Creating a Comprehensive Drug Development Strategy | Page 2
Mapping a Path to Market: Creating a Comprehensive
Drug Development Strategy
Concept of Drug Development
PRESCRIBING INFORMATION
ways to cut costs, shorten timelines, and increase the probability that their
compound will be one of the few to succeed.
Clearly, the key determinate of success is the efficacy and safety of the drug itself.
If your compound for Type II diabetes doesn’t cause significant decreases in blood
sugar levels—or if 25% of study participants develop migraines while on drug—
then it’s time to stop development. But many compounds fail for less clear-cut
reasons, such as slow study enrollment, trial designs that do not meet regulatory
expectations, or prohibitively expensive raw materials. Many of these issues can
be more easily managed or, in some cases, avoided altogether if development starts
OTH
ER
pharmaceutical and biotechnology companies large and small are looking for
ORY
LAT
EGU
R
it to market.1 With approximately 5,200 drugs in preclinical testing in 2012,2
ITY
QUAL
RING/
FACTU
MANU
every 5,000 to 10,000 compounds entering the pipeline, only one will make
CLINI
CAL D
EVELO
PMEN
T
The Pharmaceutical Research and Manufacturers of America estimate that for
Figure 1.
PRECLINICAL/NONCLINICAL DEVELOPMENT
There’s no getting around it—drug development is
expensive, time consuming, and risky. »
DRUG
DEVELOPMENT
FOUNDATIONAL
QUESTIONS
with a comprehensive strategy. Unfortunately, this critical step is often overlooked
or undervalued because of the time and significant energy required to think through
the various scenarios.
DRUG OR BIOLOGIC
This paper provides an overview of a comprehensive
drug development strategy, starting with three
foundational questions and moving through the
key areas of regulatory, manufacturing/quality,
preclinical/nonclinical development, clinical
development, and other (e.g., intellectual
property, marketplace, and reimbursement).
The Pharmaceutical Research and
Manufacturers of America estimate that for
every 5,000 to 10,000 compounds entering
the pipeline, only one will make it to market.
clinipace.com
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