Drug Development Process

Question 1

What is the process for drug development?

Answer 1

1. drug discovery
2. pre-clinical testing
3. clinical trails
4. FDA review and approval

Question 2

What occurs during drug discovery phase and how long could it take?

Answer 2

• About 5000 drugs discovered which could have potential to work and cure certain diseases.
• Could take around 5 years to make the drugs.

Question 3

What occurs during pre-clinical phase and how long could it take?

Answer 3

• drugs are tested in labs on animals to see if it drug works and find out its pharmacokinetic pathways along with safety and efficacy, narrowing down to about 250 drugs.
• could take around 1.5 years.

Question 4

What occurs during clinical trials phase and how long could it take?

Answer 4

• phase 1: few drugs (5) are tested on small healthy usually young population to evaluate safety and pharmacokinetics of the drugs.
• phase 2: drugs are tested on population (100-500) with the disease to test safety and efficacy and comparison with placebo starts.
• phase 3: drugs are tested on larger (1000-5000), more diverse group to collect more data on the safety and efficacy of the drugs, extension of phase 2.
• could take around 6 years.
• IND (investigational new drug) application needed to start clinical trials.

Question 5

What occurs during FDA review phase and how long could it take and the cost?

Answer 5

• NDA (new drug application) needed to be filled for the drug along with $2 million application fee.
• FDA reviews application and approves or disapproves.
• could take 1-3 years

Question 6

How long does a patent for a drug last and does it cover generic?

Answer 6

• lasts 20 years starting on day 1 when drug was first discovered/developed.
• Generics can’t be available until patent expires.

Question 7

What is the process for generic drug approval?

Answer 7

• Has to be same pharmacokinetic pathway as original, and only has to go through phase 1 to prove safety and same pharmacokinetic pathways.
• NDA should be filled for FDA approval

Question 8

What is considered phase 4 of clinical trail?

Answer 8

-Any testing done after the drug is FDA approved, including testing the drug for different indication or generic. May look like phase 1, 2 or 3

Question 9

What is ADME in drug development?

Answer 9

• Absorption
• Distribution
• Metabolized
• Elimination

Question 10

What are the three focuses of the drug development?

Answer 10

• safety (toxicity?)
• pharmacokinetics (how drug is processed in the body)
• efficacy (administration, how effective it is)

Question 11

Can drugs be prescribed for indications that are not approved?

Answer 11

Yes because the drug is already FDA approved and is safe even if not for that specific indication.

Question 12

Can you promote and market off-label drugs (meant for different indications)?

Answer 12

No, it is illegal to promote or market off-label drugs if they are not FDA approved for the indication.

Question 13

What is the total cost of bringing a new drug to the market?

Answer 13

about $1 - 2 billion

Question 14

What are the emerging trends in drug development?

Answer 14

• # of new drugs approved every year stays the same (about 30 drugs per year)
• There has been an emerging trend in partnership between industries and academia for research purposes (industries will fund certain research)
• There has also been an emerging trend in industries pairing with other industries to get a drug on the market.

Question 15

What are the pros and cons of primary literature vs secondary/tertiary literature?

Answer 15

PROS: Primary literature is original journey, has no biases, and has every detail about the research that you can replicate it if wanted to.
Secondary literature is short, and much easier to digest (abstract, summary or review of the primary literature)

CONS: Primary literature is too lengthy, difficult to digest, time consuming, less efficient. Secondary literature can have biases, and incorrect interpretation.