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NSF
Risk-Based Decision Making
San Francisco Airport Marriott Hotel, Burlingame, CA
November 16 - 18, 2010
Course Fee $2675 Discounted Fee $2140
This NSF-DBA interactive course is about good decision making and the appropriate application of risk-based decision making tools and techniques (HACCP, FMEA) in the pharma industry.
The ICH Q9 Quality Risk Management guideline is reviewed and strategies for implementation are covered. Case studies are included.
Ideal for people in Quality, Manufacturing, Product and Process Development, Validation and other technical disciplines.
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Abbott (Abbott Park, IL) will voluntarily withdraw its weight-loss drug Meridia (sibutramine) from the US market at the request of the US Food and Drug Administration. Abbott said in a press release that FDA's request is based primarily on the results of a clinical trial whose results conflict with the “vast body of sibutramine data” collected over 13 years. The trial, called the SCOUT (Sibutramine Cardiovascular OUTcome Trial) study, was an approximately 10,000 patient, 6-year study requested by European regulatory authorities as a postmarketing commitment to evaluate cardiovascular safety in high-risk patients. The majority of these patients had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling, says Abbott. The drug was banned for sale in Europe in January 2010.
Genzyme’s (Cambridge, MA) board of directors unanimously rejected the unsolicited, $69-per-share tender offer from sanofi-aventis (Paris), and advised shareholders not tender their shares. Genzyme said in a press release that the offer does not adequately compensate shareholders. See the details of sanofi’s offer in last week’s ePT story, “sanofi-aventis Attempts Hostile Takeover of Genzyme.”
Halozyme Therapeutics (San Diego), a biopharmaceutical company, plans to decrease research related to the discovery of new compounds, resulting in a workforce reduction of approximately 25%. The company instead will focus on development of its programs in Ultrafast Insulin (at the Phase II stage); PEGPH20, its tumor-shrinking compound, in Phase I; and HTI-501, a preclinical treatment for disfiguring scars, contractures and cellulite.
Johnson & Johnson (J&J, New Brunswick, NJ) agreed to acquire Crucell (Leiden, The Netherlands), a biopharmaceutical company focused on vaccine development, approximately EUR 1.75 billion ($2.4 billion) in a cash tender offer. J&J expects to keep Crucell's existing facilities, senior management, and headquarters in Leiden, The Netherlands, and will consider Crucell as the center for vaccines within the its pharmaceutical group, according to a company press release.
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ImmunoGen (Waltham, MA), a biotechnology company, entered into a collaboration with Novartis (Basel) to discover and develop targeted anticancer therapeutics using antibodies to several antigen targets to be named by Novartis. ImmunoGen will receive an upfront payment of $45 million, and for each target that results in an anticancer therapeutic, milestone payments potentially totaling $200.5 million, plus royalties on product sales.
Separation technologies equipment and service provider KMPT USA (Florence, KY), which is a part of KMPT AG (Vierkirchen, Germany), is now ANDRITZ KMPT following the acquisition of KMPT AG by the ANDRITZ Group (Graz, Austria). ANDRITZ KMPT joins the Environment & Process division of ANDRITZ.
sanofi-aventis US (Bridgewater, NJ) will restructure its US pharmaceutical operations and eliminate an estimated 25% of its workforce, or approximately 1700 positions. According to a company press release, of the 13,000 people employed by sanofi-aventis in the United States, currently 6900 are employed in the pharmaceutical operations division. In addition, the company’s US pharmaceuticals business will shift its focus to diabetes, atrial fibrillation, and oncology.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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Advaxis (North Brunswick, NJ), a biotechnology company focused on live, attenuated Listeria monocytogenes immunotherapies, appointed Robert Petit to the newly created position of vice-president of clinical operations and medical affairs. Petit will report to John Rothman, executive vice-president of science and operations.
AMRI (Albany, NY) named David C. Lathbury as its vice-president of chemical development. Lathbury will assume leadership for AMRI’s Chemical Development business, which includes operations in Albany, Rensselaer, and Syracuse, New York. He will report to Steven Hagen, vice-president of pharmaceutical development and manufacturing.
Caraco Pharmaceutical Laboratories (Detroit) named G.P. Singh Sachdeva as its CEO following the resignation of Jitendra N. Doshi as interim CEO and as a director, effective Nov. 1, 2010. Doshi resigned due to personal and health-related reasons.
Ricerca Biosciences (Concord, OH), a preclinical contract-research organization, named Eric J. Lubert as a scientist in its drug-safety division. Lubert will be responsible for the technical management of Ricerca’s biotherapeutics assay group and biotherapeutic-development programs.
Spectrum Pharmaceuticals (Irvine, CA), a biotechnology company focused on oncology, appointed Brett L. Scott senior vice-president and acting chief financial officer. Scott will report to Rajesh C. Shrotriya, chairman, CEO, and president, and will be responsible for all financial aspects of the company.
WaferGen Biosystems (Fremont, CA), a developer of genomic analysis systems, appointed Gary P. Schroth senior vice-president of genomics research and applications. Schroth previously served as senior director of research and development at Illumina (San Diego).
WEX Pharmaceuticals’s (Vancouver) Vice-President of Research and Development, Larry Gontovnick, will retire at the end of 2010. Gontovnick joined the company as senior director of clinical development in September 2008 and was promoted to vice-president of research and development in March 2009. A search is underway for a replacement, and Gontovnick will assist in the transition until the end of the year. |
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Last week, in Bethesda, Maryland, ISPE and PDA hosted a workshop on the implementation of pharmaceutical development, risk management, and quality systems as part of the ICH quality-trio workshop series. ICH Quality Implementation Working Group (IWG) leaders presented a case study based on a fictional API to demonstrate how key quality principles may be applied, including design space, control strategy, quality systems, and risk management. Approximately 400 participants—representing industry and regulators—participated in breakout sessions to discuss these applications. IWG is expected to issue official breakout reports after the third workshop is completed later this month in Japan (one workshop is being held in each ICH region—North America, Europe, Japan). The group will then decide on its next deliverables. See related blogs from the workshop at blog.PharmTech.com. |
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| Collaborative Innovation in Sourcing and Procurement |
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Patricia Van Arnum
Gregg Brandyberry, CEO of Wildfire Commerce, senior advisor of AT Kearney procurement and analytic solutions, and former vice-president of procurement of global systems and operations for GlaxoSmithKline, discusses collaborative innovation in customer-supplier relations..
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Implementing Cleanrooms
What is the biggest challenge to implementing cleanroom conditions?
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Software manages asset performance in real time
