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COMPANY AND FINANCIAL STRUCTURE Total Revenue: $4.71 billion Total Equity: $5.4  billion Operating Income: $1.24 billion Net Income: $0.89 billion
CEO:  George A. Scangos CFO & Management: Paul Clancy VP of R&D: Douglas Williams Regulatory: Nadine Cohen The Brains and Goals Behind Biogen Idec Business Goals as of 2007: --  100,000 patients on TYSABRI(R) (natalizumab); Not yet met. --  More than 40% of the Company's revenue coming from its International business; Not yet met. --  Four new products and/or existing products launched in new indications; Not yet met. --  Six programs in late-stage clinical development. Goal achieved.
FIVE MAIN AREAS OF RESEARCH ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
PHASES DRUGS FDA  APPROVED DRUGS PHASE 1 ANTI-LINGO, NEBULASTIN, CD40L, ANTI-TWEAK, BIIB037 (HUMAN ANTI-AMYLOID B MAB) PHASE 2 OCRELIZUMAB (HUMANIZED ANTI-CD20 MAB). PHASE 3 PEG IFN (PEGYLATED INTERFERON BETA-1A), BG-12 (DIMETHYLFUMARATE), DACLIZUMAB, LONG LASTING r FACTOR IX, LONG LASING r FACTOR VIII, GA101 (HUMANIZED ANTI-CD20 MAB), DEXPRAMIPEXOLE. PHASE 4 ------- FILLING -------
WORK DONE IN QUALITY ASSURANCE DEVELOPMENT, MAINTENANCE AND MANAGEMENT OF QUALITY SYSTEMS  ENSURE THAT EXCEPTIONS ARE ANALYZED FOR PREVENTIVE ACTIONS AND PRODUCT IMPACT. DEVELOP AND MAINTAIN DATA ANALYSIS AND TRENDING SYSTEMS FOR PRODUCT SPECIFIC DATA GENERATED AT THE FACILITY. PROVIDE TECHNICAL EXPERTISE FOR PRODUCT QUALITY DECISIONS.  MAINTAIN PRODUCT DISPOSITION PROCEDURES. EVALUATION OF FACILITY, PROCEDURES, EQUIPMENT, PERSONNEL AND PROCESSES. PROCESSES USED MASS SPECTROSCOPY: ESI TOF MS, MALDI MS,LC UV MS. CHROMATOGRAPHY: HIC, RPLC, SEC, ION EXCHANGE CHROMATOGRAPHY,  SDS PAGE cIEF
References ,[object Object],[object Object],[object Object],[object Object],[object Object]

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Biogen

  • 1. COMPANY AND FINANCIAL STRUCTURE Total Revenue: $4.71 billion Total Equity: $5.4 billion Operating Income: $1.24 billion Net Income: $0.89 billion
  • 2. CEO: George A. Scangos CFO & Management: Paul Clancy VP of R&D: Douglas Williams Regulatory: Nadine Cohen The Brains and Goals Behind Biogen Idec Business Goals as of 2007: -- 100,000 patients on TYSABRI(R) (natalizumab); Not yet met. -- More than 40% of the Company's revenue coming from its International business; Not yet met. -- Four new products and/or existing products launched in new indications; Not yet met. -- Six programs in late-stage clinical development. Goal achieved.
  • 3.
  • 4. PHASES DRUGS FDA APPROVED DRUGS PHASE 1 ANTI-LINGO, NEBULASTIN, CD40L, ANTI-TWEAK, BIIB037 (HUMAN ANTI-AMYLOID B MAB) PHASE 2 OCRELIZUMAB (HUMANIZED ANTI-CD20 MAB). PHASE 3 PEG IFN (PEGYLATED INTERFERON BETA-1A), BG-12 (DIMETHYLFUMARATE), DACLIZUMAB, LONG LASTING r FACTOR IX, LONG LASING r FACTOR VIII, GA101 (HUMANIZED ANTI-CD20 MAB), DEXPRAMIPEXOLE. PHASE 4 ------- FILLING -------
  • 5. WORK DONE IN QUALITY ASSURANCE DEVELOPMENT, MAINTENANCE AND MANAGEMENT OF QUALITY SYSTEMS ENSURE THAT EXCEPTIONS ARE ANALYZED FOR PREVENTIVE ACTIONS AND PRODUCT IMPACT. DEVELOP AND MAINTAIN DATA ANALYSIS AND TRENDING SYSTEMS FOR PRODUCT SPECIFIC DATA GENERATED AT THE FACILITY. PROVIDE TECHNICAL EXPERTISE FOR PRODUCT QUALITY DECISIONS. MAINTAIN PRODUCT DISPOSITION PROCEDURES. EVALUATION OF FACILITY, PROCEDURES, EQUIPMENT, PERSONNEL AND PROCESSES. PROCESSES USED MASS SPECTROSCOPY: ESI TOF MS, MALDI MS,LC UV MS. CHROMATOGRAPHY: HIC, RPLC, SEC, ION EXCHANGE CHROMATOGRAPHY, SDS PAGE cIEF
  • 6.