Sentences with phrase «new clinical applications»

We find out how advances are deepening our understanding of cancer biology and resistance processes, which will lead to new clinical applications such as non-invasive biomarkers and drug development.

«By creating a personalized Patient - on - a-Chip, we can really begin to understand how diseases, medicines, chemicals, and foods affect an individual's health,» said Geraldine A. Hamilton, PhD, president and chief scientific officer of Emulate, Inc. «The goal of Emulate working with Cedars - Sinai is to advance and qualify the system for new clinical applications and ultimately democratize the technology so that it can have a broad impact on patient healthcare.»

For example, in experimental work developing new clinical applications, researchers should be careful not to create false hopes in patients.

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.

The combo proved non-inferior to competing HIV medicines in a slew of late - stage clinical trials, and Gilead is expected to file a new drug application with the FDA soon.

The FDA added that «additional well - controlled clinical trials are needed prior to the resubmission of the [new drug application] for ALKS 5461,» the release said.

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).

Given the clinical trial results underpinning a new drug application for Kite Pharma's lead candidate, which the Food and Drug Administration is currently reviewing, I'd say there's a solid chance Gilead can squeeze out a return on its investment.

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

The new material, described online 25 April in Science by synthetic chemist Andreas Lendlein of mnemoScience GmbH in Aachen, Germany, and biomedical engineer Robert Langer of the Massachusetts Institute of Technology, is composed of two polymers, each already used separately in clinical applications such as drug delivery.

Those services include clinical trials management and U.S. Food and Drug Administration (FDA) new drug submissions and marketing applications.

«But what's exciting about the new protocol is that we avoid some techniques that would prohibit clinical applications.

The article went on to proclaim this «the first clinical application of iPS cells» and said the results were being presented at a conference in New York.

The contest involves writing a 500 - word essay in English, or 1,500 characters in Japanese, about translational medicine, which is a relatively new scientific field where human health is promoted by facilitating communication among those dedicated to basic and clinical research and its application.

A new application of a common clinical test, the positron emission tomography (PET) scan, seems to be able to differentiate between minimally conscious brains and those in a vegetative state.

Kayyem is president of a new company, Clinical Micro Sensors, which is developing the applications further.

I prepared clinical - trial protocols, grants, and new - drug applications.

It has also stopped processing grant applications and accepting new patients at its clinical research center in Bethesda, Maryland, just outside of Washington, D.C.

It is still too early to think about its clinical application, but the work reveals a new genetic target on which to look for new possible therapeutic strategies.

A new picture of the hormonal progression to ovulation could eventually have clinical applications.

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.

«This result has strong application potential» says Dr. Parise, who has just accepted a new position as research scientist at Oculus VR (Facebook): «A deep understanding of multisensory processing opens new clinical perspectives for neurological syndromes that are associated with multisensory impairments, such as Autism Spectrum Disorder and Dyslexia.

Raman says the next big steps are in overcoming the technical challenges of delivering the drug, and completing the experiments essential to file for an Investigational New Drug Application with the Food and Drug Administration to start clinical trials.

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).

The Helmholtz Zentrum München aims to make basic research findings available quickly for clinical application as well as to develop new approaches to diagnostic and therapeutic procedures and prevention.

Although this classification was removed a decade later, since 1965, in order to conduct clinical studies of Coley's Toxins, investigators are required to submit an Investigational New Drug (IND) application with the FDA.

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.

Her expertise includes optimization of standard operating procedures for cGMP manufacture of transgenic T cells, stem cells and dendritic cells to be used in clinical trials, planning and writing clinical trial protocols, IND (investigational new drug) applications and other regulatory documents.

The $ 1 million grant will be used for preclinical trial work with the goal of submitting an Investigational New Drug application to the FDA to begin clinical trials.

The results of long - term safety studies in mice were previously submitted to the Food and Drug Administration to gain permission for a Phase 1 clinical trial under an Investigational New Drug (IND) application.

