Chapter 1 - Introduction To The Industry

25 Questions | By Msquared | Updated: Mar 22, 2022 | Attempts: 446

Questions

Settings

Feedback

During the Quiz End of Quiz

Play as

Quiz Flashcard

Create your own Quiz

In the olden days people mostly chose to be farmers or miners but with the introduction of industries people moved to get job in cities which tended to grow with the introduction of new companies. What do you know about the manufacturing industry within your region? Take up the test below and see if you understood the basics from chapter one on introduction to the industry. All the best of luck!

Questions and Answers

1.

Which best describes the Pharma industry?
- A.
  
  Low risk, high reward
- B.
  
  Low risk, low reward
- C.
  
  High risk, high reward
- D.
  
  High risk, low reward
2.

Which are the organizations that fall under the Food and Drug Administration (FDA)?
- A.
  
  Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Device & Radiology/Vet Medicine/Food Safety Centers, Office of Regulatory Affiars/Center for Toxicological Research/Office of Orphan Product Development
- B.
  
  Drug Enforcement Agency (DEA), Office of Regulatory Affiars/Center for Toxicological Research/Office of Orphan Product Development, Center for Biologics Evaluation and Research (CBER)
- C.
  
  Office of Regulatory Affiars/Center for Toxicological Research/Office of Orphan Product Development, Office of the Inspector General, Federal Trade Commission (FTC)
- D.
  
  Drug Enforcement Agency (DEA), Office of the Inspector General (OIG), Federal Trade Commission (FTC)
3.

The most powerful and influential pharma association designed to develop/regulate industry-wide guidelines is:
4.

Due to the nature of Americans and the American health insurance system, health care has become very expensive. Its costs must somehow be controlled. What is the most common form of health insurance cost-control in this country?
- A.
  
  Indemnity-type coverage plans
- B.
  
  Restricted access to products/services
- C.
  
  Reduced level of service to patients depending on level of patient health insurance
- D.
  
  Increase the cost of most commonly use products
5.

In the United States, what type of company dominates the pharmaceutical industry?
- A.
  
  Multi-national corporations
- B.
  
  Public, not-for-profit companies
- C.
  
  For-profit, private companies
- D.
  
  M Squared Life Sciences Practice
6.

Which statement best describes the worldwide pharmaceutical industry?
- A.
  
  A giant, unethical body of greedy people
- B.
  
  Scientists without borders
- C.
  
  Drugs and lots of them
- D.
  
  A complex amalgam of science and business
7.

Why does "Big Pharma" turn to smaller pharmaceutical companies?
- A.
  
  They are smaller so they carry less inherent risk making them a safer investment.
- B.
  
  They are more innovative and focused and can supplement the internal pipelines of their larger partners
- C.
  
  To help out when Big Pharma gets into trouble.
- D.
  
  Smaller pharmaceutical companies have less stringent regulatory standards to which they must adhere, thus bringing products to market more quickly.
8.

The two ways Pharma companies are generally structured:
- A.
  
  Large or small
- B.
  
  Research based or focused on meeting regulatory guidelines.
- C.
  
  Focused on meeting regulatory guidelines or maintaining high ethical standards
- D.
  
  Research based or focused on manufacturing
9.

What role does Business Development play in a Pharmaceutical company?
- A.
  
  In-licensing, out-licensing and co-promotion
- B.
  
  Supply chain management, commercial manufacturing, customer service
- C.
  
  Legal, information technology, HR, finance and accounting
- D.
  
  Sales, marketing, and customer service
10.

What three divisions/departments of a pharmaceutical company are responsible for accelerating the business, guiding the company in adhering to regulatory guidelines, and providing general administrative support?
- A.
  
  Research and development, marketing and sales, regulatory
- B.
  
  Marketing and sales, manufacturing and operations, corporate and administrative
- C.
  
  Marketing and sales, research and devlopment, manufacturing and operations
- D.
  
  Business development, regulatory, corporate and administrative
11.

What is the purpose of the FDA?
- A.
  
