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Genetic Engineering Drug Development with Regulation Policy and Humans and the Environment and Ethical Issues

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  1. Genetic Engineering Drug Development with Regulation Policy and Humans and the Environment and Ethical Issues Cai Wu (4/24/2006)

  2. Outline • Introduction • Biotechnology and Drug Development • Genetic engineering Pharmaceuticals • Biotechnology Industry Facts • Government Regulations • Potential Risks to Humans and the Environment and Ethical Issues

  3. Introduction • The main driver for genetic engineering pharmaceutics comes from the biotech and pharmaceutical industry, where there is a growing recognition of the vast economic potential of using genetically engineering products for drugs and therapeutic compounds. • Efficient methods now exist to produce a wide variety of biologically active recombinant proteins – both large and small, simple and complex. Transgenic animals can provide a cost-competitive large-scale production alternative for these complex proteins, in which some cannot be made in any other way. • However there is little regulatory experience, potential for viral contamination, and long time scales for this method to produce the new drug. It also may creates new viral diseases through transfer and increases instrumentalisation of animals.

  4. Biotechnology and Drug Development • In the last two decades, the drug development process within the pharmaceutical industry has experienced a significant transformation, driven largely by biotechnology advances. Biotechnology played a key role in the expansion of large-molecule drugs (as opposed to the small-molecule drugs manufactured by chemical synthesis).

  5. Genetic engineering Pharmaceuticals • Genetic engineering is being used in the production of pharmaceuticals, gene therapy, and the development of transgenic plants and animals.

  6. Product Use Host Organism Insulin human hormone used to treat diabetes Bacteria /yeast HGH human growth hormone, used to treat dwarfism Bacteria BST bovine growth hormone, used to increase milk yield of cows Bacteria Factor VIII human blood clotting factor, used to treat haemophiliacs Bacteria Anti-thrombin anti-blood clotting agent used in surgery Goats Penicillin antibiotic, used to kill bacteria fungi / bacteria Vaccines hepatitis B antigen, for vaccination yeast AAT enzyme used to treat cystic fibrosis and emphysema sheep -glucosidase enzyme used to treat Pompe’s disease rabbits DNase enzyme used to treat CF Bacteria rennin enzyme used in manufacture of cheese Bacteria /yeast cellulase enzyme used in paper production Bacteria PHB Biodegradable plastic Plants Table 1 Examples of genetically engineered products that are already available.  

  7. New Biotech Drug and Vaccine Approvals / New Indication Approvals by Year Figure 1. New Biotech Drug and Vaccine Approvals / New Indication Approvals by Year, source: BIO 2005-2006 Guide to Biotechnology

  8. Figure 2. Biotech Drug Discovery Process. Source: Ernst & Young LLP, Biotechnology Industry Report: Convergence, 2000

  9. Figure 3. The regulatory pathway for products depending on the type of organism (plant, animal, or microorganism) being modified. Source: Guide to US Regulation of Genetically Modified Food and Agricultural Biotechnology Products.

  10. Figure 4. The production of transgenic plants regulatory pathways. Source: Guide to US Regulation of Genetically Modified Food and Agricultural Biotechnology Products. PIP: Plant Incorporated Protectant.

  11. Figure 5. FDA regulatory coverage of transgenic animals. Source: Guide to US Regulation of Genetically Modified Food and Agricultural Biotechnology Products.

  12. Potential Risks to Humans and the Environment and Ethical Issues • A wide variety of social and ethical issues are associated with biotechnology research, product development and commercialization • The current debate over biotechnology raises complex policy questions about the appropriate use and regulation of a technology that has begun to alter the way we produce food and manufacture a wide range of industrial products. • Critics have raised concerns about food safety, environmental risks, and ethical issues associated with the technology, while supporters have pointed to a range of potential benefits, including reduced pesticide use and more nutritious foods.

  13. A Example: • Companies on both sides of the Atlantic have engineered pigs to carry human protein on the surface of their cells so that the organs will not be rejected by the human immune system. At first glance this seems to be a brilliant way of meeting the demand for organs for transplant operations. Unfortunately, researchers have found that the pigs can carry at least two retroviruses,

  14. Conclusion • The drug development process within the pharmaceutical industry has experienced a significant transformation, driven largely by biotechnology advances. • Biotechnology played a key role in the expansion of large-molecule drugs (as opposed to the small-molecule drugs manufactured by chemical synthesis). • Efficient methods now exist to produce a wide variety of biologically active recombinant proteins – both large and small, simple and complex.

  15. Conclusion (Cont.) • Transgenic animals can provide a cost-competitive large-scale production alternative for these complex proteins, in which some cannot be made in any other way. • However there is little regulatory experience, potential for viral contamination, and long time scales for this method to produce the new drug. It also may creates new viral diseases through transfer and increases instrumentalisation of animals.