Module #1 - Biopharmaceutical Industry

Question 1

What are drugs?

Answer 1

chemical substances

used in treatment, prevention, or diagnosis of disease

used to enhance/improve quality of life

modify some function in body

Question 2

What are the two types of drugs?

Answer 2

Biologic and small molecule

Question 3

What are biologic drugs?

Answer 3

very large + high molecular weight

must be made from living things

Question 4

Examples of biologic drugs

Answer 4

protein, antibody, nucleic acid

Question 5

What is a small molecule drug?

Answer 5

very small, lower molecular weight

can be made either from living things or by chemical synthesis in a lab

Question 6

General Characteristics about Pharmaceutical Industry

Answer 6

lots of money

heavily regulated

research intensive

high risk

Question 7

Why is pharmaceutical company high risk?

Answer 7

because you could spend a ton of money for nothing

very high drug fail rate

Question 8

What are the four types of pharmaceutical companies

Answer 8

ethical, generic, biotech, and contract research organizations

Question 9

Characteristics of Ethical Research Companies

Answer 9

research oriented

discover and develop new molecule entities

very large

ex. Novartis, AstraZeneca, Pfizer, Johnson and Johnson

Question 10

Characteristics of Generic Biopharmaceutical Companies

Answer 10

not research oriented

large to medium size companies

focused on manufacturing methods

want to break/adapt patents

Question 11

Characteristics of Biotech Companies

Answer 11

created to exploit academic discoveries

highly research intensive

tend to be smaller

usually only sell a few specialty products

typically bought out by larger companies who develop the drug on a much larger scale

ex. Pfizer took advantage of one of these companies to develop covid vaccine

common in university labs

Question 12

Characteristics of Contract Research Organizations

Answer 12

provide specialty services for Biopharmaceutical companies such as biological testing, specialty chemical synthesis, specialty manufacturing, specialty research areas, clinical trials, etc.

tend to be small-medium sized

low risk to work for these companies because they don’t actually develop drugs –> only do small services to help out other companies

Ex. Paraxel, WuXi

Question 13

What is the drug product database

Answer 13

part of health Canada

contains data on over 47,000 products (not drugs) - is such as big number because it includes all the different formations of a certain drug

Question 14

What is a molecular entity

Answer 14

the active ingredient inside a drug

a pure ingredient

aka innovator drugs

can be small molecule or biologic

ex. acetaminophen or ibuprofen

Question 15

What is a product

Answer 15

a formation of a particular drug

contains the molecule entity

ex. Tylenol is the product to acetaminophen

Question 16

Roughly how many molecular entities are approved each year?

Answer 16

about 40 - 30 of which are small molecules

Question 17

Are more small molecules or biological entities produced each year?

Answer 17

small molecules - make up about 30/40 of the molecular entities produced each year

Question 18

Why are more biological molecules being produced in today’s society?

Answer 18

because of newer technology

Question 19

What are the typical steps for the production of a new drug

Answer 19

idea,
project initiation and feasibility study
discovery
development
clinical trials
fda approval
market

Question 20

What is the idea stage of drug production

Answer 20

a starting point

something is discovered

Question 21

Description of Project Initiation/Feasibility Study of Drug Development

Answer 21

deciding if you have enough money/technology to carry out the research

Question 22

Description of Discovery Phase of Drug Production

Answer 22

drug candidate is acquired (something that could be turned into a product)

typically takes 1-3 years

Question 23

Description of Development Stage of Drug Production

Answer 23

the drug becomes a product by adding any necessary ingredients

typically takes about 1-2 years

essentially the outcome is the drug candidate becoming an investigational new drug (the product)

Question 24

Description of Clinical Trial Stage of Drug Development

Answer 24

product is tested for safety and efficacy

new drug application is filed to FDA

Question 25

What is a drug candidate

Answer 25

the substance that is identified after the discovery process

Question 26

How are most small molecules discovered?

Answer 26

Through trial and error

Question 27

Is approval necessary for most testing?

Answer 27

No - you can generally test as much as you want without testing

Approval becomes required once animals/humans become involved with the testing process

Question 28

What is an abbreviated new drug application

Answer 28

a certain type of NDA (new drug application)

an application made to the FDA by generic drug companies to allow for their generic drug to enter the market

application must show that they product does the same thing as the name brand product

Question 29

What is the first stage of the discovery process?

Answer 29

Project Initiation

Question 30

What are the 3 stops of project initiation?

Answer 30

market analysis
competitive assessment
research analysis

Question 31

What does the market analysis stage of project initiation involve

Answer 31

focus groups take place

literature is examined to see if product will actually sell

nature of disease is assessed (one pill or chronic condition)

nature of consumer is assessed (can people afford?)

Question 32

What is involved in the competitive assessment stage of project initiation?

Answer 32

the patent literature is searched to see what other companies are doing (find out what the competition is)

Question 33

Why is timing important for getting drug on the market?

Answer 33

1st drug - the first thing a doctor starts to prescribe (becomes preferred drug = makes the most money)

2nd drug - makes less money than first because doctors already have preferences, but still has lots of potential to make money

3rd drug - makes even less money

In general, the market will be big enough for first 3 drugs out to make money. typically all are the same in terms of efficacy - it is all about timing

Question 34

What does the Research Analysis (feasibility study) part of discovery involve?

Answer 34

look into whether it is even possible to make the product (in terms of money/equipment)

look into if the disease is well understood/is something that can be solved