#clinical pharmacology boston-cambridge

[azuredeltaconsulting]

Discover the top benefits of Modeling and Simulation (M&S) in North Carolina’s economy. From driving innovation in tech and healthcare to boosting manufacturing and defense industries, M&S is transforming the state's economic landscape. Learn how these advanced technologies are creating new opportunities, fostering growth, and positioning North Carolina as a leader in simulation-driven industries.

[pharmaphorumuk]

MSD attracts top British scientist to head up UK discovery centre

In November, MSD made a high profile unveiling of plans for a new multi-million pound discovery centre in London – and today it has announced a heavyweight researcher to lead it.

Dr Fiona Marshall joins MSD (Merck & Co. in North America) from Heptares, the UK biotech company she co-founded more than a decade ago, and which was acquired by Sosei in 2015.

Dr Fiona Marshall

Dr. Marshall is a world renowned expert in GProtein-Coupled-Receptor (GPCR) biology, a hugely promising area of drug research where new understanding of molecular targets means it is entering a new era, with many GPCR-targeting candidates in industry pipelines.

In her career of more than 25 years in drug discovery, Dr Marshall achieved numerous significant advances, including leading the first group to show that GPCRs could form heterodimers, and has published more than 80 peer-reviewed papers on GPCRs.  (Last year one of her co-founders at Heptares, Richard Henderson, was a joint Nobel prize winner  for his work in the field.)

MSD says it has invested in the UK because of the excellence of its drug discovery, and finding a British scientist to lead its new centre helps back up the country’s claim to world-leading status.

Roger Perlmutter

“Fiona’s exemplary scientific accomplishments and in-depth drug discovery experience will enable her to make important contributions to the scientific environment within MRL, said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We are pleased to welcome her to MSD, where she will set an enormously high standard as the leader of our new London-based, UK Discovery Research Centre.”

Dr. Marshall is currently the chair of the UK Medical Research Council developmental pathway funding scheme committee and is on the translational advisory groups of the Francis Crick Institute and the Wellcome Trust – to leading academic centres also located in the heart of London.

Also a member of the board of trustees of Alzheimer’s Research UK (ARUK), on the council of the Academy Of Medical Sciences and the industry and translation committee of the Royal Society, Marshall is among the best-connected UK science leaders.

“I am delighted to be joining MSD as it expands its discovery network into London. I relish the challenge of leading MRL’s new team of scientists in the UK as we embark upon the development of the new Discovery Centre in London announced late last year,” said Dr Marshall. “MSD’s commitment to bringing the brightest and best scientific talent to London presents exciting opportunities to discover new medical advances as part of the vibrant London life sciences community.”

Before founding Heptares, Dr. Marshall spent 12 years at GlaxoWellcome/GlaxoSmithKline, eventually rising to become head of the department of Molecular Pharmacology. She then moved on to be director of Discovery Pharmacology, Europe for Millennium Pharmaceuticals, and has also served as a consultant for numerous venture capital and biotech companies.

Dr Marshall’s departure will be a blow for Heptares, which has thrived in recent years, and has now a full pipeline of novel GPCR-targeting early-stage candidates, mostly in partnerships with companies such as Allergan, AstraZeneca and Teva.

The new MSD UK Discovery Centre is expected to create 150 new research roles with the aim of attracting the best research scientists to work in London. The new site will accommodate around 800 additional staff for the UK domestic market and other European clinical functions currently based in MSD in the UK’s Hoddesdon headquarters.

The relocation is part of a wider industry trend to relocate R&D facilities from out-of-town locations to city centre locations – AstraZeneca has nearly completed its move to central Cambridge, another key UK location. The success of its US namesake, the concentrated biotech cluster of Boston and Cambridge biotech in Massachusetts is the main model for this new approach.

MSD is currently evaluating several potential locations in and around London, and aims to have the new centre open for business in 2020. A small temporary research facility in the area will be opened in the meantime to begin recruiting scientific talent.

The post MSD attracts top British scientist to head up UK discovery centre appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/msd-attracts-top-british-scientist-head-uk-discovery-centre/

[ellymackay]

When Will There Be a Pharmacological Intervention for Sleep Apnea?

The post When Will There Be a Pharmacological Intervention for Sleep Apnea? is republished from https://www.ellymackay.com

Clinical trials could begin next year for a new class of drugs that have shown promising results in treating sleep-disordered breathing in rodents.

By Lisa Spear

It’s no secret that many sleep apnea patients struggle to use their CPAP machines. What if there was a pharmacological fix, a pill that they could take just before bed that would target the cause of their disordered breathing and keep their airways open throughout the night?

A collaborative project between scientists at the University of Chicago and the IIT Research Institute is working to make this a reality. They are investigating a new class of drugs to treat patients who refuse or fail more traditional sleep apnea therapies. Clinical trials could start as early as the second quarter of next year and could lead to a paradigm shift in how sleep medicine physicians treat their sleep apnea patients, says David McCormick, PhD, president of IIT Research Institute and professor at the Illinois Institute of Technology.

“We identified a completely novel class of drugs, completely novel compounds that are synthesized by a completely novel chemistry,” says McCormick.

The team of researchers presented their findings on April 23 to the Cambridge biotech community at Science2Startup (S2S), an invitation-only symposium in Boston aimed at strengthening connections between biotech investors and therapeutics researchers at academic research institutions.

The scientific presenters were selected by an advisory group of biotech investors, who received over 175 presentation submissions from 64 institutions across 3 continents. Submissions were narrowed down to 12 presenting groups, which then received hands-on coaching and feedback on their scientific translation and drug development plans during the day-long event, according to a press release.

“The goal of events like S2S is to accelerate the translation of innovative discoveries made by some of the world’s preeminent researchers from basic research to the bedside,” says Bill Harrington, managing partner at Osage University Partners.

McCormick’s research group is still in communication with some of the funding agencies from the symposium. According to McCormick, there is the possibility of future collaboration on the development of pharmacological therapies for sleep apnea, the study of which has already received grant funding from the National Heart, Lung, and Blood Institute of the National Institutes of Health.

According to the group’s research published in the peer-reviewed journal PNAS, the administration of L-propargyl glycine to rodents with disordered breathing can help the animals maintain open airways to prevent obstructive sleep apnea (OSA) and inhibit the chemoreflux loop gain that underlies central sleep apnea.

The compounds were shown to decrease apneas when tested on genetically engineered mice, which reliably recapitulate human sleep apnea. The efficacy was also tested on rats, which demonstrated that the decrease in apneas was not a mouse-specific phenomenon, says McCormick, a coauthor on the study.

“The underlying mechanisms of what is going on in a rodent model and a human model appear to be very similar,” says McCormick. “This is the only therapeutic strategy that we are aware of that’s under development that targets both obstructive and central sleep apnea.”

