L2

Question 1

What part of R & D is innovation?

Answer 1

New product development

Question 2

What is drug research?

Answer 2

discovery & design

Question 3

What are the 5 qs a company asks when coming up with a new idea?

Answer 3

1. How valuable is this new idea?
2. Does the technology exist to help deliver this new idea into a product?
3. Do we have this technology?
4. Do we have the organizational architecture? (managerial) Do we have the necessary procedures to run this development?
5. Can this group live with the uncertainty that this new idea will bring to the company?

Question 4

What power doess the boss have?

Answer 4

Referent
Reward
Expert
Legitimate

Question 5

What power do the scientists have?

Answer 5

Expert

Question 6

What does the NPV rely on?

Answer 6

Quality of the drug

Question 7

What ae the 6 stages of drug discovery & design

Answer 7

1. exploratory
2. Assay development
3. Screening
4. Hit-to-lead
5. Early lead optimization
6. late lead optimization

Question 8

What is NPV of each molecule discovered determined by?

Answer 8

by calculating potential market of drug

Question 9

What are 4 approaches in drug discovery?

Answer 9

Phenotypic based
Target based
Molecular drug design
Repurposing

Question 10

What type of discovery is cheaper phenotypic or target based?

Answer 10

Target based

Question 11

What is a down fall of target based discovery?

Answer 11

Do not show adverse effects of drug
need both phenotypic & target based

Question 12

Define attrition?

Answer 12

Removal of molecules from a study to find desired target

Question 13

What is the generic process of innovation?

Answer 13

stage gate process

Question 14

What are 3 phases of drug development?

Answer 14

Early
Late
Milestone

Question 15

What are milestones in drug development?

Answer 15

First-in-human trail
end of phase 2
plant transfer
submission for marketing authorization
Launch

Question 16

What is the preclinical stage?

Answer 16

when a product is tested on animals and is well tolerated

Question 17

What is the clinical phase?

Answer 17

product is developed for launching

Question 18

What is phase 1?

Answer 18

take few mg of drug from pre clinical trails and introduced into a formulation & administered to a healthy human volunteer

Question 19

What is phase 1 called?

Answer 19

Human pharmacology trails (volunteers)

Question 20

What is phase 2 called?

Answer 20

Therapeutic exploratory (patients)

Question 21

What is phase 3 called?

Answer 21

Therapeutic confirmatory

Question 22

When are patients used in phase 1?

Answer 22

Serious diseases

Question 23

What does phase 1 look at?

Answer 23

Safety of drug
Pharmacokinetics

Question 24

What does phase 2 look at?

Answer 24

Therapeutic exploration of dosage in patients

Question 25

Why are human pharmacology studies repeated throughout phases?

Answer 25

If a patient is taking other drugs so need to identify if that drug affects the PKa of our drug
Drug is changed from tablet to solution
Finer particle product is discovered

Question 26

What is a reason for decline?

Answer 26

IP (generics)
Better drug is invented
Resistance
S/Es