Sentences with phrase «in clinical trial design»

She is the Principle Investigator of the I - SPY TRIAL program, a multi-site neoadjuvant clinical trial (which includes phase 2 and 3 trials) that has evolved into a model for translational research and innovation in clinical trial design.

\ n \ nI've blogged about Geron's work here http://speakingofresearch.com/2009/01/23/a-new-era-for-embryonic-stem-cells/ and I'll confess that I'm quite optimistic about this one, as Geron seem to have been pretty thorough in their pre-clinical work and conservative in their clinical trial design.

In just the last 6 years the EID outbreaks of MERS, Ebola, Zika, CHIKV as examples have underscored the importance of rapid vaccine development and deployment capabilities to meet EID challenges, as well as growing appreciation for creativity and flexibility in clinical trial design.

It will house 150 researchers and clinician scientists, as well as an additional 100 people working in clinical trial design and administration.

He subsequently completed his Masters in Science (MS) in clinical trials design and biostatistics at the school of public health at the university of Michigan.

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 NDIn 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 NDin 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 NDin the FDA issuing a refusal to file letter to Celgene regarding the NDA.

In December, Tehrani signed a deal with GlaxoSmithKline that will allow the pharmaceutical giant to test at least four of its drug candidates on a Zymeworks - designed platform, which combines a computer simulation with a way of engineering protein molecules and allows products to be refined before they move to expensive clinical trials.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Many have used this data in designing new methods to supplement and even replace clinical trials, which are notoriously difficult to fill with patients.

We have numerous ongoing clinical trials designed to evaluate our drugs in a variety of health conditions.

In those areas that we have mapped, it typically takes us a few hours to go from a mechanism - inspired idea for treating a disease to knowing the companies that might have relevant clinical and preclinical assets to license, the companies from whom a candidate could be commissioned, trial designs and endpoints, competing and complementary agents, current and future standard of care, market size, comparable pricing, financing strategy, and potential acquirers, all meant to enable a thoughtful first - pass assessment of whether an idea could be worth a much deeper assessment.

We need to design clinical trials and outcomes in a way that captures the downsides of aging in a quantitative way» that allows targets for drug approvals by the FDA.

Although a considerable body of scientific evidence substantiates the positive correlation between curcumin consumption and a reduction in the risk of cancer, the paucity of suitably designed human clinical trials that clearly demonstrate any direct effect of curcumin on cancer markers may prevent Health Canada from approving a cancer risk reduction claim for curcumin within the current regulatory framework.

His primary research interests since 1996 have been in the design and conduct of a number of randomized trials in clinical obstetrics and perinatology.

In 1984 Avent introduced a baby bottle that set the standard for feeding bottles worldwide and since then Avent has designed and manufactured products that are inspired by nature and developed through extensive research and clinical trials.

In addition, structured training in study design, epidemiology, clinical investigation and health policy research is available for fellows interested in systematic pursuit of a career in clinical research or clinical trialIn addition, structured training in study design, epidemiology, clinical investigation and health policy research is available for fellows interested in systematic pursuit of a career in clinical research or clinical trialin study design, epidemiology, clinical investigation and health policy research is available for fellows interested in systematic pursuit of a career in clinical research or clinical trialin systematic pursuit of a career in clinical research or clinical trialin clinical research or clinical trials.

In her translational science training program, she says, «I have a bioengineer who can now design a clinical trial.

However, as many anti-inflammatory drugs are already available, there may be a relatively short path to designing clinical trials for drugs that modulate the inflammatory response in people with neurodegenerative disease.

«Given the enormous societal toll of chronic pain, being able to predict placebo responders in a chronic pain population could both help the design of personalized medicine and enhance the success of clinical trials,» said Marwan Baliki, research scientist at RIC and an assistant professor of physical medicine and rehabilitation at Northwestern University Feinberg School of Medicine.

