Target Health Highlights Target Document Version 1.4 at DIA
Target Health Inc., has released version 1.4 of Target Document®, its innovative document management software solution. This enhanced version of the company’s proven document management software provides the pharmaceutical industry and CROs with a cost-effective, highly sophisticated, web-based, document management system that allows authorized users to view, download, and manage any document for their organization. Target Document features include: 1) Routing for electronic signatures; 2) Project templates; 3) Automatic email alerts; 4) Communication tools; 5) Document renewals; 6) User management; 7) Audit trail of transactions; 8) Recovery of deleted documents; 9) Archiving of projects; and 10) Compliance with 21CFR Part 11. According to Target Health’s President, Dr. Jules T. Mitchel, “Target Document Version 1.4 was developed as one of the tools to allow Target Health to run a paperless clinical trial operation.” Mitchel added that “the product was so successful for our company that we decided to allow others, including our competitors, to use it.”
Visit Target Health at Booth 2322 at this year’s DIA meeting in San Diego. We are right by the food.
For more information about Target Health and any of 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
Laying the Foundation for Diabetes Personalized Medicine
Translational Genomics Research Institute (TGen) scientists have identified five genetic biomarkers that could help lead to improved treatments, with fewer side-effects, for patients with diabetes. TGen Senior Investigator Dr. Johanna DiStefano presented the findings in New Orleans on June 6, 2009, at the 69th Scientific Sessions of the American Diabetes Association. Stefano said that “We identified genetic variants that may predict how well someone will respond to the common anti-diabetes drug, Actos. The implications of these findings include determining which patients will best respond to the drug for the 1) ___or treatment of diabetes. In addition, this work lays the foundation for personalized medicine for patients with this disease.” Personalized medicine involves the rapid application of laboratory discoveries to therapies, depending on the individual 2) ___make-up. The team investigated why as many as 30-40% of diabetes patients treated with thiazolidinediones (TZDs), such as Actos, fail to respond to the drug with the expected improvement in insulin sensitivity. TZDs are a class of insulin-sensitizing drugs used to treat type 2 diabetes mellitus (T2DM) and are agonists for the nuclear receptor peroxisome proliferator-activated receptor-g (PPARG). Although the exact mechanism by which TZDs act is not yet known, data indicate that TZDs improve insulin sensitivity by direct and indirect effects on adipose tissue and muscle. TZD therapy can significantly lower diabetes incidence in at-risk subjects, suggesting this treatment may be an effective means to prevent the 3) ___. Previously, the investigators found that genetic variations in the PPARG gene were associated with TZD metabolism and the biological effects of TZD, and thereby contribute to the therapeutic response associated with TZD. However, these variants did not fully account for the non-response rate, suggesting that other variants may contribute to TZD response. To identify other variants that predict response to TZDs, a genome-wide analysis was performed of 115,352 single nucleotide polymorphisms, or SNPs (a DNA sequence variation within the more than 3 billion base pairs in the human genome). In addition, 28 key genes involved in TZD metabolism or PPARG-stimulated pathways were screened. Of the markers examined, five critical markers were identified that may predict response to TZD mono-therapy. These markers include variants in a key drug metabolizing gene called cytochrome P450 3A4 and a PPARG-coactivator known as PPARGC1B. Other markers were located in genes associated with PPARG function and include the protein kinase MAP2K6, a potassium inwardly-rectifying channel called KCNJ16, and the farnesoid X receptor (NR1H4). Together, these markers predicted both response to Actos therapy and improvement in 4) ___ sensitivity in the patients taking the drug. The next steps in this research will be to characterize the functional effects of the polymorphisms and assess the effect of these variants in other 5) ___. This work may help treat the right people with the right drug, design better drugs that will effectively improve insulin sensitivity for more people, and possibly safeguard against adverse side reactions seen with some members of this drug class. Importantly, these findings will enable the dissection of the 6) ___ of TZD response, which will expand our understanding of the genetic determinants of insulin resistance and its treatment. The findings will also provide critical baseline information for the development and implementation of genetic screening into the therapeutic decision making process, and lay the foundation for “individualized medicine” for patients with T2D. Source: The Translational Genomics Research Institute
1) prevention; 2) genetic; 3) disease; 4) insulin; 5) patients; 6) pharmacogenetics
The Common Cold
Colds were known in ancient Egypt; there were hieroglyphs for cough and for the common cold. The Greek physician, Hippocrates gave a description of the common cold in the 5th century BCE. The common cold was also known in the ancient American Indian Aztec and Maya civilizations. A mixture of chili pepper, honey, and tobacco was one common Aztec treatment for colds. The name “common cold” came into use in the 16th century, due to the similarity between its symptoms and those of exposure to cold weather. Norman Moore, in his history of the Study of Medicine, noted that James I continually suffered from nasal colds, which were then thought to be caused by polypi, sinus trouble, or autotoxaemia. In the 18th century, Benjamin Franklin considered the causes and prevention of the common cold. After several years of research he concluded: “People often catch cold from one another when shut up together in small close rooms, coaches, etc., and when sitting near and conversing so as to breathe in each other’s transpiration.” Although viruses had not yet been discovered, Franklin hypothesized that the common cold was passed between people through the air. He recommended exercise, bathing, and moderation in food and drink consumption to avoid the common cold. Franklin’s theory on the transmission of the cold was confirmed some 150 years later. In the 18th century, John Wesley wrote a book about curing diseases and advised cold baths as prevention. He also stated that chilling causes the common cold. Another book by William Buchan in the 18th century also gave wet feet and clothes as the cause of the common cold. The idea of microscopic infectious agents causing disease arose in the second half of the 19th century. Initially, bacteria were suspected to be the cause of the common cold, and vaccines were produced based on this theory. Viruses had been described beginning with the 1890s as infectious agents so small that they could pass through all filters and could not be seen under a microscope. In 1914, Walter Kruse, a professor in Leipzig, Germany, showed that viruses caused the common cold; nose secretions of a cold sufferer were diluted, filtered, and introduced into the noses of volunteers, producing colds in about half of the cases. These findings were not widely accepted, until they were repeated in the 1920s by Alphonse Dochez, first in chimpanzees, and then in human volunteers using a proper double-blind study.
