Sentences with phrase «clinical development phase»

BioMS is in a clinical development phase with a phase - two and a couple of phase - three clinical trials going on, which means that there are clinical - trial agreements, indemnification agreements, budget - amendment agreements, as well as research and development contracts with outside agencies and those with outside consultants.

Not exact matches

Cambridge, MA — March 30, 2017 — Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that it has enrolled and dosed the first patient in its Phase 1b clinical trial of light - activated AU - 011, an investigational, first - in - class targeted therapy in development for the treatment of ocular melanoma, a rare and life - threatening disease.
This includes a stem cell research centre, a network of drug discovery institutes and a # 20 million global clinical development fund dedicated to supporting Phase I and II clinical trials; and a # 2 million collaboration between University of Cambridge and University College London that will use donated cells from people with Alzheimer's to test potential new treatments
For example, you might make a list of 20 or 30 companies, all with cancer drugs in Phase II of clinical development.
But highly trained life scientists will still be needed for such tasks as late - stage development (ensuring smooth implementation of final phase (III and IV) clinical trials) as well as compliance with regulatory demands (so - called commissioning and validation specialists), according to Croonen.
Last month, Biopure launched a revamped clinical development program, emphasizing testing in Europe, with three phase II clinical trials planned for 2008 to study the impact of its product on heart attack patients, chemotherapy patients with anemia and the terminally ill.
Under the new organizational structure, Genentech Research and Early Development program, dubbed gRED, which essentially comprises basic research up to Phase 2 clinical trials, will maintain its autonomy.
The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.
However, RA professionals are increasingly involved with products during the research and development phases, in the design and monitoring of clinical studies, marketing, advertising, and communications.
Her research at Stanford University has contributed to the development of a small molecule peptide that is currently in Phase IIA clinical trials for AD.
These results support Afferent's current development strategy to initiate a Phase 2b clinical trial early in 2015.
Development of a second CETP inhibitor, dalcetrapib, was stopped when a phase 2 clinical trial found the drug to be ineffective.
The authors believe that the incorporation of such a blood test into routine clinical practice could provide a prime opportunity for intervention during the pre-cancerous phase before the development of pancreatic malignancy.
The phase in the development of a new treatment where clinical trials are conducted using many patients, to determine whether the treatment is effective
P - BCMA - 101 is Poseida's lead CAR - T therapy currently in Phase 1 clinical development for the treatment of multiple myeloma.
Research Interests: Clinical pharmacology of anticancer agents; early phase drug development; drug tolerability in cancer patients with HIV / AIDS; drug tolerability in cancer patients with organ dysfunction; blood - brain barrier penetration of drugs.
Dr. Laikind will review recent progress with the company's VC - 01 ™ islet replacement product candidate for the treatment of type 1 diabetes, which recently entered the clinical phase of development.
The Pilot Bioproduction Facility at WRAIR manufactured the ZPIV vaccine being used in Phase 1 clinical studies, and the Army recently signed a cooperative research and development agreement to transfer the ZPIV technology to Sanofi Pasteur to explore larger scale manufacturing and advanced development.
Under the agreement, Biotecnol and Cancer Research UK's Centre for Drug Development will collaborate to take forward Tb535H through a Biotecnol - sponsored first - in - man Phase I clinical trial, using Cancer Research UK's drug development expertise in return for shareholdings inDevelopment will collaborate to take forward Tb535H through a Biotecnol - sponsored first - in - man Phase I clinical trial, using Cancer Research UK's drug development expertise in return for shareholdings indevelopment expertise in return for shareholdings in Biotecnol.
She is CEO of PsychoGenics Inc., a profitable preclinical CNS service company, CEO of PGI Drug Discovery LLC, a company engaged in psychiatric drug discovery with three partnered Phase II clinical programs and Adjunct Associate Professor of Neuroscience at Mount Sinai School of Medicine, Dr. Leahy has more than 25 years of experience in drug discovery, clinical develop and business development for pharmaceutical and biotechnology companies, including extensive knowledge of technology assessment, licensing, mergers and acquisitions, and strategic planning.
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.
Once this development culminated in the product of the successive phases of clinical trials, for a provision of patients.
