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Biopharmaceuticals Final > Module #1 - Biopharm Industry > Flashcards

Module #1 - Biopharm Industry Flashcards

1
Q

4 main types of pharmaceutical companies

A

ethical
generic
biotech
contract research organizations

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2
Q

characteristics of ethical companies (3)

A

research heavy

discover new molecular entities

very large

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3
Q

characteristics of generic companies (5)

A

research limited

focused on manufacturing and breaking/adapting patents

don’t discover new molecular entities

large to medium sized

market products no longer protected by patents

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4
Q

characteristics of biotech companies (4)

A

exploit academic discoveries

smaller

specialty products

research intensive

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5
Q

characteristics of contract research organizations (4)

A

provide specialty services for pharmaceutical companies (ex. testing, manufacturing, clinical trials, etc.)

small to medium sized

low risk because they don’t have to worry about drug failing

hired by big companies

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6
Q

what is the drug product database?

A

health Canada

contains data on over 47000 products

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7
Q

what are molecular entities (drugs) (4)

A

active ingredient in drug products

pure ingredient

small molecule or biologic

produce the effects of the product

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8
Q

what are drug products (2)

A

materials that contain a molecular entity

formulation of a drug

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9
Q

how many molecular entities approved each year? how many of those are small molecules?

A

40 entitites

30 small molecules

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10
Q

are small molecules or biologic molecules more common? trends?

A

small molecules more common

but trend for biologic molecules due to newer technologies

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11
Q

what are the five major phases of drug development?

A

discovery
development
clinical trails
FDA approval
market

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12
Q

describe the discovery phase of drug development (time, goals, and end product)

A

1-3 years

start with an idea + discover a new molecular entity (drug candidate)

end product = drug candidate

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13
Q

describe the development phase of drug development (time, goals, and end product)

A

1-2 years

turn drug candidate into a potentially sellable product

end product = investigational new drug

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14
Q

describe the clinical trial phase of drug development (time, goals, and end product)

A

1-5 years

test investigational new drug for safety, establish safe dosing limits, test for efficacy, test for rare side effects, etc.

end product = new drug application

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15
Q

describe the FDA approval phase of drug development (time, goals, and end product)

A

6 months to 1.5 years

review data from clinical trials, make sure benefits outweigh risks

end product = market approval

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16
Q

describe the market phase of drug development (time, goals, and end product)

A

unlimited time

make money, continue safety testing (rare side effects could occur because bigger test group)

end product = $$$

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17
Q

what is a drug candidate? (6)

A

molecular entity that could potentially be a drug

identified in the discovery process

structure kept secret

no approval necessary to discover this

lots of synthesis/testing and gene expression/protein isolation

used to create investigational new drug

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18
Q

what is an investigational new drug (4)

A

the product that results from the drug candidate

is an application made to the FDA to enter clinical trials

includes data: pharmacology + toxicity data from animal studies, and manufacturing info

includes plan on how clinical trials on humans will take place

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19
Q

what is a new drug application (3)

A

application made to FDA to enter the market during the clinical trials

includes full data: efficacy, safety, dosing, labelling, results of clinical trials + animal experiments, manufacturing methods etc.

application must show that benefits outweigh risks

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20
Q

what is an abbreviated new drug application

A

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

must show that product does same thing as name brand product

shows drug identity, formulation, route of administration, dosing, performance, etc.

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21
Q

what are the 3 main steps of project initiation (3) (not official step)

A

market analysis
competitive assessment
research analysis

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22
Q

what is involved in market analysis stage of project initiation (3)

A

assess number/nature of customers (able to pay? lots of people?)

assess nature of disease (chronic? life threatening?)

focus groups take place + literature is observed to see if product will sell

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23
Q

why do drug companies prefer chronic conditions?

A

because long-term, not just one and done - more money can be made

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24
Q

what is involved in the competitive assessment stage of project initiation (3)

A

patent literature observed to see what competition is like and what other companies are doing

want to be one of first 3 drugs on the market

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25
Q

why do you want to be one of first three drugs on the market?

A

1st = first thing the doctor starts to prescribe (becomes favourite)

2nd = makes less money because doctors prefer the first drug

3rd = same as second basically

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26
Q

what is involved in the research analysis stage of project initiation (4)

A

observe literature to see what is already known

determine if possible to make product

see if disease is understood and can be solved

see if you have tools necessary to carry out research

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27
Q

what is proof of principle?

