Sentences with phrase «clinical development plans»

A further update will be provided on clinical development plans in due course.

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 cancers.

The objectives to achieve within the 4 years of the NAREB project are: 1 / to select antibacterial molecules and design nanocarriers with strong antibacterial activity, 2 / to test in vitro and in vivo the best therapeutic combinations including innovative genomic and bioimaging approaches, 3 / to assess safety, regulatory and production (GLP / GMP) aspects for the most promising nanoformulations, and 4 / to establishing the Clinical Development Plan for the preparatory work for the subsequent clinical testing of the selected nanoformulations.

Not exact matches

With a critical mass of 450,000 patients annually among them, the six centers have agreed to combine their efforts on planning clinical trials in immunotherapy, recruit patients quickly, and share the information learned — which could be the single biggest factor in speeding up drug development.

Says Bapty: «If a CRO is nimble and can evolve technology that can enable its clients to get a drug approved faster or to reduce the risk of a clinical study, or even save them development money in the long run, that company will find it has a long - term business plan.»

In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third - party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment.

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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

For guidance, I turn to Jessica Bihuniak, assistant professor of clinical nutrition at NYU's Steinhardt School of Culture, Education, and Human Development, who — in her infinite patience — was willing to not only help me map out my hypothetical healthy Hudson game plan but harshly judge the results.

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.

A key component of our early development engine is our planned 200,000 square foot Good Manufacturing Practices (GMP) mRNA clinical manufacturing facility in Norwood, Mass..

To strengthen its clinical research profile, Dresden has created a strategic plan, to be funded by the German Research Ministry (BMBF), that focuses on three aspects of clinical research: tissue engineering and development of physical and molecular medical technologies for clinical application; therapeutic strategies after cell and tissue damage; and diagnosis and therapy of malignant diseases.

The research team plans to proceed with clinical trials evaluating the treatment of vitamin D deficiency and to investigate the mechanisms by which vitamin D can influence the development of atherosclerosis.

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.

Identify your own learning needs as a clinical supervisor and create a personal development plan to address them.

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

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.

Thailand Clinical Trials Development Trial MHRP, in collaboration with the P5, is planning an efficacy trial in a high - risk population of men who have sex with men (MSM) to hopefully improve upon the RV144 result and extend its relevance to at - risk populations to achieve the greatest public health impact.

Study of nutrients and how the body handles them based on principles of chemistry and molecular biology; the effect of nutrition choices on diabetes, hypoglycemia and disorders of the major organ systems; food choices and diet planning principles; nutrition prescription for illness; the development and evaluation of nutrition plans; nutrition assessment; the relationship between nutrition and illness; strategies for providing nutritional support for people with serious illness; practical examples in clinical nutrition case studies.

Includes individualized At - Home plan and 12 months of FREE on - call support from our experienced clinical and child development specialists

As more clients required global support of clinical trials, we needed to ramp our resources outside of the U.S. My role in market outreach and development consisted of helping map out the plan for growth.

The flexibility provided by ESSA presented an opportunity for states to invest in pipeline - spanning changes that address several components of the teaching profession.48 While most states focused primarily on one or two aspects of the pipeline to improve in their ESSA plans or addressed challenges and solutions in broad terms, other states presented a more holistic theory of change with targeted strategies that address the entire pipeline — from the intentional recruitment of diverse teachers and more clinical teacher preparation experiences, to data - driven professional development and career advancement frameworks.

The program design provides training modules that develop clinical skills for the following: diagnosis of professional performance, diagnosis of student performance, feedback on performance, preparation and implementation of professional development plans, and reflection.

AGTC plans to use the net proceeds of the offering primarily to continue the development, preclinical and clinical trials of its product candidates for treating X-linked retinoschisis, achromatopsia and X-linked retinitis pigmentosa.

Tags for this Online Resume: Clinical Programs, Compliance, Development Activities, Documentation, Planning, Policies and Procedures, Services, Support, Training, Computer Aided Software Engineering

Tags for this Online Resume: Strategic Planning, Executive Leadership, Budgeting, Finance, Program Management, Mentoring, Business Development, Government Contracting, Proposal Development, Proposal Pricing, Accounting, Communications, Information Technology, Human Resources, Acquisitions, Insurance, Treasury, Operations, Customer Service, Negotiations, OMB Ciculars, Compliance, Clinical Services, Medical Research

Kept accurate and timely documentation on patients that was utilized by multi-disciplinary team in the development of clinical plan and to measure patient compliance with treatment.

