FDA Staff Questions Benefits of GSK, MRK CA Drugs - Mar. 16, 2012

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Friday, March 16, 2012  |   |   |   |  Your goals. Our expertise. Norwich Clinical Services is a global contract research organization for the pharmaceutical and biotech industries. Dedicated Norwich program management will guide your program from the initial stages of development through study-end reconciliation with specific focus on budget efficiency and schedule adherence. Please click here for more information. •  FDA Staff Questions Benefits of GlaxoSmithKline (GSK), Merck & Co., Inc. (MRK) Cancer Drugs More... •  Galderma Laboratories Announces Completion of Phase 3 Trials of Investigational Drug Targeting Facial Erythema of Rosacea More... •  Threshold Pharmaceuticals, Inc. (THLD)' TH-302 Receives Orphan Drug Designation in the European Union for the Treatment of Soft Tissue Sarcoma More... •  CSL Behring Announces First Patient Treated in Phase III Study of Fibrinogen Concentrate (Human)(FCH) to Control Bleeding During Aortic Aneurysm Surgery More... •  SK Bio-Pharmaceuticals to Initiate Phase 2 Trials in US More... 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Request Now! •  Stanford University Doctor's Genetic Profile Yields Surprises, Watches Himself Get Diabetes in Close Detail More... •  White Rice Linked to Diabetes Risk, Harvard School of Public Health Study More... •  Sperm May Feel the Weight of Extra Pounds, Harvard School of Public Health Study More... •  Too Much Exercise Delays Pregnancy in Normal-Weight Women, Boston University Study More... •  New Gel Treats Precancerous Skin Condition in Days, Oregon Health & Science University (OHSU) Study More... More General Clinical Research News Technical and Regulatory Challenges in Drug Development March 28, 2012 The Chauncey Hotel and Conference Center 1 Chauncey Road, Princeton, NJ Reaching drug development milestones quickly is a challenging process. During this half-day seminar, four scientific leaders will share their experiences and answer your questions on regulatory and technical strategies for progressing through the drug development cycle. They will focus on regulatory affairs, API supplies, and complex dosage forms and will provide case studies and lessons learned on developing a regulatory strategy, moving beyond Phase I and developing formulations to extend the life-cycle of a drug. Patheon is committed to providing effective science-based learning opportunities for local professionals. Lunch and an evening reception will be served and cost of event is free. E-mail events@patheon.com or view more information via the website: http://www.patheon.com/marketing/NJseminar/. New Emerging R&D and Clinical Trial Locations • Compare 5 new emerging R&D locations in terms of population, economic activity, healthcare infrastructure, and current R&D activity. • Analyze how clinical trial numbers are changing in China, India, and Eastern Europe. • Develop strategies for geographic outsourcing. Click Here for More Information. • Southern Pharm (Gainesville, Florida) Ipsen Endo Clinical Science Specialist Responsible for the sales of Increlex, Somatuline Depot and other products as they become available, to clinicians in his/her area of responsibility. The CSS will sell the values, features and benefits of Ipsen and its products to customers within the assigned territory. • Pharm Country (Hartford, Connecticut) Roche Diagnostics Clinical Specialist Support all aspects of clinically focused sales for Roche's ACCU-CHEK product line, which includes blood glucose meters, insulin delivery systems, diabetes information management solutions, diabetes programs and services, and co-promoted product solutions within an assigned territory. • Genetown (Billerica, Massachusetts) PAREXEL International Clinical Logistics Assistant / Clinical Logistics Specialist In this role you will perform sample tracking, support query processes, and various site distribution activities. Hired individuals will be responsible for keeping clinical trial material inventories updated daily, collection, tracking, and checking shipment forms and other shipment-related communications (paper based and/or electronically), as well as quality control. • BioMidwest (Lake Forest, Illinois) Hospira, Inc. Senior Clinical Quality Compliance Auditor Perform effective audits for Hospira Global Clinical Quality Compliance to ensure compliance and conformance with global GCP regulations and guidance. Work closely with Global Clinical Operations, the various clinical trail sites, and the corporate leadership team to drive a proactive culture of quality and compliance for clinical trial processes. • Biotech Bay (Sunnyvale, California) Pharmacyclics, Inc. Clinical Trial Manager/Senior Clinical Trial Manager Leads Clinical Research Associates and/or Clinical Trial Assistants for the implementation and management of clinical trials. Plans and manages clinical development trials to ensure studies are completed, on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Pharm Country 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 tri-state area. 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. • Pharm Country Career Fair, Bridgewater, NJ March 22, 2012 • Biotech Beach Career Fair, La Jolla, CA April 17, 2012 • BioCapital Career Fair, Bethesda, MD April 25, 2012 • Pharm Country Career Fair, King Of Prussia, PA May 1, 2012 • BioNC Career Fair, Durham, NC May 2, 2012 • Biotech Bay Career Fair, Burlingame, CA May 29, 2012 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 •  National Institute for Clinical Excellence (NICE) Backs Novartis AG (NVS) MS Drug, Overturning Earlier Decision More... •  Johnson & Johnson (JNJ) Hepatitis C Drug Wins Backing From UK's National Institute for Clinical Excellence (NICE) More... •  Little Benefit From Pfizer Inc. (PFE) & Bristol-Myers Squibb Company (BMY) Bloodthinner More... •  Aptalis Pharmaceutical Technologies Begins Promotion of RECTIV(TM) to Physicians in the U.S. More... More Drug Product News Hot Company Accelovance 2275 Research Boulevard, Suite 700 Rockville, Maryland 20850 U.S.A. Phone: 240-238-4900 Fax: 240-238-4901 Accelovance, Inc., based in Rockville, MD, is a clinical services company specializing in high patient throughput from recruitment through study completion. Accelovance has developed a model to increase the reliability and productivity on Phase I (outpatient) and Phase II-IV trials. 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. Editor & Publisher: Rosemary Do Editorial & Production Staff: Lana Ho, Maysa Darwish, Tammy Liu, Michelle Wong ClinicaSpace.com - Clinical Trials. 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