The compounds work to suppress disordered breathing by targeting an enzyme called cystathionine gamma-lyase, also known as CSE. This enzyme is present in certain tissues including the carotid body, a cluster of cells near the fork of the carotid artery, which runs along both sides of the throat.

Emerging research now suggests that a certain percentage of OSA can be due to a decrease in the neurons that control tongue movement, which causes the tongue to become placid, blocking the airways. This process can be interrupted by inhibiting the CSE enzyme, says Nanduri R. Prabhakar, PhD, director of the Institute for Integrative Physiology and the Center for Systems Biology at The University of Chicago.

“For a long time people thought that OSA is primarily an anatomical problem that concerned the upper airways. But now emerging evidence suggests that not only are there anatomical disturbances but also the chemoreflux coming from the carotid body, which controls the respiratory movement,” Prabhakar says.

At least one third of patients with OSA are estimated to have this particular underlying cause. Currently, there are a number of compounds under investigation for sleep apnea, but most are not designed to treat the underlying disease. Other medications might only target sleep apnea symptoms, such as daytime sleepiness or high blood pressure.

This new class of drugs takes aim at the cellular roots of the disorder, according to the researchers. “This is attacking what we believe is the underlying biochemical mechanism,” says McCormick. “What we believe is that by targeting the sleep apneas, many of the very important comorbidities are likely to be improved.”

Lisa Spear is associate editor of Sleep Review.

from Sleep Review http://www.sleepreviewmag.com/2019/05/pharmacological-intervention-sleep-apnea/

from Elly Mackay - Feed https://www.ellymackay.com/2019/05/28/when-will-there-be-a-pharmacological-intervention-for-sleep-apnea/

[randybenedict]

Neuroelectrics touts FDA IDE Starstim epilepsy treatment study data

Medical device dev Neuroelectrics today released results from an FDA investigational device exemption trial of its Starstim device intended to treat patients with drug resistant epilepsy, touting a significant reduction in seizure frequency.

The Starstim device from the Cambridge, Mass.-based company provides transcranial current stimulation, delivering mild electrical currents to the specific areas of the patient’s brain where seizures originate. The system is intended to be worn for 20 minutes per day, and is non-invasive, the company said.

“We are pleased that this clinical study has demonstrated the safety and efficacy of Starstim in treating epilepsy. We are proud of having conducted the first FDA-sanctioned clinical trial in transcranial current stimulation in any indication, positioning Neuroelectrics as the leader in developing an option for patients that employs this powerful therapeutic brain stimulation technology,” CEO Ana Maiques said in a prepared statement.

The study was performed at Boston Children’s Hospital, with adult patients referred from Beth Israel Deaconess Medical Center. A parallel study was also conducted at the National Institute of Neurology and Neurosurgery in Mexico City, the company said. Patients selected for the trial had not responded to at least two anti-epileptic medications, Neuroelectrics said.

Results from the trial indicated that treatment with the Starstim device resulted in a 40% reduction in seizure frequency in 75% of the patient population, measured out to eight weeks post-treatment. No device-related adverse events were reported during the study.

“We and our patients are delighted to have a non-invasive and non-pharmacologic option for those whose seizures have not been controlled by drugs or by surgery. Our patients and families have seen clear improvements in well-being and quality of life,” co-principal investigator Dr. Alexander Rotenberg said in a press release.

The post Neuroelectrics touts FDA IDE Starstim epilepsy treatment study data appeared first on MassDevice.

from MassDevice https://ift.tt/2T3PdJL

[nathanstalbot]

MSD attracts top British scientist to head up UK discovery centre

In November, MSD made a high profile unveiling of plans for a new multi-million pound discovery centre in London – and today it has announced a heavyweight researcher to lead it.

Dr Fiona Marshall joins MSD (Merck & Co. in North America) from Heptares, the UK biotech company she co-founded more than a decade ago, and which was acquired by Sosei in 2015.

Dr Fiona Marshall

Dr. Marshall is a world renowned expert in GProtein-Coupled-Receptor (GPCR) biology, a hugely promising area of drug research where new understanding of molecular targets means it is entering a new era, with many GPCR-targeting candidates in industry pipelines.

In her career of more than 25 years in drug discovery, Dr Marshall achieved numerous significant advances, including leading the first group to show that GPCRs could form heterodimers, and has published more than 80 peer-reviewed papers on GPCRs.  (Last year one of her co-founders at Heptares, Richard Henderson, was a joint Nobel prize winner  for his work in the field.)

MSD says it has invested in the UK because of the excellence of its drug discovery, and finding a British scientist to lead its new centre helps back up the country’s claim to world-leading status.

Roger Perlmutter

“Fiona’s exemplary scientific accomplishments and in-depth drug discovery experience will enable her to make important contributions to the scientific environment within MRL, said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We are pleased to welcome her to MSD, where she will set an enormously high standard as the leader of our new London-based, UK Discovery Research Centre.”

Dr. Marshall is currently the chair of the UK Medical Research Council developmental pathway funding scheme committee and is on the translational advisory groups of the Francis Crick Institute and the Wellcome Trust – to leading academic centres also located in the heart of London.

Also a member of the board of trustees of Alzheimer’s Research UK (ARUK), on the council of the Academy Of Medical Sciences and the industry and translation committee of the Royal Society, Marshall is among the best-connected UK science leaders.

“I am delighted to be joining MSD as it expands its discovery network into London. I relish the challenge of leading MRL’s new team of scientists in the UK as we embark upon the development of the new Discovery Centre in London announced late last year,” said Dr Marshall. “MSD’s commitment to bringing the brightest and best scientific talent to London presents exciting opportunities to discover new medical advances as part of the vibrant London life sciences community.”

Before founding Heptares, Dr. Marshall spent 12 years at GlaxoWellcome/GlaxoSmithKline, eventually rising to become head of the department of Molecular Pharmacology. She then moved on to be director of Discovery Pharmacology, Europe for Millennium Pharmaceuticals, and has also served as a consultant for numerous venture capital and biotech companies.

Dr Marshall’s departure will be a blow for Heptares, which has thrived in recent years, and has now a full pipeline of novel GPCR-targeting early-stage candidates, mostly in partnerships with companies such as Allergan, AstraZeneca and Teva.

The new MSD UK Discovery Centre is expected to create 150 new research roles with the aim of attracting the best research scientists to work in London. The new site will accommodate around 800 additional staff for the UK domestic market and other European clinical functions currently based in MSD in the UK’s Hoddesdon headquarters.

The relocation is part of a wider industry trend to relocate R&D facilities from out-of-town locations to city centre locations – AstraZeneca has nearly completed its move to central Cambridge, another key UK location. The success of its US namesake, the concentrated biotech cluster of Boston and Cambridge biotech in Massachusetts is the main model for this new approach.

