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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.
Big Multiple Sclerosis Breakthrough
Phase 1 trial safely resets patients’ immune systems, reduces attack on myelin protein.
Combined Immunotherapy Shows Promising Results Against Advanced Melanoma
Combining two cancer immunotherapy drugs in patients with advanced melanoma produced rates of tumor regression that appeared greater than in prior trials with either drug alone.
NIH to Fund Clinical Research Network on Antibacterial Resistance
Researchers at Duke University will lead the initiative.
Combined Immunotherapy Shows Promising Results Against Advanced Melanoma
Tumor regression rates are produced by combining two cancer immunotherapy drugs.
Promising Drug Prevents Cancer Cells from Shutting Down Immune System
Data from Phase 1 trial presented at the 2013 annual meeting of the ASCO in Chicago.
Double Dose of Tamiflu Offers No Added Benefit in Severe Flu
Early treatment with Tamiflu is beneficial for patients with uncomplicated flu infection.
Enzyme-Activating Antibodies Revealed As Marker for Severe Rheumatoid Arthritis
Finding could lead to earlier diagnosis and new, more aggressive treatment for worst cases.
Researchers Identify Novel Class of Drugs for Prostate Cancers
A new study on prostate cancer describes a novel class of drugs that interrupts critical signaling needed for prostate cancer cells to grow.
Icahn School of Medicine at Mount Sinai and Rensselaer Polytechnic Institute Collaborate
Partnership will accelerate the pace of discovery and innovation in Biomedical Sciences.
First Patient Dosed in the Phase I/II Study of UC1010 for PMDD Patients
First patient has been dosed with UC1010 in a double-blind, multicenter study.
Phase 1 trial safely resets patients’ immune systems, reduces attack on myelin protein.
Combined Immunotherapy Shows Promising Results Against Advanced Melanoma
Combining two cancer immunotherapy drugs in patients with advanced melanoma produced rates of tumor regression that appeared greater than in prior trials with either drug alone.
NIH to Fund Clinical Research Network on Antibacterial Resistance
Researchers at Duke University will lead the initiative.
Combined Immunotherapy Shows Promising Results Against Advanced Melanoma
Tumor regression rates are produced by combining two cancer immunotherapy drugs.
Promising Drug Prevents Cancer Cells from Shutting Down Immune System
Data from Phase 1 trial presented at the 2013 annual meeting of the ASCO in Chicago.
Double Dose of Tamiflu Offers No Added Benefit in Severe Flu
Early treatment with Tamiflu is beneficial for patients with uncomplicated flu infection.
Enzyme-Activating Antibodies Revealed As Marker for Severe Rheumatoid Arthritis
Finding could lead to earlier diagnosis and new, more aggressive treatment for worst cases.
Researchers Identify Novel Class of Drugs for Prostate Cancers
A new study on prostate cancer describes a novel class of drugs that interrupts critical signaling needed for prostate cancer cells to grow.
Icahn School of Medicine at Mount Sinai and Rensselaer Polytechnic Institute Collaborate
Partnership will accelerate the pace of discovery and innovation in Biomedical Sciences.
First Patient Dosed in the Phase I/II Study of UC1010 for PMDD Patients
First patient has been dosed with UC1010 in a double-blind, multicenter study.
Therapure Biopharma Awarded US Government Contract
DoD contract to manufacture materials for anti-nerve gas agent.
MHRA Approval for CDMO’s Commercial Facility
To supply licensed commercial products and aid clinical projects.
Phyton Biotech Receives CEP for Docetaxel API
Helps alleviate docetaxel shortage through plant cell fermentation process.
Impact Analytical Opens New Laboratory Facility
Expands capacity by more than 20%.
Protalix and Brazil's Ministry of Health Enter into Technology Transfer Agreement
Exclusive license and supply agreement with Pfizer amended to facilitate the technology transfer.
TKL Research is Building New Clinical Research Facility in Fair Lawn, N.J.
New facility include a 30-bed, Phase 1 unit as well as multiple, outpatient clinical examination rooms.
New Metals Lab Opens
Company sign laboratory partnership agreement with Agilent.
Aragon Pharmaceuticals Announces Acquisition by Johnson & Johnson
Aragon to spin off new corporation, Seragon Pharmaceuticals, focused on Selective Estrogen Receptor Degrader Platform.
AMRI Burlington Receives DEA Approval to Handle Controlled Substances
Approval to handle Schedule 2 and 2N controlled substances at this location further supports AMRI SMARTSOURCING™ offering.
NIH to Fund Collaborations with Industry to Identify New Uses for Existing Compounds
Crowdsourcing initiative will enable exploration of potential treatments in eight disease areas.
DoD contract to manufacture materials for anti-nerve gas agent.
MHRA Approval for CDMO’s Commercial Facility
To supply licensed commercial products and aid clinical projects.
Phyton Biotech Receives CEP for Docetaxel API
Helps alleviate docetaxel shortage through plant cell fermentation process.
Impact Analytical Opens New Laboratory Facility
Expands capacity by more than 20%.
Protalix and Brazil's Ministry of Health Enter into Technology Transfer Agreement
Exclusive license and supply agreement with Pfizer amended to facilitate the technology transfer.
TKL Research is Building New Clinical Research Facility in Fair Lawn, N.J.
New facility include a 30-bed, Phase 1 unit as well as multiple, outpatient clinical examination rooms.
New Metals Lab Opens
Company sign laboratory partnership agreement with Agilent.
Aragon Pharmaceuticals Announces Acquisition by Johnson & Johnson
Aragon to spin off new corporation, Seragon Pharmaceuticals, focused on Selective Estrogen Receptor Degrader Platform.
AMRI Burlington Receives DEA Approval to Handle Controlled Substances
Approval to handle Schedule 2 and 2N controlled substances at this location further supports AMRI SMARTSOURCING™ offering.
NIH to Fund Collaborations with Industry to Identify New Uses for Existing Compounds
Crowdsourcing initiative will enable exploration of potential treatments in eight disease areas.
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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.
