HOSA Biotech Chp 1: Biotechnology - Health, Careers, and Government Regulation

biotechnology

the use of modern molecular and microbial techniques to make useful products or processes

bioinformatics

the use of information technology for biological applications

drug development

the whole process of developing drugs, can take 10-15 years and cost over $2.5 billion

personalized medicine

pharmaceuticals based on genomics (aka pharmacogenomics)

- gender, race/ethnicity, and family history all affect responses to a drug/drug therapies

FDA

Food and Drug Administration, ensures that foods & beverages are safe for human consumption, and therapeutic drugs are safe & effective

EPA

The Environmental Protection Agency, protects human health and the environment

USDA

United States Department of Agriculture ensures agriculture and livestock are protected

GMO's

genetically modifed/engineered organisms

- use of GMO's in labs is regulated by guidelines from the NIH

- GMO's in the food supply is regulated by the USDA

clinical trials

- usually conducted by splitting patients into two groups (arms), one receives the drug and the other receives a placebo

- occurs in three phases

clinical trials phase 1

small group (<100) of often healthy individuals, testing for safety + dosage levels, how the body metabolizes the drug

clinical trials phase 2

100-300 participants, investigate if the drug helps people in the specific patient population who are suffering from the disease

clinical trials phase 3

large trial in the specific patient population (hundreds to thousands of patients), monitoring the drug's effectiveness and side effects

Institutional Review Board (IRB)

A committee that makes sure research involving human subjects is both lawful and ethical

- reviews the purposes/methods of the research

- conducts risk-benefit analysis

biohazardous waste

any type of medical waste, such as tissue samples, blood cell/microbrial cultures, viruses, and sharps

sharps waste

needles, microscope slides, used ampules, razors. Transported to special facilities

autoclaving

steam sterilization to kill microorganisms/infectious agents of biohazardous materials

Occupational Safety and Health Administration (OSHA)

regulates the safety of workers in the workplace

laboratory technician

works under the supervision of a scientist and carries out the hands-on work

- setting up assays, using instrumentation, recording data, etc.

- usually required to have a associate's degree, often required to have a bachleor's degree

Quality Assurance Technician

manages the quality system + regulatory compliance procedures

- check equipment, inspect storage areas, issue/review documents

- usually required to have a associate's or bachleor's degree

Research Associate

carries out hands-on work in the lab under the supervision of a scientist, BUT with more responsibility for experimental design and data analysis

- also expected to produce reports about data/present those to senior members

- requires a bachleor's or master's degree

Research and Development Scientist

studies/develop methods to investigate bio. processes, develops products/processes for the biotech industry

- design experiments, analyze data, draw conclusions, perform hands-on lab work, train + supervise technicians/research associates

- usually required to have a doctoral degree, master's can also be sufficient

clinical scientist

performs all levels of work in biomedical research, responsible for proper handling of medical supplies, ensure appropriate testing is performed, train + supervise clinical technologists/technicians

- analyzing blood samples, designing/overseeing clinical drug trials, etc

- required to have a bachelor's or graduate degree or a specialized certification

engineer

use science/math to solve biological problems

- solving agricultural problems, developing instruments/machines and software, improving manufacturing processes

- require a bachleor's degree, sometimes a graduate degree

non-laboratory careers

many positions are filled by people with experience in biological sciences

- administrators, sales rep, marketing, public relations specialists, tech/customer suport reps, lawyers, project managers, etc

systems biology

An approach to life science research based on investigating how whole cells, organisms, populations, or ecosystems function at the molecular level

genomics

study of the whole genome, the full complement of DNA in a cell

proteomics

study of the proteome, the entire protein complement of a cell or organism

transcriptomics

study of the transcriptome, every RNA transcript expressed in a cell or organism

metabolomics

study of the metabolome, all metbolites in a cell or organism present at a specific time

microbiomics

study of the microbiome, all microorganisms living in a place at the same time

Drug discovery process

1. identify a target (usually genes/proteins)

2. develop drugs to inhibit a particular gene or protein

3. screen drug candidate molecules (using automated high-throughpt tools/techniques)

4. once a lead canditate is identified perform extensive testing/development

protein based drug production

- some grown in bacteria, others are grown using yeast, plant/animal cell cultures, or whole plants/animals

- protein is extracted from the cells + purifed and tested one last time before being packaged/shipped to the customer

immunotherapy

a type of personalized medicine that uses parts of a person's immune system to fight diseases

antibodies

proteins that specificially recognize and bind to other proteins, commonly used in diagnostic tests