Sentences with phrase «from clinical applications»

The second part of the course includes examples from the clinical applications of pharmacogenomics.

A special show all about synthetic biology, from clinical applications and regulatory issues to the do - it - yourself biology movement.

He cautions that the study is years from a clinical application, but says, «most studies so far have concentrated on bacterial factors.

Not exact matches

In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDA.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

MobiHealthNews recently reported that more and more consumer - facing digital health companies are signaling a shift in focus away from unregulated fitness and wellness space and towards clinical applications for their technologies.

In her latest book, The Developmental Science of Early Childhood: Clinical Applications of Infant Mental Health Concepts from Infancy Through Adolescence, she describes how larger forces in the family and in the child's biology can affect behavior and how to understand a child's deep story.

Hosted by Chief Clinical Officer Dr. Rachel McClements, Psy D, and Director of Clinical Training, Katherine Tsai, Ph D. this year's conference offered the more than two hundred clinicians from Five Acres and other local agencies a live seminar, «Understanding and Working Within Diverse Contexts of Child Development: Connecting Research to Applications» presented by Ioakim Boutakidis, Ph. D. Associate Dean of Student Success

Gold, C.M. (2017) The Developmental Science of Early Childhood: Clinical Applications of Infant Mental Health Concepts from Infancy to Adolescence New York, NY: W.W. Norton & Company

Three of these themes represent the key scientific steps in moving stem cells from the laboratory into the clinic — the bioengineering and biology of stem cells, and the clinical applications of that research.

A phase II clinical trial is just beginning to evaluate whether prolonged application of one of the most potent good bacteria from human skin can provide long - term protection against S. aureus and improve atopic dermatitis.

«Students have the opportunity to do things from the very fundamental cellular and molecular level all the way through to clinical applications.

Apart from its research applications, aCGH is well on its way to becoming a standard clinical diagnostic tool.

«For several years the potential for the use of gene expression data in research and clinical applications has been underappreciated due to the inconsistency of the data coming from the various types of equipment.

Applicants can have either research or clinical backgrounds, with applications encouraged from scientists seeking to return to their home countries.

In the United States, such clinical trials are effectively banned by a rule that prevents the Food and Drug Administration from reviewing applications for any procedure that would introduce heritable changes in human embryos.

One of the study's clinical investigators, Dr Eric Widra from Shady Grove Fertility in Washington DC, USA, acknowledged that interest in a freeze - all approach to IVF is growing, but not yet with broad application.

As their novel technique for drug delivery is non-invasive and easy to use, the NUS team envisioned that the microneedles patch has great potential for applications in clinical and home care settings for the management of perioperative pain and chronic pain in patients suffering from conditions like diabetes and cancer.

As such, it provides a means of moving organoids from basic research to actual pharmaceutical and clinical applications in the future.

«Clinical application of the findings from this study could help avoid unnecessary biopsies and excess immunosuppression.»

During the webinar, our expert panel of researchers will discuss: • Strategies and technologies for successful cancer biomarker discovery through robust detection and analysis of miRNAs in biofluids • Research into analytic and biological variables that impact miRNA measurements in serum and plasma from the clinical pathologist's point of view • The novel application of miRNAs in serum as biomarkers of aging and chronic disease • The answers to questions submitted by the live, online viewers.

«This is the first demonstration of a shared brain - machine interface, a paradigm that has been translated successfully over the past decades from studies in animals all the way to clinical applications,» said Miguel Nicolelis, M.D., Ph. D., co-director of the Center for Neuroengineering at the Duke University School of Medicine and principal investigator for the study.

Bringing together bench and bedside is the purpose of a new institute that aims to become a world - class «translational» cancer research centre, where the knowledge gained from basic research is translated into clinical applications.

The Japanese newspaper that published what turned out to be false news of the first clinical application of cells derived from induced pluripotent stem cells has detailed the lessons it learned and the steps it is taking to prevent a recurrence.

Although further studies are necessary, potential clinical applications of the team's finding would involve developing methods or drugs that prevent Mtb from entering M - cells.

Medical writers produce the documents that help companies push a drug or device from clinical trials through FDA approval, including literature summaries, applications to FDA to investigate a new device or drug, and documents intended for review by institutional review boards (IRBs).

