Sentences with phrase «including trial design»

Dr. Jerry Mendell of Nationwide Children's Hospital recently joined us for a webinar to discuss his upcoming gene therapy trial, including trial design, inclusion / exclusion criteria, and timelines.

Rethinking the traditional drug development process for rare diseases will be critical, including trial design for small populations, real - world evidence collection, stronger patient engagement for data collection and definition of clinical end - points.

Not exact matches

Mr. Siegal's other client successes include securing a 2016 trial victory in federal court defending Marvel Entertainment against a claim that it stole a patent - holder's design for a Spiderman role play web - shooting toy, and numerous federal and state appellate arguments in criminal and civil matters.

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.

Included with your FREE trial membership — Jim Cramer's best - selling book Get Rich Carefully, plus exclusive bonus reports all designed to help you become a more successful investor — FREE!

NOVA Intelligent Design on Trial http://www.pbs.org/wgbh/nova/evolution/intelligent-design-trial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parTrial http://www.pbs.org/wgbh/nova/evolution/intelligent-design-trial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover partrial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover partrial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parents,

NOVA Intelligent Design on Trial — PBS http://www.pbs.org/wgbh/nova/evolution/intelligent-design-trial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parentTrial — PBS http://www.pbs.org/wgbh/nova/evolution/intelligent-design-trial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parenttrial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parenttrial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parents,...

Declan Devane is a co-author in one of the included trials in this review (Begley 2011) Jane Sandall was and is principal investigator for two studies evaluating models of midwife - led continuity of care (Sandall 2001), and co-investigator on the «Birthplace in England Research Programme», an integrated programme of research designed to compare outcomes of births for women planned at home, in different types of midwifery units, and in hospital units with obstetric services.

Pellecchia said the road to a therapeutic for human trials is still long and includes the iterative design and synthesis of more potent and selective agents.

They may have done a thesis with a translational focus, but few will have received training in the requirements for doing modern patient - oriented research, which includes large doses of epidemiology, statistics, and human - subject trial design.

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.

IHR will test their operation as hearing aids, including human trials of the new designs.

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.

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

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.

The team is now readying the vaccine for human trials and is designing related vaccines to treat other autoimmune diseases, including multiple sclerosis, rheumatoid arthritis, and inflammatory bowel disease.

This pivotal trial is the largest study conducted of renal artery denervation as a treatment for resistant hypertension and the most rigorously designed, including blinding and a sham treatment in the control arm.

The fourth cohort — an ongoing trial known as PANGEA, Personalized ANtibodies for GastroEsophageal Adenocarcinoma designed by Catenacci and based at the University of Chicago Medicine — included 28 patients.

This includes all regulatory documents, IRB submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on Lombardi website, design of electronic case report forms for institutional trials.

The aim of the Interdisciplinary Training in Cancer Research training program is to train young scientists to design and conduct research on significant problems in cancer by combining information and approaches from different scientific disciplines, including basic cellular and molecular biology, epidemiology, clinical trials and studies, and behavioral - social sciences.

We designed a virtual version of the assay for human subjects that includes the visible - target training, hidden - target learning, and probe trials that are typically administered in the mouse version.

Her research interests include study design, clinical trials, data management methodology, and electronic data capture methodologies.

His research interests have included the immunogenetics of diabetes, the biology of tumour - associated antigens and cell adhesion molecules, and ethical aspects of the design of trials involving human subjects.

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.

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

The Scientific Review Committee (SRC) ensures that all cancer clinical trials conducted under the auspices of the Vanderbilt - Ingram Cancer Center meet peer - reviewed standards of scientific design, including appropriate scientific rationale, specific aims, study endpoints, biostatistical analysis, and adequate ability to accrue patients.

Scientific contributions include publication of the first randomized trials to assess the impact of common complex genetic risk markers, empirically measuring the outcomes of DTC genetic testing, design of a variant classification pipeline and single page summary for reporting clinical results of whole genome sequencing.

Impediments to conducting clinical trials include long bureaucratic delays, the tendency of ethical committees to be overcautious, overly restrictive confidentiality rules, unrealistic study designs, and a separation between those who look after patients and those who conduct clinical studies.

We believe that many trials included in this review have limitations regarding their study design, analysis and reporting of their results.

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 deTRIAL 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 detrial (which includes phase 2 and 3 trials) that has evolved into a model for translational research and innovation in clinical trial detrial design.

The next steps include further refinement of the design of the patch to optimise the number of sensors in the array, to demonstrate full functionality over a 24 - hour wear period, and to undertake a number of key clinical trials.

He wanted to find out, so he designed a trials that included a placebo group.

«Given that the majority of studies included in our review weren't well - designed trials, better - quality research on this topic is needed to better inform consumers and clinicians as to whether foot [orthotics] or shock - absorbing insoles can be used to decrease injury risk,» he said.

Gluten and casein free diets have been systematically studied in the autistic population, including in randomized trials; however, no such study design could account for the potential high yield outcomes in any given individual.

The template prepared by the Subcommittee to review the clinical trials included the citation, the design, populations, groups, outcomes, duration, baseline level for the different endpoints, results, and relevant comments.

He served as the Director of MDRC's K - 12 Education Policy Area and specialized in the design and management of rigorous evaluations, including randomized controlled trials of educational and other social policy reforms.

She leads a number of studies that evaluate education programs using rigorous econometric methods, including randomized control trials, propensity score matching methods, and other quasi-experimental evaluation designs.

This device included a 1 year unlimited warranty and a protective case that was designed to withstand the trials and tribulations of capricious youth.

Thanks for including Trial by Twelve and it's nice to see Jenny's design on City of Fae won!

The company is currently focused on conducting the clinical trials necessary for regulatory approval and commercialization of advanced hormone therapy, pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause - related hormone deficiencies, including hot flashes, osteoporosis, and vaginal dryness.

Other promotional vehicles that Old Mill will be using to support the launch of Nature's Bits include special point - of - purchase displays that are designed to acquaint consumers with the new brand and inspire trial, as well as a national sweepstakes campaign.

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

To date, with their support, we've completed a variety of activities to accomplish this goal, including environmental toxicological monitoring on islands where rodent removal has been achieved, and conducting field trials to inform, design, and implement appropriate management strategies to reduce risk to non-target wildlife species during invasive species removal.

There's a lot regarding the history of the intelligent design movement available on the web, including the entire transcript of the trial in Dover during which the conservative Bush - appointed federal district judge became convinced that it is nothing more than old testament - based creationism with a new label.

Hristov and colleagues, including several researchers from DSM, designed and carried out a trial in which 48 cows, receiving varying amounts of the inhibitor in their feed, were observed over 12 weeks.

That includes, among many others, trial and appellate work concerning design patent and trademark litigation implicating national brands, digital technology, the Digital Millennium Copyright Act, trade dress, trade secrets and unfair competition, and myriad forms of false advertising and royalty disputes.

Serve as national trial and coordinating counsel for a leading manufacturer of food equipment systems in product liability matters, including the defense of product designs for meat grinders, mixers, slicers, saws, tenderizers and deep fat fryers.

Let us craft a strategy that is designed to obtain the outcome that best matches your needs, including litigation and trial when necessary.

These include a variety of case management tools, from client - specific extranet sites, linked to an ongoing matter and designed to keep attorneys and clients informed of important case developments, to risk assessment and management applications that can weigh the benefits of early settlement versus going to trial.

This includes programs designed to develop your skills in persuasive communications, negotiations and trial advocacy.