Small Numbers of Stem-Like Immune Cells Destroy Large Tumors in Mice
Current clinical immunotherapies based on the transfer of tumor-specific T cells, generated and expanded in the laboratory, rely on the use of large numbers of tumor-specific T cells. These treatments have had some beneficial but usually limited success. According to a study published online in Nature Medicine (14 June 2009), a new approach to stimulating immune cells, results in a powerful anti-tumor response in mice. The study found that a subset of immune cells, T lymphocytes called CD8+ memory stem cells, were capable of mediating strong anti-tumor immune response. These potent cells were generated in the laboratory by stimulating anti-tumor T cells in the presence of drugs designed to mimic an important signaling pathway called Wnt, which describes a complex network of proteins whose interactions are essential during development and stem cell maintenance. Under the influence of Wnt, T lymphocytes acquired stem cell-like properties of multipotency and self renewal; that is, they generate differentiating daughter cells while regenerating themselves when they are transferred back to mice. These stem cell-like qualities enabled tiny numbers of T cells (about 40,000 cells) to trigger the destruction of large melanoma tumors (containing about one billion malignant cells). This therapy, in which mice received CD8+ T memory stem cells together with a tumor vaccine and an immune system stimulant known as interleukin 2, improved the survival of treated mice compared with similar treatment using other types of memory T cells. If confirmed in humans, the use of tumor-reactive CD8+ memory stem cells could reduce the numbers of tumor-specific T cells needed for successful immunotherapy, thus making this type of therapy easier to develop so that more patients could benefit. These findings mark the latest advance in the field of cancer immunotherapy using tumor-specific T cells, which is moving from proof-of-concept to a promising treatment for patients with metastatic cancer.
Zika Virus Outbreak on Yap Island, Federated States of Micronesia
The Zika virus is a mosquito-borne virus of the genus Flavivirus (family Flaviviridae), and is found in parts of Africa and in Malaysia, and causes Zika fever. The virus was first isolated in the Zika forest in Uganda and is similar to the dengue virus. In 2007, physicians on Yap Island reported an outbreak of illness characterized by rash, conjunctivitis, and arthralgia. Although serum from some patients had IgM antibody against dengue virus, the illness seemed clinically distinct from previously detected dengue. Subsequent testing with the use of consensus primers detected Zika virus RNA in the serum of the patients, but no dengue virus or other arboviral RNA. No previous outbreaks and only 14 cases of Zika virus disease have been previously documented. As part of the followup to this initial report, a study was reported in the New England Journal of Medicine (2009;360:2536-2543) where blood samples were obtained for additional analyses and patients were interviewed concerning information on their clinical signs and symptoms. To confirm Zika virus disease, Zika virus RNA or a specific neutralizing antibody response to Zika virus in the serum had to be present. Patients with IgM antibody against Zika virus who had a potentially cross-reactive neutralizing-antibody response were classified as having probable Zika virus disease. Results showed that there were 49 confirmed and 59 probable cases of Zika virus disease and these patients resided in 9 of the 10 municipalities on Yap. Rash, fever, arthralgia, and conjunctivitis were common symptoms. No hospitalizations, hemorrhagic manifestations, or deaths due to Zika virus were reported. It was estimated that 73% of Yap residents 3 years of age or older had been recently infected with Zika virus. Aedes hensilli was the predominant mosquito species identified. According to the authors, the outbreak of Zika virus illness in Micronesia represents transmission of Zika virus outside Africa and Asia. Although most patients had mild illness, clinicians and public health officials should be aware of the risk of further expansion of Zika virus transmission.
