Sentences with phrase «clinical trial application for»

Compilation of an investigational medicinal product dossier (IMPD) for the clinical trial application for two candidate vaccines, allowing them to proceed to phase I clinical trials.

Heidi's unrelenting style can be seen across all areas of Hookipa, including a major role in the clinical strategy, scientific advice and clinical trial application for the Vaxwave cytomegalovirus vaccine candidate HB - 101.

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.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

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.

Meanwhile, Eisai will conduct clinical trials for seeking regulatory approval, and make the applications in Asia.

In this randomized, double - blind clinical trial, virgin coconut oil was the clear winner: «among pediatric patients with mild to moderate AD, topical application of virgin coconut oil for eight weeks was superior to that of mineral oil based on clinical (SCORAD) and instrumental (TEWL, skin capacitance) assessments.»

Pharmaceutical companies / clinical trial sponsors (69 %) and service providers / contract research organizations (CROs)(67 %) do not feel that the current technological applications for clinical trials have adequate functionality to meet the current needs.

In the United States, such clinical trials are effectively banned by a rule that prevents the Food and Drug Administration from reviewing applications for any procedure that would introduce heritable changes in human embryos.

He moderated a premeeting session where scientists discussed advances with officials of the U.S. Food and Drug Administration, which would review any application for a clinical trial.

The downside includes cultural resistance to Good Clinical Practice (GCP), clinical research process real - time compliance, inadequate information systems leading to unpredictable project milestones, a «no clock» application process in the regulatory machinery, and inconsistent time frames for export / import of clinical trial materials at theClinical Practice (GCP), clinical research process real - time compliance, inadequate information systems leading to unpredictable project milestones, a «no clock» application process in the regulatory machinery, and inconsistent time frames for export / import of clinical trial materials at theclinical research process real - time compliance, inadequate information systems leading to unpredictable project milestones, a «no clock» application process in the regulatory machinery, and inconsistent time frames for export / import of clinical trial materials at theclinical trial materials at the border.

Still more applications may yet emerge: Lyrica is also in advanced clinical trials as a treatment for epilepsy and for generalized anxiety disorder.

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 gift will be distributed to the researchers in annual increments through 2021 to account for the long - term process of translating scientific insights into clinical trials and applications.

Notice Number: NOT - NS -11-005 Key Dates Release Date: December 7, 2010 Issued by National Institute of Neurological Disorders and Stroke (NINDS) Purpose The National Institute of Neurological Disorders and Stroke (NINDS) will hold a pre-application meeting regarding the Request for Applications (RFA) for Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (RFA - NS -11-008), -LSB-...]

Consultancy will also be offered for the development of funding applications and especially for all aspects regarding the organisation of the management and logistical aspects of multinational clinical trials.

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.

This includes the adaptation of the protocol to national requirements, preparation and adaptation of the patient information sheet and informed consent form, preparation of the documentation required for submission to Ethics Committees and Competent Authorities, submission of the clinical trial Application dossier (CTA) and regulatory follow - up.

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.

CBR is dedicated to advancing the clinical application of cord blood and cord tissue stem cells by partnering with institutions to establish FDA - regulated clinical trials for conditions that have no cure today.

Other applications include designing clinical trials to identify at - risk populations for adverse drug reactions.

Applications involving contracts (such as used for large, multicenter clinical trials) were not included in these analyses.

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.

Today the FDA issued a Complete Response Letter regarding PTC Therapeutics» application for ataluren, noting that «an additional adequate and well - controlled clinical trial (s) will be necessary at a minimum to provide substantial evidence of effectiveness.»

Initially founded in 2011 as a Heart Institute, our treatment protocols were later expanded to include adult stem cell therapy for patients with severe and chronic medical needs that, per scientific research, clinical trials and application, can be safely and potentially efficaciously treated with patients» own stem and regenerative cells.

In September 2016, we announced the first clinical application of our GLAAS discovery platform in Sanofi's Phase 1 clinical trial evaluating a novel therapeutic candidate for the treatment of peanut allergy.

Because cyclodextrin treatment in humans is safe (FDA approved application of 2 hydroxypropyl - β - cyclodextrin for the treatment of Niemann - Pick disease, type C. Phase I clinical trial) and cyclodextrin beneficially affects key mechanisms of atherogenesis, it may therefore be used clinically to prevent or treat human atherosclerosis http://stm.sciencemag.org/content/8/333/333ra50.