MSD is currently evaluating several potential locations in and around London, and aims to have the new centre open for business in 2020. A small temporary research facility in the area will be opened in the meantime to begin recruiting scientific talent.

The post MSD attracts top British scientist to head up UK discovery centre appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/msd-attracts-top-british-scientist-head-uk-discovery-centre/ from HealthReviewsAndViews via Nathan Talbot on Inoreader https://pharmaphorumuk.tumblr.com/post/169995822040

[jakehglover]

MSD attracts top British scientist to head up UK discovery centre

In November, MSD made a high profile unveiling of plans for a new multi-million pound discovery centre in London – and today it has announced a heavyweight researcher to lead it.

Dr Fiona Marshall joins MSD (Merck & Co. in North America) from Heptares, the UK biotech company she co-founded more than a decade ago, and which was acquired by Sosei in 2015.

Dr Fiona Marshall

Dr. Marshall is a world renowned expert in GProtein-Coupled-Receptor (GPCR) biology, a hugely promising area of drug research where new understanding of molecular targets means it is entering a new era, with many GPCR-targeting candidates in industry pipelines.

In her career of more than 25 years in drug discovery, Dr Marshall achieved numerous significant advances, including leading the first group to show that GPCRs could form heterodimers, and has published more than 80 peer-reviewed papers on GPCRs.  (Last year one of her co-founders at Heptares, Richard Henderson, was a joint Nobel prize winner  for his work in the field.)

MSD says it has invested in the UK because of the excellence of its drug discovery, and finding a British scientist to lead its new centre helps back up the country’s claim to world-leading status.

Roger Perlmutter

“Fiona’s exemplary scientific accomplishments and in-depth drug discovery experience will enable her to make important contributions to the scientific environment within MRL, said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We are pleased to welcome her to MSD, where she will set an enormously high standard as the leader of our new London-based, UK Discovery Research Centre.”

Dr. Marshall is currently the chair of the UK Medical Research Council developmental pathway funding scheme committee and is on the translational advisory groups of the Francis Crick Institute and the Wellcome Trust – to leading academic centres also located in the heart of London.

Also a member of the board of trustees of Alzheimer’s Research UK (ARUK), on the council of the Academy Of Medical Sciences and the industry and translation committee of the Royal Society, Marshall is among the best-connected UK science leaders.

“I am delighted to be joining MSD as it expands its discovery network into London. I relish the challenge of leading MRL’s new team of scientists in the UK as we embark upon the development of the new Discovery Centre in London announced late last year,” said Dr Marshall. “MSD’s commitment to bringing the brightest and best scientific talent to London presents exciting opportunities to discover new medical advances as part of the vibrant London life sciences community.”

Before founding Heptares, Dr. Marshall spent 12 years at GlaxoWellcome/GlaxoSmithKline, eventually rising to become head of the department of Molecular Pharmacology. She then moved on to be director of Discovery Pharmacology, Europe for Millennium Pharmaceuticals, and has also served as a consultant for numerous venture capital and biotech companies.

Dr Marshall’s departure will be a blow for Heptares, which has thrived in recent years, and has now a full pipeline of novel GPCR-targeting early-stage candidates, mostly in partnerships with companies such as Allergan, AstraZeneca and Teva.

The new MSD UK Discovery Centre is expected to create 150 new research roles with the aim of attracting the best research scientists to work in London. The new site will accommodate around 800 additional staff for the UK domestic market and other European clinical functions currently based in MSD in the UK’s Hoddesdon headquarters.

The relocation is part of a wider industry trend to relocate R&D facilities from out-of-town locations to city centre locations – AstraZeneca has nearly completed its move to central Cambridge, another key UK location. The success of its US namesake, the concentrated biotech cluster of Boston and Cambridge biotech in Massachusetts is the main model for this new approach.

MSD is currently evaluating several potential locations in and around London, and aims to have the new centre open for business in 2020. A small temporary research facility in the area will be opened in the meantime to begin recruiting scientific talent.

The post MSD attracts top British scientist to head up UK discovery centre appeared first on Pharmaphorum.

from https://pharmaphorum.com/news/msd-attracts-top-british-scientist-head-uk-discovery-centre/

from HealthyLife via Jake Glover on Inoreader http://pharmaphorumuk.weebly.com/blog/msd-attracts-top-british-scientist-to-head-up-uk-discovery-centre

[abbkineeu]

New Post has been published on Biotech Advisers

New Post has been published on http://www.bioadvisers.com/weekly-top-scientific-research-review-1742017-2142017/

Weekly Top Scientific Research Review (17/4/2017 – 21/4/2017)

A new week again! What is the progress of your research this week? Anyway, be relax, and read the latest research report with us.

1. Assembly of embryonic and extraembryonic stem cells to mimic embryogenesis in vitro.

Mammalian embryogenesis requires intricate interactions between embryonic and extraembryonic tissues to orchestrate and coordinate morphogenesis with changes in developmental potential. Here, Sarah Ellys Harrison at University of Cambridge, Department of Physiology, Development and Neuroscience in Cambridge, UK and her colleagues combined mouse embryonic stem cells (ESCs) and extraembryonic trophoblast stem cells (TSCs) in a three-dimensional scaffold to generate structures whose morphogenesis is markedly similar to that of natural embryos. By using genetically modified stem cells and specific inhibitors, the team show that embryogenesis of ESC- and TSC-derived embryos—ETS-embryos—depends on cross-talk involving Nodal signaling. When ETS-embryos develop, they spontaneously initiate expression of mesoderm and primordial germ cell markers asymmetrically on the embryonic and extraembryonic border, in response to Wnt and BMP signaling. Their study demonstrates the ability of distinct stem cell types to self-assemble in vitro to generate embryos whose morphogenesis, architecture, and constituent cell types resemble those of natural embryos.

Read more, please click http://science.sciencemag.org/content/356/6334/eaal1810

2. A murine preclinical syngeneic transplantation model for breast cancer precision medicine.

Lorenzo Federico at Department of Systems Biology, University of Texas MD Anderson Cancer Center in Houston, USA and his colleagues previously demonstrated that altered activity of lysophosphatidic acid in murine mammary glands promotes tumorigenesis. They have now established and characterized a heterogeneous collection of mouse-derived syngeneic transplants (MDSTs) as preclinical platforms for the assessment of personalized pharmacological therapies. Detailed molecular and phenotypic analyses revealed that MDSTs are the most heterogeneous group of genetically engineered mouse models (GEMMs) of breast cancer yet observed. Response of MDSTs to trametinib, a mitogen-activated protein kinase (MAPK) kinase inhibitor, correlated with RAS/MAPK signaling activity, as expected from studies in xenografts and clinical trials providing validation of the utility of the model. Sensitivity of MDSTs to talazoparib, a poly(adenosine 5′-diphosphate-ribose) polymerase (PARP) inhibitor, was predicted by PARP1 protein levels and by a new PARP sensitivity predictor (PSP) score developed from integrated analysis of drug sensitivity data of human cell lines. PSP score–based classification of The Cancer Genome Atlas breast cancer suggested that a subset of patients with limited therapeutic options would be expected to benefit from PARP-targeted drugs. These results indicate that MDSTs are useful models for studies of targeted therapies, and propose novel potential biomarkers for identification of breast cancer patients likely to benefit from personalized pharmacological treatments.

