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 | Companies in Translation with CIRM Dr Alan Trounson, California Institute for Regenerative Medicine, speaking at Stem Cells 2012 |
 | Drug Discovery Outsourcing: the Importance of Integration in the Selection of Higher Quality Clinical Candidates Simone Braggio, Director, Head of Drug Metabolism & Pharmacokinetics, Aptuit speaking at Pharma Outsourcing Congress 2011 |
Outsourced Ion Channel Testing Trends 2013
HTStec
HTStec's Outsourced Ion Channel Testing Trends 2013 report was published on 3 May 2013. This 58 page market report summarizes the results of HTStec's industry-wide global web-based benchmarking survey on outsourced ion channel testing carried out in April 2013.
Biomarkers in Late-Stage Clinical Trials: Applications, opportunities and activities of leading players
Business Insights
Biomarkers reduce the attrition rate of late-stage clinical trials by assessing drug potential in terms of efficacy and toxicity at the early stages of clinical development. Thus, biomarkers significantly increase productivity, lower the cost and duration of clinical trials, and help researchers complete the drug development process at a faster pace.
Pharmaceutical Analytical Services Outsourcing in India: Cost Savings, Product Quality and Shorter Delivery Times are Key Drivers
GBI Research
The report provides market landscape, competitive landscape and market trends information on the segments within the analytical services market and provides comprehensive information on the key trends affecting these categories.
The Drug Discovery Outsourcing Market
Business Insights
This report investigates current trends and opportunities affecting decisions on whether or not to outsource drug discovery. Outsourcing to low cost offshore destinations such as China and India are examined in detail. The report also covers a variety of strategic collaborations, academic partnerships and outsourcing opportunities along with case studies.
The Future of R&D Outsourcing: Investigating development hurdles, key challenges & strategies to optimize CRO relationships
Business Insights
While some drug-makers have optimized their R&D outsourcing methodologies and developed sophisticated processes to select, monitor and manage a wide range of projects, many other R&D outsourcing projects fail due to poor planning. A large proportion of these failures could be averted, as many of the most common reasons for failure are preventable problems relating to R&D outsourcing strategy.
Drug Discovery in India and China - Gaining Momentum with Increasing Pressure on Cost Cutting
GBI Research
This report reviews the key data, information and analysis of the major trends and issues affecting the drug discovery market in India and China and provides a comprehensive insight into the drug discovery process and the model followed by the companies providing such services. The report also provides a detailed analysis of the factors that are driving the drug discovery market, a key segment of the pharmaceutical and healthcare industry, in India and China.
Global Drug Eluting Balloons (DEB) Pipeline Analysis, Opportunity Assessment and Market Forecasts to 2016
GlobalData
Small vessel disease, bifurcated lesions, in-stent restenosis and peripheral vascular disease represent a nearly $2 billion market. In addition, the complications associated with long term antiplatelet therapy such as the risk of bleeding and contraindications limit the use of the current interventions. The associated cost and patient compliance for current treatments open the door for drug eluting balloons to these markets.
HTStec
HTStec's Outsourced Ion Channel Testing Trends 2013 report was published on 3 May 2013. This 58 page market report summarizes the results of HTStec's industry-wide global web-based benchmarking survey on outsourced ion channel testing carried out in April 2013.
Biomarkers in Late-Stage Clinical Trials: Applications, opportunities and activities of leading players
Business Insights
Biomarkers reduce the attrition rate of late-stage clinical trials by assessing drug potential in terms of efficacy and toxicity at the early stages of clinical development. Thus, biomarkers significantly increase productivity, lower the cost and duration of clinical trials, and help researchers complete the drug development process at a faster pace.
Pharmaceutical Analytical Services Outsourcing in India: Cost Savings, Product Quality and Shorter Delivery Times are Key Drivers
GBI Research
The report provides market landscape, competitive landscape and market trends information on the segments within the analytical services market and provides comprehensive information on the key trends affecting these categories.
