Title: Unit 16 Review
Course: SAT 170 Introductory Biotechnology > Section: SAT 170 Introductory Biotechnology

Q: Compare and contrast the technology-platform and disease-focused models of biotechnology companies.

Q: Genentech is often regarded as the first biotechnology company.
- True
- False
A: True

Q: What is an angel investor? How is this term different from venture capital?

Q: What is an investigational new drug (IND) application? Why is this an important step in the drug approval process?

Q: One of the main roles of a(n) ___________________________________ is to maintain and stock lab equipment and supplies.

Q: Phase IV clinical trials are also known as postapproval trials.
- True
- False
A: True

Q: What is a scale-up process? Whose responsibility is it to ensure that scale-up processes are effectively implemented within a biotechnology company?

Q: Describe the role(s) of the research and development (R & D) department of a biotechnology company.

Q: What is the role of a chief financial officer (CFO)?

Q: ___________________________________ is a field which focuses on the storage and analysis of large amounts of data such as the data generated from sequencing experiments.

Q: What role would a chemical, electrical, environmental, or an industrial engineer play within a biotechnology company?

Q: Both Amylin and MedImmune are examples of biotechnology companies which have adopted the technology-platform model.
- True
- False
A: False

Q: Who are the key players in this department in the research and development (R & D) department of a biotechnology company? Briefly describe the role(s) of each of these key players.

Q: The sale of a company’s stock to the general public for the first time is known as the ___________________________________ or stock market launch.

Q: What is unique about the skill set of a bioinformaticist?

Q: Which of the following individuals are directly involved in operations, or biomanufacturing within a biotechnology company?
- lab technicians
- research associates
- senior scientists
- material handlers
- all of the above
A: material handlers

Q: The later in the drug approval process an investor becomes involved, the less of a risk the investment.
- True
- False
A: True

Q: One would expect to find a customer relations specialist or product complaint specialist in a marketing and sales department of a biotechnology company.
- True
- False
A: False

Q: What is intellectual property (IP)? Explain the role of patents in protecting IP.

Q: What is the role of the regulatory affairs (RA) department? What are some of the organizations that are responsible for developing regulatory guidelines in the U.S.?