Animal Health Drug Development ( Opportunities for vets in research and development) Dr. Owens september 12

Question 1

Who regulates US Animal health Products

Answer 1

Center for Veterinary Medicine (CVM)

USDA

EPA

Question 2

Center for Veterinary Medicine

Answer 2

One of the 6 FDA Centers
Regulates Pharmaceuticals,
Feed additives

Question 3

USDA

Answer 3

Regulates Biologicals, vaccines

Question 4

EPA

Answer 4

Regulates topical parasiticides

Question 5

Food Animals

Answer 5

Cattle
Swine
Chickens
Turkeys

Question 6

Companion Animal Species

Answer 6

Dogs
Cats
Horses

Question 7

Minor Species

Answer 7

Goats
Deer
Fish
Honey Bees
Ferrets
Sheep
Game Birds
Zoo animals

Question 8

What are the differences in drug development in humans vs animals

Answer 8

Humans
takes 10-15 years
AVG Cost is 800M
Market: Billions
Submission IND/NDA

Animal
takes 5-15 years
AVG Cost 10-50 M
Market: Millions
Submission INAD/NADA

Question 9

What are the Similarities for Humans and animals : Drug Development

Answer 9

The approval process
–> Pre-market FDA review of data
–> Expectations of data and product quality
–> Manufacturing process
–> Post approval surveillance
–> Generics
–> Orphan Drugs/MUMS

Question 10

The Phases of R& D

Answer 10

Pre-Clinical
Research Phase
Development Phase

Clinical
Registration Phase

Approval and marketing
Support Phase