The Drug Discovery Outsourcing Market
Business Insights
This report investigates current trends and opportunities affecting decisions on whether or not to outsource drug discovery. Outsourcing to low cost offshore destinations such as China and India are examined in detail. The report also covers a variety of strategic collaborations, academic partnerships and outsourcing opportunities along with case studies.
The Future of R&D Outsourcing: Investigating development hurdles, key challenges & strategies to optimize CRO relationships
Business Insights
While some drug-makers have optimized their R&D outsourcing methodologies and developed sophisticated processes to select, monitor and manage a wide range of projects, many other R&D outsourcing projects fail due to poor planning. A large proportion of these failures could be averted, as many of the most common reasons for failure are preventable problems relating to R&D outsourcing strategy.
Drug Discovery in India and China - Gaining Momentum with Increasing Pressure on Cost Cutting
GBI Research
This report reviews the key data, information and analysis of the major trends and issues affecting the drug discovery market in India and China and provides a comprehensive insight into the drug discovery process and the model followed by the companies providing such services. The report also provides a detailed analysis of the factors that are driving the drug discovery market, a key segment of the pharmaceutical and healthcare industry, in India and China.
Global Drug Eluting Balloons (DEB) Pipeline Analysis, Opportunity Assessment and Market Forecasts to 2016
GlobalData
Small vessel disease, bifurcated lesions, in-stent restenosis and peripheral vascular disease represent a nearly $2 billion market. In addition, the complications associated with long term antiplatelet therapy such as the risk of bleeding and contraindications limit the use of the current interventions. The associated cost and patient compliance for current treatments open the door for drug eluting balloons to these markets.
Patient Openness to Research Can Depend on Race and Sex of Study Personnel
Researchers have found that the race and sex of study personnel can influence a patient’s decision on whether or not to participate in clinical research.
Results of the ROTAVAC Rotavirus Vaccine Study in India
Statement of Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health.
Vince and Associates Clinical Research Joins the Altasciences Group
The Altasciences Group is proud to announce the addition of Vince and Associates Clinical Research to its team providing comprehensive Phase I/IIa clinical drug development capabilities.
Cocaine Vaccine Passes Key Testing Hurdle
New anti-cocaine vaccine research shows drug can't reach the brain, human clinical trials on the horizon.
Redx Pharma Opens £10.5 Million R&D Centre in UK
Liverpool-based drug discovery and development company Redx Pharma is to open a new research and development facility at AZ's Alderley Park site in Cheshire.
NIH Clinical Trial Begins for Treatment of Rare, Fatal Neurological Disorder
Government, industry, academia, and patient groups collaborate on Niemann-Pick Type C research.
NIH-Developed Candidate Dengue Vaccine Shows Promise in Early-Stage Trial
The trial results appeared in the April 1 issue of the Journal of Infectious Diseases.
Galapagos Discovers Novel Candidate Drug to Treat Breast Cancer
GLPG1790 has high efficacy against triple-negative breast cancer.
Genticel Announces Positive Data from Phase I Trial in HPV Infected Women
First ever trial to recruit HPV infected women with no cervical lesions.
Nanosponges can Remove Toxins from Bloodstream
Engineers have invented a “nanosponge” capable of safely removing a broad class of dangerous toxins from the bloodstream.
Researchers have found that the race and sex of study personnel can influence a patient’s decision on whether or not to participate in clinical research.
Results of the ROTAVAC Rotavirus Vaccine Study in India
Statement of Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health.
Vince and Associates Clinical Research Joins the Altasciences Group
The Altasciences Group is proud to announce the addition of Vince and Associates Clinical Research to its team providing comprehensive Phase I/IIa clinical drug development capabilities.
Cocaine Vaccine Passes Key Testing Hurdle
New anti-cocaine vaccine research shows drug can't reach the brain, human clinical trials on the horizon.