Read more, please click http://advances.sciencemag.org/content/3/4/e1600957

3. CRISPR-Cpf1 correction of muscular dystrophy mutations in human cardiomyocytes and mice.

Duchenne muscular dystrophy (DMD), caused by mutations in the X-linked dystrophin gene (DMD), is characterized by fatal degeneration of striated muscles. Dilated cardiomyopathy is one of the most common lethal features of the disease. Yu Zhang at Department of Molecular Biology, University of Texas Southwestern Medical Center in Dallas, USA and his colleagues deployed Cpf1, a unique class 2 CRISPR (clustered regularly interspaced short palindromic repeats) effector, to correct DMD mutations in patient-derived induced pluripotent stem cells (iPSCs) and mdx mice, an animal model of DMD. Cpf1-mediated genomic editing of human iPSCs, either by skipping of an out-of-frame DMD exon or by correcting a nonsense mutation, restored dystrophin expression after differentiation to cardiomyocytes and enhanced contractile function. Similarly, pathophysiological hallmarks of muscular dystrophy were corrected in mdx mice following Cpf1-mediated germline editing. These findings are the first to show the efficiency of Cpf1-mediated correction of genetic mutations in human cells and an animal disease model and represent a significant step toward therapeutic translation of gene editing for correction of DMD.

Read more, please click http://advances.sciencemag.org/content/3/4/e1602814

4. The kinase TPL2 activates ERK and p38 signaling to promote neutrophilic inflammation.

Tumor progression locus 2 (TPL2; also known as MAP3K8) is a mitogen-activated protein kinase (MAPK) kinase kinase (MAP3K) that phosphorylates the MAPK kinases MEK1 and MEK2 (MEK1/2), which, in turn, activate the MAPKs extracellular signal–regulated kinase 1 (ERK1) and ERK2 (ERK1/2) in macrophages stimulated through the interleukin-1 receptor (IL-1R), Toll-like receptors (TLRs), or the tumor necrosis factor receptor (TNFR). Kate Senger at Genentech Research, Genentech Inc. in South San Francisco, USA and his colleagues describe a conserved and critical role for TPL2 in mediating the effector functions of neutrophils through the activation of the p38 MAPK signaling pathway. Gene expression profiling and functional studies of neutrophils and monocytes revealed a MEK1/2-independent branch point downstream of TPL2 in neutrophils. Biochemical analyses identified the MAPK kinases MEK3 and MEK6 and the MAPKs p38α and p38δ as downstream effectors of TPL2 in these cells. Genetic ablation of the catalytic activity of TPL2 or therapeutic intervention with a TPL2-specific inhibitor reduced the production of inflammatory mediators by neutrophils in response to stimulation with the TLR4 agonist lipopolysaccharide (LPS) in vitro, as well as in rodent models of inflammatory disease. Together, these data suggest that TPL2 is a drug target that activates not only MEK1/2-dependent but also MEK3/6-dependent signaling to promote inflammatory responses.

Read more, please click http://stke.sciencemag.org/content/10/475/eaah4273

5. Improving genetic diagnosis in Mendelian disease with transcriptome sequencing.

Exome and whole-genome sequencing are becoming increasingly routine approaches in Mendelian disease diagnosis. Despite their success, the current diagnostic rate for genomic analyses across a variety of rare diseases is approximately 25 to 50%. Beryl B. Cummings at Analytic and Translational Genetics Unit, Massachusetts General Hospital in Boston, USA and his colleagues explore the utility of transcriptome sequencing [RNA sequencing (RNA-seq)] as a complementary diagnostic tool in a cohort of 50 patients with genetically undiagnosed rare muscle disorders. The team describe an integrated approach to analyze patient muscle RNA-seq, leveraging an analysis framework focused on the detection of transcript-level changes that are unique to the patient compared to more than 180 control skeletal muscle samples. They demonstrate the power of RNA-seq to validate candidate splice-disrupting mutations and to identify splice-altering variants in both exonic and deep intronic regions, yielding an overall diagnosis rate of 35%. They also report the discovery of a highly recurrent de novo intronic mutation in COL6A1 that results in a dominantly acting splice-gain event, disrupting the critical glycine repeat motif of the triple helical domain. They identify this pathogenic variant in a total of 27 genetically unsolved patients in an external collagen VI–like dystrophy cohort, thus explaining approximately 25% of patients clinically suggestive of having collagen VI dystrophy in whom prior genetic analysis is negative. Overall, this study represents a large systematic application of transcriptome sequencing to rare disease diagnosis and highlights its utility for the detection and interpretation of variants missed by current standard diagnostic approaches.

Read more, please click http://stm.sciencemag.org/content/9/386/eaal5209

[bioadvisers]

New Post has been published on Biotech Advisers

New Post has been published on http://www.bioadvisers.com/weekly-top-scientific-research-review-1742017-2142017/

Weekly Top Scientific Research Review (17/4/2017 – 21/4/2017)

A new week again! What is the progress of your research this week? Anyway, be relax, and read the latest research report with us.

1. Assembly of embryonic and extraembryonic stem cells to mimic embryogenesis in vitro.

Mammalian embryogenesis requires intricate interactions between embryonic and extraembryonic tissues to orchestrate and coordinate morphogenesis with changes in developmental potential. Here, Sarah Ellys Harrison at University of Cambridge, Department of Physiology, Development and Neuroscience in Cambridge, UK and her colleagues combined mouse embryonic stem cells (ESCs) and extraembryonic trophoblast stem cells (TSCs) in a three-dimensional scaffold to generate structures whose morphogenesis is markedly similar to that of natural embryos. By using genetically modified stem cells and specific inhibitors, the team show that embryogenesis of ESC- and TSC-derived embryos—ETS-embryos—depends on cross-talk involving Nodal signaling. When ETS-embryos develop, they spontaneously initiate expression of mesoderm and primordial germ cell markers asymmetrically on the embryonic and extraembryonic border, in response to Wnt and BMP signaling. Their study demonstrates the ability of distinct stem cell types to self-assemble in vitro to generate embryos whose morphogenesis, architecture, and constituent cell types resemble those of natural embryos.

