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Genetic Engineering Drug Development with Regulation Policy and Humans and the Environment and Ethical Issues. Cai Wu. (4/24/2006). Outline. Introduction Biotechnology and Drug Development Genetic engineering Pharmaceuticals Biotechnology Industry Facts Government Regulations

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slide1

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

Cai Wu

(4/24/2006)

outline
Outline
  • Introduction
  • Biotechnology and Drug Development
  • Genetic engineering Pharmaceuticals
  • Biotechnology Industry Facts
  • Government Regulations
  • Potential Risks to Humans and the Environment and Ethical Issues
introduction
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.
biotechnology and drug development
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).
genetic engineering pharmaceuticals
Genetic engineering Pharmaceuticals
  • Genetic engineering is being used in the production of pharmaceuticals, gene therapy, and the development of transgenic plants and animals.
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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.  

new biotech drug and vaccine approvals new indication approvals by year
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

slide9

Figure 2. Biotech Drug Discovery Process. Source: Ernst & Young LLP,

Biotechnology Industry Report: Convergence, 2000

slide10

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.

slide11

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.

slide12

Figure 5. FDA regulatory coverage of transgenic animals.

Source: Guide to US Regulation of Genetically Modified Food

and Agricultural Biotechnology Products.

potential risks to humans and the environment and ethical issues
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.
a example
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,
conclusion
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.
conclusion cont
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.
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