AGING THESIS 101Quick Primer: How are new medicines developed?
The high level steps to develop a new medicine are to:
understand the biology of the disease —> develop a drug that targets the relevant biology —> show the drug works in people.
The first step usually occurs in academic research laboratories, with the second and third usually within biotechs or pharmaceutical companies.
understand the biology of the disease
Identify a drug target that is thought to be relevant to a disease of interest.
Demonstrate preclinical efficacy of the modification of that target leading to improved disease via genetic manipulation, a drug
develop a drug
Develop a drug that affects the target in the way desired
Show the drug is effective in preclinical models (usually mice)
Show the drug is safe in preclinical models (usually mice and monkeys)
show it works in people
File relevant paperwork, manufacture batches of the drug to you can start clinical studies in humans.
Phase I study - show the drug is safe in humans
Phase II clinical study - dose confirmation & preclinical efficacy for the target use
Phase III clinical study - show the drug has the desired positive impact on the disease of interest