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Introduction

Introduction. Corsee Sanders, PhD VP Genentech Development Design, Analysis, Technology & Administration (DATA). Overview of Genentech . Product Highlights (1). 1978 • Human insulin cloned by Genentech scientists. 1979 • Human growth hormone cloned by Genentech scientists.

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Introduction

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  1. Introduction Corsee Sanders, PhD VP Genentech Development Design, Analysis, Technology & Administration (DATA)

  2. Overview of Genentech

  3. Product Highlights (1) • 1978 • Human insulin cloned by Genentech scientists. • 1979 • Human growth hormone cloned by Genentech scientists. • 1982 • First recombinant DNA drug marketed: human insulin (licensed to Eli Lilly and Company). • 1985 • Protropin® (somatrem for injection) growth hormone for children with growth hormone deficiency — the first recombinant pharmaceutical product to be manufactured and marketed by a biotechnology company. • 1987 • Activase® (Alteplase, recombinant), a tissue-plasminogen activator (t-PA), to dissolve blood clots in patients with acute myocardial infarction (heart attack). • 1990 • Actimmune® (Interferon gamma-1b) for the treatment of chronic granulomatous disease, a rare, inherited deficiency of the immune system resulting in frequent and severe infections. • Activase for the management of acute massive pulmonary embolism (blood clots in the lungs).

  4. Product Highlights (2) • 1993 • Nutropin® [somatropin (rDNA origin) for injection] for treating growth failure in children with chronic renal insufficiency before they undergo kidney transplantation. • Pulmozyme (dornase alfa, recombinant for treating cystic fibrosis • 1996 • • Activase for the treatment of acute ischemic stroke or brain attack. • 1997 • Rituxan® (Rituximab) for the treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkins lymphoma. • 1998 • Herceptin® (Trastuzumab) as a first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy for patients with metastatic breast cancer who have tumors that overexpress the HER2 (human epidermal growth factor receptor2) protein. • 2000 • TNKase_ for the treatment of acute myocardial infarction (heart attack).

  5. Product Highlights (3) • 2001 • Cathflo™ Activase® (Alteplase), a tissue plasminogen activator (t-PA), for the restoration of function to central venous access devices (CVADs). • 2003 • Xolair® (Omalizumab) for Subcutaneous Use for moderate-to-severe persistent asthma in adults and adolescents. • RAPTIVA® (efalizumab) for the treatment of chronic moderate-to-severe plaque psoriasis in adults age 18 or older who are candidates for systemic therapy or phototherapy. • 2004 • Avastin™ (bevacizumab) for use in combination with 5-Fluorourcil-based chemotherapy in the treatment of first-line metastatic cancer of the colon or rectum. Avastin™ is the first FDA-approved therapy designed to inhibit angiogenesis, a process fundamental to cancer growth and metastasis. • Tarceva™ (erlotinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva™ is an oral tablet indicated for daily administration.

  6. patients Post Marketing Preclinical Research Clinical Research Clinical Data BLA ! NDA! Systems and Business Operations Overview of the DATA Group Nonclinical Biostat Clin Biostat, Epidemiology Data Management, Programming Editing E-pub Health Econ

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