Target Health is pleased to announce that FDA has accepted our validation package for eSubmissions and our Gateway account has been activated. Most of our INDs are being submitted electronically, and we are preparing an eCTD NDA to be submitted Q4 2009. One of the main operational advantages of the eIND submissions is that the NDA submission is being built right from the get-go without much additional costs, and the stress of preparing the NDA is dramatically reduced.
All of our software tools save time and the ROI is significant. For example, the reduction in the direct and indirect costs of sending overnight mail are easily offset when companies use Target Document. Electronic signature “pages” cannot be misplaced and we also save trees.
For more information about Target Health or any of its software tools for clinical research, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website,
Diffuse large B-cell lymphoma is an aggressive form of non-Hodgkin lymphoma that represents 30% of newly diagnosed cases. DLBCL consists of different subtypes that vary biologically and differ significantly in their survival rates following chemotherapy. Among the subtypes, the germinal center B cell-like (GCB) subtype is more responsive to treatment than the activated B cell-like (ABC) subtype. The current standard of care for DLBCL, a combination chemotherapy including four drugs collectively known as CHOP, is able to cure 50% to 60% of patients. Gene activity, or expression, is a measure of the biological activity of a gene. According to an article published in the New England Journal of Medicine (2008;359:2313-2323), patterns of gene activity in a type of non-Hodgkin lymphoma has provided a better understanding of factors that contribute to the survival of patients treated for the disease. Determining the activity levels of all genes in lymphoma patients’ genomes allowed the research team to identify sets of genes in diffuse large B-cell lymphoma (DLBCL) that influenced the effectiveness of treatment. For the study, after thousands of genes in DLBCL tumors were analyzed. One signature, termed the germinal center B-cell signature, was expressed by malignant cells in the tumors and reflected whether the tumors were of the GCB or ABC DLBCL subtype. In contrast, the other two gene expression signatures reflected different activities of the non-malignant cells within the tumor microenvironment. One signature, termed stromal-1, was found in tumors that expressed genes involved in forming or modifying the extracellular matrix, the fibrous network of molecules between cells that regulates the structure and function of tissues. These tumors also contained many macrophages, a type of white blood cell. High expression of this signature was associated with good prognosis. Another signature, termed stromal-2, was present in DLBCL tumors that had abundant angiogenesis, the process whereby new blood vessels are formed. The stromal-2 signature was associated with poor prognosis. The authors used the data from these three gene expression signatures to create a mathematical formula. Using this formula, they found that it was possible to divide patients who had been treated with R-CHOP or CHOP chemotherapy alone into subgroups that had better or poorer survival. The International Prognostic Index (IPI), a predictive index used by physicians to evaluate patients with DLBCL, is based on clinical factors including age, stage of the tumor, and whether cancer has spread to other parts of the body. Combining the gene signature model with the IPI improved the predictive power of both models. According to the authors, the ability of a patient with DLBCL to be cured by current therapy can be predicted by looking at the pattern of gene activity in the tumor biopsy sample taken at diagnosis. The authors also suggested that in the near term, there is a need to incorporate gene expression profiling in clinical trials to allow researchers to standardize results according to the variety of DLBCL tumors included in the trial. In the longer term, new therapies will emerge that are tailored to the particular gene expression profile of a patient’s lymphoma.
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 Teams With WebMD For New Online Consumer Health Information
Consumers have increasingly consulted all types of sources to find health information, and the Internet is their fastest growing resource, according to a national study released in August 2008 by the Center for Studying Health System Change. Researchers found that 32% of American consumers – 70 million adults – conducted online health searches in 2007, compared with 16% in 2001. The study also found that most consumers who researched health concerns reported positive outcomes. More than half of those surveyed said the information changed their overall approach to maintaining their health. Four in five said the information helped them better understand how to treat an illness or condition.
WebMD, which attracts nearly 50 million unique visitors each month, provides consumers with credible and timely health news and information. The FDA and WebMD today announced a collaboration that expands consumers’ access to the agency’s timely and reliable important health information. This joint effort reflects the FDA’s emphasis on using innovative, technology-based strategies to carry out its foremost mission, which is to promote and to protect the public health.
The partnership includes:
• A new online consumer health information resource on WebMD.com: Consumers can access information on the safety of FDA-regulated products, including food, medicine and cosmetics, as well as learn how to report problems involving the safety of these products directly to the FDA. In addition, WebMD will bring the FDA public health alerts to all WebMD registered users and site visitors that request them. The cross-linked joint resource will also feature FDA’s Consumer Updatestimely and easy-to-read articles that are also posted on the FDA’s main consumer Web page.
• The FDA contributions to WebMD The Magazine: FDA Consumer Updates will also be featured at least three times a year in WebMD’s bimonthly magazine, which reaches nearly nine million consumers. The magazine is distributed to physician office waiting rooms across the country.
The complete terms and components of the partnership are described in a Memorandum of Understanding which is on display today at the Federal Register office and available online. An agency policy statement summarizing the criteria and processes for development of such partnerships is available on the FDA’s Web site.
For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
Can radiation from cell phones affect the memory? Yes — at least it appears to do so in rat experiments conducted at the Division of Neurosurgery, Lund University, in Sweden. Henrietta Nittby studied rats that were exposed to mobile phone 1) ___ for 2 hours a week for more than a year. These rats had poorer results on a memory test than rats that had not been exposed to radiation. The memory test consisted of releasing the rats in a box with four objects mounted in it. These objects were different on the two occasions, and the placement of the objects was different from one time to the other. The actual test trial was the third occasion. This time the rats encountered two of the objects from the first and two of the objects from the second occasion. The control rats spent more time exploring the objects from the first occasion, which were more interesting since the rats had not seen them for some time. The experiment rats, on the other hand, showed less pronounced differences in 2) ___. The authors believe that the findings may be related to the team’s earlier findings, that is, that microwave radiation from cell phones can affect the so-called blood-brain 3) ___. This is a barrier that protects the brain by preventing substances circulating in the blood from penetrating into the brain tissue and damaging nerve cells. Studies have previously found that albumin, a protein that functions as a transport 4) ___ in the blood, leaks into brain tissue when laboratory animals are exposed to mobile phone microwave radiation. The research team also found certain 5) ___ damage in the form of damaged nerve cells in the cerebral cortex and in the hippocampus, the memory center of the brain. Albumin leakage occurs directly after radiation, while the nerve damage occurs only later, after four to eight weeks. Moreover, they have discovered alterations in the activity of a large number of genes, not in individual genes but in groups that are functionally related. We now see that things happen to the 6) ___ of lab animals after cell phone radiation. The next step is to try to understand why this happens. The author has a cell phone herself, but never holds it to her ear, using hands-free equipment instead, a behavior we all might want to follow.
ANSWERS: 1) radiation; 2) interest; 3) barrier; 4) molecule; 5) nerves; 6) brains