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Thursday, February 23, 2012
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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.

AUDIT OF THE FOLLOW UP OF CHILDREN WITH LD AND EPILEPSY IN NEWCASTLE CTLD (COMMUNITY TEAM FOR LEARNING DISABILITIES)
Dr.Andrew Ntanda

I would be grateful if you could consider my brief paper for publication. I have had the opportunity to present it as a poster at the Annual ILAE-UK chapter meeting which concluded on the 7/10/09. It focuses on Children with Learning disability and Epilepsy and the standards of their care and follows up under a Child and Adolescent Mental Health/ Learning disability consultant in an outpatient setting.

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.

Clinical Evaluation of induced pluripotent stem cells (iPSc) to cure patients with Psoriasis Vulgaris. An Open Study.
Timothy S. Andersson, David K. Chin, Wendy H. Wong

To evaluate the clinical efficacy of iPSc directed to interfere T-cell activation to cure patients with psoriasis. Twenty subjects were enrolled. Each patient was administered iv with syngenic iPS. Those showing lower PASI score were considered cured. The study states that induced iPSCs are safe and impart significant clinical efficacy to cure patients with psoriasis.

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Showing Results 1 - 10 of 32
Scientific News
Genomic Sequencing in Clinical Trials
In this article, researchers from Northwestern University Feinberg review the current and future directions of clinical research with respect to genomic sequencing.
Diffusion Pharmaceuticals Begins Clinical Trial for Treatment of Primary Brain Cancer
Company announced clinical trial testing of its lead drug candidate trans sodium crocetinate (TSC) as a first-line treatment for newly diagnosed primary brain cancer, also known as glioblastoma or GBM.
BioSante Pharmaceuticals Reports Positive LibiGel Safety Data Review for Phase III Program
BioSante Pharmaceuticals Reports Positive LibiGel Safety Data Review for Phase III Program.
Insmed Incorporated Provides Update on Clinical Program for ARIKACE®
The Company is proceeding with phase 2 clinical trial in patients with non-tuberculous mycobacteria lung disease, as well as the previously planned European registration phase 3 clinical study of ARIKACE in Cystic Fibrosis patients with Pseudomonas aeruginosa lung infections.
Results From Phase I Clinical Trials Demonstrate Positive Safety Data of AVI BioPharma's RNA-Based Therapeutics
AVI BioPharma, Inc. have announced positive safety results from all six dose cohorts in the single ascending dose studies of AVI-6002 and AVI-6003, AVI's lead drug candidates being evaluated for the treatment of Ebola virus and Marburg virus, respectively.
Titan Pharmaceuticals Announces Positive Results of Six-Month Open-Label Safety Retreatment Study of Probuphine
Patients report high satisfaction, decreased opioid dependence problems and significant overall improvement with Probuphine; NDA expected to be filed in 3Q 2012.
Anacor Pharmaceuticals Announces Preliminary Results from Two Safety Studies
AN2728 studies provide positive results, ointment well tolerated on large body surfaces and sensitive skin.
Rapid Bone Loss Possible Side Effect of Anti-Obesity Drug
Research from UT Southwestern Medical Center has raised concern about the safe use of fibroblast growth factor 21.
Anacor Pharmaceuticals Announces Its Partner GSK Voluntarily Paused Clinical Trials
Trials paused due to a recently identified microbiological finding in a small number of patients in the Phase 2b trial of GSK '052 for the treatment of complicated urinary tract infections (cUTI).
NIH-funded HIV Clinical Research Sites to Join Pediatric Tuberculosis Vaccine Study
Several U.S. government-funded HIV/AIDS clinical research sites in Africa will join other collaborators in an ongoing clinical trial testing an investigational tuberculosis vaccine in infants at risk for TB infection.
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