Chapter 1 Review

When writing a conclusion, technicians use the "REE, PE, PA" method to ensure that all important data, evidence, and applications are discussed. Explain the meaning of the terms represented by the abbreviations "REE," "PE," and "PA."

"REE" - gives an answer to the purpose/question by using numerical data and results while also stating whether the outcome supports or refutes the hypothesis. "PE" - identifies the possible errors and explains how these errors could have affected the experiment. "PA" - discusses the benefits the experiment results could have.

Describe how the Strategy for Values Clarification can be used to solve a problem such as the use of embryonic stem cells for basic research.

- Identify and understand the problem - List all possible solutions - Identify pros and cons - Rank all solutions from best to worst - Decide if problem is important enough to take a position - Decide position and be prepared to describe and defend it

What are the educational requirements for these types of employees?

- Most laboratory positions require a 4-year college degree. - Lab directors, senior scientists, and staff scientists usually require more advanced degrees like a PhD.

Name a biotechnology product that has a medical use?

Examples include human insulin for the treatment of diabetes and antibodies for recognizing and fighting certain diseases.

Why do valid experiments contain many trials repeating the same version of an experiment?

Experiments are repeated to make sure there are no experimental errors.

The use of what kind of enzymes allows scientists to cut and paste pieces of DNA together to form recombinant DNA?

The use of restriction enzymes (for cutting DNA) and the enzyme DNA ligase (for pasting pieces of DNA together) allows the creation of new combinations of DNA information.

A drug discovery process can take nearly 15 years. Explain why it takes to long to bring a new drug to market.

Three rounds of clinical trials, over many years, test larger numbers of patents to check safety. It takes about 10-15 years for a company to move a drug product through all of these steps in the "product pipeline" process. Before going into the pipeline a company review it to determine its worth and creates a product development plan.

Getting a pharmaceutical approved for sale in the United States takes much longer than getting an industrial product, such as laundry enzyme, approved. This is because of the required clinical testing. Explain why clinical testing slows down the approval of pharmaceutical products.

Clinical testing slows down the approval of pharmaceutical products because, by definition, it's a strict series of tests that evaluates the effectiveness and safety of a medical treatment in humans, meaning it would take a while to test for side effects or other problems.

The following activities (Testing for safety and efficacy, Sales and Marketing, Product Identification, Small-scale Manufacturing, Research and Development, Manufacturing) represent stages in product development and manufacturing. Make a list of them in the order in which they take place.

- Product Identification - Research and Development - Small-scale Manufacturing - Testing for Safety and Efficiency - Manufacturing - Sales and Marketing

Name two ways that scientists share their experimental results with other scientists.

- Publications or presentations - Journals

Which questions must be answered to the satisfaction of company officials before a product goes into research and then into development?

-Does the product meet a critical need? Who will use the product? -Is the market large enough to produce enough sales? How many customers are there? -Do preliminary data support that the product will work? Will the product do what the company claims? -Can patent protection be secured? Can the company prevent other companies from producing it? -Can the company make a profit on the product? How much will it cost to make it? How much can it be sold for?

Biotechnology companies are grouped into four categories based on the products they make and sell. Name the four categories of products.

1. Pharmaceutical/ Medical products 2. Agricultural products 3. Industrial/Environmental products 4. Research or production instruments, reagents or data

Scientific positions in most biotechnology companies fall into one of four categories. List them.

1. Research an development 2. Manufacturing and production 3. Clinical research 4. Quality control

One approach to scientific studies is to follow a five step process in which a question is asked and answered. Outline these five steps.

1. State testable scientific question or problem based on some information or observation. 2. Develop a testable hypothesis 3. Plan a valid experiment 4. Conduct the outlined experiment and collect and organize the data 5. Formulate a conclusion based on experimental data and error analysis

What are the major differences between a biotechnology company and University/government research labs.

Gov. pure science (helps understand phenomena) Comp. applied work (products)

Biotechnologists can find job opportunities in many areas. In addition to biotechnology companies, where can a scientist with a biotechnology background find employment?

Government agency/research labs and universities.

What group of potential products must be tested in clinical trials before it can be marketed?

If the products is a pharmaceutical it must undergo strict testing (clinical trials), under the guidance of the FDA, before it can be marketed.

Why might having laboratory experience be a benefit for a nonscientific employee at a biotechnology company?

It helps employees work more productively with all members of the company.

Besides biotechnology companies, where can biotechnologists work?

Not all biotechnologists work at "for-profit" biotechnology companies. Some work in university labs or government agencies conducting what is considered "pure science" research.

Name two antibiotics used as medicine

Penicillin, from the fungus Penicillium sp, has been used to treat diseases such as pneumonia and syphilis. Modifications of penicillin include amoxicillin and carbenicillin

Does every produce in research and development make it to market? Yes or no? Explain.

Products must demonstrate "proof of concept" and will often be in the R & D stage for many years. Several aspects are assessed: is it feasible to produce this new medicine? What needs to be done to ensure safety? Efficacy? Many products do not make it past these strict guidelines and requirements.

For which types of Biotechnology employees is there currently a large demand?

Scientific and nonscientific staff.

In a conclusion, evidence for statements must be given. Describe the kind of evidence that is given in a conclusion statement.

The kind of evidence that is given in conclusion statements is quantitative data.

Explain how making human tissue plasminogen activator (t-PA) in Chinese hamster ovary (CHO) cells is an example of genetic engineering?

To produce t-PA for therapeutic use, researchers genetically engineered mammalian cell sussing Chinese hamster ovary cells. The ovary cells are grown into culture and given a segment of human DNA with the genetic instructions to make the human t-PA enzyme.

Give an example of an event that might lead a lab employee to be faced with an ethical issue.

When a vaccine for a disease can have negative effects on a person.

What is biotechnology?

the study and manipulation of living things or their component molecules, cells, tissues, or organs.

Define the term bioethics

the study of decision-making as it applies to moral decisions that have to be made because of advances in biology, medicine, and technology