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
Product and Humans and the Environment and
human hormone used to treat diabetes
human growth hormone, used to treat dwarfism
bovine growth hormone, used to increase milk yield of cows
human blood clotting factor, used to treat haemophiliacs
anti-blood clotting agent used in surgery
antibiotic, used to kill bacteria
fungi / bacteria
hepatitis B antigen, for vaccination
enzyme used to treat cystic fibrosis and emphysema
enzyme used to treat Pompe’s disease
enzyme used to treat CF
enzyme used in manufacture of cheese
enzyme used in paper production
Table 1 Examples of genetically engineered products that are
Figure 1. New Biotech Drug and Vaccine Approvals / New Indication Approvals
by Year, source: BIO 2005-2006 Guide to Biotechnology
Figure 2. Approvals by YearBiotech Drug Discovery Process. Source: Ernst & Young LLP,
Biotechnology Industry Report: Convergence, 2000
Figure 3. Approvals by YearThe 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
Figure 4. The Approvals by Yearproduction of transgenic plants regulatory pathways.
Source: Guide to US Regulation of Genetically Modified Food and
Agricultural Biotechnology Products. PIP: Plant Incorporated Protectant.
Figure 5. FDA regulatory coverage of transgenic animals. Approvals by Year
Source: Guide to US Regulation of Genetically Modified Food
and Agricultural Biotechnology Products.