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• W4247492712 abstract "The National Institutes of Health's National Center for Advancing Translational Sciences (NCATS) is partnering with 8 pharmaceutical companies to give researchers access to compounds or molecules to test their effectiveness in a variety of different diseases. As part of its new Therapeutics Discovery program, NCATS will provide $20 million a year for the next 3 years starting in 2013. The 58 molecules being provided by participating companies have already cleared a number of hurdles, including preclinical and Phase 1 testing, and are ready for additional testing in humans. Leaders of the effort note that, although researchers have identified the causes of more than 4,500 diseases, effective treatments exist for only about 250. Meanwhile, the average time to develop a drug is currently 13 to 15 years. With these molecules, researchers can test biological hypotheses about new uses in unexplored disease areas, says Christine Colvis, PhD, NCATS Therapeutics Discovery program director. The program also provides template agreements between the company and biomedical research partner, which will significantly reduce the amount of time it takes the parties to negotiate terms. “We have seen interest and enthusiasm for this concept from the pharmaceutical industry, as demonstrated by their contribution of molecules for the pilot program,” Dr. Colvis says. “Now that the funding opportunities and information on the molecules have been published, we’re also seeing a lot of enthusiasm from the academic research community.” The molecules selected for the pilot program have advanced to clinical studies but have either been unsuccessful in their original therapeutic indication or were not pursued for business reasons. Under the new agreement, drug companies will retain ownership of their compounds while their research partners retain intellectual property rights and the rights to publish the research. The partners will determine how profits will be divided when they negotiate the contract. This pilot program ultimately will be assessed by its ability to achieve any one of the following: The development of fundamental new information and scientific insight about disease; The advancement of a molecule for new therapeutic uses; Information on the science of translation and drug development from the data and tools produced by the initiative; or The creation of a larger number of partners at a faster rate than traditional public–private partnerships. Above all, Dr. Colvis adds, the program “is an incredible opportunity to try to improve the lives of patients.” The Translational Genomics Research Institute (TGen) is partnering with Persistent Systems to develop a biospecimen management system, Bio4D, that they say will offer a sophisticated method for collecting, storing, and processing a variety of biomedical specimens, including blood, DNA, and tissue samples. TGen, based in Phoenix, Arizona, is a nonprofit biomedical research institute focused on developing earlier diagnostics and improved treatments. Persistent Systems specializes in software product development services. TGen and the Integrated BioBank of Luxembourg initially developed Bio4D to address the many requirements not just for collecting and storing biospecimens and associated data but also for the distribution, analysis, and legalities of blood and tissue banking. Initially, the system was developed to manage biological repositories for genetic and genomic research. Now Persistent Systems and TGen have developed a robust commercial version that the developers say could play an important role in personalized medicine. Beyond the collection point, many clinical trial protocols do not address the management of these samples, notes William Burleson, Bio4D program manager. At the same time, what can and cannot be done with biospecimens is a target for increased legal and ethical scrutiny. The Bio4D system “gives you a full window into the life management of the specimen,” he says. “A lot of other systems are built from the wet lab perspective—they’re very focused on specific lab samples and ignore why you collect samples or track consent from donors.” As genetic material moves increasingly into the privacy sphere, many people want to limit or improve the uses of their genetic material, and they want to know where it is and what is being done with it, Burleson adds. Another important feature of Bio4D is its ease of use, he says. Unlike generic LIMS (Laboratory Information Management Systems), it will have features and functionality designed specifically for biobank scientists and biospecimen managers. Its web-based technology will enable researchers to access data and system analysis results in real time from most web browsers. At press time, the companies were still working on a licensing agreement and conducting beta testing. They expect to have Bio4D available this month. Arizona State University (ASU) scientists have developed a method of detecting bone loss that they say is safer and more sensitive than the standard x-ray technique used currently. Bone loss is a particular concern in a number of diseases, ranging from osteoporosis to metastatic breast cancer to multiple myeloma. It generally cannot be detected until a person begins to feel pain and often after a significant amount of loss has occurred. The work at ASU, funded by NASA, involves analysis of calcium isotopes that are naturally present in urine. When the body is resorbing bone faster than making it, the isotope ratio of calcium in the urine will vary. “We’re taking concepts that are commonplace in geochemistry and using them in a biomedical application,” says Ariel Anbar, PhD, senior author of the study and professor in ASU's department of chemistry and biochemistry. When bone is being resorbed faster than new bone is being made, there is a pulse of lighter calcium isotopes going from the bone into the tissue. The lighter isotopes of calcium enter the bone a little faster than the heavier isotopes when bone is formed, and the difference is known as “isotope fractionation.” The differences can be measured using mass spectrometry methods developed by ASU's Jennifer Morgan, lead author of the study, along with Dr. Anbar and colleagues, Joseph Skulan and Gwyneth Gordon. Their paper, published in the Proceedings of the National Academy of Sciences, is a proof-of-concept study.1 Researchers examined calcium isotopes in the urine of a dozen healthy subjects confined to bed rest for 30 days at the University of Texas Medical Branch at Galveston's Institute for Translational Sciences–Clinical Research Center. Extended periods of bed rest induce bone loss. NASA is particularly interested in the research because weightlessness also contributes to bone loss. “Within a week of bed rest, we saw evidence of bone loss,” Dr. Anbar notes. “Our next step is to look at clinically relevant samples from patients with known histories of having progressed to bone loss. We have a long way to go, but the research is very promising.” He and colleagues also believe that their work is a trailblazer for a much larger application: measuring a variety of inorganic biomarkers in a number of other diseases. In a review of more than 96,000 studies that have been entered into the ClinicalTrials.gov registry, researchers found that the majority of trials have fewer than 100 enrolled patients, while only 4% had more than 1,000 patients. Additionally, most studies were conducted at 1 site, which indicates a lack of diversity in subjects. The analysis raises questions about the value and statistical accuracy of these studies. The results were recently published in the Journal of the American Medical Association.1 “We have an enormous gap in knowledge that can only be answered by trials that are large enough to be definitive,” says lead author, Robert Califf, MD, vice chancellor of clinical and translational research and director of the Duke Translational Medicine Institute in Durham, North Carolina. “It's clear that the portfolio is not designed to answer the questions that people have in order to make choices about drugs or devices.” The researchers focused on cardiovascular, mental health, and oncology trials. Although small trials are useful—particularly in early phase drug evaluations—they are not able to detect rare adverse events or determine the effectiveness of treatments. A very high percentage of these small trials do not complete enrollment and are not published, Dr. Califf notes. The ClinicalTrials.gov registry was created in 1994 with the primary goal of helping patients locate clinical trials. In 2005, trials were required to be registered on the website as a prerequisite to journal publication, and now study authors are required by law to record key data elements and report basic results and adverse events. Dr. Califf says that the quality of clinical trials could dramatically be improved by comparing how studies are conducted in various different fields. For example: More than 80% of cancer clinical trials are not randomized; in other fields, these types of studies are called “registries” rather than trials. Cardiovascular trials were the least likely to have 1 or more sites in North America. Mental health trials were the most likely to enroll children but also were more likely to exclude elderly patients. Improving the quality of trials will require a concerted effort among many stakeholders, Dr. Califf notes. “It's a dream some of us have that, in each major field, there will be a group of patient advocates, providers, professional societies, and the relevant braches of the NIH [and Food and Drug Administration] who can look at the quality of the data in the portfolio and—if it's poor—put pressure on the researchers to fix it,” he says. He cites both the breast cancer and cystic fibrosis advocacy communities as being successful in ensuring that relevant research is conducted in these fields." @default.
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