Read more, please click http://science.sciencemag.org/content/356/6334/eaal1810

2. A murine preclinical syngeneic transplantation model for breast cancer precision medicine.

Lorenzo Federico at Department of Systems Biology, University of Texas MD Anderson Cancer Center in Houston, USA and his colleagues previously demonstrated that altered activity of lysophosphatidic acid in murine mammary glands promotes tumorigenesis. They have now established and characterized a heterogeneous collection of mouse-derived syngeneic transplants (MDSTs) as preclinical platforms for the assessment of personalized pharmacological therapies. Detailed molecular and phenotypic analyses revealed that MDSTs are the most heterogeneous group of genetically engineered mouse models (GEMMs) of breast cancer yet observed. Response of MDSTs to trametinib, a mitogen-activated protein kinase (MAPK) kinase inhibitor, correlated with RAS/MAPK signaling activity, as expected from studies in xenografts and clinical trials providing validation of the utility of the model. Sensitivity of MDSTs to talazoparib, a poly(adenosine 5′-diphosphate-ribose) polymerase (PARP) inhibitor, was predicted by PARP1 protein levels and by a new PARP sensitivity predictor (PSP) score developed from integrated analysis of drug sensitivity data of human cell lines. PSP score–based classification of The Cancer Genome Atlas breast cancer suggested that a subset of patients with limited therapeutic options would be expected to benefit from PARP-targeted drugs. These results indicate that MDSTs are useful models for studies of targeted therapies, and propose novel potential biomarkers for identification of breast cancer patients likely to benefit from personalized pharmacological treatments.

Read more, please click http://advances.sciencemag.org/content/3/4/e1600957

3. CRISPR-Cpf1 correction of muscular dystrophy mutations in human cardiomyocytes and mice.

Duchenne muscular dystrophy (DMD), caused by mutations in the X-linked dystrophin gene (DMD), is characterized by fatal degeneration of striated muscles. Dilated cardiomyopathy is one of the most common lethal features of the disease. Yu Zhang at Department of Molecular Biology, University of Texas Southwestern Medical Center in Dallas, USA and his colleagues deployed Cpf1, a unique class 2 CRISPR (clustered regularly interspaced short palindromic repeats) effector, to correct DMD mutations in patient-derived induced pluripotent stem cells (iPSCs) and mdx mice, an animal model of DMD. Cpf1-mediated genomic editing of human iPSCs, either by skipping of an out-of-frame DMD exon or by correcting a nonsense mutation, restored dystrophin expression after differentiation to cardiomyocytes and enhanced contractile function. Similarly, pathophysiological hallmarks of muscular dystrophy were corrected in mdx mice following Cpf1-mediated germline editing. These findings are the first to show the efficiency of Cpf1-mediated correction of genetic mutations in human cells and an animal disease model and represent a significant step toward therapeutic translation of gene editing for correction of DMD.

Read more, please click http://advances.sciencemag.org/content/3/4/e1602814

4. The kinase TPL2 activates ERK and p38 signaling to promote neutrophilic inflammation.

Tumor progression locus 2 (TPL2; also known as MAP3K8) is a mitogen-activated protein kinase (MAPK) kinase kinase (MAP3K) that phosphorylates the MAPK kinases MEK1 and MEK2 (MEK1/2), which, in turn, activate the MAPKs extracellular signal–regulated kinase 1 (ERK1) and ERK2 (ERK1/2) in macrophages stimulated through the interleukin-1 receptor (IL-1R), Toll-like receptors (TLRs), or the tumor necrosis factor receptor (TNFR). Kate Senger at Genentech Research, Genentech Inc. in South San Francisco, USA and his colleagues describe a conserved and critical role for TPL2 in mediating the effector functions of neutrophils through the activation of the p38 MAPK signaling pathway. Gene expression profiling and functional studies of neutrophils and monocytes revealed a MEK1/2-independent branch point downstream of TPL2 in neutrophils. Biochemical analyses identified the MAPK kinases MEK3 and MEK6 and the MAPKs p38α and p38δ as downstream effectors of TPL2 in these cells. Genetic ablation of the catalytic activity of TPL2 or therapeutic intervention with a TPL2-specific inhibitor reduced the production of inflammatory mediators by neutrophils in response to stimulation with the TLR4 agonist lipopolysaccharide (LPS) in vitro, as well as in rodent models of inflammatory disease. Together, these data suggest that TPL2 is a drug target that activates not only MEK1/2-dependent but also MEK3/6-dependent signaling to promote inflammatory responses.

Read more, please click http://stke.sciencemag.org/content/10/475/eaah4273

5. Improving genetic diagnosis in Mendelian disease with transcriptome sequencing.

Exome and whole-genome sequencing are becoming increasingly routine approaches in Mendelian disease diagnosis. Despite their success, the current diagnostic rate for genomic analyses across a variety of rare diseases is approximately 25 to 50%. Beryl B. Cummings at Analytic and Translational Genetics Unit, Massachusetts General Hospital in Boston, USA and his colleagues explore the utility of transcriptome sequencing [RNA sequencing (RNA-seq)] as a complementary diagnostic tool in a cohort of 50 patients with genetically undiagnosed rare muscle disorders. The team describe an integrated approach to analyze patient muscle RNA-seq, leveraging an analysis framework focused on the detection of transcript-level changes that are unique to the patient compared to more than 180 control skeletal muscle samples. They demonstrate the power of RNA-seq to validate candidate splice-disrupting mutations and to identify splice-altering variants in both exonic and deep intronic regions, yielding an overall diagnosis rate of 35%. They also report the discovery of a highly recurrent de novo intronic mutation in COL6A1 that results in a dominantly acting splice-gain event, disrupting the critical glycine repeat motif of the triple helical domain. They identify this pathogenic variant in a total of 27 genetically unsolved patients in an external collagen VI–like dystrophy cohort, thus explaining approximately 25% of patients clinically suggestive of having collagen VI dystrophy in whom prior genetic analysis is negative. Overall, this study represents a large systematic application of transcriptome sequencing to rare disease diagnosis and highlights its utility for the detection and interpretation of variants missed by current standard diagnostic approaches.

Read more, please click http://stm.sciencemag.org/content/9/386/eaal5209

[abbkine]

New Post has been published on Biotech Advisers

Weekly Top Scientific Research Review (17/4/2017 – 21/4/2017)

A new week again! What is the progress of your research this week? Anyway, be relax, and read the latest research report with us.

1. Assembly of embryonic and extraembryonic stem cells to mimic embryogenesis in vitro.

Mammalian embryogenesis requires intricate interactions between embryonic and extraembryonic tissues to orchestrate and coordinate morphogenesis with changes in developmental potential. Here, Sarah Ellys Harrison at University of Cambridge, Department of Physiology, Development and Neuroscience in Cambridge, UK and her colleagues combined mouse embryonic stem cells (ESCs) and extraembryonic trophoblast stem cells (TSCs) in a three-dimensional scaffold to generate structures whose morphogenesis is markedly similar to that of natural embryos. By using genetically modified stem cells and specific inhibitors, the team show that embryogenesis of ESC- and TSC-derived embryos—ETS-embryos—depends on cross-talk involving Nodal signaling. When ETS-embryos develop, they spontaneously initiate expression of mesoderm and primordial germ cell markers asymmetrically on the embryonic and extraembryonic border, in response to Wnt and BMP signaling. Their study demonstrates the ability of distinct stem cell types to self-assemble in vitro to generate embryos whose morphogenesis, architecture, and constituent cell types resemble those of natural embryos.

