Gilead Seeks Approval for Potential HIV Super Drug - Oct. 28, 2011

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Friday, October 28, 2011  |   |   |   |  The Master of Science (MS) in Medical Product Development Management (MPDM) at San Jose State University is a comprehensive, master's degree program and can be completed in either 2 or 3 years. The emphasis of the program is on the management of products undergoing clinical research and clinical development, i.e. clinical trial stages I, II, III and IV or other testing as required by the Federal Food and Drug Administration (FDA) or international regulatory authorities. The curriculum includes customized courses from the Colleges of Science and Business, and was designed in consultation with biomedical industry employers in the greater San Francisco Bay area. The MPDM program continues to have interaction with the industry and provides expert industry speakers in the classroom, in order to present the latest advancements to students. Please click here for more information. •  Gilead Sciences, Inc. (GILD) Submits NDA for Potential HIV Super Drug More... •  Dynavax Technologies Corporation (DVAX) Confirms HEPLISAV(TM) Submission Strategies With U.S. FDA and European Medicines Evaluation Agency More... More BLA/NDA/ANDA News More IND News More MAA News •  Side Effects Prompt European Recall of Baxter Healthcare Corporation (BAX)'s Flu Vaccine Preflucel More... More Discontinuations News More Recalls and Warning News •  Bioniche Life Sciences Inc. (BNC) Receives Canadian Regulatory Approval for Equine Anti-Inflammatory Product More... •  Eli Lilly and Company (LLY) Release: ALIMTA First Chemotherapy Approved in Europe as Continuation Maintenance Therapy for Most Common Form of Lung Cancer More... More Drug Approval News •  Halozyme Therapeutics, Inc. (HALO) Announces Positive Results From Enzyme-Augmented Insulin Pump Trial More... •  Threshold Pharmaceuticals, Inc. (THLD) Reports Further Promising Data With TH-302 in Soft Tissue Sarcoma More... •  MediciNova, Inc. Announces Repeat Dose Clinical Trial With MN-221 in Chronic Obstructive Pulmonary Disease (COPD) Patients More... •  Hybrigenics' Specific Inhibitor of Ubiquitin-Specific Protease 7 (USP7) is Cytotoxic for Chronic Lymphocytic Leukaemia (CLL) Cells in Vitro More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Bioscience Technology This magazine provides information to life science/biotech researchers searching for technology, tools and techniques to conduct better, more cost-efficient and effective research. Request Now! •  Aspirin Reduces Bowel Cancer Risk by 63 Percent, Newcastle University Study More... •  Soy Supplement May Improve Crow's Feet, Otsuka Pharmaceutical Co., Ltd. Reveals More... •  Alcohol Linked to Better Survival After Heart Attack, Harvard Medical School Study More... •  Too Much Drinking May Raise Lung Cancer Risk, Study Presented at the American College of Chest Physicians Meeting More... •  Estrogen Use Tied to Bladder Control Problems, Emory University Study More... More General Clinical Research News CHI's 11 Annual PepTalk: The Protein Science Week January 9-13, 2012 | Hotel Del Coronado | San Diego, CA www.www.chi-peptalk.com PepTalk 2012 continues the tradition of strong scientific programming centered around protein-based therapeutics. The four distinct protein pipelines focused on formulation, purification, biotherapeutics and expression range from applying protein discovery research, to developing downstream protein products that ultimately lead to clinical applications. Create your own agenda by moving between the tracks and choosing the sessions that best fit your research and networking needs. Please click here for more information. Strategies to Enhance API Manufacturing Processes • Enhance profitability by re-evaluating and re-engineering product development, manufacturing technologies, and commercialization methodologies. • Evaluate ways to simplify manufacturing technologies and implement sustainable processes. • Identify examples where process enhancements have had a substantial impact on yield and profitability. Click Here for More Information. • Biotech Bay (Foster City, California) Gilead Sciences Associate Director, Clinical Operations Responsible for oversight and strategic direction and implementation across a number of projects to ensure clinical programs are conducted to meet project milestones and budgets through close partnership with parties involved both inside and outside of the company. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Clinical Research Associate-RN I Supporting the Neuro-Oncology Division in the Cancer Control Administration Department operates under general supervision. This position ensures compliance with eligibility, prescribed interventions and evaluations of the assigned protocol(s). Provides patient care, education, and management. Prepares submission for reportable events. • BioMidwest (Minneapolis, Minnesota) DaVita Clinical Research Senior Project Manager - Early Clinical Studies Lead an experienced and dedicated team in an early clinical research centered environment. This position will be part of our Senior Management Team, overseeing 3 Project Managers with a focus on ensuring that our clinical studies are conducted effectively and sponsor deliverables are met. From planning to implementation, this role will oversee and participate in all aspects of the project management lifecycle. • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Director, Clinical Program Manager Responsible for technical leadership and successful execution of projects, facilitation of effective inter-and intra- departmental relationships, efficient functioning group, oversight of training, evaluation of new processes and methods, and achievement of departmental corporate goals and objectives on time and on budget. • Genetown(Cambridge, Massachusetts) AVEO Pharmaceuticals, Inc. Clinical Planning Manager Will serves as the point person to provide valuable analysis and clinical forecasts concerning the business needs within Clinical Development. Specific areas of expertise will include a strong business perspective, strategic planning, ability to develop and manage timelines, and present findings to related business partners. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BioCapital Career Fair Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the mid-atlantic region. Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. (Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.) Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research. Job seekers may register here. • BioCapital Career Fair, Bethesda, MD November 1, 2011 • Genetown Career Fair, Cambridge, MA November 7, 2011 More information about BioSpace's Career Fairs BioSpace White Paper Biotech Career Fairs For Job Seekers 101: Control Your Experience By June Salvati, BioSpace Director of Events and Corporate Services Hot Company Coldstream Laboratories Inc. 1500 Bull Lea Road, Suite 250 Lexington, Kentucky 40511 U.S.A. Phone: 859-257-6600 Fax: 859-323-5985 At Coldstream Laboratories Inc. (CLI), we're seasoned at turning pharmaceutical development ideas into safe, pure, and effective clinical pharmaceutical dosage forms. Since 1986, we have completed more than 200 formulation development projects that led to clinical trials providing us extensive clinical manufacturing experience with both commercial product development and grant-funded projects from such sources as the National Institutes of Health. 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