Sentences with phrase «famhl clinical trial designed»

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.

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

After Abbott, he co-founded DCVC company BlueTalon, which was initially focused on enterprise data security for data - driven clinical trial design and population health management.

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

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 pain.

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 approved.

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

A larger clinical trial designed to do just that will begin recruiting subjects later this year.

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..

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.

The FDA already has a 6 - year - old program called the Critical Path Initiative that, according to its Web site, funds a number of research projects on topics such as clinical trial design.

The original algorithm is now freely available upon request, but Origent hopes to market programs that can be tailored to specific clinical trial designs or even used to help doctors make more personalized predictions for their patients.

Everybody has to agree what is a reasonable clinical trial design.

All previous clinical trials designed to reduce the levels of amyloid - beta using one therapy at a time have had limited success.

Identifying the molecular causes of disease represented a major breakthrough in the history of medicine, moving the discipline from pattern recognition and therapeutic strategies based on syndromic pathophysiology to molecular mechanism and evidence ‐ based therapies derived from clinical trials designed on the basis of molecular mechanism.

Phase I trial - an early clinical trial designed to study an experimental vaccine in humans.

In the $ 1.47 million, four - year grant called â $ œBiomarkers of Ischemic Outcomes in Intracranial Stenosisâ $ (BIOSIS), Emory researchers are analyzing blood samples from 451 patients from around the country who were enrolled in a study known as SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis), the first randomized, multicenter clinical trial designed to test whether stenting intracranial arteries would prevent recurrent stroke.

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.

The CBER is already utilizing in silico techniques to predict clinical outcomes and product safety, inform clinical trial designs, and optimize dosing, and is also implementing the Regenerative Medicine Advanced Therapy (RMAT) designation which provides resources to expedite promising regenerative medicines that address unmet needs.

His team identified a factor that may be important for clinical trial design: progesterone was not toxic to all glioblastoma cell lines, and its toxicity may depend on whether the tumor suppressor gene p53 is mutated.

Additionally, CSCs could provide clues about the novel stem cell pathways activated during cancer progression, which, in turn, could guide further therapeutic steps and clinical trials design.

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.

The data from extensive laboratory studies on correlates of risk of HIV infection will be used in one aspect of the clinical trial design.

We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine.

To address this growing problem, NIAID is funding and conducting research on many aspects of antimicrobial (drug) resistance, including basic research on how microbes develop resistance, development of new and faster diagnostics, and clinical trials designed to find new vaccines and treatments effective against drug - resistant microbes.

Johns Hopkins Bloomberg School of Public Health Statistical methods and automated software tool for stress - testing adaptive clinical trial designs

\ 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.

A new analysis of clinical data from the TRACK - HD and COHORT studies proposes a way to design of clinical trials designed to delay the onset of HD, rather than treating symptoms after they occur.

The guideline presents possible streamlined development programs and clinical trial designs for antibacterial drugs to treat se...

We are a very active member of the Children's Oncology Group Phase I and Phase II - III consortiums, offering families access to a wide range of clinical trials designed to find new treatments for childhood cancers.

As one of the of the center's research projects, Dr. Kent P. Hymel, a child abuse pediatrician at Penn State Children's Hospital, will lead eight pediatric intensive care units from across the country in a randomized clinical trial designed to assess the impact of a novel screening tool for pediatric abusive head trauma.

The BabySeq Project: Genomic Sequencing for Childhood Risk and Newborn Illness (U19 HD077671) is a first - of - its - kind randomized clinical trial designed to examine how best to use genomics in clinical pediatric medicine by creating and safely testing methods for integrating sequencing into the care of newborns.

«The FDA would never approve a drug based on such a clinical trial design,» said Hoge.

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.

The ECCO - AACR - EORTC - ESMO Workshop on Methods in Clinical Cancer Research is an educational programme that introduces junior clinical oncologists in any oncology subspecialty to the principles of good clinical trial design.

I can also spot poor experimental and clinical trial design and methodologically flawed studies — and I know that the evidence for cause and effect in humans is incredibly tenuous at best.

Providing guidance with respect to clinical trial design including: formulation of a testable hypothesis; determination of patient entry criteria; selection of appropriate toxicity assessments; review of appropriate statistical end points; development of an accurate budget

«Veterinarians will have new, innovative therapies to offer clients, and insights gained in dogs and cats will help inform clinical trial design in humans.»

This type of trial is considered the pinnacle of clinical trial design.

Accountable for overall management of the company cardiac clinical trials designed to bring unique annuloplasty rings to market.

Managed project to establish Agile Scrum methodology into the [company name] SDLC process and competed requirements phase for the company's Clinical Trial design product

Dr Kolko directed the trial, conceived of the design, designed and interpreted most of the analyses, and was responsible for most of the writing; Dr Campo contributed to the design of the trial, provided consultation during the trial, and helped to write and edit the manuscript; Dr Kilbourne offered recommendations on the organization of the manuscript, and helped to write and edit the manuscript; Mr Hart contributed to the design and conduct of all data analyses; Dr Sakolsky served as the consulting psychiatrist on the trial, offered recommendations on study measures, and helped to edit the manuscript; Dr Wisniewski served as the primary statistician on the project and contributed to the original clinical trial design / randomization scheme and made recommendations for the analytic plan; and all authors approved the final manuscript as submitted.

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.

But the short answer for anyone who doesn't want to buy a book is that the standard old - fashioned clinical trial is designed to answer a specific question about a population with lots of different specific characteristics.

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

«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,».

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.

The candidate should be experienced designing and running clinical trials and interacting with regulatory authorities.

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.