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Biopharmaceuticals Final > Module #1 - Biopharm Industry > Flashcards

Module #1 - Biopharm Industry Flashcards

(85 cards)

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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
why do you want to be one of first three drugs on the market?
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
26
what is involved in the research analysis stage of project initiation (4)
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
27
what is proof of principle?
another experiment that shows that the idea is possible
28
what are drug testing methods?
ways to test whether drug is sticking to the target, measuring properties of drug, etc.
29
what are animal models
creating or exaggerating a disease state in animals
30
what is the first step in the discovery process? what is this? (2)
coming up with a lead some sort of molecular entity with a beneficial property
31
characteristics of a good lead (5)
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
32
what are the five methods of lead identification from most to least used
high throughput screening rational drug design natural products combinatorial chemistry de novo design
33
what is involved in high throughput screening methods? (4)
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
34
what is involved in hit to lead? (2nd step of high throughput screening)
removes false positives
35
why are most hits false in high throughput screening? (4)
impurity decomposition compound reactivity (could be a detergent, redox reaction, or strong elec/nu) could interfere with the assay
36
are most hits real or false?
false - about 99%
37
what are PAINS in high throughput screening (4)
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
how are PAINS dealt with in HTS
are flagged since it is more expensive to remove them
39
what are common patterns of drugs developed through high throughput screening? (3)
aromatic rings lots of nitrogen no chiral enters (most are achiral)
40
what is extracted from natural product lead identification (2)
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
what is involved in natural product lead identification (3)
collect large amount of organism isolate and purify collected materials to determine molecule showing activity determine structure and confirm activity
42
limitations to natural product lead identification (3)
stuck with what nature gives you (supply + demand hard) time consuming + expensive difficult to perform SAR/modifications because complex chemical structures
43
what is involved in rational drug design? (4)
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
patterns of molecules from natural products (5)
lots of oxygen big structures lots of stereochemistry lots of cyclic parts lots of stereocenters
45
patterns of molecules from rational drug design? (3)
lots of cyclic lots of O and OH has stereochemistry
46
what is involved in combinatorial chemistry? (3)
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
what is involved in denovo design?
uses a computer software to design a lead from scratch
48
what are the two main methods of lead optimization?
SAR and SPR
49
what is SAR (5)
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
what is SPR (3)
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
what is the hardest part of medicinal chemistry
getting drugs into the body difficult because the human body is designed to protect from chemicals in environment
52
what is the purpose of a patent
developed to make sure that drug candidate and other possible future drugs in class are protected
53
requirements for a patent
novelty: something made/discovered for first time utility: must be able to be used for some purpose non-obvious
54
what can be patented?
processes, machines, manufactured product, composition of matter, chemicals
55
what cannot be patented?
laws of nature, physical phenomenon, abstract ideas, and algorithms
56
what are the two main types of safety testing
in vitro (step 1) and in vivo (step 2)
57
what is involved with in vitro safety testing (6)
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
what is involved with in vivo safety tests (3)
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
why is animal testing necessary
complexity of a living thing cannot be simulated, therefore must be done
60
what are excipients
non medicinal ingredients taken from food industry mixed with active ingredient to form final product
61
what are the 8 types of excipients?
stabilizers preservatives fillers disintegrants binders flavours colours lubricants
62
what are stabilizers? (3)
acid/base protect product from chemical degradation due to oxygen drug turned into salt
63
what are preservatives?
prevent bacteria/mold from forming
64
what are fillers?
ensure consistent dosing drug is diluted into filter to make standard solution for easy measurement
65
what are disintegrants?
blow drug apart in the stomach so it can dissolve easier
66
what are binders?
hold the ingredients together in the stomach
67
what are flavours?
bitter flavours used as safety mechanism to prevent people from consuming
68
what are lubricants?
good for manufacturing so pills don't stick to machinery
69
what are colours
used to distinguish between drugs
70
what is the nuremberg code for research on humans (8)
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
what are the three main purposes of clinical trials
safety efficacy and dose range finding
72
what is the most expensive stage of drug production and why? (4)
clinical trials 60-70% of the cost doctors more expensive than biochemists high failure
73
what is dose-range finding
finding right dose to put into people
74
what are double blind studies (3)
standard for clinical trials drug group and placebo group both the groups and doctors administering are unaware of groups
75
what is involved in the first stage of clinical trials? (goals, # patients, type of patients, time, drug failure rate)
safety + finding safe max dose under 100 people healthy volunteers under 1 year 30% fail
76
what is involved in the second stage of clinical trials? (goals, # patients, type of patients, time, drug failure rate)
safety + finding effective dosing + efficacy 200-300 people patients about 1 year 70% fai
77
what is involved in the third stage of clinical trials (goals, # patients, type of patients, time, drug failure rate)
safety, efficacy, rare side effects thousands patients about 1 year 70% failure rate
78
what are orphan drugs
pharmaceutical agents for rare conditions given funding and slack in clinical trials
79
when were the first regulations for drugs created? why? (3)
1908 done so consumers would know what they were buying focused on labelling only/listing ingredients
80
describe events that led to creation of FDA (4)
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
four key requirements for animal testing
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
how does the FDA and health Canada operate? (6)
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
why is it important that government does not perform safety testing (2)
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
what are the pros of regulation in drug industry (4)
ensures safe products ensures products work provides consumer protection controls access
85
what are the cons of regulation in drug industry (3)
increases costs increases taxes limits access

Biopharmaceuticals Final (2 decks)

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