Sentences with phrase «clinical trials process in»

Maren Monsen, Director of the Stanford Program in Bioethics in Film, will present a screening of her documentary film «Rare», which focuses on a rare genetic disorder, and discussion of the importance of patient advocacy groups and clinical trials process in the United States.

Not exact matches

In addition, I think we're going to see — or begin to see — a radical rethinking of the clinical trials process.

Khoshbin says the company is in the process of applying for a device exemption, which will allow it to begin clinical trials in 2015 for its flagship product, Revanesse Ultra.

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 clinical trial of Vascepa for approval in China is in process.

In fact, one of Marathon's clinical trials that the FDA used as part of its decision - making process was conducted more than 20 years ago, saving the firm plenty of study costs.

«Many investors expected a more lengthy FDA review process of the JCAR015 trial (and potentially other CAR - T programs) and feared that a higher - degree regulatory scrutiny could increase the development risk of CAR T cell,» Leerink Research said in a note co-authored by analysts Michael Schmidt, Ph.D., Jonathan Chang, Ph.D., and Varun Kumar, Ph.D. «While it may take several weeks to reopen all clinical sites of the ROCKET trial, we believe the trial shouldn't be delayed by more than ~ 3 months.»

The company has deep expertise in pharmacology and the pharmaceutical commercialisation process, including clinical trials, drug development and optimisation, regulatory liaison and licensing / M & A plans.74

We searched the following databases to 18 February 2016: the Cochrane Central Register of Controlled Trials (CENTRAL)(the Cochrane Library), MEDLINE including In - Process & Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing tTrials (CENTRAL)(the Cochrane Library), MEDLINE including In - Process & Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing tTrials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing tTrials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing trialstrials.

Lanza says that this time, he aims to do things right: direct good science focused on treating disease, publish in reputable journals with rigorous peer - review processes and work with high - quality collaborators and clinical centres for its trials.

«It's clear that the policy has gone way out in front of the science in terms of allowing access to products that haven't been through the standard clinical trials process,» says Mark Ware, a pain specialist at McGill University in Montreal, Canada.

This proof - of - concept project will be conducted in parallel with traditional processes for an ongoing clinical trial.

Catalysis Inc. consults in the areas of strategy, process analysis, and redesign, particularly associated with «electronic clinical trials»; project management infrastructure and training; implementation of enabling technologies; and clinical trial metrics.

GABA and related therapies would have to be tested in human clinical trials, a process that could take several years, the researchers said, noting that many treatments that work in mice do not always translate into effective human therapies.

One clinical trial involves the drug CGF166, a one - time gene therapy, which, if proven successful in humans, could regenerate new hair cells within the cochlea that can signal the part of the brain that processes sound.

The researchers reprogrammed the cells to create induced pluripotent stem cells in an FDA - compliant facility at the Broad Stem Cell Research Center; the use of this facility is an important step in the process as preclinical research moves toward human clinical trials.

Consequently, enrolment in clinical trials — already often a long and difficult process — can grind to a halt.

HemoBioTech is in the process of obtaining permission from the Food and Drug Administration (FDA) to conduct clinical trials in the U.S..

Researchers only discovered this process in the late 1990s, but they've already begun dozens of clinical trials to gauge whether infusing patients with these small RNAs works against a range of diseases, from lung infections to liver cancer to age - related macular degeneration, a sight - stealing condition that mainly affects people over the age of 50.

Sometimes, toxic side effects aren't discovered until fairly late in the drug development process, when substantial amounts of time and money have already been invested in clinical trials.

Once a compound has shown its value in these tests, it will begin the process of drug development prior to clinical trials.

Phages would require a less traditional approach to get official approval, such as the annual process for influenza vaccines in which manufacturers secure approval of new formulas based on the flu bug that is going around that year, instead of conducting big clinical trials every time.

«Recruitment for clinical trials in children with autism is one of the biggest challenges we face in studying potential treatments, and we found that process to be accelerated and streamlined by using existing online communities for enrollment,» said lead author Stephen Bent, associate professor of medicine at UCSF.

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.

This shift in emphasis has created jobs in analytical chemistry, pharmacology, toxicology, regulatory affairs, bioprocess and process developments, validation, quality control, quality assurance, clinical trials management, and large - scale manufacturing.

He got involved in clinical trials after working for an internet start - up company which aimed to speed up the trials recruitment process.

An initial clinical trial of simvastatin in people with early - stage MS showed reductions in brain lesions, suggesting an effect on the underlying disease process.

To get through the FDA's demanding approval process, drug companies must demonstrate their product's safety and efficacy in costly randomized clinical trials.

There is much work to be done on the product submission process including review of the physiological properties, potency and purity of substances, as well as in monograph development, standards of evidence, chemistry and manufacturing, and clinical trial development.»

UNITY has completed a rigorous screening and preclinical testing process of candidate drugs, discovered in this study, and is launching a new clinical trial to assess its first drug, for patients with osteoarthritis of the knee this year.

screening - the process clinicians use to see if a volunteer is eligible to participate in a clinical trial.

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.

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.

These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, uncertainty regarding potential future deterioration in the market for auction rate securities which could result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

He is also in the process of launching a clinical trial of an FDA - approved anti-epileptic drug that — as his lab discovered in 2012 — might improve brain functions in Alzheimer's disease.

Research Nurse Clinicians (RNC) at Rutgers Cancer Institute of New Jersey bring specialized expertise and in - depth knowledge of the research process to patients participating in clinical trials.

Cell Therapy Catapult will develop a scalable manufacturing and differentiation process for AST - VAC2 in order to support the downstream demands of clinical trials and ultimately commercialization.

The NCTN represents «an unmatched effort to integrate and streamline the process of cancer clinical trials research,» said James Doroshow, MD, deputy director for clinical and translational research at NCI in a statement released by NCI last month.

The website is a perfect complement to the «Stem Cells in Focus» blog, housing informational pages on basic stem cell biology, the process by which science becomes medicine, clinical trials and the use of stem cells in understanding and potentially treating specific health conditions.

This small clinical trial will evaluate a treatment for improving processing speed in 20 people with MS.. This computer - based treatment has been shown to be effective in an aging population.

These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, our ability to form collaborative relationships, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

Science can seem meaningless out of context and the lengthy processes of clinical drug trials is sometimes misinterpreted as repeating the studies already carried out in animals.

In the next several years, when the laboratory process for recreating micro tumors is fast and reliable, Dr. Simeone expects to offer a Phase 1 clinical trial to design tailored single and combination therapies, as well as experimental agents targeting specific mutations.

Researchers said the ability to record those two functions would be useful to pharmaceutical companies because it could alert drug manufacturers to cardiac problems caused by a drug early in the process before reaching the clinical trial stage.

To address the challenges involved in this process, the C2T2 brings together our early phase clinical trials program, precision cancer medicine initiatives, and non-invasive imaging core.

These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, the outcome of the review of the continued listing of our common stock on The Nasdaq Stock Market, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, our ability to form collaborative relationships, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

He wants to offshore clinical trials in the same way corporate America has outsourced business processes.

Researchers note that while PCI - aided delivery of chemotherapy to the brain has proven effective in laboratory tests, additional testing prior to human clinical trials is needed to identify other less - toxic blood - brain barrier agents to be used in tandem with the photosensitizer in the PCI process.

With several human clinical trials involving the CRISPR gene - editing process moving forward, the original study resulted in a flurry of criticism from many scientists in the field.

Despite ongoing efforts toward finding novel entities for the treatment of the most challenging cancers, translation into patient benefit has been slow due to the fact that translational cancer research from early drug discovery to late stage drug development and assessment in clinical trials is a long process.