Drug discovery and development

Question 1

How do CNS drug development aspects differ from regular drugs?

Answer 1

• Take 40% longer to develop
• Clinical trials take 35% longer to complete and receive regulatory approval
• Only 1/10 of CNS drugs get clinical approval (1/6 for other drugs)

Question 2

What is the path of CNS drug development?

Answer 2

1) Lead (promising concept)
2) Animal models
3) Safety
4) Phase I/II
5) Phase II (a/b)
6) Phase III
7) FDA approval

Question 3

What are some limitations of molecular drug modeling?

Answer 3

• There needs to be an available x-ray structure of the target protein with some compound
• Tested compounds target the same binding pocket
• A lot of tests fail, but only success stories are being published

Question 4

Talk about animal models for CNS disorders

Answer 4

• There is no ideal animal model for any neurodegenerative disorder
• Animal models model certain aspects, but never recapitulate all features
• Price is the major limitation in selection of animal models