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The article evaluates several clinical products including the HEScGRO animal component-free medium from Millipore Corp., the ultrasound biomicroscopy (UBM) system from Kent Scientific Corp., and the Aqua Counter Coulometric Karl Fischer Titrator (AQ 300) from JM Science Inc.

The article discusses the United States Food and Drug Administration's rules for digitizing documents in filing new drug applications. The FDA issued Code of Federal Regulations Title 22, Part 11 defining the requirements for electronic record keeping and submission by pharmaceutical companies such as standards in digital signatures on documents and levels of security and accountability that must be built into the software that handles the data.

The article discusses the benefits of using digital pen and paper technology for data collection during clinical trial processes. It states that the use of digital pen and paper reduces delays and cuts back costs for collection and processing of clinical trial data. It cites that most pharmaceutical companies have adopted this technology since it provides faster access to information on drug development.

The article reports on the release of the paper entitled "Development of Biosimilars, A Clinical Perspective" by INC Research LLC in North Carolina.

The article focuses on the transition from the use of paper notebook to electronic laboratory notebooks (ELN) for data management in pharmaceutical research and development in the U.S. It notes that the application of digital signatures is considered as one of the challenges due to the importance in complying intellectual property (IP) requirements. It cites the creation of digital signature standard by SAFE-BioPharma Association for the security of encryption on any electronic document.

The article offers information on the United States Food and Drug Administration's 21 CFR Part 11 regulation covering the trustworthiness and reliability of electronic records and electronic signatures. An important driver for the regulation was the pharmaceutical industry. A summary of significant requirements of the 21 CFR Part 11 regulation are outlined. The impact of the Part 11 scope and applicability guidance on bioanalytic laboratories are also highlighted. The regulation also defines open and closed systems. Roles and responsibilities involved in the regulation, as well as its benefits are described.

The article discusses the use of dried blood spots (DBS) analysis in performing preclinical and clinical studies of blood and body fluids in the U.S. It states that DBS analysis allows minimally-trained staff to take samples and improve quality of data because it does not require extraction, freezing, and defrosting samples. It also mentions that the DBS can allow researchers to perform experiments which were previously impossible.

Microwave ovens aren't just for heating up leftovers and popping popcorn. The same speed that makes them so convenient in the kitchen makes them just as alluring to medicinal chemists looking to cook reactions faster. Amazingly, until a few years ago chemists had to trek to the local home electronics store to pick up their Samsung or Sharp oven just like everyone else. Reactions were liable to blow the door off the machine and be impossible to reproduce. But they continued publishing papers, and instrument vendors took note. As a result, the last few years have brought pharmaceutical chemists an increasing array of safe, consistent microwave instruments designed with their needs in mind.

Information about several papers discussed during the roundtable discussion conducted by the "Drug Discovery & Development" magazine is presented. Topics include the factors that make the G-protein-coupled receptors (GPCR) druggable targets and the reason why the GPCR targets are located in the central nervou system. The discussion featured several scientists, including Suresh Poda, Charles Lunn and Richard Eglen.

The article focuses on the political comments concerning the release of reports describing lines of pluripotent stem cells derived from adult somatic cells. Stem cell researcher Gabriela Cezar states that the results of the study by James Thomson and his group are tantalizing for drug developers. The author also claims that federally-funded stem cell scientists could benefit from the research which involves the use of a lentiviral vector to integrate the genes into the somatic cells' genomes.

The article discusses the functions of Positron Emission Tomography (PET). The imaging system is used to measure emissions from radioactively-labeled, metabolically-active chemicals that reach the brain following injection into the bloodstream. Specialized sensors in the PET scanner detect the radiotracer as it accumulates in certain areas of the brain. An onboard computer integrates the data to produce an image of the area of the brain where tracer accumulates. INSET: A Different View.

