Thursday, February 23, 2012
Technology Networks
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 | 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 |
 | RNA-Seq for High Throughput Clinical Studies Wenzhong Xiao, Assistant Professor of Bioinformatics, Massachusetts General Hospital, speaking at Next-Gen Sequencing Congress 2011. |
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.
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.
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.
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.
JHS Secures Multi-Million Dollar Contracts to Manufacture Sterile Parenteral Products
Company has secured contracts with four innovator life science companies.
Boehringer Ingelheim and Xencor Enter a Collaboration Agreement
Antibodies engineered with Xencor’s proprietary Xtend™ technology for increasing antibody half-life.
Shire Announces European Approval of Manufacturing Facility for VPRIV®
EMA approval adds significant capacity for the manufacture of Shire’s enzyme replacement therapies.
Theratechnologies Announces a Supply, Distribution and Licensing Agreement with Actelion
Agreement provides Actelion with the exclusive commercialization rights to tesamorelin in Canada.
Genticel Completed Recruitment for its Phase Ib Vaccine Trial in HPV Infected Women
Company expects the final results before the end of the second quarter 2012.
Debiopharm and Curis Announce Initiation of Phase Ib Expansion Study of Debio 0932
Company expects to initiate a combination Phase I/II study in NSCLC patients in the second quarter of 2012.
PRECOS to Unveil New Service Portfolio at Cancer Targets & Therapeutics and AACR 2012
2012 conference examines new and emerging targets and therapeutics in the area of cancer research.
Honouring the Best Innovators, Pioneers and Leaders in Asia
The BioPharma Awards aims to acknowledge the dedication and success of industry leaders and companies globally and in Asia.
TxCell Presents Immuno-Monitoring Results of its Phase I/II Clinical Trial
Results supportive of Ovasave(R) mechanism of action were presented at the seventh European Crohn’s and Colitis Organization (ECCO) meeting in Barcelona.
Venn Life Sciences and Encorium Announce a Business Combination
Venn Life Sciences and Encorium Announce a Business Combination Businesses combine into a new operation named Venn Life Sciences Limited, headquartered in Ireland. The combined business will have over 200 employees, operating from over 20 locations worldwide.
Company has secured contracts with four innovator life science companies.
Boehringer Ingelheim and Xencor Enter a Collaboration Agreement
Antibodies engineered with Xencor’s proprietary Xtend™ technology for increasing antibody half-life.
Shire Announces European Approval of Manufacturing Facility for VPRIV®
EMA approval adds significant capacity for the manufacture of Shire’s enzyme replacement therapies.
Theratechnologies Announces a Supply, Distribution and Licensing Agreement with Actelion
Agreement provides Actelion with the exclusive commercialization rights to tesamorelin in Canada.
Genticel Completed Recruitment for its Phase Ib Vaccine Trial in HPV Infected Women
Company expects the final results before the end of the second quarter 2012.
Debiopharm and Curis Announce Initiation of Phase Ib Expansion Study of Debio 0932
Company expects to initiate a combination Phase I/II study in NSCLC patients in the second quarter of 2012.
PRECOS to Unveil New Service Portfolio at Cancer Targets & Therapeutics and AACR 2012
2012 conference examines new and emerging targets and therapeutics in the area of cancer research.
Honouring the Best Innovators, Pioneers and Leaders in Asia
The BioPharma Awards aims to acknowledge the dedication and success of industry leaders and companies globally and in Asia.
TxCell Presents Immuno-Monitoring Results of its Phase I/II Clinical Trial
Results supportive of Ovasave(R) mechanism of action were presented at the seventh European Crohn’s and Colitis Organization (ECCO) meeting in Barcelona.
Venn Life Sciences and Encorium Announce a Business Combination
Venn Life Sciences and Encorium Announce a Business Combination Businesses combine into a new operation named Venn Life Sciences Limited, headquartered in Ireland. The combined business will have over 200 employees, operating from over 20 locations worldwide.
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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.
Homing of bone marrow derived mononuclears after intracoronary transventricular transplantation
Remetex
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)
Northumberland Tyne and Wear NHS Trust
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
Fondazione Istituto Nazionale Genetica Molecolare
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.
University Hospital Malmo, Sweden, Stanford Biomed Inc. Syed Skin Care, Inc.
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.
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.
Homing of bone marrow derived mononuclears after intracoronary transventricular transplantation
Remetex
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)
Northumberland Tyne and Wear NHS Trust
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
Fondazione Istituto Nazionale Genetica Molecolare
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.
University Hospital Malmo, Sweden, Stanford Biomed Inc. Syed Skin Care, Inc.
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.
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.
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