Pipeline of Hope
Drug Discovery Begins
with an Idea in an Academic, Government or Company Lab.
can take up to
Pre-Clinical Trials AND
It takes up to 10 years of extensive laboratory testing to determine initial safety and efficacy of new therapeutics. After these studies, an Investigational New Drug (IND) application is filed for FDA review.
If approved, the drug will go into clinical trials.
for about half of the average $1.2B cost of developing a new medicine.5
data for the drugs that
pass developmental trials
must be reviewed by experts at the FDA.
includes reams of data
from all stages of testing,
requiring huge amounts of
time and scientific expertise
to be reviewed.
development and review of new drugs
for serious conditions and breakthrough therapies.6
The FDA carefully reviews the data to weigh
the benefits and risks of the potential medicine.
If deemed safe and effective, it is approved for patients.
When the NDA or BLA has been approved, the medication is manufactured and distributed. Manufacturing facilities adhere to FDA regulated standards to ensure safety and quality of medicines.
In 2011 the industry supported
in U.S. economic output.8
The biopharma sector supports
jobs across the U.S.9
Post Approval Research and Monitoring
After a new medicine reaches patients, companies conduct post-approval studies to monitor safety and side effects in a larger patient population, and gain further understanding of the medicine’s potential uses.
Often it takes years of additional research and use by patients for the full value of a medicine to be recognized.
“Incremental advances can add up to transformative changes.” — Dr. Siddhartha Mukherjee10