The researchers have been in discussions with the FDA and are preparing an application for an initial clinical trial in patients with IPF.

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.

A drug company filed its application in early 2011 for the drug naltrexone for weight loss; in clinical trials, naltrexone was successful, with participants losing 22 pounds per month by reducing calorie intake 400 calories per day.

Rather than waiting for the glacial progress of modern biomedical research, which needs decades to assemble sufficient evidence to get an application for funding for a clinical trial past skeptical reviewers, anyone with a brain or neurological condition should simply experiment with a ketogenic diet themselves to see if it helps.

In July 2012, Health Canada accepted the application after reviewing the clinical trials and peer - reviewed papers as summarized by Dr.Ames and approved the health claim which states that «eating barley helps to reduce cholesterol a risk factor for heart disease.»

Clinical trials have shown safety and effectiveness in easing RLS symptoms in the course of 12 weeks, and the FDA recently asked Solzira's manufacturer to reorganize and resubmit its application for drug approval consideration.

In my corner of the industry, all of our studies are focused on real world application of these products — that is to say, we are monitoring patients using drugs that have been approved and are available for regular consumption — not just a clinical trial.

While the results are certainly valid, further clinical trials and studies are required for wider application.

For information about completing the application process please contact the Office of Veterinary Clinical Trials through their email at: [email protected].

Symetis is also developing the ACURATE neo / AS ** next generation valve system, currently in a clinical trial intended to serve as the basis for a future CE mark application.

Tags for this Online Resume: Applications, Communication Skills, Compliance, Data Analysis, Focus, Good Manufacturing Practices, Leadership, Management, Manufacturing, Media Preparation, pharmaceutical, gcp, protocol, clinical, trial, phase

Directed design, implementation and monitoring of clinical trials, preparation of INDs and periodic study reports for New Drug Applications, and ensured (GCP) was maintained.

Tags for this Online Resume: clinical, affairs, scientific, trials, innovative, management, summary, documents, submission, regulatory, 510 (k), ISE, ISS, PK / PD, communicating, monitoring, tactical, strategic, literature, direct, vision, Lead, Director, documentation, resources, execution, consensus, effectiveness, safety, CRA, IVD, medical, device, pharmaceutical, presentation, manuscript, abstract, poster, programs, leadership, career, development, appraisals, optimize, goals, objectives, internal, external, research, investigator, stakeholders, customers, prioritize, product, support, milestones, Microsoft, Word, Excel, statistics, data, analysis, Powerpoint, publication, growth, deliverables, diagnostic, prognostic, treatment, competitive, proven, ability, capable, assess, strategy, feasibility, methodology, design, develop, produce, recommend, recommendation, therapeutic, supervision, review, performance, appraisal, application, indication, company, collaborate, expert, justification, senior, executive, assessment, experienced, marketing, pre-market, pre-IDE, protocol, communication, utility, pharmacology, service, deliver, delivery, drug, metabolism, absorption, excretion, train, training, mentor, mentoring, CRO, reimbursement, XLSTAT, Prism, relationship, contract, consult, consultant, ownership, responsibility, authority, delegate, trends, direction, in - vitro, commercialize, commercialization, approval, clearance, patient, oncology, cancer, metabolic, cardiovascular, kidney, disease, health, outcomes, safe, effective, toxicity, novel, unique, unmet, need, advisors, advisory, committee, IRB, ethical, justified, supportive, care, associate

Tags for this Online Resume: Protocol, Collection, COPD, Pulmonary, Scheduling, Specimen Collection, Amazon Elastic MapReduce, Applications, Assessments, Attention to Detail, cro, pharmaceutical, clinical trials, research, clinical, regulatory, phase i, phase ii, phase iii, phase iv

A study of individual cognitive therapy for bipolar disorder showed positive outcomes at 1 - year follow - up, but the benefits were reduced over time, suggesting the need for booster sessions to sustain the gains.19 As with many forms of therapy, CBT has been found to be more successful in reducing relapse in the depressive pole compared with the manic pole.30 A large randomised trial of CBT showed no difference between CBT and treatment as usual, when all participants were included in the analyses.31 However, results of a post-hoc analysis suggested that CBT was effective for participants who reported fewer than 12 prior episodes of illness and were not acutely unwell when therapy began; numbers of episodes of mania rather than depression seemed to predict treatment response.32 Such data can help guide the clinical application of CBT for bipolar patients.