GSK Goes Hostile on HGSI; FDA Panel Rebuffs Regeneron Gout Drug - May 9, 2012

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Wednesday, May 09, 2012  |   |   |   |  Challenging Current Paradigms in Early Drug Development Please Join Aptuit at their Medicines Research Centre in Verona Italy Drug Discovery and Development is an expensive and high-risk business that can take 10 years from inception to the commercialization of a new drug. Often associated with high attrition rates, it is driven by medical need, disease prevalence and likelihood of success. Drug Development has traditionally been a long and extensive process designed for a staged assessment of the safety, efficacy and manufacture of a drug candidate. On May 16, 2012, Aptuit will welcome nine distinguished representatives from academia and industry to speak at this FREE symposium where they will cover and discuss aspects and strategies to reduce risk, costs and timelines from Candidate Selection to Phase II Clinical Trials. For a full description of this event, and to register, please go to: www.aptuit.com/verona/paradigms/introduction.aspx.   •  GlaxoSmithKline (GSK) Goes Hostile on Human Genome Sciences, Inc. (HGSI) More... •  FDA Panel Rebuffs Regeneron Pharmaceuticals, Inc. (REGN) Gout Drug More... •  Patheon Inc. (PTI.TO) to Close UK Plant & Eliminate 91 Jobs More... •  FDA Staff Focus on Safety of Arena Pharmaceuticals, Inc. (ARNA) Obesity Pill More... •  Merck KGaA (MKGAF.PK)'s Erbitux Fails in Colon Cancer Study More... •  Gilead Sciences, Inc. (GILD)'s Quad Pill Raises Kidney Questions, FDA Says More... •  Activist Investor Pushes Par Pharmaceutical, Inc. to Consider Selling Itself More... •  Pfizer Inc. (PFE) to Pump $130 Million in Belgian Facility, to Create 100 New Jobs More... More Top News JAX® Patient-derived Xenograft Resource The enormous cost, and high failure rate, of cancer drug development have highlighted the need for new preclinical strategies and resources. To this end, a library of more diverse and representative patient-derived tumor xenograft (PDX) models has been created at The Jackson Laboratory. We utilize NOD scid IL2 receptor gamma chain knockout mice (NSG), constructed by JAX Professor Lenny Shultz, as the mouse host. This PDX resource (which includes tumor gene expression and copy number variation data), developed in collaboration with renowned medical centers throughout the United States, supports large-scale basic and preclinical cancer research and is both affordable and amenable to high throughput studies. For more information, please visit The Jackson Laboratory. •  Abbott Laboratories (ABT)'s Humira Could Have Been a Pfizer Inc. (PFE) Drug More... •  U.S. May Speed Approval of "Breakthrough" Drugs More... •  Probiotics May Help Prevent Diarrhea, Rand Corporation Study More... •  Magnetic Bacteria Create a Biological Hard Drive, University of Leeds Study More... •  Long Commutes May Be Hazardous to Health, Washington University in St. Louis Study More... •  Prepregnancy Obesity Linked to Child Test Scores, Ohio State University Study More... •  Future Treatment for Nearsightedness - Compact Fluorescent Light Bulbs? University of Alabama at Birmingham Study More... •  OTC Herbal Supplement May Prevent Dangerous Blood Clots, Beth Israel Deaconess Medical Center Study More...   More Featured News SafeBridge Consultants, Inc. announces two Potent Compound Safety Training offerings (may be taken separately or consecutively) The SafeBridge original Potent Compound Safety "Boot Camp"® (Boot Camp I) is a comprehensive two-day course in pharmaceutical potent compound safety focused on training EH&S and related professionals in critical technical concepts and proactive safety programs in pharmaceutical industrial hygiene, occupational and environmental toxicology, analytical chemistry, and risk communication. The SafeBridge Advanced Concepts to Support Drug Development of Potent Compounds from R&D through Manufacturing (Boot Camp II) is a one-day advanced course focused on case studies and problem-solving to address potent compound safety issues in discovery, development, contract manufacturing and commercialization. COURSE SEATING IS LIMITED AND USUALLY SELLS OUT! San Diego, CA Boot Camp I May 15-16, 2012 Boot Camp II May 17, 2012 Contact: Susan Custer: susan.custer@safebridge.com or 650-961-4820 x 231 or www.safebridge.com. • Multiple Regions (SF, LA, Cleveland, NYC) Corcept Therapeutics Medical Science Liaison Conduct one-on-one healthcare professional education. Provide pro-active support of Corcept products related to education, and appropriate communication triaging of TLs, and the core patient support services. • Pharm Country (Ridgefield, Connecticut) Boehringer Ingelheim Pharmaceuticals, Inc. Senior Associate Director Biologics Provide vision and expertise in the bioinformatics field for high quality analysis of antibodyome data. Additional responsibilities include managing a small team of 3-4 bioinformatics scientists. • Genetown (Lexington, Massachusetts) Shire Medical Director, Global Medical Affairs Will assist the Senior Medical Director, and project teams as required, in providing expert medical input to all relevant aspects of the teams' work. Duties: Leads the HGT medical affairs support for given therapeutic area in the US. Interact with the commercial part of the organization to provide Medical affairs support etc. • BioMidwest (Deerfield, Illinois) Astellas Pharma US Senior Medical Director / Executive Director, Infectious Disease Plays a leadership role in the strategic development and implementation of drug development programs for novel compounds from P0 through global approval. This position may serve as global medical lead (GML) on Astellas Pharma Global Development (APGD) Core teams, or may support global development as an extended team member. • Rocky Bio (Salt Lake City, Utah) Watson Pharmaceuticals, Inc. Assoc Director, Regulatory Affairs Proprietary Under general direction, functions as primary regulatory contact with regulatory authorities for assigned products and projects. Manages preparation of regulatory submissions, briefing packages and presentations for regulatory agency meetings. Get Noticed! Add your resume to the BioSpace Career Center! See more than 5,000 job postings in the BioSpace Career Center! Biotech Bay 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 Bay 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. • 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 Advances in the Discovery of Protein-Protein Interaction Modulators • Understand why the discovery of PPI modulators has been difficult, and why it is crucial for pharmaceutical companies to overcome these hurdles now. • Gain insight into the most effective strategies and technologies for discovering PPI modulators. • Identify companies and academic laboratories that are leaders in the PPI modulator field. Click Here for More Information. Building Novel Applications with Pipeline Pilot to Drive Next Generation Sequencing This case study shows how scientists are streamlining the process of analyses of DNA sequence information. Enabled by new DNA sequencing technologies, many more scientists and informaticians are interrogating larger and more complex data set. Request Now! Irvine Pharmaceutical Services, Inc. 10 Vanderbilt Irvine, California 92618 U.S.A. Phone: 949-951-4425 Fax: 949-951-4909 Founded in 1988, Irvine Pharmaceutical Services is a premier contract pharmaceutical development organization supporting the pharmaceutical, biopharmaceutical, and medical device industries. More Company Profiles FREE Subscription to BioPharm International BioPharm International provides a forum for its readers to exchange practical, hands-on information for developing and manufacturing pharmaceutical products through biotechnology; and serves as a supportive, authoritative voice in the evolving business, regulatory, scientific, and technical areas of the biopharmaceutical industry. 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