Mackall's team had already designed a way to make CAR - T cells that attack the GD2 sugar; similar anti-GD2 CAR - T cells are now being tested in clinical trials in a few other cancers.

In this new study and for the first time, scientists used functional magnetic resonance imaging (fMRI) combined with a standard clinical trial design to derive an unbiased brain - based neurological marker to predict analgesia associated with placebo treatment in patients with chronic knee osteoarthritis paiIn this new study and for the first time, scientists used functional magnetic resonance imaging (fMRI) combined with a standard clinical trial design to derive an unbiased brain - based neurological marker to predict analgesia associated with placebo treatment in patients with chronic knee osteoarthritis paiin patients with chronic knee osteoarthritis pain.

He, along with his colleague Mark Rubinstein, Ph.D. also of the Hollings Cancer Center, designed a clinical trial that started in 2016.

Published in the journal Molecular Cancer Therapeutics, the study also found that use of a second inhibitor might improve the effectiveness of these drugs by possibly preventing resistance, and it recommends that clinical trials should be designed to include a second inhibitor.

She says a number of experimental drugs now in clinical trials are designed to target serotonin in other ways in the brain, and may have better success than the SSRIs.

In an interview in the spring of 2015, Damiano confidently predicted: «We're going to be running a pivotal trial by the end of the year,» referring to the type of clinical trial designed specifically to meet the FDA's standards for getting a device approveIn an interview in the spring of 2015, Damiano confidently predicted: «We're going to be running a pivotal trial by the end of the year,» referring to the type of clinical trial designed specifically to meet the FDA's standards for getting a device approvein the spring of 2015, Damiano confidently predicted: «We're going to be running a pivotal trial by the end of the year,» referring to the type of clinical trial designed specifically to meet the FDA's standards for getting a device approved.

People working in biomanufacturing need to be prepared for inspections by the US Food and Drug Administration and the European Medical Evaluation Agency designed to ensure that mass - produced proteins are of the same quality as those used in clinical trials.

In it, critical care specialist Charles Natanson of the Clinical Center at the U.S. National Institutes of Health in Bethesda, Maryland, argued that blood substitutes, no matter how they're designed, raise the risk of death by almost 30 % and nearly triple the rate of heart attacks in the people who receive them in clinical trials, mainly surgery and trauma patientIn it, critical care specialist Charles Natanson of the Clinical Center at the U.S. National Institutes of Health in Bethesda, Maryland, argued that blood substitutes, no matter how they're designed, raise the risk of death by almost 30 % and nearly triple the rate of heart attacks in the people who receive them in clinical trials, mainly surgery and trauma pClinical Center at the U.S. National Institutes of Health in Bethesda, Maryland, argued that blood substitutes, no matter how they're designed, raise the risk of death by almost 30 % and nearly triple the rate of heart attacks in the people who receive them in clinical trials, mainly surgery and trauma patientin Bethesda, Maryland, argued that blood substitutes, no matter how they're designed, raise the risk of death by almost 30 % and nearly triple the rate of heart attacks in the people who receive them in clinical trials, mainly surgery and trauma patientin the people who receive them in clinical trials, mainly surgery and trauma patientin clinical trials, mainly surgery and trauma pclinical trials, mainly surgery and trauma patients.

Northfield and Biopure in Cambridge, Massachusetts — the company that makes Hemopure, the other blood substitute that's in large clinical trials — vigorously attacked Natanson's article, saying its scientific design was flawed and its conclusions unreliable.

Since randomized clinical trials — the gold - standard in research — don't accommodate patients» preferences, Zoellner and her research team used a study design called a «doubly randomized preference trial» to investigate whether giving patients a choice affects their treatment outcomes.

Next, researchers would like to study how the two - drug approach works in humans, although no clinical trials have yet been designed or scheduled.

A U.K. team is designing a clinical trial even more radical than prenatal stem cell therapy: the first ever test of gene therapy in pregnancy.

