Sentences with phrase «approval needed for a trial»

These centres would obtain, in advance, the lengthy legal and ethical approval needed for a trial.

Not exact matches

We need to design clinical trials and outcomes in a way that captures the downsides of aging in a quantitative way» that allows targets for drug approvals by the FDA.

Research groups at universities and hospitals need to meet strict safety guidelines for clinical trials but some small private clinics are offering therapies to people without research or marketing approval.

When Theravance, the company in South San Francisco, California, that developed the drug, designed the large phase III clinical trials needed for approval, the FDA simply required a demonstration that the drug eliminated symptoms of infection as reliably as the approved antibiotic vancomycin.

With enthusiasm for cancer immunotherapy mounting thanks to recent successes in the clinic with immune - based cancer treatments such as anti-CTLA-4 and anti-PD-1 antibodies, and the FDA approvals of sipuleucel - T prostate cancer vaccine and ipilimumab for the treatment of melanoma, and in light of the many promising immunotherapies now in clinical trials with potential for near - term FDA approval, the Cancer Research Institute launched the first annual Cancer Immunotherapy Awareness Month in June 2013 as a way to increase public awareness of the power of immunotherapy to revolutionize cancer treatment and of the need for continued public support for research to bring these treatments to more patients sooner.

The cell line used by Asterias, which was originally derived in the 1990s, is sufficient to supply ALL of the AST - OPC1 needed for clinical trials and for potential commercialization of the product following regulatory approval.

While experiments have raced ahead at a breathtaking pace, the likelihood of global spread once released into the wild may prove a formidable barrier to deployment due to the need for international public support, field trials, and subsequent regulatory approval.

Tags for this Online Resume: clinical, affairs, scientific, trials, innovative, management, summary, documents, submission, regulatory, 510 (k), ISE, ISS, PK / PD, communicating, monitoring, tactical, strategic, literature, direct, vision, Lead, Director, documentation, resources, execution, consensus, effectiveness, safety, CRA, IVD, medical, device, pharmaceutical, presentation, manuscript, abstract, poster, programs, leadership, career, development, appraisals, optimize, goals, objectives, internal, external, research, investigator, stakeholders, customers, prioritize, product, support, milestones, Microsoft, Word, Excel, statistics, data, analysis, Powerpoint, publication, growth, deliverables, diagnostic, prognostic, treatment, competitive, proven, ability, capable, assess, strategy, feasibility, methodology, design, develop, produce, recommend, recommendation, therapeutic, supervision, review, performance, appraisal, application, indication, company, collaborate, expert, justification, senior, executive, assessment, experienced, marketing, pre-market, pre-IDE, protocol, communication, utility, pharmacology, service, deliver, delivery, drug, metabolism, absorption, excretion, train, training, mentor, mentoring, CRO, reimbursement, XLSTAT, Prism, relationship, contract, consult, consultant, ownership, responsibility, authority, delegate, trends, direction, in - vitro, commercialize, commercialization, approval, clearance, patient, oncology, cancer, metabolic, cardiovascular, kidney, disease, health, outcomes, safe, effective, toxicity, novel, unique, unmet, need, advisors, advisory, committee, IRB, ethical, justified, supportive, care, associate