Read more, please click http://science.sciencemag.org/content/356/6334/eaal1810

2. A murine preclinical syngeneic transplantation model for breast cancer precision medicine.

Lorenzo Federico at Department of Systems Biology, University of Texas MD Anderson Cancer Center in Houston, USA and his colleagues previously demonstrated that altered activity of lysophosphatidic acid in murine mammary glands promotes tumorigenesis. They have now established and characterized a heterogeneous collection of mouse-derived syngeneic transplants (MDSTs) as preclinical platforms for the assessment of personalized pharmacological therapies. Detailed molecular and phenotypic analyses revealed that MDSTs are the most heterogeneous group of genetically engineered mouse models (GEMMs) of breast cancer yet observed. Response of MDSTs to trametinib, a mitogen-activated protein kinase (MAPK) kinase inhibitor, correlated with RAS/MAPK signaling activity, as expected from studies in xenografts and clinical trials providing validation of the utility of the model. Sensitivity of MDSTs to talazoparib, a poly(adenosine 5′-diphosphate-ribose) polymerase (PARP) inhibitor, was predicted by PARP1 protein levels and by a new PARP sensitivity predictor (PSP) score developed from integrated analysis of drug sensitivity data of human cell lines. PSP score–based classification of The Cancer Genome Atlas breast cancer suggested that a subset of patients with limited therapeutic options would be expected to benefit from PARP-targeted drugs. These results indicate that MDSTs are useful models for studies of targeted therapies, and propose novel potential biomarkers for identification of breast cancer patients likely to benefit from personalized pharmacological treatments.

Read more, please click http://advances.sciencemag.org/content/3/4/e1600957

3. CRISPR-Cpf1 correction of muscular dystrophy mutations in human cardiomyocytes and mice.

Duchenne muscular dystrophy (DMD), caused by mutations in the X-linked dystrophin gene (DMD), is characterized by fatal degeneration of striated muscles. Dilated cardiomyopathy is one of the most common lethal features of the disease. Yu Zhang at Department of Molecular Biology, University of Texas Southwestern Medical Center in Dallas, USA and his colleagues deployed Cpf1, a unique class 2 CRISPR (clustered regularly interspaced short palindromic repeats) effector, to correct DMD mutations in patient-derived induced pluripotent stem cells (iPSCs) and mdx mice, an animal model of DMD. Cpf1-mediated genomic editing of human iPSCs, either by skipping of an out-of-frame DMD exon or by correcting a nonsense mutation, restored dystrophin expression after differentiation to cardiomyocytes and enhanced contractile function. Similarly, pathophysiological hallmarks of muscular dystrophy were corrected in mdx mice following Cpf1-mediated germline editing. These findings are the first to show the efficiency of Cpf1-mediated correction of genetic mutations in human cells and an animal disease model and represent a significant step toward therapeutic translation of gene editing for correction of DMD.

Read more, please click http://advances.sciencemag.org/content/3/4/e1602814

4. The kinase TPL2 activates ERK and p38 signaling to promote neutrophilic inflammation.

Tumor progression locus 2 (TPL2; also known as MAP3K8) is a mitogen-activated protein kinase (MAPK) kinase kinase (MAP3K) that phosphorylates the MAPK kinases MEK1 and MEK2 (MEK1/2), which, in turn, activate the MAPKs extracellular signal–regulated kinase 1 (ERK1) and ERK2 (ERK1/2) in macrophages stimulated through the interleukin-1 receptor (IL-1R), Toll-like receptors (TLRs), or the tumor necrosis factor receptor (TNFR). Kate Senger at Genentech Research, Genentech Inc. in South San Francisco, USA and his colleagues describe a conserved and critical role for TPL2 in mediating the effector functions of neutrophils through the activation of the p38 MAPK signaling pathway. Gene expression profiling and functional studies of neutrophils and monocytes revealed a MEK1/2-independent branch point downstream of TPL2 in neutrophils. Biochemical analyses identified the MAPK kinases MEK3 and MEK6 and the MAPKs p38α and p38δ as downstream effectors of TPL2 in these cells. Genetic ablation of the catalytic activity of TPL2 or therapeutic intervention with a TPL2-specific inhibitor reduced the production of inflammatory mediators by neutrophils in response to stimulation with the TLR4 agonist lipopolysaccharide (LPS) in vitro, as well as in rodent models of inflammatory disease. Together, these data suggest that TPL2 is a drug target that activates not only MEK1/2-dependent but also MEK3/6-dependent signaling to promote inflammatory responses.

Read more, please click http://stke.sciencemag.org/content/10/475/eaah4273

5. Improving genetic diagnosis in Mendelian disease with transcriptome sequencing.

Exome and whole-genome sequencing are becoming increasingly routine approaches in Mendelian disease diagnosis. Despite their success, the current diagnostic rate for genomic analyses across a variety of rare diseases is approximately 25 to 50%. Beryl B. Cummings at Analytic and Translational Genetics Unit, Massachusetts General Hospital in Boston, USA and his colleagues explore the utility of transcriptome sequencing [RNA sequencing (RNA-seq)] as a complementary diagnostic tool in a cohort of 50 patients with genetically undiagnosed rare muscle disorders. The team describe an integrated approach to analyze patient muscle RNA-seq, leveraging an analysis framework focused on the detection of transcript-level changes that are unique to the patient compared to more than 180 control skeletal muscle samples. They demonstrate the power of RNA-seq to validate candidate splice-disrupting mutations and to identify splice-altering variants in both exonic and deep intronic regions, yielding an overall diagnosis rate of 35%. They also report the discovery of a highly recurrent de novo intronic mutation in COL6A1 that results in a dominantly acting splice-gain event, disrupting the critical glycine repeat motif of the triple helical domain. They identify this pathogenic variant in a total of 27 genetically unsolved patients in an external collagen VI–like dystrophy cohort, thus explaining approximately 25% of patients clinically suggestive of having collagen VI dystrophy in whom prior genetic analysis is negative. Overall, this study represents a large systematic application of transcriptome sequencing to rare disease diagnosis and highlights its utility for the detection and interpretation of variants missed by current standard diagnostic approaches.

