Introduction Guide to Biotechnology - Biomolecular Engineering Lab

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application receipt. For a standard review product, the agency’s goal is a 10-month review. The term PDUFA date is the date by which the FDA must act to meet this goal for a particular product. In weighing an NDA or BLA, particularly for a novel product, the FDA may seek the guidance of one of its independent advisory committees. Each committee has 10-15 members and includes experts and representatives of the public. The committees host public meetings, often attracting media coverage, at which the pros and cons of the products in question are presented and debated, culminating with a recommendation either for or against approval. Advisory committee recommendations are non-binding, however. The final regulatory decision rests with the agency. Post-Approval Every approved drug comes with an official product label, in a standardized format, whose contents are developed by the FDA and the company marketing the drug. The label contents include the approved indication, as well as a description of the drug, its side effects, dosage, clinical trial summaries and other information useful to physicians. Although doctors may prescribe a therapy “off-label” for indications not expressly approved by the FDA, manufacturers are prohibited from marketing off-label indications, and insurance does not always cover such uses. The story does not end with approval and labeling. Companies often conduct additional Phase II and III trials in other indications and may apply for approval through a supplemental NDA or BLA. If approved, the new indication is added to the product label. Companies also conduct Phase IV trials to refine knowledge about the drug. In addition, drug makers are required by law to report adverse events to the FDA, and they are subject to ongoing manufacturing and marketing rules. 44 Biotech Drug Development Process Discovery (2–10 years) Preclinical Testing (Lab and animal testing) Phase I (20–30 healthy volunteers used to check for safety and dosage) Phase II (100–300 patient volunteers used to check for efficacy and side effects) Phase III (1,000–5,000 patient volunteers used to monitor reactions to long-term drug use) FDA Review & Approval Source: Ernst & Young LLP 0 2 4 6 8 10 12 14 16 Year Postmarketing Testing Biotechnology Industry Organization n Guide to Biotechnology
Approved Biotechnology Drugs (Bold text indicates recombinant and monoclonal antibody products.) Note: This list includes biologics developed by biotechnology companies and pharmaceutical companies, as well as small-molecule products developed by biotechnology companies, and other selected small-molecule or tissue-engineered products. This list covers approvals and new indications from 1982 through 2005. Selected 2006 approvals (through Oct. 31) are also included. Please check bio.org in early 2007 for a complete list of 2006 approvals. Product Company Application (use) Approval Date (FDA) Abelcet ® (liposomal formulation of anphotericin B) Enzon Treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B Nov 1995 Abraxane (paclitaxel, first-in-class protein bound particle) Abreva (docosanol) American Pharmaceutical Partners Inc. AVANIR Pharmaceuticals and GlaxoSmithKline, Inc. Treats breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy Topical treatment of recurrent cold sores (herpes simplex infection) Jan 2005 Jul 2000 Actimmune ® (interferon gamma-1b) InterMune Pharmaceuticals, Inc. Treatment of chronic granulomatous disease; treatment of severe, malignant osteopetrosis Dec 1990 Feb 2000 Activase ® /Cathflo ® Activase ® (alteplase; tissue plasminogen activator) Genentech, Inc. Treatment of acute myocardial infarction; acute massive pulmonary embolism; acute ischemic stroke within first three hours of symptom onset; dissolution of clots in central venous access devices (Cathflo ® Activase ® ) Nov 1987 Jun 1990 Jun 1996 Sep 2001 45 AcuTect (technetium Tc-99 apcitide) Berlex Laboratories Imaging agent for deep-vein thrombosis Sept 1998 Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed) Aventis Pasteur Limited Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 11 through 64 years of age Jun 