Sentences with phrase «for clinical activities»
Coordinated with caregivers and utilized appropriateequipment's and supplies for clinical activities.
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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.
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.
As for Immunovaccine's DPX - RSV, «development is advancing in the pipeline of a few firms, so we will be watching closely for Immunovaccine to advance DPX - RSV clinical activities imminently,» Loe said.
In talking with past coaches and seeing children in my clinical practice, sports have become a specialization for older kids, and one of the many harried activities for younger ones.
Additionally, researchers also found that prescribing preventive antidepressants for this group of women did not affect the risk for developing postpartum depression, and also that a better predictor of postpartum depression were clinical interviews with the women about work activities, insomnia and suicidality.
Professor Josep Tabernero, a member of the scientific committee for the EORTC - NCI - AACR Symposium and head of the medical oncology department at Vall d'Hebron University Hospital and director of the Vall d'Hebron Institute of Oncology, Barcelona, Spain, commented: «These are encouraging results, which show that galeterone has significant clinical activity in men with castration - resistant prostate cancer that fails to respond to other drugs.
Future resources from the NCI Center for Cancer Genomics (CCG), which oversees TCGA and other activities, will support more translationally focused research, including databases with genomic information on clinical samples linked to outcomes of their patient donors.
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.
For instance, clinical trial participants can avoid the inconvenience of visiting research facilities, writing down their daily activities or wearing clunky monitors.
Although more work is needed to examine whether those findings are relevant for people, «they suggest that clinical trials testing treatments that increase brain activity, such as deep brain stimulation, should be monitored carefully in people with neurodegenerative diseases,» said Dr. Duff.
The researchers believe that future research could focus on specific aspects of the self - expanding activities that produce this effect, as well as test the use of self - expansion activities in clinical interventions for smoking cessation.
This information might assist clinicians in choosing clinical treatment, and help researchers develop effective strategies for coping with the negative effects of weather - related effects on cognition that impact independence, education, employment and activities of daily living.»
«By offering the distinct advantage of subcellular resolution and avoiding the undesirable influence of fluorescent dyes, we believe our technique can complement FDG in clinical PET imaging for visualizing glucose uptake activity at the cellular level,» says the lead author Fanghao Hu, a Ph.D. candidate in chemistry.
Recent estimates from the Centers for Disease Control and Prevention (CDC) indicate that around 10 percent of adults in the United States currently suffer from clinical depression — depression that consists of symptoms such as disruptions in eating, sleeping, and concentration patterns, lack of interest in daily activities, and consistently feeling like a failure.
Many researchers are also hopeful about clinical trials under way with drugs that block certain receptors for glutamate, the main neurotransmitter in the brain that excites neural activity.
Applications include monitoring GI activity for patients outside of a clinical setting, which cuts down costs.
These patients had been undergoing an invasive procedure called manometry, one of a couple clinical gold standards for objectively monitoring GI tract activity.
It could also help distinguish healthy and unhealthy brain activity in young babies, a vitally important aspect of clinical trials for drugs aimed at protecting the brain from infection.
Their natural characteristics make them uniquely suited for research and clinical applications, including as biomarkers both for diseases and for intrinsic biological activity.
As these compounds are already approved for clinical trails in pediatric brain tumors, these findings suggest that drugs inhibiting MEK activity could offer a new therapy option for children with these devastating tumors.
By 2010, the nation will be able to host 15 world - class biomedical sciences companies and will become the region's hub for biomedical sciences activities, including drug discovery and development, clinical research, and health care delivery.
This review shows uniform recognition that exercise and physical activity are safe for those with lung cancer, patients are requesting increased activity counseling, and multiple studies and reviews show potential clinical benefit in quality of life, exercise tolerance, and post-operative complications.
Although there are no official clinical guidelines in the UK on giving bowel cancer patients advice on physical activity, several studies show that it is safe and beneficial for most patients.
«Many children unnecessarily receive broad - spectrum antibiotics for common infections, which can lead to antibiotic resistance and unnecessary side effects,» said study leader Jeffrey Gerber, MD, PhD, associate director for Inpatient Research Activities in the Center for Pediatric Clinical Effectiveness at Children's Hospital of Philadelphia (CHOP).
Initial board certifiers reported intentions for scope of practice and recertifying family physicians reported actual provision of specific clinical activities.
In particular, new developments in emission tomography, nuclear magnetic resonance imaging, and in vivo spectroscopy offer new horizons for medical research and clinical activities.
«There is very little data on the time cost of healthy eating,» said Pablo Monsivais, Ph.D., M.P.H., the study's lead author and a senior university lecturer with the Center for Diet and Activity Research at the University of Cambridge School of Clinical Medicine in England.
Dr Søren Brage (MRC Epidemiology Unit, University of Cambridge), joint senior author on the study says: «Providing quantitative estimates regarding the dose - response relationship is essential for approximating how changes in levels of physical activity in the general population would impact disease incidence, and would support more nuanced guidance to the public and evidence - based dialogue in clinical settings.»
The THaW team conducts research related to mobile and cloud technology for health and wellness applications, including authentication and privacy tools to protect health records, methods to secure small - scale clinical networks and efforts to reduce malicious activity in hospitals.