Redx Pharma Opens £10.5 Million R&D Centre in UK
Liverpool-based drug discovery and development company Redx Pharma is to open a new research and development facility at AZ's Alderley Park site in Cheshire.
NIH Clinical Trial Begins for Treatment of Rare, Fatal Neurological Disorder
Government, industry, academia, and patient groups collaborate on Niemann-Pick Type C research.
NIH-Developed Candidate Dengue Vaccine Shows Promise in Early-Stage Trial
The trial results appeared in the April 1 issue of the Journal of Infectious Diseases.
Galapagos Discovers Novel Candidate Drug to Treat Breast Cancer
GLPG1790 has high efficacy against triple-negative breast cancer.
Genticel Announces Positive Data from Phase I Trial in HPV Infected Women
First ever trial to recruit HPV infected women with no cervical lesions.
Nanosponges can Remove Toxins from Bloodstream
Engineers have invented a “nanosponge” capable of safely removing a broad class of dangerous toxins from the bloodstream.
G-BA Issues Final Assessment Report for PIXUVRI®
Pricing negotiations to begin in June.
Exco InTouch Joins C-Path ePRO Consortium
Company joins ePRO Consortium to advance electronic data capture in clinical trials.
Cubist Achieves Top Biotech Ranking in Globe 100 List
Number six overall ranking reinforces employee dedication to addressing unmet need in acute medical care.
Almac Launches US Commercial Packaging Operations in Audubon
Company also announces launch of new client partnership.
Novozymes Biopharma Helps Innovative Dry Eye Therapy Move into Clinical Trials
A novel ophthalmic solution has recently obtained FDA approval to undergo Phase I/II clinical trials in the United States.
FDA Approves Simponi to Treat Ulcerative Colitis
The U.S. FDA approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Elan Announces Transactions: Decisively Transforming the Company
Upon shareholder approval, the totality of these strategically driven decisions will form a dynamic and unique business foundation for Elan in the years ahead.
Nuvilex, Inc. and Celgene, Corp. Can Both Replace Eli Lilly's Cancer Drug Gemzar
The race is on, and patients with advanced stage, inoperable pancreatic cancer will be the recipients of the winner's treatment.
Acurian Announces Partnership Agreement with the Society for Clinical Research Sites (SCRS)
Acurian, Inc. announced it has agreed to a two-year partnership with the Society for Clinical Research Sites (SCRS), based in Rockville, MD.
GFT505 Reduces the Risk of Cardiovascular Events
Treatment with GFT505 significantly reduces the level of “remnant cholesterol”.
Pricing negotiations to begin in June.
Exco InTouch Joins C-Path ePRO Consortium
Company joins ePRO Consortium to advance electronic data capture in clinical trials.
Cubist Achieves Top Biotech Ranking in Globe 100 List
Number six overall ranking reinforces employee dedication to addressing unmet need in acute medical care.
Almac Launches US Commercial Packaging Operations in Audubon
Company also announces launch of new client partnership.
Novozymes Biopharma Helps Innovative Dry Eye Therapy Move into Clinical Trials
A novel ophthalmic solution has recently obtained FDA approval to undergo Phase I/II clinical trials in the United States.
FDA Approves Simponi to Treat Ulcerative Colitis
The U.S. FDA approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Elan Announces Transactions: Decisively Transforming the Company
Upon shareholder approval, the totality of these strategically driven decisions will form a dynamic and unique business foundation for Elan in the years ahead.
Nuvilex, Inc. and Celgene, Corp. Can Both Replace Eli Lilly's Cancer Drug Gemzar
The race is on, and patients with advanced stage, inoperable pancreatic cancer will be the recipients of the winner's treatment.
Acurian Announces Partnership Agreement with the Society for Clinical Research Sites (SCRS)
Acurian, Inc. announced it has agreed to a two-year partnership with the Society for Clinical Research Sites (SCRS), based in Rockville, MD.
