Rationale for Study Sample Clauses

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Rationale for Study. Vaccination remains the most cost-effective strategy available to combat influenza. Current influenza vaccines work by inducing strain-specific antibodies against the highly polymorphic surface proteins of the influenza virus. The need for constant redesign and remanufacture increases the vaccine’s cost, places limitations on supply and critically delays vaccine production when new strains arise. There is therefore a major demand for improved vaccination strategies that can provide protection against a broad spectrum of virus strains. Previous studies have demonstrated the safety of MVA-NP+M1 across different age groups, including older adults and in combination with seasonal influenza vaccine; the immunogenicity of MVA-NP+M1 in older adults given alone and in combination with licensed inactivated seasonal influenza vaccine; and the effect of MVA-NP+M1 in limiting the severity of influenza illness in adults. This study will therefore investigate the immunogenicity and efficacy in terms of viral and symptom endpoints in a large number of healthy adults aged 18 and over when given as an adjunct to standard QIV. This MVA-NP+M1, produced using the novel immortalised duck retinal cell line AGE1.CR.pIX®, also addresses the scalability issues of CEF manufactured vaccines.
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Rationale for Study. This study will compare the effect of varying degrees of hepatic impairment on the PK, safety, and tolerability of a single oral dose of 600 mg (2 × 300-mg tablets) aramchol in Part 1 and multiple oral doses not to exceed 300 mg twice daily for 11 days and a single 300 mg AM dose on Day 12 in Part 2 with healthy subjects. Hepatic impairment associated with cirrhosis may develop in subjects with ▇▇▇▇. Therefore, it is important to assess the effect of hepatic impairment on the PK and hence dosage requirements and safety of aramchol.
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Rationale for Study. This study is being conducted as an FDA post marketing commitment to the approved New Drug Application for TPOXX. SIGA is required to conduct a study to determine the pharmacokinetic (PK) profile of TPOXX in subjects with a body weight greater than 120 kilograms (>120 kg) to determine if a change in dosing regimen would be needed in these patients.
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Rationale for Study. Dengue is caused by 4 distinct types of RNA viruses (DENV-1, DENV-2, DENV-3, and DENV-4) belonging to the flavivirus genus. Although a vaccine is available, its efficacy is variable between the different serotypes and it is only indicated for individuals with a history of previous DENV infection. There are no effective therapeutics for dengue, and treatment options are limited to supportive care such as fluid replacement and clinical monitoring. A safe and effective antiviral therapy that targets all DENV serotypes is greatly needed to reduce the global burden of this disease and meet this unmet medical need. Atea Pharmaceuticals is developing a novel purine nucleotide prodrug, AT-752, which is designed to treat patients that have been infected with the DENV. Supported by tolerability/safety and PK in healthy subjects (see Section 1.2.1), the next logical development step for a dengue treatment is to evaluate safety, antiviral activity and PK/PD relationships of differing doses of AT-752 in DENV-infected patients. This study will evaluate the safety, PK, and PD of AT-752 in adult patients with confirmed DENV infection and further support dose selection for subsequent, later phase trials.
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Rationale for Study. A number of studies have been conducted examining school nutrition policies, practices, and environments, but none have specifically examined low-income schools in Georgia or explicitly employed the SEM as a framework for comparing these aspects among school-level demographic characteristics. Additionally, a number of researchers have conducted related studies (i.e., with different age groups, in different locations, etc.) which provided evidence for each of the chosen SEM constructs of interest. The current study investigates Georgia SNAP-Ed school nutrition policies, practices, and environments in relation to the school-level construct of the SEM, including geography, FRL, percent Caucasian, and cohort year.
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  • Joint Commercialization Committee Upon a decision by the JSC to activate the joint Commercialization committee, but in no case later than eighteen (18) months prior to the projected First Commercial Sale (the “Joint Commercialization Committee” or “JCC”), the Parties shall establish the JCC. The JCC shall hold its initial meeting within thirty (30) days of its establishment. Following its initial meeting, the JCC will meet in person, by teleconference or by video-teleconference at least [***] per [***] to review and discuss material decisions and key activities that relate to the matters set forth below. The JCC will be responsible for the communication, review and discussion of the Commercialization Plan and other Commercialization matters, including marketing strategy and planning, pricing, commercial manufacture, and [***], in each case in the Territory. Without limiting the foregoing, the JCC shall be responsible for: (a) reviewing and consulting with Coherus on the Commercialization Plan prior to adoption of the Commercialization Plan or changes by Licensee; (b) recommending the Commercialization Plan for approval by the JSC prior to adoption of the Commercialization Plan; (c) communicating with the JDC regarding the interrelationship between Development activities and potential Commercialization activities; (d) reviewing and monitoring the activities and progress against the Commercialization Plan; (e) monitoring and reporting on the competitive landscape for the Product in the Territory; (f) establishing appropriate processes for coordinating review of promotional materials for the Territory to ensure compliance with Applicable Laws and industry best practices; (g) overseeing the trademark and publication strategies for the Territory; and (h) communicating with the Parties regarding all of the foregoing.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in ▇▇▇▇ rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.