The company's lead product is for the personalized treatment of advanced renal cell carcinoma and is in phase III clinical development.
Reykjavik, ICELAND, December 17, 2004 — deCODE genetics (Nasdaq: DCGN) today announced the signing of an agreement under which it will conduct a Phase II information - rich clinical trial next year of a third - party compound as part of a drug development program in asthma.
Dr. Brandon will review recent progress with the company's VC - 01 ™ product candidate for the treatment of type 1 diabetes, which recently entered the clinical phase of development.
We have completed the active phase of a Phase 1 trial of a Vaxwave ® - based vaccine against cytomegalovirus (CMV) and are finalizing clinical development plans for TheraT ® in Human Papilloma Virus (HPV)- related head and neck canphase of a Phase 1 trial of a Vaxwave ® - based vaccine against cytomegalovirus (CMV) and are finalizing clinical development plans for TheraT ® in Human Papilloma Virus (HPV)- related head and neck canPhase 1 trial of a Vaxwave ® - based vaccine against cytomegalovirus (CMV) and are finalizing clinical development plans for TheraT ® in Human Papilloma Virus (HPV)- related head and neck cancers.
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.
Cambridge, MA, September 07, 2016 — Proclara Biosciences, a biotechnology company developing novel therapies for diseases caused by protein misfolding, today announced that it has initiated a Phase 1b clinical trial evaluating NPT088, its lead development candidate for Alzheimer's disease.
A concentrated source of information on cell therapies spanning the different stages of development: including research, pre-clinical, clinical and marketed phases, being pursued by both non-profit organizations (NPO) and industries.
Table 1: Selection, Design & Construction of HSV - based Oncolytic Viruses Table 2: Selection, Design & Construction of Adenovirus - based Oncolytic Viruses Table 3: Selection, Design & Construction of Vaccinia Virus - based Oncolytic Viruses Table 4: Selection, Design & Construction of Vesicular Stomatitis Virus - based Oncolytic Viruses Table 5: Selection, Design & Construction of Newcastle Disease Virus - based Oncolytic Viruses Table 6: Selection, Design & Construction of Various Virus - based Oncolytic Viruses Table 7: Current Company - Sponsored Clinical Trials of T - Vec Table 8: Clinical Trials of ColoAd1 Table 9: Clinical Trials with JX - 594 Table 10: Clinical Trials with GL - ONC1 Table 11: Clinical Trials of CAVATAK (CVA21) Table 12: Clinical Trials with MV - NIS Table 13: Overview of Oncolytic Viruses by Development Phase & Virus Family Table 14: Profile of Approved and Marketed Oncolytic Viruses Table 15: Pivotal Study Design of Oncolytic Viruses in Late Stage Development Based on Previous Clinical Results Table 16: Approved Indications of Immune Checkpoint Inhibitors Table 17: Active Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 18: Planned Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 19: Active or Planned Clinical Studies of Oncolytic Viruses in Combination with Other Anti-Cancer Therapeutics Table 20: Pattern of Transgenes in Oncolytic Viruses in Relation to Development Phase Tables 21a and 21b: Indications and Frquency and Way of Administration of Oncolytic Viruses in Active and / or Positive Completed Clinical Studies Table 22: Small and Medium Pharma & Biotech as Partner for Regional Co-Development of Oncolytic Viruses Table 23: Immuno - Oncology Portfolio of Major Pharma & Biotech with Interest in Oncolytic Viruses Table 24: Interests of Major Pharma & Biotech in Oncolytic Viruses Table 25: First Generation Oncology Virus Companies and their Sources of Technology Table 26: Second Generation Oncology Virus Companies and their Sources of Technology Table 27: Third Generation Oncology Virus Companies and their Sources of Technology Table 28: Fourth Generation Oncology Virus Companies and their Sources of Technology Table 29: Grants, Credits & Donations Table 30: Financing by Venture Capital, Private Equity and Other Private Placements Table 31: Collaboration & Licensing Agreements Table 32: Companies Listed on Stock Exchange & Offerings Table 33: Mergers & Acquisitions
Allan Robins, Ph.D., Senior Vice President of Science and Technology, will review recent progress with the company's VC - 01 ™ product candidate for the treatment of type 1 diabetes, which entered the clinical phase of development late last year.