Reports on the importance of knowledge management in drug development, as discussed by Roland Carel in his paper 'Knowledge Management in Drug Discovery.' Knowledge management in assay development; Major categories of knowledge management; Use of process-centric knowledge technologies. INSET: Predictive Modeling Saves Resources.

The article offers information on electronic Trial Master File (eTMF) systems in the U.S. It notes that the capabilities of the eTMF exceed the constraints of the current paper-based systems. It also notes that this system should be easily designed, produced, tested and deployed within a matter of days.

The article evaluates several products related to clinical trials technologies including the Digital Pen and Paper technology data storage from Anoto Group AB, SAS Drug Development standards from Clinical Data Interchange Standards Consortium (CDISC), and Velos eResearch Version 7 information technology from Velos Inc.

Examines data management tools for pharmaceutical industry. Challenges of generating accurate, high-quality data; Rising need for greater efficiency in the drug industry; Need for more intermediate work to be done to find proper names in different databases; Major challenges in managing vast quantities of data in an intelligent manner. INSETS: The Switzerland of Life Science Databases;Electronic Lab Notebooks.

The article announces the Good Laboratory Practice (GLP) accreditation awarded to ProImmune Ltd.

The article reports on the launch of contract diagnostics organization (CDO) by ResearchDx in Irvine, California.

The article reports on the launch of Covance Inc.'s chemistry, manufacturing, and controls (CMC) pharmaceutical development services in New Jersey.

The article offers news briefs related to medical research in the U.S. Nancy Simonian, chief medical officer of Millennium Pharmaceuticals in Cambridge, Massachusetts has discovered the efficacy of the drug Rituxan in treating several complications aside from rheumatoid arthritis. A released reseach paper revealed that the inflammation in the form of dengue fever, which has no treatment, may respond to inhibition of the tyrosine kinase, s-Src.

The article discusses the advances in Laboratory Information Management System (LIMS) and electronic laboratory notebook (ELN) technology. It mentions that these two technologies provide means to share collaborative information in an electronically captured format. It notes the benefits of ELN software from Redwood City, California-based Rescentris.

The article presents a study, conducted by researchers at the Kimmel Cancer Center at Jefferson Medical College in Philadelphia, Pennsylvania, on the growth of tumor. According to Michael P. Lisanti, professor and chair of Stem Cell Biology & Regenerative Medicine at Jefferson, they discovered that cancer cells accelerate inflammation and aging. He adds that the whole body becomes more sensitive to parasitic cancer mechanism as people age and the cancer cells accelerate the aging process.

The article offers information on the Minimum Information for Publication of Quantitative Real-Time Polymerized Chain Reaction (PCR) Experiments (MIQE) guidelines published by experts for real time PCR experiments. It notes that the guidelines is intended to standardize and streamline the real-time PCR workflow from the early planning stage through publication. It cites the importance of high-quality RNA and data analysis as the fundamental to a successful real-time PCR experiment.

The article discusses the establishment of an incurred sample analysis (ISR) program to asses the bioanalytical assay quality. It is stated that bioanalytical method validation is important ensure quality results and its guidelines are outlined by the U.S. Food and Drug Administration (FDA). It notes that the preparation of ISR process needs scientific judgment data consistency. It also mentions that laboratory information management systems (LIMS) can be used in analyzing ISR results.

The article provides information concerning on metabolomics, a science that embodies the very reason that genomes and proteomics exist in the first place. Metabolomics can give researchers greater insight into the metabolic state of an organism than do the genomics or proteomics, allowing researchers to determine whether that state is normal or pathologic.

The article discusses the different ways that experts define personalized medicine in the U.S. Some experts take the genetic angle, while others take the genomic or proteomic. Personalized medicine involves the use of information on an individual's genetic makeup to design strategies for diagnosis, treatment, and prevention of whatever disease the researcher is interested in.

The article reports that the United States Food and Drug Administration (FDA) has released guidance documents on generic biopharmaceuticals, which are the synthetic or recombinant versions of natural biologic substances. The FDA aims to help generic drug makers develop generic biopharmaceuticals once the pioneer patents on about 18 biologics expire. Some of the biopharmaceuticals are human growth hormones, insulin, erythropoietin and blood coagulation factors.

