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Random Homozygous Gene Perturbation (RHGP) as a Tool for Target Discovery and Validation
Wu-Bo Li and Michael Goldblatt

Random homozygous gene perturbation (RHGP) can identify and validate any host (cellular) gene target that directly causes a desired phenotype without requiring prior knowledge of the target. The central feature of RHGP is a unique lentiviral-based genetic element, known as a gene search vector (GSV) designed to interrogate the entire genome and identify target genes that cause the phenotype of interest.

Gene expression analysis of CD14+ monocytes immunomagnetically separated directly from whole blood: adaptation of protocols towards clinical trial requirements
Gregor Winkels1, Ines Dischinger1, Katharina Bublitz1, Evert Luesink2, Nanguneri R. Nirmala2, Frank Staedtler2, Keith J. Johnson2, Alena Fitz1, Sabrina Schmitz1, Dirk Dietrich1, Sonja Balzer1, Sabine Classen1, Silvia Rüberg1, Uwe Janssen1, and Bernhard Gerstmayer1

Peripheral blood is widely used as starting material for biomarker discovery and validation using molecular biology technologies. The vast majority of currently published transcriptome data is based on RNA derived either from stabilized whole blood or peripheral blood mononuclear cells (PBMCs). Here, gene expression profiling studies and SOPs for fast, easy and specific manual or automated isolation of monocytes directly from whole blood are being described.

Quality Standards for 14C API for use in human clinical studies
I Shaw, G Johnston, K Dare, D Dams

The Good Manufacturing Practice (GMP) state that the active pharmaceutical ingredient (API) intended for use in early stage clinical trials should be of "suitable" quality. The Clinic Ready quality standard ensures that the API is synthesised with all the appropriate documentation to facilitate QP release of the final IMP for guman clinical dosing.

LC-MS Approaches to Profiling of Non-Radiolabelled Metabolites in Response to Recent Regulatory Changes
Richard Clayton, Caroline Anderson, Brian Morrison and Lindsay Corfield

Following publication of the FDA MIST guidelines and revision of ICH M3, there is increasing interest in obtaining metabolic profiling data at an early stage in the development of a drug. This has led to a requirement to estimate the relative abundance of metabolites in samples prior to the synthesis of the radiolabelled compound and from a wider range of studies.

Fast PK and Semi Quantitative Analysis of Metabolites Using High Resolution MS
Rohan A. Thakur and Mike Koleto

It has become essential to eliminate poor candidates as early as possible in the drug development process. This realization led to the application of high throughput principles to the in vivo Lead Optimization process, wherein the NCE is first given to rodents to determine the PK profile in a rapid and limited study. This rapid primary screen is known as Fast PK and several critical decisions are based on this initial study.

How to Produce and Validate an IND Report / Validation Report in Just a Few Days
Dr Paul Denny-Gouldson, Simon Beaulah

How to Produce and Validate an IND Report / Validation Report in Just a Few Days The IDBS E-WorkBook Suite is an enterprise, data-centric ELN designed to support validated experiment data and IP capture for the entire large and small molecule preclinical development environment. It enables data required for experiments and reports to be captured, stored and searched in a consistent manner across all departments.

Tobacco use in asbestos workers
T.Medveczky, C.Turton

Asbestos related lung disease is likely to increase. Smoking, apart from being the major risk factor for lung cancer, may be a co-factor in the development of asbestos in lung disease. The Health and Safety Executive report mentions the high rate of smokers in asbestos related industry (1). We have reviewed our local population of asbestos workers to explore that further.

Homing of bone marrow derived mononuclears after intracoronary transventricular transplantation
Homing of bone marrow derived mononuclears after intracoronary transventricular transplantation

A new method of administration of bone marrow derived mononuclear cells (BMMCs) was studied using the model of acute myocardial infarction in rats. The transplanted cells were detected only in the scar tissue and had fibroblast-like phenotype. They differentiated neither into cardiomyocytes nor into the cells of blood vessels.

Protein array-based screening of autoantibody signatures
Zingaretti C., Arigò M., Colombatto P., Brunetto M., Muratori L., Bonino F., Bianchi F., Pagani M., De Francesco R., Abrignani S., Bombaci M.

The evidence for an association between autoimmune diseases and chronic HCV infection has been clearly established. To this aim, a protein array was employed to analyze serum samples of HCV patients w/wo autoimmune complications, of patients with autoimmune hepatitis but not infected with HCV and of healthy donors as controls. A panel of autoantigens able to discriminate among the three groups of patients was identified for potential use as biomarkers.

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Scientific News
Progress in AIDS Vaccine Research
Researchers have developed new vaccine candidates that are said to be promising enough to consider advancing into clinical trials within the next two years.
Two Treatments Yield Similar Results for Children After Cardiac Arrest
NIH-funded research finds therapeutic hypothermia no more effective than normal temperature control.
NIH-funded Study Points Way Forward for Retinal Disease Gene Therapy
Benefits for Leber congenital amaurosis peak after one to three years, then diminish.
Alcoholic Hepatitis Treatments Fail to Keep Patients Alive
The study is published in the New England Journal of Medicine.
NIH Launches Largest Clinical Trial Focused on HIV-related Cardiovascular Disease
Clinical trial to test whether statin administration can reduce the risk for major adverse cardiovascular events.
No Evidence to Change Current Transfusion Practices for Adults
Study found no difference in the primary clinical measure between complex cardiac surgery patients.
Personalized Melanoma Vaccines Marshal Powerful Immune Response
Vaccines target unique mutations in each patient’s tumor.
Repurposed Experimental Cancer Drug Restores Brain Function in Mouse Models
NIH-supported research enables clinical trial to explore treatment for most common form of dementia.
Experimental Ebola Vaccine Safe, Prompts Immune Response
Results from US government-sponsored phase 1 trial of VSV vaccine reported.
Ebola Test Vaccines Appear Safe in Phase 2 Liberian Clinical Trial
Liberia-U.S. partnership planning Phase 3 trial and study of Ebola survivors.
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