A

another experiment that shows that the idea is possible

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28
Q

what are drug testing methods?

A

ways to test whether drug is sticking to the target, measuring properties of drug, etc.

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29
Q

what are animal models

A

creating or exaggerating a disease state in animals

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30
Q

what is the first step in the discovery process? what is this? (2)

A

coming up with a lead

some sort of molecular entity with a beneficial property

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31
Q

characteristics of a good lead (5)

A

does the fewest amount of things (to avoid side effects)

drug-like properties

chemical structure that is easily modified

not covered by any patents

proven biological activity

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32
Q

what are the five methods of lead identification from most to least used

A

high throughput screening
rational drug design
natural products
combinatorial chemistry
de novo design

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33
Q

what is involved in high throughput screening methods? (4)

A

thousands of compounds tested to see if any benefits using biological assays

tested one at a time at same dose

generate hits

hits are sorted out using hit to lead, and then retesting hits (to remove PAINS) so that structure can be confirmed

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34
Q

what is involved in hit to lead? (2nd step of high throughput screening)

A

removes false positives

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35
Q

why are most hits false in high throughput screening? (4)

A

impurity
decomposition
compound reactivity (could be a detergent, redox reaction, or strong elec/nu)
could interfere with the assay

36
Q

are most hits real or false?

A

false - about 99%

37
Q

what are PAINS in high throughput screening (4)

A

promiscuous bioactive components

show up positive with virtually any biological test (show up as hit)

redox activity, strong acid/base, detergents, strong nuc/elec, lipophilic, photo reactive, etc.

38
Q

how are PAINS dealt with in HTS

A

are flagged since it is more expensive to remove them

39
Q

what are common patterns of drugs developed through high throughput screening? (3)

A

aromatic rings
lots of nitrogen
no chiral enters (most are achiral)

40
Q

what is extracted from natural product lead identification (2)

A

chemicals/small molecules extracted from living things

are secondary metabolites - chemicals not directly required for the life of the thing they are apart of (produced by organism for secondary purpose)

41
Q

what is involved in natural product lead identification (3)

A

collect large amount of organism

isolate and purify collected materials to determine molecule showing activity

determine structure and confirm activity

42
Q

limitations to natural product lead identification (3)

A

stuck with what nature gives you (supply + demand hard)

time consuming + expensive

difficult to perform SAR/modifications because complex chemical structures

43
Q

what is involved in rational drug design? (4)

A

utilizes knowledge of chemical reactions + metabolism to design drugs

uses known enzymes, inhibitors, ligands, receptors, existing drugs, etc.

could also be modification method

start with known information, and use to advantage to design drug

44
Q

patterns of molecules from natural products (5)

A

lots of oxygen
big structures
lots of stereochemistry
lots of cyclic parts
lots of stereocenters

45
Q

patterns of molecules from rational drug design? (3)

A

lots of cyclic
lots of O and OH
has stereochemistry

46
Q

what is involved in combinatorial chemistry? (3)

A

similar to HTS - difference is that a bunch of compounds are mixed together and tested (instead of being tested separately)

mixture testing to generate hits

only one drug has been discovered using this methods

47
Q

what is involved in denovo design?

A

uses a computer software to design a lead from scratch

48
Q

what are the two main methods of lead optimization?

A

SAR and SPR

49
Q

what is SAR (5)

A

structure activity relationships

new structure designed based on lead structure

molecule then tested

test results used to determine relationship between change in structure and change in activity

occurs using one compound at a time

50
Q

what is SPR (3)

A

structure property relationships

optimizes several properties simultaneously (instead of one like SAR)

optimizes: potency, selectivity, solubility, lipophilicity, chemical stability, acid-base behaviour, toxicity, metabolism, and ease of synthesis

51
Q

what is the hardest part of medicinal chemistry

A

getting drugs into the body

difficult because the human body is designed to protect from chemicals in environment

52
Q

what is the purpose of a patent

A

developed to make sure that drug candidate and other possible future drugs in class are protected

53
Q

requirements for a patent

A

novelty: something made/discovered for first time

utility: must be able to be used for some purpose

non-obvious

54
Q

what can be patented?

A

processes, machines, manufactured product, composition of matter, chemicals

55
Q

what cannot be patented?

