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1.4 Biotechnology - The Biotechnology Workplace - Coggle Diagram
1.4 Biotechnology - The Biotechnology Workplace
Biotechnology Workplace
Healthcare Biotech
Industrial Biotech
Agricultural Biotech
Who develops Biotech Products?
Universities
"Pure Science"
Funded Through
Grants
- Like the
National Institutes of Health (NIH )
Grant for the Human Genome Project Led by Francis Collins
May not lead to Product Development
Biotech Companies
Profit Driven
Research leads to Product Development
Incentive to Research: Receive a
Patent
Product Pipeline
A series of steps to develop, prepare, and produce products
Product Identification
Research & Development (R&D)
Small Scale Manufacturing
Testing for Safety & Efficacy
Large Scale Manufacturing
Sales & Marketing
Positions within Biotechnology
Most require a Bachelors Degree
Example: Genetech was started by Francis Collins and first Biotechnology company
https://www.gene.com/
Federal (Government) Agencies that Regulate Biotechnology Companies
FDA: Food & Drug Administration
Established in the 1930s, however in
1906 President Roosevelt
passed the Food & Drug Act. In response to a book "The Jungle" is a documentary where a guy exposes health violations in a meat industry
Promote Public safety through food safety, supplements, pharmaceuticals, vaccines, and cosmetics
USDA: United States Department of Agriculture
Regulate Crops, Cattle, Livestock, and Genetically Modified Organisms
Established in the 1860s by Abraham Lincoln
Develop and execute laws related to farming, forestry, and food (crops)
EPA: Environmental Protection Agency
Established in 1
970 by President Nixon
, in response to book " Silent Spring, that exposes the dangers of pesticides, which led to the ban of DDT (studies birds and finds decline in Bald Eagle and connects it to delicate egg shells due to pesticides called bio cumulation. As a result of run off it was ending up in water, and the eagles were eating contaminated organisms
The responsibility of the EPA is to
4 Phases of Clinical Trials
Phase III:
Confirm the drugs safety and effectiveness and compare the new drug to other drugs or therapies. This phase must have a large group of volunteers.
Phase IV:
This phase begins only if after Phase III the drug is approved by the FDA for a specific group of patients. Once the drug is approved, researchers study the effectiveness in a wide variety of patients and monitor the safety in a large group to develop new ways to use the drug.
Phase II:
Assess the short-term safety and effectiveness of the drug, find the dose that works best with the least side effects, and conduct a small scale placebo comparison and includes 100 to 300 with the condition
Phase I:
Assess the drugs safety, determine the side effects, and determine how it should be taken and usually includes 50 to 100 healthy volunteers