Creating a Comprehensive Drug Development Strategy | Page 3
The Foundation of a Comprehensive
Drug Development Strategy »
But before diving straight into regulatory strategy or clinical trial
Drug development has been described as the process of obtaining
development strategy:
the information you want to be included your drug’s prescribing
1. What is the end goal?
information. This approach can be visualized as an inverted triangle
(Figure 1). At the bottom tip is the drug itself, and across the broad
top is the prescribing information. Everything in between is drug
development.
design, stop and consider three foundational questions that form
a base for building the specific sections of the comprehensive drug
While the obvious answer to this question is “get the drug on the market”,
many small companies may choose instead to focus on attracting a larger
biopharmaceutical firm to buy, in-license, or partner on the compound
in development. To borrow a popular phrase, if you don’t know where
Figure 2.
What
?
?
?
is the
end goal
What are
the desired
product
attributes
Where
Three Foundational Questions
will the
drug be
marketed
you’re going, how will you know when you get there?
2. What are the desired product attributes?
A good way to approach this question is to draft the ideal prescribing
GETTING YOUR DRUG TO MARKET?
LICENSING YOUR COMPOUND?
information for your product. At this stage much of the information
is educated guesses and conjecture, but the process helps companies
focus their objectives before building a detailed plan. In particular,
consider indication/usage, dosage/administration, clinical pharmacology,
adverse reactions/toxicology, and clinical data. In whom will the drug
be used? How much of an effect is needed for the drug to be considered
worthwhile by patients, providers, or payers? What level of toxicity will
INDICATION/USAGE & DOSAGE?
be acceptable?
ADMINISTRATION & PHARMACOLOGY?
ADVERSE REACTIONS & TOXICOLOGY?
3. Where will the drug be marketed?
CLINICAL DATA?
It may be tempting to start by seeking approval in the United States and
planning to file the paperwork for other regions later, but the process just
isn’t that simple. No single country or region has the most conservative
regulations in all areas, and having to repeat key studies because the air
handling procedures on the tablet compression line didn’t meet European
standards or because the Phase III trial included only one investigative
UNITED STATES?
site in Europe is time consuming, expensive, and frustrating. In most
EUROPE?
cases, it is worthwhile to plan the development program to meet the most
stringent criteria among the intended markets. That may mean using the
US standard for safety monitoring, the European Union (EU) standard
for manufacturing quality controls, and including at least 100 patients in
from several sites in Europe in the Phase III trials.
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