GFT505 Reduces the Risk of Cardiovascular Events
Treatment with GFT505 significantly reduces the level of “remnant cholesterol”.
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Comparison of Dissociated Phoria Measuring Methods. Repeatability and Reliability
CBO
The aim of this study is to determine the reliability and compare reproducibility of different dissociated phoria measure tests.
Secondary Prevention of Stroke: The role of the General Practitioner
NHS
This study aims to review the literature to further elucidate the potential impact of primary care physicians in reducing the burden of stroke.
Participation in “The Airways Program” (TAP) and Associated Mortality Reduction
National Healthcare Group
Research objectives were to assess the impact of “The air way program” on patients length of stay, readmission and mortality.
Random Homozygous Gene Perturbation (RHGP) as a Tool for Target Discovery and Validation
Functional Genetics
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
1Miltenyi Biotec GmbH
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
Quotient Bioresearch
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
Covance
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
PharmaNet
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
IDBS
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
Brighton and Sussex University Hospitals , Brighton and Sussex Medical School, Brighton, England
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.
CBO
The aim of this study is to determine the reliability and compare reproducibility of different dissociated phoria measure tests.
Secondary Prevention of Stroke: The role of the General Practitioner
NHS
This study aims to review the literature to further elucidate the potential impact of primary care physicians in reducing the burden of stroke.
Participation in “The Airways Program” (TAP) and Associated Mortality Reduction
National Healthcare Group
Research objectives were to assess the impact of “The air way program” on patients length of stay, readmission and mortality.
Random Homozygous Gene Perturbation (RHGP) as a Tool for Target Discovery and Validation
Functional Genetics
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
1Miltenyi Biotec GmbH
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
Quotient Bioresearch
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
Covance
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
PharmaNet
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
IDBS
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
Brighton and Sussex University Hospitals , Brighton and Sussex Medical School, Brighton, England
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.
Cellular Dopamine and Intracellular Calcium Signaling Using the Next Generation HTS Microplate Reader
BMG Labtech
Two cell-based signaling assays from Invitrogen, Fluo-4 Direct™ Calcium Assay and Tango™-bla U2OS GPCR Assay, were performed on the PHERAstar FS HTS instrument. The PHERAstar FS has several unique features that enhance the performance of these assays including direct optic bottom reading, high resolution cell layer scanning, injection at the point of measurement and dual emission detection.
Reaction Optimisation and Large Scale Synthesis
Syrris Ltd
A major benefit of flow chemistry is the ease and consistency of reaction scale up. In a flow reactor, high quality, reproducible mixing, excellent temperature control and superheating are maintained when increasing reaction volume.
Automated Turnkey Solubility and Permeability Assays
Molecular Devices
Millipore Corporation and Molecular Devices have partnered to provide platforms for solubility and permeability screening. The objective is to create automation-compatible 96- and 384-based systems with pre-validated methods, devices and analysis that can be run manually or in conjunction with standard laboratory automation.
BMG Labtech
Two cell-based signaling assays from Invitrogen, Fluo-4 Direct™ Calcium Assay and Tango™-bla U2OS GPCR Assay, were performed on the PHERAstar FS HTS instrument. The PHERAstar FS has several unique features that enhance the performance of these assays including direct optic bottom reading, high resolution cell layer scanning, injection at the point of measurement and dual emission detection.
Reaction Optimisation and Large Scale Synthesis
Syrris Ltd
A major benefit of flow chemistry is the ease and consistency of reaction scale up. In a flow reactor, high quality, reproducible mixing, excellent temperature control and superheating are maintained when increasing reaction volume.
Automated Turnkey Solubility and Permeability Assays
Molecular Devices
Millipore Corporation and Molecular Devices have partnered to provide platforms for solubility and permeability screening. The objective is to create automation-compatible 96- and 384-based systems with pre-validated methods, devices and analysis that can be run manually or in conjunction with standard laboratory automation.