Summary: A two day meeting to demonstrate to the wider scientific community where the IMPC is trying to go and how to include clinical scientists, geneticists and the rare disease research community, followed by two simultaneous one day workshops (phenotyping and EUCOMMTOOLS) to plan for Phase II phenotyping and discuss production technology development Attended by: IMPC members, corporate sponsors, external delegates, EUCOMMTOOLS members and IKMC members Hosted / funded by: Infrafrontier, EUCOMMTOOLS, CNR Monterotondo
Finally, the plans for the future development of the vaccine and the next steps to phase II clinical trial were presented.
Roche (SIX: RO, ROG; OTCQX: RHHBY) and Prothena Corporation plc (NASDAQ: PRTA), announced today that they have entered into a worldwide collaboration to develop and commercialize antibodies that target alpha - synuclein, including PRX002... which is currently in preclinical development and is expected to enter Phase 1 clinical trials in patients with Parkinson's disease in 2014.
We believe this finding will assist us in designing the next phase of clinical development, in which DG031 will be studied for the prevention of heart attack.»
Gladstone established the Assay Development and Drug Discovery Core to help scientists accelerate their research into target and drug - discovery phases and move their findings into clinical trials and potential therapies for disease.
Texas Children's Cancer Center is a member of the COG Phase I Consortium, a small and select group of institutions that administer Phase I clinical trials of drugs in early development.
TBVI aims to accelerate and support promising candidates to early clinical development (up to Phase IIa):
The clinical biostatistics team has strong connection with the Biometry department (Head A. Savignoni), the early phase clinical trial and precision medicine unit where patients are treated with drugs in development (Head C. Le Tourneau), the translational research department in particular the Circulating Tumor Biomarkers laboratory (Charlotte Proudhon), and of course the other teams of the U900.
The scientific goal of the Developmental Cancer Therapeutics Program is to discover and characterize unique agents and pathways that will impact the development of more effective cancer therapies and to translate these discoveries into clinical applications by using proof - of - principle, early phase clinical and correlative science studies.
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.
deCODE genetics (Nasdaq: DCGN) today announced that it has begun enrolling patients in its Phase I clinical development program for DG051, the company's follow - on developmental compound for the prevention of heart attack.
CDP is a joint initiative between Cancer Research UK's Drug Development Office and Cancer Research Technology, to progress promising anti-cancer agents which pharmaceutical companies do not have the resources to progress through early phase clinical trials.
Reykjavik, ICELAND, December 17, 2004 — deCODE genetics (Nasdaq: DCGN) today announced the signing of an agreement under which it will conduct a Phase II information - rich clinical trial next year of a third - party compound as part of a drug development program in...
Recent clinical studies support the development of DG041 as an effective anti-platelet that does not increase bleeding risk deCODE genetics (Nasdaq: DCGN) today announced progress in the development of DG041, the company's Phase II developmental compound for the...
Translational medicine is the integrated application of innovative pharmacology tools, biomarkers, clinical methods, clinical technologies and study designs to improve disease understanding, confidence in human drug targets and increase confidence in drug candidates, understand the therapeutic index in humans, enhance cost - effective decision making in exploratory development and increase phase II success.
Essentially, Roche has committed to paying Isis $ 30 million for the development of its Huntington's disease drugs and the first «phaseclinical trial in patients.
The positive results from the two phase III studies of ipilimumab were made possible in part through the evolution of the clinical science, which is based on new models of academic - industry partnership to advance immunotherapy development.
Approximately a dozen other active immunotherapies for cancer are in phase III clinical development.
GENYO is the first national centre devoted to genomics that integrates the Public Administration, the University and the biotechnology and pharmaceutical business sector, which would allow the integration of research in all its phases, from the generation of knowledge to its development in clinical and pharmaceutical applications, the development of new projects and services for the prevention, diagnosis and treatment of diseases associated to human genetic variability, such a cancer and rare diseases, diabetes, hypertension or degenerative diseases, among others.
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