Toxicologist Thomas Hartung of the Johns Hopkins Bloomberg School of Public Health in Baltimore agrees: «Clinical drug trials in general are very well designed.

A statin drug commonly used to lower cholesterol is not effective in reducing the number and severity of flare ups from chronic obstructive pulmonary disease (COPD), according to the results of a large multicenter clinical trial designed and directed by Gerard J. Criner, MD, Director of Pulmonary and Critical Care Medicine at Temple University Hospital in Philadelphia, PA..

The determination of each efficacy level was also based on the rigor and quantity of published studies on the drug class: to be in Level A, for example, a class of drugs must have been supported by at least two «Class I» studies — well - designed, double - blind, randomized, placebo - controlled clinical trials.

He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials.

His work in designing anticancer compounds had led to millions of dollars in funding and multiple patents, as well as two compounds in clinical trials.

Of the 10 patients enrolled in the study — a clinical trial designed to evaluate safety and feasibility — none of the participants experienced any dangerous side effects and one patient's disease remained stable after 18 months.

Professor Melanie Calvert, from the University of Birmingham, explained, «Researchers face a difficult task in designing effective clinical trials that include PROs.

«Part of what was exciting about the design of this clinical trial is that we decided early on to accept women from a younger and generally sicker population than is typically enrolled in clinical trials,» says Dr. Cristofanilli, who is also a researcher at the Sidney Kimmel Cancer Center at Thomas Jefferson University.

In support of harmonising regulations between the US and Europe through the Transatlantic Trade and Investment Partnership (TTIP), designed to break down barriers to trade, Tracey Brown asks who would defend a return to the wasteful delays of countries running separate clinical drug trials to meet local regulations.

«What most pharma look to me for is my 10 years of experience in pharmacogenomic clinical drug trial design and result interpretation,» he explains.

Working with the pharma and biotech industries, Poirier focuses on both performing the genetic tests in his laboratory and designing the clinical drug trials.

In a novel animal study design that mimicked human clinical trials, researchers at University of California, San Diego School of Medicine report that long - term treatment using a small molecule drug that reduces activity of the brain's stress circuitry significantly reduces Alzheimer's disease (AD) neuropathology and prevents onset of cognitive impairment in a mouse model of the neurodegenerative conditioIn a novel animal study design that mimicked human clinical trials, researchers at University of California, San Diego School of Medicine report that long - term treatment using a small molecule drug that reduces activity of the brain's stress circuitry significantly reduces Alzheimer's disease (AD) neuropathology and prevents onset of cognitive impairment in a mouse model of the neurodegenerative conditioin a mouse model of the neurodegenerative condition.

When Theravance, the company in South San Francisco, California, that developed the drug, designed the large phase III clinical trials needed for approval, the FDA simply required a demonstration that the drug eliminated symptoms of infection as reliably as the approved antibiotic vancomycin.

The results also highlighted trade - offs to consider in designing future clinical trials, he said.

The pharmaceutical industry, the National Institutes of Health, the FDA, academia, clinical research organizations and other key stakeholders will have the opportunity to focus on these disparities and identify the barriers and challenges in educating, recruiting and designing clinical trials.

«While the present report suggests that optimal outcome measures for FXS are not yet fully developed, the recent failures of clinical trials in the FXS treatment field represent an opportunity to implement novel study designs and methodologies,» concludes Budimirovic.

Angélica Nogueira - Rodrigues, MD, PhD, of the Brazilian National Cancer Insitute, and her colleagues designed a phase 2 clinical trial to test the potential of the EFGR inhibitor erlotinib combined with chemoradiation therapy in 36 women with cervical cancer.

This information was critical in the design and implementation of the current Phase 1 trial and will be of significant benefit in planning the Phase 2/3 clinical efficacy trial.»

However, the first Mayo trial, designed to be double - blind, randomised, placebo - controlled research and purporting to have duplicated the conditions in Cameron's clinical trial, disproved the Cameron - Pauling thesis.