Topline Data for GSK's Ph3 Study; GILD Scores Win With QUAD Trial - Aug. 15, 2011

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Monday, August 15, 2011  |   |   |   |  UC Berkeley Extension Clinical and Regulatory Sciences Get the specialized instruction you need to advance your career. UC Berkeley Extension offers targeted certificates and programs to provide the skills to design and manage clinical trials, navigate compliance issues, and ensure new products and processes adhere to U.S. and international regulatory specifications. Choose from programs in: • Clinical Research Conduct and Management (available online) • Quality and Compliance for Biotechnology • Regulatory Affairs Fall courses are open for enrollment. Learn more. •  Topline Data for GlaxoSmithKline (GSK)'s Phase 3 Study More... •  Gilead Sciences, Inc. (GILD) Scores Win With QUAD Trial More... •  NexBio, Inc. Reports Safety and Significant Antiviral Activities of DAS181 (Fludase)* from a Dose-Ranging Phase II Clinical Trial More... •  First Patients Enrolled in RegeneRx Biopharmaceuticals, Inc. (RGRX)’s Phase 2 Dry Eye Trial More... •  Starpharma Holdings Ltd Commences Bacterial Vaginosis Prevention Study of VivaGel(R) More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Deaths Prompt Revisions in Japanese Precautions for Boehringer Ingelheim Corporation's Prazaxa More... More Discontinuations News More Recalls and Warning News •  Intersect ENT Announces U.S. FDA Approval for First Drug Releasing Implant for Chronic Sinusitis Patients More... More Drug Approval News Nature Methods Nature Methods provides techniques for life scientists and chemists. It is a print and online publication dedicated to publishing novel methods together with significant advances to tried and tested techniques allowing researchers to perform faster, better and more efficient experimental research. Request Now! •  Drawing Too Much Blood for Diagnostics Increases Anemia Risks for AMI Patients, University of Missouri Study More... •  Nighttime-Breathing Machine is Effective Treatment for Sleep Apnea, Tufts Medical Center Reveals More... •  Gene Therapy Cures Adult Leukemia, University of Pennsylvania Study More... •  Daiichi Sankyo, Inc. (D4S.F)'S Effient(R) (Prasugrel) Showed Significant 26 Percent Reduction in Cardiovascular Events Over Clopidogrel in New Core Clinical Cohort Population Sub-Analysis of the TRITON-TIMI 38 Pivotal Study More... •  Patients Taking Antipsychotics Urged to Get Routine Physicals, University of Leicester Study More... More General Clinical Research News Biomarker Applications for Improved Clinical Trial Outcomes November 15 - 16, 2011 Hilton Boston Back Bay - 40 Dalton Street Event Website The only personalized medicine conference allowing you to make biomarkers and diagnostics available during every stage of clinical research, to stratify patients, prove clinical validity, and streamline the regulatory approval and reimbursement process. Featuring up-to-date analysis of new FDA legislation regulations and a special spotlight from Blue Cross Blue Shield. For more information, please visit here. Advancing Molecular Diagnostics to Personalize Cancer Therapy • Identify key innovations in molecular diagnostics for oncology that may compete with those in development at your company. • Understand the regulatory challenges facing the developers of molecular diagnostics for cancer. • Understand the challenges that surround successfully commercializing a combined drug-diagnostic product and learn how to overcome them. Click Here for More Information • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Clinical Supplies Specialist II Coordinates the packaging & labeling activities required to provide Investigational Product (IP) for clinical studies in time for scheduled First-Patient-In (FPI) date. This person is also responsible for participating in the coordination of the IP returns & reconciliation process to provide for appropriate destruction of IP within a defined time period following the close-out of a study. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Coordinator - Clinical Research Contracts Develops, initiates, and negotiates contractual arrangements with industry sponsors and/or collaborating sites (domestic and international) derived from existing clinical research study protocols. Reviews and understands clinical research protocols for Investigational New Drugs (IND) or Investigational Device Exemptions (IDE). • Pharm Country (Cranbury, New Jersey) On Assignment Clinical Research Clinical Project Manager Responsible for the operational oversight of our clinical development programs and management of our CRO. Providing input to our clinical development strategies. He/she is responsible for technical leadership and successful execution of projects involving clinical operations, etc. • BioForest (Bothell, Washington) AVI BioPharma Sr. Director, Clinical Operations, Infectious Diseases Responsible for overseeing the anti-viral programs for Ebola, Marburg and H1N1. This person will manage the CROs in the trials and work with Program Management to ensure that timelines and budgets are adhered to etc. • Biotech Bay (San Francisco, California) Johnson & Johnson Family of Companies Manager, Clinical Data Management - Janssen AI, LLC Manages one or more clinical studies in a predominantly outsourced Data Management model and manages all aspects of study conduct in relation to data management: vendor oversight, study timelines, data quality and database lock deliverables etc. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Biotech Beach 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 Southern California 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. • Biotech Beach Career Fair, San Diego, CA September 22, 2011 • BioMidwest Career Fair, Chicago, IL October 4, 2011 • Pharm Country Career Fair, Bridgewater, NJ October 5, 2011 • Biotech Bay Career Fair, Burlingame, CA October 11, 2011 • Bio NC Career Fair, Durham, NC October 20, 2011 • BioCapital Beach 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 •  Pfizer Inc. (PFE) Wins Viagra Patent Battle Against Teva Pharmaceutical Industries Limited (TEVA) More... •  Apricus Biosciences (APRI) Announces Expansion of Its NexACT(R) Patent Portfolio More... More Patent News •  Pernix Therapeutics, Inc. (PTX) and ParaPRO Announce Commercial Launch of Natroba(TM) For Treatment of Head Lice More... More Drug Product News Hot Company Gentris Corporation 133 Southcenter Court, Suite 400 Morrisville, North Carolina 27560 U.S.A. Gentris Corporation, is a leading global provider of applied clinical pharmacogenomic services. As pioneers in the field of pharmacogenomics, Gentris assists pharmaceutical companies and clinical research organizations to effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective drugs to market more quickly. More Company Profiles Post Your: News | Jobs | Company Profile | Event | Advertising / Sponsorship ClinicaSpace 6465 South Greenwood Plaza, Suite 400 Centennial, Colorado 80111 U.S.A. Phone: 877-277-7585 Fax: 800-595-2929 ClinicaSpace 90 New Montgomery Street, Suite 414 San Francisco, California 94105 U.S.A. Phone: 877-277-7585 Fax: 415-576-9217 Send questions and comments to the ClinicaSpace News Beat Team. 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