Challenges 3

Question 1

describe a risky venture

Answer 1

Investment very large, long term and high risk of failure
Potential return needs to be very high - exclusive rights short period, no sale if drug fails, needs to cover losses from other failed candidates

Question 2

How do companies reduce risk & increase profit

Answer 2

Therapeutic area - complexity of trials and models effectiveness
Compound protection or repurposing
Standardised manufacturing - similar to what they already produce (capital expense)
Standardised trials & regulatory processes (out-of-pocket expense)

Question 3

What is intellectual property

Answer 3

Protect knowledge
- Enable to earn recognition or benefit financially
- New drugs, formulations or disease applications
Granted for 20 years - have to apply for patent in every country you want to sell in

Question 4

How much do patents cost

Answer 4

Application and maintenance fees
Invest in families of drugs in each country

Question 5

How can repurposing drugs help

Answer 5

Extend IP on existing drugs
Less risk of failure due to safety concerns
Reduces time & costs of development
Faster benefit than first-in-class drugs

Question 6

Describe increased costs for biologistics

Answer 6

Require extra purification & virus elimination prior to formulation
Infrastructure costs should reduce over time

Question 7

Describe me-too drugs

Answer 7

Me-too drugs mimic existing compounds & have same target
Minor variations relative to existing drug to bypass patency law
Utilise established production systems
Improved ADME/Tox -> reduced risk & development costs -> faster benefit

Question 8

Describe biosimilars

Answer 8

Me-too equivalent for biologics
Same clinical benefit and adverse effects
- differ in inactive ingredients
- Only need to show bioequivalence

Question 9

Describe biosimilars

Answer 9

Correct ingredients but fake packaging
Wrong ingredients, no or insufficient active ingredients

Question 10

Describe global site inspections

Answer 10

Previously only pre-approval - review of application to market new brand or generic drug
Surveillance - monitor manufacturing process and quality of distributed drugs
For-cause - triggered when quality problems reported, improving identification of quality control issues