Work alongside a clinical therapist to facilitate treatment planning and lead crisis plan development for six youth placed in the Family and Community Ties program, the highest level of foster care in the state of Connecticut.

Patient Care / Health Administration • Clinical Trials & Practices • Data Monitoring and Evaluation • Organizational Leadership • Clinical Polices / Procedures Compliance • Staff Development & Training • Procedural Compliance Planning, Prioritizing & Coordinating Patient Load • Patient Records / Documentation • Patient Assessment

Core Competencies Patient Care / Health Administration • Organizational Leadership • Physical Examination / Patient Assessment • Clinical Polices / Procedures Compliance • Patient Records / Documentation • Training & Development • Certification and Recertification Programs • Site Emergency Evacuation Plans • Basic to Advanced Level Medical Training • Logistics Site Medical Plans and Operation • Planning and Coordination • Emergency Management • NIMS Compliant

Educator: Developed and presented presentations on three separate topics to a national multi-disciplinary audience: Clinical Information Systems Implementation, outlining weaknesses and strengths in the process; development of a Network level Informatics Office and DataMart, identifying the synchronized plan to develop the office and address Network - wide weaknesses in performance management; and the benefits of utilizing the VistaWeb application in enhancing the overall continuum of care for the Veteran.

CORE STRENGTHS Leader / Mentor ♦ Student - Centered Instruction ♦ Program Development ♦ Education Plans Curriculum Development ♦ Adjunct Clinical Faculty ♦ Inclusion Model ♦ Specific Learning Disabilities

Served as patient advocate enhancing collaborative relationships to maximize patient / family abilities to stay informed when making decisions Facilitated clinical staff in the implementation and development of a plan of care to achieve patient goals.

• Monitored site management and coordinated with Director of Clinical Studies to achieve satisfactory compliance with company standards and regulatory demands • Trained, monitored and coordinated incoming staff and oversaw clinical study completion • Developed clinical study plans that were in compliance with industry standards and created assigned studies issued by company R&D department • Oversaw the development and creation of clinical study materials, trained and supervised investigators and field staff of various sizes depending on individual studies • Compiled clinical study data and directed corrections as needed • Worked with Director of Clinical Studies and department managers to compile final reports and create presentations for CEO and Board of DClinical Studies to achieve satisfactory compliance with company standards and regulatory demands • Trained, monitored and coordinated incoming staff and oversaw clinical study completion • Developed clinical study plans that were in compliance with industry standards and created assigned studies issued by company R&D department • Oversaw the development and creation of clinical study materials, trained and supervised investigators and field staff of various sizes depending on individual studies • Compiled clinical study data and directed corrections as needed • Worked with Director of Clinical Studies and department managers to compile final reports and create presentations for CEO and Board of Dclinical study completion • Developed clinical study plans that were in compliance with industry standards and created assigned studies issued by company R&D department • Oversaw the development and creation of clinical study materials, trained and supervised investigators and field staff of various sizes depending on individual studies • Compiled clinical study data and directed corrections as needed • Worked with Director of Clinical Studies and department managers to compile final reports and create presentations for CEO and Board of Dclinical study plans that were in compliance with industry standards and created assigned studies issued by company R&D department • Oversaw the development and creation of clinical study materials, trained and supervised investigators and field staff of various sizes depending on individual studies • Compiled clinical study data and directed corrections as needed • Worked with Director of Clinical Studies and department managers to compile final reports and create presentations for CEO and Board of Dclinical study materials, trained and supervised investigators and field staff of various sizes depending on individual studies • Compiled clinical study data and directed corrections as needed • Worked with Director of Clinical Studies and department managers to compile final reports and create presentations for CEO and Board of Dclinical study data and directed corrections as needed • Worked with Director of Clinical Studies and department managers to compile final reports and create presentations for CEO and Board of DClinical Studies and department managers to compile final reports and create presentations for CEO and Board of Directors

Launched project plans for numerous items requiring software development and collaborated with clinical product teams to resolve bugs and plan features in future builds to further support patient charting as well as HL7 and HIE interface technologies