In addition to proposing several conditions for initial investigations, the report recommends principles to guide the potential trajectory of MRT from research to clinical applications.

However, the need for the rapid point - of - care clinical application of BM stem cells for bone defect repair will not allow for the purification of hMSCs from the BM, and so, the authors assessed the effect of transient BIO exposure to whole BM samples.

In order to dissect these defects, we utilize a unique approach including deep assessment of patient phenotype, clinical genetic testing to identify underlying genetic contributions to these features, and the application of combinatorial functional omics (transcriptome, metabolome, etc.) to uncover the pathological cellular states that result from these genetic changes.

Application in detecting mutations and microsatellite instability (MSI) using circulating DNA from clinical cancer samples will be presented.

Areas of focus include the clinical and health implications of using probiotics, potential forensic uses of microbiome profiles, bioterrorism and biodefense applications, the application of new technologies from the project, and patenting and privacy issues.

While translational research has traditionally moved basic immunology knowledge forward into clinical application, varying clinical presentations of human immune - related disease processes, as well as variability in therapeutic outcomes, have provided opportunities for discovery of novel mechanistic hypotheses directly from patients.

Thirdly, the current, almost universal dependency of organoid culture on the use of Matrigel as a replacement for the function of the extracellular basement matrix in providing structural support and survival signals to the epithelial cells hampers clinical application, considering its origin from a mouse sarcoma cell line, its poorly defined composition and its mechanical rigidity after plating.

Anthelminthics were initially developed for treating veterinary parasites and have advanced from treatment of livestock to first clinical applications for patients.

One chapter describes the clear clinical applications of hematopoietic stem cells from cord blood.

The findings support a path to improving clinical applications, specifically for restoring vision in humans by allowing photoreceptors derived from human stem cells to integrate and thrive in the eye.

The provided information has been manually curated from multiple literature sources, such as: scientific publications, press releases, patent applications and clinical trials registries.

«If the valves they've engineered prove successful in experimental animals, this could open the door to generating complex tissues from stem cells for a wide variety of clinical application.

Proud to receive #SCNfunding from @StemCellNetwork to continue moving our #stemcell - derived liver tissue towards a clinical application for #liver failure: advancing #regenerativemedicine for children @ChuSteJustine and @UMontreal

The potentially unlimited supply of transplantable cells, sourced from stem cell lines, opens the door to clinical application on a much broader scale.

This study shows a real application for our mouse model, making it relevant from both an academic and a clinical perspective.»

The Srinivasan Laboratory at the University of California, Davis, develops novel optical imaging techniques and diagnostics with applications spanning from basic to clinical research.

Improvements in computer memory can be expected to have far - reaching effects on all areas of science and technology, especially by facilitating and extending the application of big data and data science in areas from genomic research to clinical medicine to increasingly general artificial intelligence applications.

Atul Butte, PhD, who is Priscilla Chan and Mark Zuckerberg Distinguished Professor at UCSF and directs the Institute for Computational Health Sciences, a hub for precision medicine research on campus, echoed the excitement felt across UCSF about moving towards clinical application of precision medicine: «Precision medicine is not just a «nice idea» at UCSF — it is benefitting real people, from cancer patients with unusual tumor mutations to children with undiagnosed genetic diseases.

Study sections that reviewed no clinical applications were excluded from this analysis.

Some clinical applications are exempt from human subjects regulations (eg, research conducted in an educational setting involving normal educational practices, research involving the collection of deidentified existing data, research and demonstration projects).

In a substudy, review outcomes were also compared across different types of clinical research, based in large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical research, based in large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanClinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified human tissue.

European Heart Journal, 33 (5), 564 - 566, from http://eurheartj.oxfordjournals.org/content/early/2011/10/20/eurheartj.ehr385.full Clinical Applications of Mesenchymal Stem Cells in Chronic Diseases (30 April 2014) in Stem Cells International.

We aim to enable the passing of the torch from pioneering researchers and developers of genome technologies to first movers in healthcare who are establishing cutting edge standard of care applications of genome technology in every day clinical practice.