1- pharma general

Question 1

drugs

Answer 1

chemical substances that are used in the treatment, prevention or diagnosis of disease

Question 2

what are biologic drugs, and what are some examples? (3 points)

Answer 2

made from living things such as plants, animals, humans, single cells (bacteria, yeast), have high molecular weight (>2000). examples are: vaccine, protein, antibody, nucleic acid

Question 3

what are small molecule drugs? an example? (4 points)

Answer 3

manufactured using chemical synthesis and made from living things such as antibiotics, steroids. have low molecular weight (<2000). examples are: pain medication, stomach medication.

Question 4

what are three component of the pharmaceutical industry

Answer 4

highly regulated (FDA), research intensive, high risk, high profit

Question 5

what are ethical pharmaceutical companies and what do they do? an example? (4 points)

Answer 5

• invest heavily in research
• discover and develop new molecular entities (active ingredients)
• very large companies (100,000’s of employees)
• novartis, astrazeneca, pfizer

Question 6

what are generic pharmaceutical companies? what do they do? example? (5 points)

Answer 6

• research is very limited (try and find ways to sell another companies product)
• don’t discover molecular entities
• focus on breaking/adapting patents (sell drugs no longer protected by patents)
• very large to medium sized companies (100,000’s of employees)
• teva, apotex, biovail

Question 7

what are biotech companies (5 points)

Answer 7

• created to exploit academic discoveries
• heavily research intensive
• tend to be smaller (10’s to 1000’s of employees)
• usually only sell few specialty product
• often bought by larger companies when their product can be brought to market

Question 8

what do contract research organizations (CRO) do? (7 points)

Answer 8

• Biological testing
• Specialty chemical synthesis
• Specialty manufacturing
• Special research areas
• Clinical trials
• provide speciality services,
• treated as consultants exist for long period of time

Question 9

what are two facts about drugs sold in canada?

Answer 9

• thousands of products are licensed (most are versions of other products)
• drug product database

Question 10

what does the compendium of pharmaceuticals and specialties contain?

Answer 10

data on over 2000 molecular entities

Question 11

what are innovator drugs?

Answer 11

new molecular entities, worldwide only 40 are approved each year.

Question 12

what is a molecular entity?

Answer 12

pure ingredient (manufactured stuff that gives you the effect/relief you are looking for)

Question 13

what is a product?

Answer 13

material containing the molecular entity

Question 14

what are the trends in approved new molecular entities? (3 points)

Answer 14

• consistent average of 30-40 approved each year
• number of new small molecule drugs stay consistent around 20
• number of new biologic drugs is increasing