Read more, please click http://stm.sciencemag.org/content/9/386/eaal5209

[abbkineus]

New Post has been published on Biotech Advisers

New Post has been published on http://www.bioadvisers.com/weekly-top-scientific-research-review-1742017-2142017/

Weekly Top Scientific Research Review (17/4/2017 – 21/4/2017)

A new week again! What is the progress of your research this week? Anyway, be relax, and read the latest research report with us.

1. Assembly of embryonic and extraembryonic stem cells to mimic embryogenesis in vitro.

Mammalian embryogenesis requires intricate interactions between embryonic and extraembryonic tissues to orchestrate and coordinate morphogenesis with changes in developmental potential. Here, Sarah Ellys Harrison at University of Cambridge, Department of Physiology, Development and Neuroscience in Cambridge, UK and her colleagues combined mouse embryonic stem cells (ESCs) and extraembryonic trophoblast stem cells (TSCs) in a three-dimensional scaffold to generate structures whose morphogenesis is markedly similar to that of natural embryos. By using genetically modified stem cells and specific inhibitors, the team show that embryogenesis of ESC- and TSC-derived embryos—ETS-embryos—depends on cross-talk involving Nodal signaling. When ETS-embryos develop, they spontaneously initiate expression of mesoderm and primordial germ cell markers asymmetrically on the embryonic and extraembryonic border, in response to Wnt and BMP signaling. Their study demonstrates the ability of distinct stem cell types to self-assemble in vitro to generate embryos whose morphogenesis, architecture, and constituent cell types resemble those of natural embryos.

Read more, please click http://science.sciencemag.org/content/356/6334/eaal1810

2. A murine preclinical syngeneic transplantation model for breast cancer precision medicine.

Lorenzo Federico at Department of Systems Biology, University of Texas MD Anderson Cancer Center in Houston, USA and his colleagues previously demonstrated that altered activity of lysophosphatidic acid in murine mammary glands promotes tumorigenesis. They have now established and characterized a heterogeneous collection of mouse-derived syngeneic transplants (MDSTs) as preclinical platforms for the assessment of personalized pharmacological therapies. Detailed molecular and phenotypic analyses revealed that MDSTs are the most heterogeneous group of genetically engineered mouse models (GEMMs) of breast cancer yet observed. Response of MDSTs to trametinib, a mitogen-activated protein kinase (MAPK) kinase inhibitor, correlated with RAS/MAPK signaling activity, as expected from studies in xenografts and clinical trials providing validation of the utility of the model. Sensitivity of MDSTs to talazoparib, a poly(adenosine 5′-diphosphate-ribose) polymerase (PARP) inhibitor, was predicted by PARP1 protein levels and by a new PARP sensitivity predictor (PSP) score developed from integrated analysis of drug sensitivity data of human cell lines. PSP score–based classification of The Cancer Genome Atlas breast cancer suggested that a subset of patients with limited therapeutic options would be expected to benefit from PARP-targeted drugs. These results indicate that MDSTs are useful models for studies of targeted therapies, and propose novel potential biomarkers for identification of breast cancer patients likely to benefit from personalized pharmacological treatments.

Read more, please click http://advances.sciencemag.org/content/3/4/e1600957

3. CRISPR-Cpf1 correction of muscular dystrophy mutations in human cardiomyocytes and mice.

Duchenne muscular dystrophy (DMD), caused by mutations in the X-linked dystrophin gene (DMD), is characterized by fatal degeneration of striated muscles. Dilated cardiomyopathy is one of the most common lethal features of the disease. Yu Zhang at Department of Molecular Biology, University of Texas Southwestern Medical Center in Dallas, USA and his colleagues deployed Cpf1, a unique class 2 CRISPR (clustered regularly interspaced short palindromic repeats) effector, to correct DMD mutations in patient-derived induced pluripotent stem cells (iPSCs) and mdx mice, an animal model of DMD. Cpf1-mediated genomic editing of human iPSCs, either by skipping of an out-of-frame DMD exon or by correcting a nonsense mutation, restored dystrophin expression after differentiation to cardiomyocytes and enhanced contractile function. Similarly, pathophysiological hallmarks of muscular dystrophy were corrected in mdx mice following Cpf1-mediated germline editing. These findings are the first to show the efficiency of Cpf1-mediated correction of genetic mutations in human cells and an animal disease model and represent a significant step toward therapeutic translation of gene editing for correction of DMD.

Read more, please click http://advances.sciencemag.org/content/3/4/e1602814

4. The kinase TPL2 activates ERK and p38 signaling to promote neutrophilic inflammation.

Tumor progression locus 2 (TPL2; also known as MAP3K8) is a mitogen-activated protein kinase (MAPK) kinase kinase (MAP3K) that phosphorylates the MAPK kinases MEK1 and MEK2 (MEK1/2), which, in turn, activate the MAPKs extracellular signal–regulated kinase 1 (ERK1) and ERK2 (ERK1/2) in macrophages stimulated through the interleukin-1 receptor (IL-1R), Toll-like receptors (TLRs), or the tumor necrosis factor receptor (TNFR). Kate Senger at Genentech Research, Genentech Inc. in South San Francisco, USA and his colleagues describe a conserved and critical role for TPL2 in mediating the effector functions of neutrophils through the activation of the p38 MAPK signaling pathway. Gene expression profiling and functional studies of neutrophils and monocytes revealed a MEK1/2-independent branch point downstream of TPL2 in neutrophils. Biochemical analyses identified the MAPK kinases MEK3 and MEK6 and the MAPKs p38α and p38δ as downstream effectors of TPL2 in these cells. Genetic ablation of the catalytic activity of TPL2 or therapeutic intervention with a TPL2-specific inhibitor reduced the production of inflammatory mediators by neutrophils in response to stimulation with the TLR4 agonist lipopolysaccharide (LPS) in vitro, as well as in rodent models of inflammatory disease. Together, these data suggest that TPL2 is a drug target that activates not only MEK1/2-dependent but also MEK3/6-dependent signaling to promote inflammatory responses.

Read more, please click http://stke.sciencemag.org/content/10/475/eaah4273

5. Improving genetic diagnosis in Mendelian disease with transcriptome sequencing.

Exome and whole-genome sequencing are becoming increasingly routine approaches in Mendelian disease diagnosis. Despite their success, the current diagnostic rate for genomic analyses across a variety of rare diseases is approximately 25 to 50%. Beryl B. Cummings at Analytic and Translational Genetics Unit, Massachusetts General Hospital in Boston, USA and his colleagues explore the utility of transcriptome sequencing [RNA sequencing (RNA-seq)] as a complementary diagnostic tool in a cohort of 50 patients with genetically undiagnosed rare muscle disorders. The team describe an integrated approach to analyze patient muscle RNA-seq, leveraging an analysis framework focused on the detection of transcript-level changes that are unique to the patient compared to more than 180 control skeletal muscle samples. They demonstrate the power of RNA-seq to validate candidate splice-disrupting mutations and to identify splice-altering variants in both exonic and deep intronic regions, yielding an overall diagnosis rate of 35%. They also report the discovery of a highly recurrent de novo intronic mutation in COL6A1 that results in a dominantly acting splice-gain event, disrupting the critical glycine repeat motif of the triple helical domain. They identify this pathogenic variant in a total of 27 genetically unsolved patients in an external collagen VI–like dystrophy cohort, thus explaining approximately 25% of patients clinically suggestive of having collagen VI dystrophy in whom prior genetic analysis is negative. Overall, this study represents a large systematic application of transcriptome sequencing to rare disease diagnosis and highlights its utility for the detection and interpretation of variants missed by current standard diagnostic approaches.