PA Reps for staff development and growth opportunities * Plan, assign, and direct work, appraise performance, reward and discipline employees, address complaints and resolve problems within the team * Assist in the hiring process * Assist in the preparation of performance reviews * Deliver performance reviews in conjunction with the Prior Auth Manager * Meet monthly with each staff member to go over performance status * Assist with training as needed * Lead weekly Team meetings with staff to keep them informed of changes to policy and procedures and corporate communications * Meet with the Prior Authorization Management team weekly to report on clinical call center performance and personnel issues Required Qualifications: * High School Diploma or equivalent * Current and unrestricted Pharmacy Technician license * 2 years» experience supervising Pharmacy Technicians in a Call Center environment * Prior Authorization experience * Knowledge of the Pharmacy Benefit Management and / or Health Insurance * Knowledge of Call Center industry through work experience and as obtained through related courses * Proficient in Microsoft Word and Excel Preferred Qualifications: * Bachelors» Degree * PBM experience * National Pharmacy Technician Certification Required Competencies: * Must have strong leadership and problem solving skills * Strong written and verbal communication skills * Strong interpersonal skills * Ability to effectively present information and respond to questions from groups of associates, managers and clients * Ability to comprehend ACD statistical reporting and apply it to the operation of the department * Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form * Ability to maintain a high level of consistency while working with team members * Ability to recognize the needs of the staff, heighten morale, and decrease stress and burnout * Ability to understand what style of conflict resolution is best suited for a particular situation * Ability to determine the needs of each individual team member and assist them in achieving set goals * Demonstrate a clear understanding of company and client confidentiality * Excellent organizational skills * Exemplary coaching / motivational skills at both an individual and team level * Adaptable and able to move with change while maintaining a positive attitude and strong role model for the Team.

Assist with development and implementation of Individualized Service Plans with clinical team.

Effectively managed time and caseloads based on 20 sessions per week.Efficiently gathered information from families and social services agencies to inform development of treatment plans.Documented all patient information including service plans, treatment reports and progress notes.Collaborated closely with treatment team to appropriately coordinate client care services.Interacted with clinical staff and external resources such as school or community personnel.Developed comprehensive treatment plans that focused on accurate diagnosis and behavioral treatment of problems.Taught clients anger management techniques, relaxation skills, impulse control, social skills, emotional coping skills and functional living skills.Consulted with psychiatrists about client medication changes, issues with medicine compliance and efficacy of medications.Created and reviewed master treatment and discharge plans for each client.Referred clients to other programs and community agencies to enhance treatment processes.Evaluated patients to determine potential need to transfer to specialized inpatient mental health facilities.Led patients in individual, family, group and marital therapy sessions.

Tags for this Online Resume: Profitability, Growth, Change agent, Exceptional service, • Strategic Business Planning, Multiple Site Management, Marketing, Financial Management, Risk Management, Operational Management, Leadership development, Budgeting, Cost Control, Payroll, Talent Acquistion, Strategic Partnerships, Social Media, Policy Development, Process Improvement, Performance Management, Clinical Trials, Integration of Information Technology, Implementation of EHR Technology, Servicedevelopment, Budgeting, Cost Control, Payroll, Talent Acquistion, Strategic Partnerships, Social Media, Policy Development, Process Improvement, Performance Management, Clinical Trials, Integration of Information Technology, Implementation of EHR Technology, ServiceDevelopment, Process Improvement, Performance Management, Clinical Trials, Integration of Information Technology, Implementation of EHR Technology, Service Excellence

With a strong background in clinical research (immunoassay development, protein extraction and purification, molecular and cell biology and pharmacology), in combination with medical and scientific writing as well as working experience with regulatory affairs and clinical trial planning and designing, my education and experience can bring a solid foundation to the ar...

Strategic Sales and Marketing Manager with a unique perspective on the current environment, expertise in optimization of life cycle planning and competitive marketing, product positioning, key opinion leader relationship development, and clinical program design implementation.

