Module #1 - Biopharmaceutical Industry Flashcards
What are drugs?
chemical substances
used in treatment, prevention, or diagnosis of disease
used to enhance/improve quality of life
modify some function in body
What are the two types of drugs?
Biologic and small molecule
What are biologic drugs?
very large + high molecular weight
must be made from living things
Examples of biologic drugs
protein, antibody, nucleic acid
What is a small molecule drug?
very small, lower molecular weight
can be made either from living things or by chemical synthesis in a lab
General Characteristics about Pharmaceutical Industry
lots of money
heavily regulated
research intensive
high risk
Why is pharmaceutical company high risk?
because you could spend a ton of money for nothing
very high drug fail rate
What are the four types of pharmaceutical companies
ethical, generic, biotech, and contract research organizations
Characteristics of Ethical Research Companies
research oriented
discover and develop new molecule entities
very large
ex. Novartis, AstraZeneca, Pfizer, Johnson and Johnson
Characteristics of Generic Biopharmaceutical Companies
not research oriented
large to medium size companies
focused on manufacturing methods
want to break/adapt patents
Characteristics of Biotech Companies
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
Characteristics of Contract Research Organizations
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
What is the drug product database
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
What is a molecular entity
the active ingredient inside a drug
a pure ingredient
aka innovator drugs
can be small molecule or biologic
ex. acetaminophen or ibuprofen
What is a product
a formation of a particular drug
contains the molecule entity
ex. Tylenol is the product to acetaminophen
Roughly how many molecular entities are approved each year?
about 40 - 30 of which are small molecules
Are more small molecules or biological entities produced each year?
small molecules - make up about 30/40 of the molecular entities produced each year
Why are more biological molecules being produced in today’s society?
because of newer technology
What are the typical steps for the production of a new drug
idea,
project initiation and feasibility study
discovery
development
clinical trials
fda approval
market
What is the idea stage of drug production
a starting point
something is discovered
Description of Project Initiation/Feasibility Study of Drug Development
deciding if you have enough money/technology to carry out the research
Description of Discovery Phase of Drug Production
drug candidate is acquired (something that could be turned into a product)
typically takes 1-3 years
Description of Development Stage of Drug Production
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)
Description of Clinical Trial Stage of Drug Development
product is tested for safety and efficacy
new drug application is filed to FDA
What is a drug candidate
the substance that is identified after the discovery process
How are most small molecules discovered?
Through trial and error
Is approval necessary for most testing?
No - you can generally test as much as you want without testing
Approval becomes required once animals/humans become involved with the testing process
What is an abbreviated new drug application
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
What is the first stage of the discovery process?
Project Initiation
What are the 3 stops of project initiation?
market analysis
competitive assessment
research analysis
What does the market analysis stage of project initiation involve
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?)
What is involved in the competitive assessment stage of project initiation?
the patent literature is searched to see what other companies are doing (find out what the competition is)
Why is timing important for getting drug on the market?
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
What does the Research Analysis (feasibility study) part of discovery involve?
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
