Sentences with phrase «drug trial design»

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

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.

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.

«It essentially gives us a periodic table,» Ron DePinho, President of MD Anderson Cancer Center says, which has provided us with both diagnostic and therapeutic value as well as helped us design clinical trials to accelerate the development of new cancer drugs,».

Dr. Chawla designed and led the ATHOS 3 Phase 3 trial for La Jolla Pharmaceutical's FDA - approved drug for shock, Giapreza ™.

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

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.

And in several large - scale pharmaceutical trials, drugs specifically designed to elevate HDL had no effect on heart disease risk.

Two other multi-national trials randomized 27,438 patients to either bococizumab or placebo and were designed to evaluate the impact of the drug on cardiovascular outcomes, including nonfatal heart attack and stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death.

So Szmulewitz and colleague Mark Ratain, MD, the Leon O. Jacobson professor of medicine and director of the Center for Personalized Therapeutics at the University of Chicago Medicine, designed a randomized clinical trial to see if the drug could be used more efficiently and at less expense.

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.

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.

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.

«We're doing a lot of work to improve clinical trial design and to improve the way drugs are discovered and developed,» Perlmutter says.

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

Set up to mimic the design of a drug trial, the study randomly assigned aid to a subset of people within a development project called the «Graduation program.»

«This will require discussions about alternative approaches to the design and conduct of clinical trials as well as to how interventions are approved by the Food and Drug Administration.»

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..

Phase 1 trials are typically only designed to determine if a new drug is safe, and can't answer whether a new drug works.

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.

Downing and the team evaluated the strength of clinical trial evidence supporting FDA approval decisions for new drugs by characterizing key features of efficacy trials, such as trial size, design duration, and end points.

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.

As a member of their scientific advisory boards, he helps the study directors design the pharmacogenomic portion of new clinical drug trials.

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

It was conducted under a special protocol assessment with the US Food and Drug Administration, which considers an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses acceptable for FDA approval.

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 condition.

With «a little chemistry and some trial and error,» they should be able to design drugs which mimic arachdonic acid, but plug the pocket.

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 researchers caution that the reliable detection of small to moderate risks and benefits of drug therapies requires cogent data from large - scale randomized trials designed a priori to test the hypothesis.

Senior CRAs can become project managers, responsible for the design and overall management of a trial, and then on to be programme managers or directors in charge of multiple drug trials or of a therapeutic area.

They will have been involved in the design of the drug trial so they can shape the way the results are analysed.

The usual thought is that big pharma design trials to favour their drugs and suppress the placebo response.

One project involves probing Foundation Medicine's growing database of tumor profiles for specific mutations and using that information to either design drugs or to parse patients into clinical trials of the company's drugs, says Pao.

When asked about the ethics of offering a drug to people who may never get the disease it's designed to prevent, Michael Sand, the Boehringer scientist overseeing the clinical trial, acknowledges that psychosis risk prediction is far from perfect.

The benefits of psychiatric drugs have been exaggerated and the harms underplayed due to poor trial designs, argues one expert in The BMJ.

If doctors had known that TNF - blocking drugs mimic the effects of a major risk factor for the disease, they might have designed their clinical trials differently, he says.

Well - designed, placebo - controlled trials of the drug in men who do not meet the standard criteria for treatment have been scant in number, and their results have been inconsistent.

Moreover, trials are often designed as best - case scenarios to show a drug's potential; in patients» hands, the drug may not work as well.

«The mouse work is promising enough to adapt these technologies for real time analysis of patient materials so that clinical trials can be designed to test this new diagnostic and drug selection approach,» he said.

«FDA's approach to evaluation of recent hepatitis C drugs underscores the Agency's flexibility in considering innovative or alternative trial designs for drugs that have demonstrated highly promising outcomes in early phase development,» said Dr. Poonam Mishra, deputy director for Safety, Division of Antiviral Products / Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research and lead author of the Hepatology paper.

The findings suggest that clinical trials should be designed to test the drug in diabetic patients.

The two phase 3 trials were designed to better investigate the drug's safety, compare dosage frequency and determine whether improvement would persist after treatment was discontinued.

«This is the first instance I am aware of where an academic drug discovery group moved a molecule designed to hopefully treat a chronic brain disorder all the way from early discovery to human trials without there being, at some point along the way, a pharmaceutical partner,» said P. Jeffrey Conn, Ph.D., Lee E. Limbird Professor of Pharmacology in the Vanderbilt University School of Medicine and director of the Vanderbilt Center for Neuroscience Drug Discovery (VCNdrug discovery group moved a molecule designed to hopefully treat a chronic brain disorder all the way from early discovery to human trials without there being, at some point along the way, a pharmaceutical partner,» said P. Jeffrey Conn, Ph.D., Lee E. Limbird Professor of Pharmacology in the Vanderbilt University School of Medicine and director of the Vanderbilt Center for Neuroscience Drug Discovery (VCNDrug Discovery (VCNDD).

The work should be significant for pharmaceutical companies that design drugs through painstaking processes and at great cost by eliminating some of the trial and error in identifying new sites on proteins that could be more easily manipulated to treat disease, said Rice biological physicist José Onuchic.

The trial was not designed to shed light on the question of whether the drug also can help to create new brown fat cells.

On the other hand, first clinical trials with drugs designed to target cancer stem cells are now under way, so far yielding moderately positive results.