A

laws of nature, physical phenomenon, abstract ideas, and algorithms

56
Q

what are the two main types of safety testing

A

in vitro (step 1) and in vivo (step 2)

57
Q

what is involved with in vitro safety testing (6)

A

can be done if product capable of being mass-produced

use lots of biochemical assays

goal is a clean profile (under 300 positive results)

cheapest option

look for deal-breakers like carcinogens, or organ interference

done before animal testing

58
Q

what is involved with in vivo safety tests (3)

A

performed after in vitro

requires smallest and fewest animals possible (so less drug used, and less money spent)

requires to species, at least one being a primate

59
Q

why is animal testing necessary

A

complexity of a living thing cannot be simulated, therefore must be done

60
Q

what are excipients

A

non medicinal ingredients

taken from food industry

mixed with active ingredient to form final product

61
Q

what are the 8 types of excipients?

A

stabilizers
preservatives
fillers
disintegrants
binders
flavours
colours
lubricants

62
Q

what are stabilizers? (3)

A

acid/base

protect product from chemical degradation due to oxygen

drug turned into salt

63
Q

what are preservatives?

A

prevent bacteria/mold from forming

64
Q

what are fillers?

A

ensure consistent dosing

drug is diluted into filter to make standard solution for easy measurement

65
Q

what are disintegrants?

A

blow drug apart in the stomach so it can dissolve easier

66
Q

what are binders?

A

hold the ingredients together in the stomach

67
Q

what are flavours?

A

bitter flavours used as safety mechanism to prevent people from consuming

68
Q

what are lubricants?

A

good for manufacturing so pills don’t stick to machinery

69
Q

what are colours

A

used to distinguish between drugs

70
Q

what is the nuremberg code for research on humans (8)

A

participation is voluntary

informed consent

prior animal studies must be performed

benefits outweigh risks

qualified scientists used

least suffering possible

experiments stopped if becomes dangerous

used for clinical trials to prevent unecessesary/unethical experiments

71
Q

what are the three main purposes of clinical trials

A

safety efficacy and dose range finding

72
Q

what is the most expensive stage of drug production and why? (4)

A

clinical trials

60-70% of the cost

doctors more expensive than biochemists

high failure

73
Q

what is dose-range finding

A

finding right dose to put into people

74
Q

what are double blind studies (3)

A

standard for clinical trials

drug group and placebo group

both the groups and doctors administering are unaware of groups

75
Q

what is involved in the first stage of clinical trials? (goals, # patients, type of patients, time, drug failure rate)

A

safety + finding safe max dose

under 100 people

healthy volunteers

under 1 year

30% fail

76
Q

what is involved in the second stage of clinical trials? (goals, # patients, type of patients, time, drug failure rate)

A

safety + finding effective dosing + efficacy

200-300 people

patients

about 1 year

70% fai

77
Q

what is involved in the third stage of clinical trials (goals, # patients, type of patients, time, drug failure rate)

A

safety, efficacy, rare side effects

thousands

patients

about 1 year

70% failure rate

78
Q

what are orphan drugs

A

pharmaceutical agents for rare conditions

given funding and slack in clinical trials

79
Q

when were the first regulations for drugs created? why? (3)

A

1908

done so consumers would know what they were buying

focused on labelling only/listing ingredients

80
Q

describe events that led to creation of FDA (4)

A

formation of sulfanilamide poisoned children because contained toxic ingredient (company hadn’t done any safety testing + drug was sold without instructions)

FDA introduced safety testing in humans/animals

directions on label and safety testing became required

FDA started inspecting companies

81
Q

four key requirements for animal testing

A

two species minimum

one must be primate

take blood samples to show drug is bioavailable

must use dose that is relevant to future human use

82
Q

how does the FDA and health Canada operate? (6)

A

safety testing done by companies

full data given to FDA/health canada

data checked to make sure testing done properly

marketing of drugs approved

companies required to continue monitoring on market and report difficulties to FDA

FDA continues to inspect over time

83
Q

why is it important that government does not perform safety testing (2)

A

costs of testing drugs paid by consumer instead of taxpayer

forcing companies to spend their own money ensures companies will only test things they think will make it on the market

84
Q

what are the pros of regulation in drug industry (4)

A

ensures safe products

ensures products work

provides consumer protection

controls access

85
Q

what are the cons of regulation in drug industry (3)

A

increases costs

increases taxes

limits access

Biopharmaceuticals Final (2 decks)

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