2005 Adagen ® (adenosine deaminase) Enzon, Inc. Treatment of severe combined immunodeficiency disease (SCID) Mar 1990 ADVATE (recombinant clotting factor) Baxter Healthcare Corp. Hemophilia A Jul 2003 Agenerase ® (amprenavir) Vertex Pharmaceuticals and GlaxoSmithKline HIV Apr 1999 Albutein ® (human albumin) Alpha Therapeutic Corp. Treatment of hypovolmeic shock; an adjunct in hemodialysis; used in cardiopulmonary bypass procedures Jan 1986 Aldurazyme ® (laronidase) BioMarin Pharmaceutical Inc. and Genzyme Mucopolysaccharidosis-1 Apr 2003 Alferon N ® (interferon alfa-N3, human leukocyte derived) Interferon Sciences, Inc. Treatment of genital warts Oct 1989 Aloxi (palonosetron HCl) MGI Pharma Inc. and Helsinn Healthcare SA Prevention of acute nausea and vomiting in chemotherapy Jul 2003 Guide to Biotechnology n Biotechnology Industry Organization
Page 1 and 2: There are more than 400 biotech dru
Page 3 and 4: Contents Biotechnology: A Collectio
Page 5 and 6: Biotechnology: A Collection of Tech
Page 7 and 8: Market Capitalization, 1994-2005* 4
Page 9 and 10: Total Financing, 1998-2005 (in bill
Page 11 and 12: 1911 n The first cancer-causing vir
Page 13 and 14: 1967 n The first automatic protein
Page 15 and 16: compared to traditional techniques
Page 17 and 18: gen-fixing species, and Agrobacteri
Page 19 and 20: n Global biotech crop acreage reach
Page 21 and 22: 1998 n Congress undertakes a doubli
Page 23 and 24: n Tositumomab (Bexxar ® ) is a con
Page 25 and 26: Recombinant DNA Technology Recombin
Page 27 and 28: When the substance of interest bind
Page 29 and 30: Biotech Tools in Research and Devel
Page 31 and 32: Scientists had assumed a specialize
Page 33 and 34: as we coincidentally learned more a
Page 35 and 36: Bioinformatics Technology Biotechno
Page 37 and 38: agricultural biotechnology companie
Page 39 and 40: logical substances also rely on nat
Page 41 and 42: Xenotransplantation Organ transplan
Page 43 and 44: Regenerative Medicine Biotechnology
Page 45 and 46: Plant-Made Pharmaceuticals The flex
Page 47: Some drugs, for very rare and devas
Page 51 and 52: Product Company Application (use) A
Page 53 and 54: Product Company Application (use) C
Page 59 and 60: Product Company Application (use) M
Page 63 and 64: Product Company Application (use) R
Page 67 and 68: Product Company Application (use) V
Page 69 and 70: Agricultural Production Application
Page 71 and 72: Crop Biotechnology in Developing Co
Page 73 and 74: Regulation of Crop Biotechnology Si
Page 75 and 76: Animal cloning offers benefits to c
Page 77 and 78: n Genetic analysis of animal pathog
Page 79 and 80: n Further, the EnviroPig is a biote
Page 81 and 82: Companion Animals Approximately 164
Page 83 and 84: Global Area of Transgenic Crops in
Page 85 and 86: Transgenic Crop Area as % of Global
Page 87 and 88: corn rootworm. Current products inc
Page 89 and 90: with YieldGard ® Corn Borer or oth
Page 91 and 92: Food Biotechnology We have used bio
Page 93 and 94: Food Additives and Processing Aids
Page 95 and 96: Today at least 5 billion kilograms
Page 97 and 98: Green Plastics Biotechnology also o
Page 99 and 100:
Some Industrial Biotech Application
Page 101 and 102:
Consumer Product Old Process New In
Page 103 and 104:
Enzymes Source or Type Applications
Page 105 and 106:
ogy could be applied to other biowa
Page 107 and 108:
in political upheavals. American so
Page 109 and 110:
hensive vision of ways to ensure bi
Page 111 and 112:
involve taking the nucleus of a som
Page 113 and 114:
BIO Statement of Ethical Principles
Page 115 and 116:
Intellectual Property Biotechnology
Page 117 and 118:
The inventor must teach or “enabl
Page 119 and 120:
Biotechnology Resources BIO has com
Page 121 and 122:
Genomics and Global Health. This re
Page 123 and 124:
Glossary A Acclimatization Adaptati
Page 125 and 126:
Biotransformation The use of enzyme
Page 127 and 128:
DNA probe A small piece of nucleic
Page 129 and 130:
Germplasm The total genetic variabi
Page 131 and 132:
Linker A fragment of DNA with a res
Page 133 and 134:
Fully differentiated cells from man
Page 135 and 136:
Tertiary structure The total three-
Page 137 and 138:
Notes
Page 140:
Biotechnology Industry Organization
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