I am tremendously excited about expanding our knowledge of this new scientific field and pioneering the clinical application of this modality, which holds such great potential to treat a vast array of human diseases,» Dr. Bolen said.

Finally, Eng described new genomics advances including whole genome sequencing for potential clinical application with its opportunity for changing the paradigm of healthcare and its multiple attendant challenges.

These signal gains can be exploited either to reduce the cost of the technique by working in a weak magnetic field or to open up new applications: for example, hyperpolarisation methods provide new routes to probe disease in clinical MRI.

As part of Sanford Health, the largest rural non-profit health care system in the nation, we can integrate research and patient care so that information flows seamlessly — translational genomic research discoveries are accelerated into clinical applications, such as new treatments and diagnostics to benefit patients, and clinical data about patient response flows back to the labs to inform more discoveries.

ViaCyte, Inc. announced in July 2014 that it had filed its first Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence.

HERCULES, Calif. — April 14, 2018 — New research showcasing the importance of Bio-Rad's Droplet Digital PCR (ddPCR) technology in clinical applications will be featured in more than 60 presentations at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, April 14 - 18.

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.

For clinical applications, Clifford emphasizes that his plans focus on tracking disease severity for patients who are already diagnosed, rather than screening for new diagnoses.

At the same time, the President of the United States and the Director of NIH are spearheading a new Precision Medicine Initiative (PMI) to create a cohort of a million individuals that will support research into precision medicine and its clinical application.

«We are pleased to contribute to this important initiative, which will facilitate the application of new strategies to the clinical care of stroke survivors,» said A.M. Barrett, M.D., director of Stroke Rehabilitation Research at Kessler Foundation, and chief of NeuroRehabilitation Program Innovation at Kessler Institute.

GENYO is the first national centre devoted to genomics that integrates the Public Administration, the University and the biotechnology and pharmaceutical business sector, which would allow the integration of research in all its phases, from the generation of knowledge to its development in clinical and pharmaceutical applications, the development of new projects and services for the prevention, diagnosis and treatment of diseases associated to human genetic variability, such a cancer and rare diseases, diabetes, hypertension or degenerative diseases, among others.

The approval process involves several steps including preclinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, and FDA review and approval of the aApplication by the manufacturer of the drug, and FDA review and approval of the applicationapplication.

The aim of the Deciphering Developmental Disorders (DDD) Study is to advance clinical genetic practice for children with developmental disorders by the systematic application of the latest microarray and sequencing methods while addressing the new ethical challenges raised.

â $ I canâ $ ™ t say I am aware of any major studies in the literature exploring topical application of eggshell membrane on collagen formation or inflammation in the skin, â $ says Dr. Julia Tzu, clinical assistant professor of dermatology from New York University.

«If future clinical studies demonstrate that this strategy is effective, we hope our work will lead to development of new, low - cost atopic dermatitis therapies that do not require daily application,» Myles, an NIAID researcher, said in an institute news release.

UC Davis veterinarians, led by Drs. Mathieu Spriet and Pablo Espinosa, are making breakthroughs in their discoveries of the diagnostic capabilities of positron emission tomography (PET) through a clinical trial and other research focused on advancing the clinical applications of this new modality.

UC Davis veterinarians, led by Drs. Mathieu Spriet and Pablo Espinosa, are continuing to see successes in their discoveries of the diagnostic capabilities of PET through this clinical trial and other research focused on advancing the clinical applications of this new modality.

16.25.2.11 LICENSURE BY ENDORSEMENT: A veterinarian who has been licensed in another state and has performed at least 5 years of clinical veterinary practice with at least 6,000 hours immediately preceding application for a New Mexico license, may qualify for licensure by endorsement.

This exclusive new peer - reviewed journal couples our Brief format with the most complete picture of drug applications in clinical practice from leading veterinary authorities, featuring concise, hands - on, real - world practical applications.

Corporate lawyers experienced in the areas of research and development, manufacturing and marketing of new products, including clinical trial structuring, investigational new product applications, and compliance issues.