Presents views on the immediacy of a pharmaceutical reform law in the United States. Policies of the U.S. government under the administration of reelected President George W. Bush; Concern for patient safety from drugs resulting from the recall of the Vioxx drug developed by Merck & Co.Inc.; Requirement for companies to incorporate labels on their products and more intensive clinical testing prior to approval.

The article informs about the draft guidance, entitled "Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations," published by the U.S. Food & Drug Administration (FDA).

The article discusses the effort of biopharmaceutical firms in taking clinical trials to face the challenges on the need to speed up global studies particularly on cloud computing. It asserts that adopting Web-based technologies will make for improvements to communication among stakeholders. It also notes the huge importance of cloud computing in delivering services on the Internet through shared resources and software solutions laying foundation for hastening exchange of information.

The article presents a study, conducted by scientists at the Dana-Farber Cancer Institute in Boston, Massachusetts, on an overactive network of growth-spurring genes in 2011. The genes drive stem-like breast cancer cells with triple-negative breast tumors, an aggressive cancer which resists to current therapies. Kornelia Polyak, a breast cancer geneticist at Dana-Faber, and colleagues discovered that a large proportion of cells in the tumors revealed elevated activity in Jak2/Stat3 pathway.

The article focuses on the issue of data management in research laboratories. It notes that several companies are investing in a laboratory information management system (LIMS) to address some of the challenges in operating a research laboratory. It also notes that an enterprise-level LIMS in big organization is managed by a team of information technology (IT) or LIMS professionals who will monitor installation and upgrades.

The article reports that scientists from University of Chicago, Illinois has discovered that proteins can locate and repair damaged genetic material inside the cells. Researchers cite that one protein detects and enhances damage in cancer cells. The study concludes that the two crystal structures of DNA-repair proteins, AlkB and its related human protein, ABH2 played important role in repairing damage in cancer cells.

The article discusses the genetic sequencing of a 68 million-year-old Tyrannosaurus from the dinosaur's femu. The sequencing method cites the connection of T. rex protein with birds and femur, wherein the dinosaur protein is extracted from a T. rex femur fossil. The study exemplifies the primary use of molecular data to identify non-avian dinosaur in a phylogenetic tree that described the species evolution.

The article focuses on the findings of the study conducted by University of Pittsburgh School of Medicine in Pennsylvania. According to researchers, protein signature transform diagnosis and enhance idiopathic pulmonary fibrosis (IPF) are important biomarkers. The primary goal of the study is to examine the blood protein combinations in a IPF patients and distinguish its blood controls with sensitivity and precision.

The article mentions that a scientist from Portland had discovered that a cough medicine and schizophrenia drug can help patients with Parkinson's disease (PD).

The article introduces several papers in the current issue of "Drug Discovery & Development," including articles on autism, obesity, and phenocopy, as well as introducing its newly designed website "www.dddmag.com."

The article offers news briefs related to genetic studies in the U.S. Researchers at Yale School of Medicine claimed that bacterial proteins within the Legionnaire's disease work together. They found that a protein turns on a molecular switch and subverts its function. Another study identified naturally occurring processes that allow many genes to both slow aging and protect againts cancer in the roundworm C. elegans.

The article reports on the new research which identifies naturally occurring processes that allow many genes to slow aging and protect against cancer in Caenorhabditis elegans roundworm. It notes that many of the worm genes have counterparts in humans and it suggests that new drugs may be produced to fight cancer diseases through this discovery. The new research indicate that cellular changes leading to longevity counteract tumor cell growth.

The article reports on the analyses of the second-generation map of human genetic variation, published by International HapMap Consortium in the U.S. It contains three times more markers than the initial version revealed in 2005. It describes how the higher resolution map offers greater power to detect genetic variants involved in common diseases and explores the structure of human genetic variation.