«In this study, a new «source analysis» method was used for the first time to measure functional networks in the infant brain: with the help of a computer model, the measured EEG signals were interpreted as activity in the infant cortex, which enabled the evaluation of the functional networking of neurons in a very versatile manner on the cortical level,» says Sampsa Vanhatalo, a professor in clinical neurophysiology and the head of the study.
For example, last month's spending bill that established NCATs requests several reports and outside studies of the center's activities and stipulates that it can not support expensive, late - stage clinical trials of the kind typically done by industry.
Through a combination of a variety of information gathering activities and Committee deliberations, the Committee has concluded that the nation's need for these scientists remains strong and that the NRSA program, while small compared to the many other sources of doctoral and postdoctoral support, is enormously powerful in terms of its ability to change research emphases and to attract the highest quality individuals to research careers in the basic biomedical, behavioral and clinical sciences.
«Given the alarming trend of resistance to our current antimalarial therapies, this is really an exciting finding,» says Dr. Mota, the senior author of the study, «and we are already working to develop Torin molecules suitable for clinical trials of antimalarial activity in humans.»
In summary, the results of this study show the potential for functional MRI to bridge the dissociation that can occur between behavior that is readily observable during a standardized clinical assessment and the actual level of residual cognitive function after serious brain injury.14 - 16 Thus, among 23 patients who received a diagnosis of being in a vegetative state on admission, 4 were shown to be able to willfully modulate their brain activity through mental imagery; this fact is inconsistent with the behavioral diagnosis.
As VRC Director, Dr. Mascola provides scientific leadership to the basic, clinical, and translational research activities of the VRC; develops vaccine research programs to meet public health needs; allocates VRC resources; and develops policies for the execution of multi-disciplinary research.
Although we agree that greater investments are needed in the clinical development of these therapies, we disagree with the authors» suggestion that, relative to embryonic stem cells, adult stem cells provide a superior vehicle for cell - based therapies because they lack tumorigenic activity, can be prepared by methods approved by the Food and Drug Administration (FDA), and have been free of ethical controversy.
«Activity - based therapy and exercise is essential for someone who has experienced a spinal cord injury,» said Susan J. Harkema, PhD, NeuroRecovery Network Director for the Reeve Foundation, Director of Research at Frazier Rehab Institute, Professor and Rehabilitation Research Director at the University of Louisville Kentucky Spinal Cord Injury Research Center and Owsley B. Frazier Chair in Clinical Rehabilitation Research.
These activities are being performed in the context of several public or industry - funded R&D projects, and the in house GMP - facility has been used for process development and production of clinical trial material in different expression systems, including E.coli, Pichia pastoris and transgenic tobacco plants.
When questions were raised about whether a study published in the American Journal of Clinical Nutrition adhered to requirements for human subjects research, the Tufts Institutional Review Board (IRB) and Tufts University launched both internal and external reviews of the study activities.
For the purposes of this award, research activities during your residency or clinical fellowship are not considered postdoctoral training.
The Transnational Access 1 (TNA1) «Cross platform screening and optimization service «and the corresponding Joint Research Activity (JRA1) «Improved optimization and harmonization of cross-vector screening «will combine the expertise of six different partners (IME, SSI, UOXF, iBET, BPRC and UNISI) to provide the unique offer to test vaccine candidates in a comprehensive range of different expression hosts, to identify the optimal production system for further pre-clinical and clinical development.
GenIbet's core activity is the manufacture and supply of materials for use in early stage drug development, pre-clinical studies and cGMP manufacturing from Phase I to Phase III clinical trials.
He led Daiichi Sankyo's international research unit focused on early oncology therapeutic programs, strategy and development, and was accountable for development activities from post-target identification basic science research to first - in - man trials and proof - of - clinical concept.
Further to my research and clinical activities, as President of the World Federation of Nuclear Medicine and Biology, the peak global Nuclear Medicine organisation, I am engaged in strategic planning for training, health care policy, and advocacy for molecular imaging and nuclear medicine therapy within the US, European, South American, Asia - Oceania, and African regions, and with the IAEA and WHO.
His laboratory (The Laboratory for Cell and Gene Medicine) specializes in the development of manufacturing processes and QC assays and provides cGMP compliant clinical materials production and regulatory support activities for investigational cell products.
Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $ 14.3 million of non-dilutive funding for the Phase 1 / 2a clinical trial and other product development activities for AST - OPC1.
Using an array of techniques, including RNA sequencing and targeted gene expression profiling, the researchers searched for links between gene activity and protein production in these tumors and the clinical outcomes of patients.
To enable this activity we are actively engaged in clinical teaching and training in the University of Southampton, are active members of the Institute for Life Sciences (Joint PhD students and projects between mathematicians, biologists, chemists, engineers, bioengineers, physical scientists etc.).
Plus, the grant will help them work with researchers led by Doug Nordli, M.D., at the Lurie Children's Hospital at Northwestern University, which has a large clinical program for Dravet syndrome and will look at heart rhythm activity during and after seizures in its patients as part of the study.