuchins because they are a highly social species that forms strong social groups. As part of the experiment, each monkey was given a wiffle ball since the monkeys commonly display three behaviors when given this ball: poking the ball with their fingers, putting it in their mouths, or pounding it on a surface. In sequence, each monkey was paired with two human investigators, each of which also had a wiffle ball. One investigator would mimic the monkey’s behavior, poking, mouthing, or pounding the ball, as appropriate. The other investigator would adopt a different behavior, for example, pounding the ball when the monkey poked it. Results showed that after the imitation sequence, the monkeys consistently spent more time near the investigator who imitated them than with the investigator who did not-which the researchers interpreted as a sign that the monkeys felt a sense of affiliation toward their imitator. In addition, the monkeys were given a simple task: taking a small trinket from the investigator’s hand, and then returning it to the investigator, in exchange for a small food reward. Although the imitator and the non imitator each had identical rewards, the monkeys consistently chose the imitator to execute the task. Wild capuchin monkeys have been observed to match each other’s behaviors when feeding, traveling, or avoiding predators. According to the authors, such behavior matching may provide the basis for the formation of social groups. Individuals who match each others’ behaviors feel a sense of affinity for each other, making conflicts less likely, and cooperation more likely. Eventually, such connections extend throughout the group. The authors added that the link between behavior matching and increases in affiliation might have played an important role in human evolution by helping to maintain harmonious relationships between individuals.

ONCOLOGY

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MicroRNAs May Identify Risk of Pancreatic Cancer

Pancreatic cancer, the fourth most common cause of cancer death in the United States, has a poor survival rate compared with that of other types of cancer. Less than 5% of the patients with pancreatic cancer survive five years past diagnosis. Pancreatic cancer is difficult to detect at early stages. In most patients, symptoms do not appear until the cancer is locally advanced or has spread to other parts of the body. The absence of symptoms in early-stage disease and the current lack of effective, minimally invasive screening and diagnostic techniques limit the available treatment options. Both contribute to the high mortality rate observed for patients with pancreatic cancer. According to an article published online in Cancer Prevention Research (1 September 2009), small molecules known as microRNAs, which can be detected in blood samples, have the potential to help identify patients with pancreatic cancer. MicroRNAs, or miRNAs, are short strands of RNA. The miRNAs regulate gene expression by controlling the translation of a specific type of RNA called messenger RNA which relays the genetic instructions for making proteins. Previous research has indicated that miRNAs play important roles in regulating normal cell proliferation and in cancer. Altered patterns of miRNA expression have been seen in pancreatic cancer as well as many other cancers. In addition, it has recently been reported that tumor-derived miRNAs can be detected in blood and that these molecules are stable in stored samples. Thus, miRNAs circulating in the blood may have the potential to serve as novel biomarkers for the detection and diagnosis of pancreatic cancer. To evaluate the feasibility of using miRNAs in the blood as biomarkers for pancreatic cancer, a set of four miRNAs were selected that have been associated with pancreatic cancer — miR-21, miR-210, miR-155, and miR-196a. Among these, miR-155 has been identified as a candidate biomarker for early pancreatic cancer, and expression of miR196a has been shown to increase during disease progression. Levels of all four miRNAs were assessed in blood samples from 28 pancreatic cancer patients and 19 healthy volunteers. The study population consisted of patients with pathologically confirmed pancreatic cancer and healthy disease free individuals recruited at the M.D. Anderson Cancer Center between 2002 and 2008. The team found that sensitivity, or ability to accurately detect pancreatic cancer, using the panel of four miRNAs was 64%. The panel also showed an 89% specificity, which indicates the proportion of study participants who did not have pancreatic cancer and were correctly identified as being disease free.

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 Study Indicates Most Industry Postmarketing Studies Meet Timelines

According to FDA, makers of approved drugs and biologics generally are meeting their regulatory obligations and complete their postmarketing studies in a timely manner. A review of 1531 open postmarketing studies indicated that over 80% are proceeding according to the established timelines, have been submitted for FDA review, or have been determined by the FDA to have met their goals or are no longer needed. The study, done under a contract with Booz Allen Hamilton and supported by additional funds from Congress, examined the backlog of industry postmarketing studies for FDA-approved drugs and biologics. The review found that most companies meet their obligations in a timely manner. The study also recommended changes designed to improve the quality of the information submitted to the FDA, the timeliness of the FDA review, and the accuracy of the FDA’s databases. The agency is evaluating the recommendations and already has made significant improvements based upon the study:

Establishment of a postmarketing study development coordinator and a tracking coordinator within each new drug division. 

Development of new Manuals of Policies and Procedures (MAPP) for development of postmarketing studies and tracking the status of postmarketing studies.

Creation of a new postmarketing study database in the Document Archiving and Records Retention System (DARRTS) that includes increased capabilities for data capture, tracking, and generating reports related to postmarketing studies. This system was implemented the end of July 2009.

Under the Food and Drug Administration Amendments Act of 2007, the FDA must undertake such a review annually. The review showed that the industry has been initiating most studies on time and submitting final reports for many studies, as required.  Many of these reports are pending completion of a thorough FDA review. The FDA will continue to work with Booz Allen Hamilton to complete the agency’s review of all submitted reports in a timely manner. Manufacturers of drugs and biologics are also required to report to the FDA in a timely manner any serious safety issues that are identified from studies or other sources. For more information, go to Booz Allen Hamilton report

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

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*CTMSTM, 3) Target Document®, 4) Target Encoder®, 5) Target Newsletter®, 6) Target e*CTRTM (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.