Sentences with phrase «clinical trials designed with»

Not exact matches

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.

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.

«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,».

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

Amyloid buildup is a key pathological feature of Alzheimer's, and determining the degree to which someone's brain is riddled with the molecule is essential for designing effective clinical trials.

The clinical trial is designed to assess safety and activity of escalating doses of the special cells (AST - OPC1) for individuals with a complete cervical spinal cord injury.

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.

«Complex models are needed to effectively evaluate PMed study designs, and this proof - of - concept trial validates the dog with cancer as a model for clinical evaluation of novel PMed approaches,» said Dr. Melissa Paoloni, the study's lead author and former director of the COTC.

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.

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

Researchers are designing the first clinical trials of stem cell treatments for fetuses afflicted with rare bone and blood diseases.

The next step, says Salem, will be to try to correlate these findings with patient treatment outcomes, initially as a retrospective, or backward looking study, and then hopefully design a forward looking clinical trial to determine which treatments may be best for patients with SBAs.

«The current landscape of stem cell tourism should prompt a re-evaluation of current approaches to study cell - based interventions with respect to the design, initiation and conduct of U.S. clinical trials,» the authors wrote.

«It was clear from our findings that many people with IBS should have their vitamin D levels tested, and the data suggests that they may benefit from supplementation with vitamin D. «As a result of this exploratory study, we're now able to design and justify a larger and more definitive clinical trial.»

«With knowledge like this, we can design clinical trials using JAK inhibitors for SS patients based on their JAK mutations,» said Elenitoba - Johnson.

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.

Hodi designed this investigator - initiated clinical trial to find out if giving sargramostim along with ipilimumab would have a synergistic effect against the melanoma — like pressing the immune system's accelerator while releasing the brake.

Some of my duties include the design, testing, and manufacturing of the product; working with the contractors and clinical - trials teams; and exploring different distribution systems.

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.

But he says their findings may have more immediate implications as well, for the design of clinical trials evaluating the benefits of providing nutrients to patients with sepsis.

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.

Appel and Sacks led three earlier clinical trials that tested ways to reduce the risk of cardiovascular disease and diabetes, providing volunteers with carefully designed diets and measuring the effects on key health indicators.

This study was designed to use readily available agents in an accepted large - animal model of human heart attack with the goal of obtaining evidence that this treatment is ready to be moved into human clinical trials.»

Described this week in the New England Journal of Medicine (July 4, 2013 print issue), the clinical trial was conducted at multiple sites in China and designed in partnership with a physician at UC San Francisco.

Two years ago, Bouton and his team began collaborating with Ohio State neuroscience researchers and clinicians Dr. Ali Rezai and Dr. Jerry Mysiwto design the clinical trials and validate the feasibility of using the Neurobridge technology in patients.

Innovative clinical trial approaches that have proven successful in other disease areas such as oncology (e.g., platform trials, umbrella and basket designs) might be employed with stratification of subjects by AT (N) profile, enabling a data - driven approach to identify the biological stage of disease in which an intervention has maximal treatment effects.

However, in this Phase II clinical trial, designed to prospectively evaluate the safety and effectiveness of ACHT for patients with HIV - related lymphoma, researchers discovered that this population had no greater likelihood of developing these complications compared to those without the virus.

«This is the first human trial of this novel stem cell - based implant, which is designed to replace a single - cell layer that degenerates in patients with dry age - related macular degeneration,» says lead author and surgeon for the study Dr. Amir H. Kashani, assistant professor of clinical ophthalmology at the Keck School of Medicine of USC.

Biostatisticians and bioinformaticians must have a high level of understanding of the research question being asked, and design the trial accordingly with the information available, setting reasonable expectations for a new treatment based on input from the clinical investigator.

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.

