Sentences with phrase «of preclinical safety»

«To better understand safety issues, we are making efforts to employ more modern investigational, molecular approaches to safety assessment — and increase our safety testing work force by about 10 percent,» says Phil Bentley, vice president and global head of preclinical safety at Novartis Institutes for BioMedical Research in New York City.

Not exact matches

In a new advancement, they have developed a system in preclinical models that offers a finer degree of control — and, therefore, safety — in opening the barrier.
If these preclinical studies are successful, the researchers plan to further develop their CAR T cell therapy and test its safety and efficacy for different types of metastatic cancer in upcoming clinical trials.
«We are at a point in our research where we have validated the efficacy of this combination treatment approach in preclinical animal models, and we now need to define its safety through toxicology and pharmacology studies,» says Fisher, Thelma Newmeyer Corman Endowed Chair in Cancer Research and co-leader of the Cancer Molecular Genetics research program at VCU Massey, chairman of VCU School of Medicine's Department of Human and Molecular Genetics and director of the VCU Institute of Molecular Medicine.
Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), helped identify the viral strain used in the ZPIV vaccine, supported the preclinical safety testing, and is sponsoring the conduct of this trial.
Seres is developing SER - 401, a preclinical stage oral microbiome therapy comprising a consortium of live bacteria to improve the efficacy and safety of immunotherapy.
Preclinical Safety of Human Embryonic Stem Cell - Derived Oligodendrocyte Progenitors Supporting Clinical Trials In Spinal Cord Injury.
Published new efficacy and safety data from preclinical studies of AST - OPC1 in the peer - reviewed journal «Stem Cells Translational Medicine.»
Previously we reported the development of liposome - based vaccines and their efficacy and safety in preclinical mouse models for tauopathy.
BIRMINGHAM, Alabama — December 9, 2014 — Southern Research is broadening its preclinical service offerings in drug development with the addition of Good Laboratory Practices (GLP)- compliant in vitro safety pharmacology -LSB-...]
Then, in preclinical models of MYCN leukemia, the researchers tested a strategy of knocking out the gene for the safety - valve protein.
Overall, SR - Tiget represents a multi-disciplinary research environment, which provides a unique blend of scientific expertise in the development of innovative gene and cell therapy strategies, access to relevant preclinical models to evaluate their efficacy and safety, as well as competence in conducting early phase clinical trials.
The encouraging safety data from this program and our preclinical and clinical experience in other neurodegenerative diseases support the broadening of our efforts to develop antisense drugs to treat a number of severe neurodegenerative diseases.»
Performs genome - wide profiling of vector integration sites as readout of cell growth at clonal level, in basic research studies and technology development, in preclinical safety studies and in gene therapy treated patients.
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 application.
Although both forms are highly active, ADCs with alkylating IGNs demonstrated a better safety profile, and high therapeutic indices in vivo.23, 24 Here we describe the development and preclinical characterization of a novel CD123 - targeting ADC, IMGN632, consisting of a humanized anti-CD123 antibody conjugated to an alkylating IGN payload via a protease cleavable linker.
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