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BPS 2110 > Drug Development Canada (2) > Flashcards

Drug Development Canada (2) Flashcards

1
Q

Canadian Biopharmaceutical Industry

A
  • Only 3% of sales in the world
  • R+D = 78% of total sales
  • Generic = 22% of total sales
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2
Q

R/D companies

A
  • Research and development

- They develop new drugs to treat various diseases

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3
Q

How to Generic companies work?

A
  • Manufacture cheaper drugs after a big company’s patent expires (17-20 years)
  • Hire lawyers to make patent “weak”/get their patent
  • Drug needs to be proven effective and safe in order for generic companies to take over
  • They will release the drug close to the expiry date so that they don’t lose $$$
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4
Q

Theories as to why the pharma industry is so big ($$)

A
  1. 1st world nations are much wealthier
  2. Older/sicker populations
  3. We utilize more healthcare than needed
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5
Q

Drug development General Process: Timeline, major phases (4), approval

A
  • Timeline: 8-18 years
  • Major phases:
    1. Pre-Clinical R&D (3-8 years)
    2. Clinical trials (4-8 years)
    3. New Drug Application (2 years)
    4. Post-marked surveillance
  • Approval for drug occurs after phase 3
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6
Q

Preclinical R+D; cost

A
  • First + most important phase
    1. Understand Disease/condition
    2. Where will you intervene in the disease pathology?
    3. Identify a lead compound + drug candidate
    4. Development of appropriate bio assay
    5. Chemical synthesis
    6. Testing for Toxicity
  • $5-10 million
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7
Q

How to Identify a lead compound? (1)

A
  • Could be an accidental discovery
  • Natural library of compounds (complex structural diversity)
  • HTS (high put screening)
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8
Q

How to develop a bio assay? (1)

A
  • Test a compound every 5 days
  • Need to identify “food” concept
  • Need to isolate the enzyme and see when and if molecules will bind to its substrate (in vitro)
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9
Q

What is a bio assay?

A
  • The use “in vivo” or “in vitro” to determine the biological activity of a substance
  • Guides the rational design for the drug
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10
Q

In vitro

A
  • Test tubes – tissue or cell

- Immortalize cells (liver or kidney)

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11
Q

In vivo

A
  • Testing on animal or plant models

- Ex. Dog RBC’s are very similar to humans’

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12
Q

Suicide inhibitor

A

Kills the enzyme as it will stay locked in the substrate

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13
Q

Why do we need to perform chemical synthesis? (1)

A
  • Optimize destruction of the lead compound
  • Need to change properties of the compound to see what essentially happens
  • Need to identify which parts of the compound is essential for the drug
  • Improves efficacy, efficiency and solubility of lead compound
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14
Q

Designer drugs

A
  • Having different structures of a specific compound that doesn’t affect the overall process
    - OR-
  • a compound that is designed to mimic the pharmacological effects of the original drug
  • ex. cocaine (50-60’s)
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15
Q

Efficacy vs Efficiency (1)

A
  • Efficacy: Ability of a compound to inhibit an enzyme completely (100%) - MAXIMIZE EFFECT
  • Efficiency/effectiveness: Measure of how well the drug works + concentration at which inhibition is reached (amt of drug that - POWER TO PRODUCE THE DESIRED EFFECT WITH A LOWER DOSE
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16
Q

IC50 values

A
  • Shows the % of inhibition (y-axis) a certain amount of a compound can do on an enzyme (x-axis)
  • normally in the nano-molar range
  • measure of how effective a drug is
17
Q

How to test for toxicity + activity (1)

A
  • Studies are mostly done on animals (but also in vitro)
  • Massive dosages are used in vivo to test toxicity/activity (metabolic workups)
  • Very expensive (animals need to have certain size + perfect genes)
  • Documented thoroughly to prevent errors
18
Q

Clinical Trials; Step 1

Timeline, Volunteers, Purpose, cost

A
  • 1-2 months
  • 20 healthy volunteers
  • Purpose: safety of drug (based on the toxicity studies done on pre-clinical)
  • Need to document everything for Health Canada for review
  • $15-20 million
19
Q

Clinical Trials; Step 2

Timeline, Volunteers, Purpose, cost

A
  • 3 months-1 year
  • Small highly controlled group of patients (who have the condition you are trying to treat) - 50 patients
  • Assess the EFFICACY and SAFETY of the drug
  • $15-20
20
Q

Clinical Trials; Step 3

Timeline, Volunteers, Purpose, cost

A
  • 3-8 years
  • Large + DIVERSE test subjects (100-1000)
  • Generates most of the data
  • Assesses EFFICACY + SAFETY
  • Costly + waiting game - $400-500 million
  • Most critical!!
21
Q

New Drug Application Review + Regulatory Approval (NDA) (3)

A
  • Need to convince the FDA or Health Canada that the drug is safe and works!
  • Need allll data; $5-10 million
22
Q

What data is needed for NDA?

A

a) Material manufacture specifications (GMP- good manufacture procedure)
b) Extensive knowledge of metabolism/pharmacokinetics + ADME
c) Safety - no toxic effects

23
Q

ADME

A

Absorption (how and when), Distribution(where does it go in the body), Metabolism(how long it lasts in body) and Excretion(urine or what?)

24
Q

If 1000 compounds have been identified in pre-clinical R&D… How many will enter each step of clinical trials? What is the success rate of this?

A 
Step 1: 1000 compounds 
Step 2: 600 compounds
Step 3: 400 compounds 
After step 3: 50 compounds
5% SUCCESS RATE :O
25
Q

Total cost of drug development

A

650+ million

26
Q

Post Marketing Surveillance (4) + biggest concerns

A
  • Monitoring the safety of the drug as it is out of the market
  • Genetic diversity in the world makes it impossible to test for ALL adverse effects
  • Drugs that treat more severe conditions = bigger SE’s
  • Chemo drugs are not selective -lots of side effects
27
Q

Blackbox warnings

A
  • commercial that claims all the warnings of a drug
28
Q

How to manage cost and increase success rates?

A
  1. “Weed out” poor candidates before clinical trials
  2. Apply ADME
  3. Lipinski’s rules
29
Q

Lipinski’s rules

A
  • No more than 5 H bond donors (NH,OH)
  • No more than 10 hydrogen bond acceptors (N, O + LP)
  • ## Molecular mass of less than 500
30
Q

What kinds of molecules allow/don’t allow excretion?

A
  • Aromatic compounds are not soluble in water – will not go through the body
  • Nitrogen is found in metabolites in urea = good
31
Q

What if there is an epidemic? Do we spend up to 18 years trying to get a treatment?

A
  • Pharmacists will create a “cocktail” of various drugs that treats all the elements of a disease process
  • Hope it works while they look for another option
  • reasons why some vaccines may not work (ie polio)
32
Q

How does pharma decide on a disease to treat?

A
  1. Reacting to an opportunity.
    - New development in the understanding of a disease process (Cox 1-2 with merck + pfizer)
  2. Filling a need (when something is urgent and is untreatable)
    - HIV (took a very long time to figure it out, so you have to develop a drug)

BPS 2110 (10 decks)

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