Tags for this Online Resume: Software, Software Development, IT, Business Planning, Documentation, Drafting, Financial, SaaS, Clinical Trial, Construction, Master Services Agreement, SOW, NDA, Contracts Manager, Corporate Counsel, Software License, Commercial Contracts, Maintenance, negotiate, document and maintain commercial contracts

Highly educated and experienced Social Services professional with demonstrated history of effective clinical assessments, accurate case management procedures, and treatment planning development.

Leading and Development of Consistently Top Performing Teams, Broad Clinical - Disease State Knowledge, Business Planning and Execution, Successfully Launching New Products, Regional Sales Director, District Sales Management, Regional Marketing, Managed Care National Account Marketing, Regional Busi...

Tags for this Online Resume: Microsoft Office, Citrix, Visual Basic, HTML, MedHost, Clinical Documentation, Training, Needs / Requirements Analysis, System Configuration, System Validation Testing, Quality Assurance, Implementation Planning, Project Planning and Management, SNOMED, Physician Documentation, Healthland Classic, Team Supervision, Training documentation development

Areas of Expertise * Territory Management * Product Knowledge & Research * Develop Key Oncology Leaders * Disease Management Programs * Product Launches * Clinical Registry Development * New Business Development * Strong Client Relations * Hands - on Experience in Healthcare * Outcomes Marketing & Registry Research * CME Coordinator w / Medical Event Planning * Work w / Payers & State Associations

Medical and Public Health professional with experience in Clinical Research, healthcare risk management, data management, corporate compliance, quality improvement, project management and program planning and development.

Tags for this Online Resume: Senior healthcare business development executive, Revenue and profit gains, Bio-technology, Excellent communicator, Relationship builder, Team builder, Consultative communications approach, Strong negotiator, Exceptional problem solving abilities, Expert knowledge of worldwide healthcare trends, Analysis, planning, Plan execution, Thoughtful outcome analysis, Revenue Cycle management, Technology integration, Managed Human Clinical Trials, Country specific product registration, Global distribution network, Business Development, VP, Vice President,development executive, Revenue and profit gains, Bio-technology, Excellent communicator, Relationship builder, Team builder, Consultative communications approach, Strong negotiator, Exceptional problem solving abilities, Expert knowledge of worldwide healthcare trends, Analysis, planning, Plan execution, Thoughtful outcome analysis, Revenue Cycle management, Technology integration, Managed Human Clinical Trials, Country specific product registration, Global distribution network, Business Development, VP, Vice President,Development, VP, Vice President, Healthcare

Tags for this Online Resume: Biotechnology, Diagnostic, Pharmaceutical, Marketing, Oncology, Strategy, Brand Planning, Global Marketing, New Product Planning, Pricing, Market Research, Brand Leader, Commercial, Commercialization, Launch, Drug Development, Matrix, Cross Functional, Digital, KOL, Key Opinion Leader, Portfolio, Management, Brand Team, Agency, Diabetes, Cardiovascular, Commercial Strategy, Corporate Affairs, Communications, Hematology, Urology, Neuroscience, phase 2, phase 3, phase II, phase III, Powerpoint, Excel, Word, Part B, Part D, Seattle, Portland, San Francisco, Executive Director, Senior Director, Director, Vice President, Go - To - Market, Value Proposition, Go To Market, Launch Planning, Access, Reimbursement, Payer, Market Development, Market Assessment, Pipeline, In - Line, Brand Management, Coaching, Leadership, Marketing Strategies, Marketing Strategy, Strategic Planning, Autoimmune, Early Stage, Pre-Launch, Pre Launch, Regulatory, Operations, Marketing Plan, Business Plan, Business Development, Market Analysis, Segmentation, Targeting, Companion Diagnostic, Target Product Profile, Pre-Clinical, Competition, Positoning, Branding, Sales, Budget, Sales Management, Communication Plan, Publication Plan, Project Management, Genetic, Genomic, Lifecycle, Long Range, Device, Late Stage, Direct Report, Indirect Report, New Molecular Entities, Competitive, Biopharmaceutical, Medical Device, Non-Promotional, Tactical, Execution, IND, Revenue, Partner, Clinical, Consult, Analytical, Problem Solver, Global, International, Affordable Care Act, Lymphoma, Leukemia, Prostate, Breast, Cancer, OPDP, Promotional, Promotions, Brand, Healthcare, Distribution, Infrastructure, IMS, Priority Review, Experienced, Patient, Consumer