The article reports on the study on the vast majority of protein-coding genes by scientists at the Johns Hopkins Kimmel Cancer Center in the U.S. It observed a landscape dominated by genes in which each are mutated in relatively few cancers. It indicated that while little is known about these less-commonly mutated genes, they can be grouped into clusters according to their pathways. Scientists found that an average of 77 genes are mutated in an individual colon cancer and 81 in breast cancer.

The article reports on the discovery of a gene at Wake Forest University of School of Medicine in Winston-Salem, North Carolina that has been linked to systemic lupus erythematosus (SLE). It was discovered by Fred Perrino, a professor of biochemistry in the university in 1998. A study conducted by Min Ae Lee-Kirsch from the Technische Universität Dresden in Germany and colleagues described findings variations of the TREX1 gene discovered by Perrino in patients with SLE.

The article reflects on using identification and analysis of biomarkers to supplement information regarding drug response and potential clinical response. The author describes that information on efficacy and dosing gained from biomarkers enables scientific evaluations for advancing drugs from early phase development to later stage trials.

The article discusses various papers published within the issue, including one by Gina Shaw on biomarkers and another by Patrick McGee on animal models in research.

The article discusses the necessity of defining time and concentration interactions in antibiotic development, with the target organisms as early as possible. It notes on the minimum inhibitory concentration (MIC), the quantitative measurement of the drug's potency, which is the lowest concentration of antibiotic that prevent bacterial inoculum from growing to visibly detectable levels. It is the first and most important specification for antibiotic which help define its therapeutic potential.

The article focuses on the expansion of human embryonic stem cells (hESC) lines and further use of induced pluripotent stem (iPS) cells as well as better tools for stem cell analysis which increase the success for stem cell-based therapies. It looks into the new guidelines released by the National Institutes of Health (NIH) for funding stem cell research involving embryonic stem cells. It also describes some research discoveries in global laboratories related to stem cell analysis. INSETS: Inking a Better Surface;hESC Guidelines Detail Funding Conditions.

The article provides information regarding the use of high content screening (HCS) for medical researchers in the U.S. The authors state that, by measuring the what, where and when of a process around the cells, HCS can offer information about how cells respond to a stimulus. In addition, it allows difficult targets to be assessed and helps researchers understand how cells respond to stimuli. The adoption of HCS deliver new therapies for emerging and existing diseases in a timelier manner.

The article focuses on various assaying methods used to detect apoptosis. Research scientist Gary Schwartz uses 4.6-diamidino-2-phenylindole (DAPI) staining to quantify apoptosis and chief scientific officer at Gemin X Pharmaceuticals Inc. Gordon C. Shore advocates the use of cell-based assays. The Cancer Center in the Burnham Institute for Medical Research in California is conducting a research to convert tumor-protective molecules into tumor killers. INSET: Tumor Killers.

The article focuses on the use of severe combined immunodeficiency (SCID) mice as animal models for various researches. It mentions that for many years, human tissue has been transplanted into these mice to study immune function, hematopoiesis, HIV infection, and to test the potential for novel gene therapies. Some researches that have used SCID-humanized rodent model, which include an investigation on the effect of HIV infection on hematopoiesis, are also highlighted. INSET: A New System.

The article discusses the interests in the field of oncology on protein kinase inhibitors as a potential drug against cancer. According to Robert T. Abraham, vice president of Oncology Discovery Research, pharmaceutical industry has recognized the potential of protein kinases because it is druggable. GlaxoSmithKline Oncology Center examined protein kinases that are involved in signal transduction as it relates to oncogenesis.

The article reports on the high-throughput screens for inhibitors of essential enzymes, especially kinases, for development into new tuberculosis therapies in the U.S. According to Said Goueli, a lead research and development scientist at Promega Corp., the pipeline in the pharmaceutical industry is drying up except the kinase inhibitors. INSET: Screening Goes to School.