Read more, please click http://stm.sciencemag.org/content/9/386/eaal5209

[azuredeltaconsulting]

Why Biomarkers Matter In Bioanalysis- FDA New York - New York City, Buffalo

Biomarkers are transforming the medicine industry by providing insights into disease progression, drug efficiency, and patient health. It is crucial in developing new therapies, clinical trials, and ensuring the safety of medications and the advanced bioanalysis support it. The scientific teams of FDA New York - New York City, Buffalo play a key role in regulating and guiding these innovations. They ensure the safety and effectiveness of new treatments.

What Are Biomarkers?

Biomarkers are measurable indicators of biological states or conditions in the body. These indicators can be genes, proteins, enzymes, or hormones. They are used to identify diseases, measure their progression, or determine how well a treatment is working.

FDA’s Role in Biomarker Research and Bioanalysis:

The regulatory agency FDA New York - New York City, Buffalomanages the approval and regulation of new drugs and therapies that rely on biomarkers. The FDA has set strict guidelines for bioanalysis to ensure that biomarkers used in clinical studies are validated and reliable. By setting guidelines and providing oversight, the FDA New York helps ensure that new therapies are safe and efficient.

How Biomarkers Improve Drug Development and Clinical Trials:

Biomarkers play a major role in reforming drug development. It allows researchers to identify specific patient populations that are most likely to benefit from a particular drug, reducing the time and cost associated with trials. It allows life-saving therapies to reach patients faster.

The Importance of Biomarkers:

Personalized medicine tailors treatments to individual patients. This is where Biomarkers play a key role by allowing healthcare providers to predict how a patient will respond to a particular treatment. FDA New York - New York City, Buffalo advances personalized medicine by ensuring that the biomarkers are scientifically validated and clinically relevant. It ensures that patients receive treatments that are both safe and effective.

With the advancement of technology, identifying and measuring new biomarkers is getting easier. It can lead to more effective therapies.

Looking for a professional consulting team for clinical research? We offer data analysis plans for biomarkers, correlation to dose, and PK metrics, depending on the type of biomarkers and frequency of sampling from intense sampling to sparse data, planning and presentation of PK/PD data to regulatory agencies – FDA, EMA, other. Learn more at www.azuredeltaconsulting.com

[biochemadda]

BioChem Adda

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How Pharmacometrics in New Jersey – Princeton Helps Improve Drug Development

Pharmacometrics in New Jersey – Princeton plays a key role in modern drug development. Pharmacometrics is a major tool in reforming the drug development process. They help in providing a scientific approach to understanding how some drugs interact with the human body.

What is Pharmacometrics in New Jersey – Princeton?

Pharmacometrics is the process of explaining and quantifying the relationship between drugs and patients using mathematical models. Pharmacokinetics and pharmacodynamics, which are two mathematical models in the field of pharmacometrics, contribute to the quantitative understanding of drug actions and responses. Pharmacokinetics defines how the body absorbs, distributes, metabolizes, and excretes drugs and pharmacodynamics defines how drugs affect the body.

Pharmacometrics can calculate the results of drug administration, optimize dosage regimens and minimize the impact of associated risks.

The Role of Pharmacometrics New Jersey – Princeton in Drug Development:

1. Early Drug Development-

Using preclinical data, pharmacometric models can predict the concentration of drugs, toxic effects, and therapeutic effects. Thus, the professionals help to make the right decision at the right time which is beneficial for saving the drug development costs. This result is priceless, it saves the time and money required to introduce a drug in the market and have it legal for use.

2. Clinical Trial Design and Optimization-

Pharmacometrics also plays an important role in designing and optimizing the clinical trial. Due to that, the professionals determine such parameters as the dosage, frequency, and duration of the drug treatment, as well as the degree of its effectiveness and possible adverse consequences.

There are several pharmaceutical companies and research institutes located in New Jersey – Princeton. They use pharmacometric models to improve the design of clinical trials. It ensures the best results and saves time and cost

3. Regulatory Decision-Making-

When it comes toapproving drugs for the market, Regulatory agencies like the FDA require extensive data on the safety and efficacy of drugs. This is where Pharmacometrics provides the quantitative evidence. It presents reliable data that shows the effectiveness and safety of drugs.

4. Personalized Medicine-

Pharmacometrics encourages personalized medicine. This model aims to understand how drugs interact with different patient populations. This process helps tailor treatments to individual needs. The factors like gender, genetics, and pre-existing health conditions are measured.

The Benefits of Pharmacometrics in New Jersey – Princeton:

1. Accelerated Drug Development-

Pharmacometrics accelerates drug development. Reputed medicine companies can avoid costly trial-and-error methods by using this model.

2. Cost Efficiency-

Pharmacometrics helps to save money in different ways. It reduces the number of patients required and predicts potential issues earlier. It keeps pharmaceutical projects within budget.

3. Increased Success Rates-

Pharmacometrics models improve the success rate of drug development. Companies can make informed decisions at every stage of drug development.

The Final Thought:

In a nutshell, Pharmacometrics in New Jersey–Princeton is the way to transform the drug development industry. It helps and supports pharmaceutical companies in different ways. Explore the benefits of your next pharmaceutical project. My company is devoted to consulting in clinical research and the name represents multiple meanings related to Clinical Pharmacology. Learn more at www.azuredeltaconsulting.com

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Modeling and simulation M&S in North Carolina - Durham to Raleigh, Research Triangle Park!! We develop modeling and simulation strategies for clinical programs. We use simulation methods to support dose and dosing regimen selection, trial design, and Go/No-Go decisions and dosing in pediatric studies and simulation of multiple options for the selection of the best approach in drug development. For more information, you can visit our website.

[azuredeltaconsulting]

Modeling and simulation M&S North Carolina

Modeling and simulation M&S in North Carolina - Durham to Raleigh, Research Triangle Park!! We develop modeling and simulation strategies for clinical programs. We use simulation methods to support dose and dosing regimen selection, trial design, and Go/No-Go decisions and dosing in pediatric studies and simulation of multiple options for the selection of the best approach in drug development. For more information, you can visit our website.