Pipeline of Hope

The discovery and development process, from initial research to delivery of life-saving or life-enhancing medicine.

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Drug Discovery Begins

with an Idea in an Academic, Government or Company Lab.

Scientists identify a medical need and set specific
objectives for the therapeutic compound development.

The research
can take up to
6 YEARS.1
Scientists analyze 5,000-10,000 natural and synthetic compounds made in labs or through bioengineering to narrow it down to a single targeted compound or biologic.2

Pre-Clinical Trials AND
Investigational New
Drug Application

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.

Clinical trials

3 Phases of clinical trial research
takes an average of 6-7 years.4
More than 3k medicines are in clinical trials or under review by the FDA in the U.S., a 40% increase since 2005.3
Clinical trials account
for about half of the average $1.2B cost of developing a new medicine.5
New Drug Application (NDA)
or Biologics License Application (BLA)
All accumulated research
data for the drugs that
pass developmental trials
must be reviewed by experts at the FDA.
A typical application
includes reams of data
from all stages of testing,
requiring huge amounts of
time and scientific expertise
to be reviewed.
The FDA can expediate the
development and review of new drugs
for serious conditions and breakthrough therapies.6

FDA Review

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.

Manufacturing
and Distribution

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
$789B
in U.S. economic output.8

The biopharma sector supports
more than
3.4M
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