VI. PUBLIC HEALTH
School-Based Prevention Program Reduces Problem Behaviors in 5th Graders
A study published on line in the American Journal of Public Health (June 2009), suggests that school-based prevention programs begun in elementary school can significantly reduce problem behaviors in students. Fifth graders who previously participated in a comprehensive interactive school prevention program for one to four years were about half as likely to engage in substance abuse or violent behavior as those who did not take part in the program. The study was conducted in 20 public elementary schools in Hawaii. Participating schools had below-average standardized test scores and diverse student populations, with an average of 55% of students receiving free or reduced-price lunches. The intervention tested was Positive Action (PA), a comprehensive K-12 social and emotional development program for enhancing behavior and academic achievement. Schools were randomly assigned from matched pairs either to implement PA or not. The program consists of daily 15-20 minute interactive lessons focusing on such topics as responsible self-management, getting along with others, and self-improvement. At schools implementing the intervention, these lessons occupied a total of about 1 hour per week beginning in the first or second grade. In fifth grade, 976 students (most of whom were aged 10 or 11) responded to a written questionnaire that asked about their use of substances, including tobacco, alcohol, and illicit drugs; involvement in violent behaviors, such as carrying a knife or threatening someone. The total number of students reporting that they had engaged in any of these behaviors was small. Strikingly, however, students exposed to the PA program were about half as likely to report engaging in any of these behaviors as students not exposed to PA. Among students who were exposed to PA, those who had received the lessons for 3 or more years reported the lowest rates of experience with any of these problem behaviors. PA is an interactive program that integrates teacher/student contact and opportunities for the exchange of ideas as well as feedback and constructive criticism. The program is school-wide and involves teachers and parents as well as students. It takes a positive, holistic approach to social and emotional development rather than focusing on the negative aspects of engaging in substance abuse and violence. Additionally, at 1 hour per week, students’ exposure to the program was intensive. A follow up study is planned to determine whether the beneficial effects of the PA program on fifth graders are sustained as the children grow older.
VII. REGULATORY AFFAIRS
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 Warns Consumers Not to Eat Nestle Toll House Prepackaged, Refrigerated Cookie Dough
E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing Hemolytic Uremic Syndrome (HUS), which can lead to serious kidney damage and even death. The FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). The FDA advises that if consumers have any prepackaged, refrigerated Nestle Toll House cookie dough products in their home that they throw them away. Cooking the dough is not recommended because consumers might get the bacteria on their hands and on other cooking surfaces. Retailers, restaurateurs, and personnel at other food-service operations should not sell or serve any Nestle Toll House prepackaged, refrigerated cookie dough products subject to the recall. Nestle USA, which manufactures and markets the Toll House cookie dough, is fully cooperating with the ongoing investigation by the FDA and CDC. The warning is based on an ongoing epidemiological study conducted by the CDC and several state and local health departments. Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called HUS. No one has died. Individuals who have recently eaten prepackaged, refrigerated Toll House cookie dough and have experienced any of these symptoms should contact their doctor or health care provider immediately. Any such illnesses should be reported to state or local health authorities. The FDA reminds consumers they should not eat raw food products that are intended for cooking or baking before consumption. Consumers should use safe food-handling practices when preparing such products, including following package directions for cooking at proper temperatures; washing hands, surfaces, and utensils after contact with these types of products; avoiding cross contamination; and refrigerating products properly. For more information on safe food handling practices, go to http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm109899.htm.
For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
VIII. TARGET HEALTH INC.
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
By Daily Mail Reporter
Last updated at 12:11 PM on 18th June 2009
Fallopian tubes removed during hysterectomies could provide a rich new source of stem cells, it was claimed today.
Scientists in Brazil found large numbers of ‘mesenchymal’ stem cells in fallopian tubes taken from women of reproductive age.
Grown in the laboratory, they were able to differentiate into muscle, fat, cartilage and bone cells.
The finding unveils a new way to create the promising cells, hoped to replenish tissues lost to disease, without using embryos.
Mesenchymal stem cells are a particular family of ‘mother’ cell described as ‘pluripotent’ – meaning they have the potential to develop into a range of different tissues.
They have also been obtained from umbilical cords, the inner pulp of teeth, and fat tissue.
Scientists hope that one day stem cells will be used to treat a huge range of disorders in which parts of the body become damaged or lost. Examples include heart disease, brain diseases such as Parkinson’s and insulin-dependent diabetes, in which insulin-producing beta cells of the pancreas are destroyed.
Women have a pair of fallopian tubes which transport eggs from the ovaries to the womb and are essential to pregnancy.
The tubes are removed when women undergo certain gynaecological procedures, including hysterectomies. Usually they are discarded.
The new research led by Tatiana Jazedje, from the University of Sao Paulo, is reported online in the Journal of Translational Medicine.
Writing in the journal the researchers concluded: ‘Tissue fragments of hFTs (human fallopian tubes), which are usually discarded after surgical procedures, may represent a new potential source of pluripotent cells for regenerative medicine.’