Table 1: Selection, Design & Construction of HSV - based Oncolytic Viruses Table 2: Selection, Design & Construction of Adenovirus - based Oncolytic Viruses Table 3: Selection, Design & Construction of Vaccinia Virus - based Oncolytic Viruses Table 4: Selection, Design & Construction of Vesicular Stomatitis Virus - based Oncolytic Viruses Table 5: Selection, Design & Construction of Newcastle Disease Virus - based Oncolytic Viruses Table 6: Selection, Design & Construction of Various Virus - based Oncolytic Viruses Table 7: Current Company - Sponsored Clinical Trials of T - Vec Table 8: Clinical Trials of ColoAd1 Table 9: Clinical Trials with JX - 594 Table 10: Clinical Trials with GL - ONC1 Table 11: Clinical Trials of CAVATAK (CVA21) Table 12: Clinical Trials with MV - NIS Table 13: Overview of Oncolytic Viruses by Development Phase & Virus Family Table 14: Profile of Approved and Marketed Oncolytic Viruses Table 15: Pivotal Study Design of Oncolytic Viruses in Late Stage Development Based on Previous Clinical Results Table 16: Approved Indications of Immune Checkpoint Inhibitors Table 17: Active Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 18: Planned Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 19: Active or Planned Clinical Studies of Oncolytic Viruses in Combination with Other Anti-Cancer Therapeutics Table 20: Pattern of Transgenes in Oncolytic Viruses in Relation to Development Phase Tables 21a and 21b: Indications and Frquency and Way of Administration of Oncolytic Viruses in Active and / or Positive Completed Clinical Studies Table 22: Small and Medium Pharma & Biotech as Partner for Regional Co-Development of Oncolytic Viruses Table 23: Immuno - Oncology Portfolio of Major Pharma & Biotech with Interest in Oncolytic Viruses Table 24: Interests of Major Pharma & Biotech in Oncolytic Viruses Table 25: First Generation Oncology Virus Companies and their Sources of Technology Table 26: Second Generation Oncology Virus Companies and their Sources of Technology Table 27: Third Generation Oncology Virus Companies and their Sources of Technology Table 28: Fourth Generation Oncology Virus Companies and their Sources of Technology Table 29: Grants, Credits & Donations Table 30: Financing by Venture Capital, Private Equity and Other Private Placements Table 31: Collaboration & Licensing Agreements Table 32: Companies Listed on Stock Exchange & Offerings Table 33: Mergers & Acquisitions

As a Web Applications Engineer he contributes extensive experience with relational database technologies such as MySQL, MSSQL and Oracle to the development and design of the Clinical Trials Registry and Internet Stroke Center web applications.

Early anti-pseudomonal acquisition in young patients with cystic fibrosis: rationale and design of the EPIC clinical trial and observational study».

Before joining IDRI, Tracey worked as a Protocol Development Manager with the HIV Vaccine Trials Network at the Fred Hutchinson Cancer Research Center where she led multi-disciplinary teams in the design and implementation of clinical trials evaluating candidate HIV and tuberculosis vacTrials Network at the Fred Hutchinson Cancer Research Center where she led multi-disciplinary teams in the design and implementation of clinical trials evaluating candidate HIV and tuberculosis vactrials evaluating candidate HIV and tuberculosis vaccines.

Our program is collaborating with researchers around the globe to dissect the results from this trial to inform basic research and design future clinical trials to translate a scientific milestone into an eventual public health tool.

May 3, 2006 deCODE genetics (Nasdaq: DCGN) today announced that it has reached an agreement with the US Food and Drug Administration (FDA) on the design of its Phase III clinical trial for DG031, deCODE's lead developmental compound for the prevention of heart attack...

With carefully designed Phase I clinical trials, they begin with small, effective doses and gradually increase to determine the correct dosage and to observe the toxicity of new therapWith carefully designed Phase I clinical trials, they begin with small, effective doses and gradually increase to determine the correct dosage and to observe the toxicity of new therapwith small, effective doses and gradually increase to determine the correct dosage and to observe the toxicity of new therapies.

CancerNetwork speaks with Patricia S. Steeg, PhD, who has recently written a perspective in the journal Nature calling for a shift in both the types of drugs that are developed for breast cancer and in the way clinical trials are designed and executed.

Immune Design entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate the safety and efficacy of its CMB305 cancer immunotherapy product candidate combined with the investigational cancer immunotherapy atezolizumab in a randomized Phase 2 trial in patients with soft tissue sarcoma.

Immune Design entered into clinical collaboration agreements with Merck, known as MSD outside the U.S. and Canada, to evaluate the safety and efficacy of two Immune Design immuno - oncology investigative agents, G100 and LV305, separately combined with KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in Phase 1 trials in patients with non-Hodgkin's lymphoma (NHL) and melanoma, respectively.

She designs and leads clinical trials, and works with both laboratory and public health investigators.

In fact, Morgan, Palinkas, Barrett - Connor, and Winged (1993) articulate this with, «In several clinical trials of interventions designed to lower plasma cholesterol, reductions in coronary heart disease mortality have been offset by an unexplained rise in suicides and other violent deaths» (p. 75).

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

The mission of Animal Clinical Investigation LLC is to help in the development of new treatment opportunities for pet animals with cancer through the design and implementation of prospective clinicalClinical Investigation LLC is to help in the development of new treatment opportunities for pet animals with cancer through the design and implementation of prospective clinicalclinical trials.

Safety considerations in the design and interpretation of clinical trials indicates that «some animal studies have suggested the potential for dose - dependent fetal toxicities (for example, growth impairment, skeletal malformations and cardiovascular anomalies) associated with excess Vitamin D supplementation.

Results of this study will be used to help design future clinical trials evaluating VSV - IFNβ - NIS in dogs with relapsed or refractory cancer.

Operationalized Phase III & IV clinical trials with responsibility for protocol designs, site and vendor selection, resulting in on - time delivery of clinical study results.