  Same as OSHA - to create obnoxious rules to which no one can adhere and to make nice people jump through a lot of hoops
- B.
  
  To prevent the production of harmful drugs, and to protect consumers against anti-competitive behavior and misleading claims
- C.
  
  To ensure drug safety and efficacy and to prevent misleading product claims and illicit inducements
- D.
  
  To regulate the distribution and use of narcotics and other controlled substances
12.

What happens when a drug patent expires?
- A.
  
  Other companies are free to market drugs with the same active ingredient and equivilent efficacy.
- B.
  
  Other companies are free to market drugs with the same active ingredient but they must alter the efficacy so they are not creating an identical drug.
- C.
  
  Other companies may make drugs with an equivilent efficacy but they must contain a different active ingredient.
- D.
  
  A company loses its ability to market the product
- E.
  
  All hell breaks loose.
13.

Why do pharmaceutical companies need M Squared?
- A.
  
  Because we have sexy employees. I mean, have you checked out Steve Jaben lately?
- B.
  
  Companies have been forced to downsize recently due to the economic downturn and so consultants supply a source of cheap, effective labor.
- C.
  
  Because they are too large to handle finding quality talent on their own.
- D.
  
  Because the requirements and market environment in the industry are so compex, pharma companies need the support of vendors who are dedicated to the industry and are well versed in its intricacies.
14.

A drug with "blockbuster" status typically refers to:
- A.
  
  A drug with sales over $1 billion annually
- B.
  
  A drug with more than several hundred million dollars in sales annually
- C.
  
  A drug that is first to market in a novel therapeutic area
- D.
  
  A drug with over $100 million in investment
- E.
  
  A drug sold through video retail chains
15.

What unique regulatory framework has evolved in the pharmaceutical industry?
- A.
  
  Country specific regulatory requirements
- B.
  
  Industry-wide guidelines with input from relevant regulatory bodies
- C.
  
  A combination of active company and industry self-regulation with governmentally enforced standards
- D.
  
  Ethical guidelines for physicians adopted by pharmaceutical companies
16.

Most pharmaceutical firms maintain several internal "watchdog" departments to oversee compliance of all functions with internal policies and regulatory mandates. Name one as listed in the book.
17.

What does the acronym CRO stand for? (Use exact words for credit)
18.

What does the acronym CSO stand for? (Use exact words for credit)
19.

What does the acronym CMO stand for? (Use exact words for credit)
20.

The US accounts for roughly _______ of the world's pharmaceutical revenues
- A.
  
  One quarter
- B.
  
  One half
- C.
  
  Three quarters
- D.
  
  80%
21.

What is the second largest world market for pharmaceuticals?
- A.
  
  Japan
- B.
  
  Western Europe
- C.
  
  Eastern Europe
- D.
  
  Asia
- E.
  
  China
22.

Why would a small innovative company partner with a large pharma company by giving them access to their promising chemicals and molecules? (check all that apply)
- A.
  
  To obtain funding
- B.
  
  To obtain expertise
- C.
  
  To exploit the product's full market potential
- D.
  
  To avoid regulatory burdens
- E.
  
  To expand their product portfolio
23.

L be What is another name for unpatented drugs with the same active ingredient and equivalent efficacy as a patented drug?
24.

Most major activities of full-service pharmaceutical companies can be divided into three functional categories. These three "core functions" are:
- A.
  
  1. Research and Development, 2. Manufacturing and Operations, 3. Marketing and Sales.
- B.
  
  1. Research and Development, 2. Business Development, 3. Marketing and Sales
- C.
  
  1. Regulatory, 2. Manufacturing and Operations, 3. Business Development
- D.
  
  Marketing and Sales, 2. Corporate and Administrative, 3. Research and Development
25.

What are the 4 common organizations with which Pharma companies often partner or outsource to?
- A.
  
  HMO, PPO, HSA, CRAP
- B.
  
  CMO, CRO, CBO, CDO
- C.
  
  FDA, DEA, CBA, ADA
- D.
  
  CSO, CRO, CPO, CMO