n 10 NOVEMBER/DECEMBER 2015 | PHARMACEUTICAL PROCESSING
nPHARMPRO.COM n GAP ANALYSIS
The process of getting a drug to market involves a number of steps—including preclinical, clinical, and approval. The FDA breaks these down even further: toxicology, INDA, phase I, II, and III trials,
an NDA, and then a postmarket surveillance (phase IV).
According to an analysis conducted at Forbes, companies
can expect to spend $350 million in their journey of trying to
bring a single drug to market. Large pharmaceutical companies are often reported to spend even more—$5 billion per
new medicine if they are working on dozens of drug projects
at once (many of which fail).
One website reports that only 5 in 5,000 drugs make it to
human testing after preclinical testing, and about 1 in 5,000
new drugs makes it to the market.
With many new drugs to try to bring to market, companies
often need to be proactive in the various phases of planning
as they go through the necessary steps. Sometimes, having an
extra pair (or pairs) of eyes may be of great assistance to companies in the process of trying to bring a new drug to market.
Claravant cites research that found that only 10 percent of
drugs that enter into clinic will go on to enter the market. Of
the other 90 percent of drugs that never make it to the market,
only half of these failures—according to the same research—
are due to a lack of efficacy.
Claravant recently introduced a 175-point rating system,
termed as a “GAP Analysis,” for drug development programs.
The company has found that many of these failures in the
clinic are caused by avoidable problems, such as:
• Failing to disclose plans for drug substance development
with the FDA
• Not reviewing and addressing FDA comments carefully
• Providing the bare minimum amount of information to
• Waiting too long to prepare for the FDA’s facility inspec-
• Inadequate preparations
Not all companies face these challenges, but for those that
do, timing is critical.
Chris Plaford, CEO and Managing Partner of Claravant
Analytics, commented on the importance of timing provided
by Claravant’s GAP Analysis: “It’s important to get feedback
as early as possible and often.
“We can do our analysis when an NDA has already been
filed with the FDA,” continues Plaford. “But at that point
there is nothing that can be done to address outstanding
issues. A much better outcome is to identify potential issues
earlier in the development program when they can be re-
solved without creating a delay to market.”
The nine different categories under consideration in the
GAP Analysis, which have varying weights depending on
what phase the drug is in (pre-IND, phase I, phase II, phase
III, or NDA-filed), are as follows:
2. Regulatory communications
4. Clinical trial efficacy
5. Clinical trial safety
8. Chemistry, manufacturing, and controls—drug product
9. Chemistry, manufacturing, and controls—drug substance
The review process, according to Plaford, can be done
very quickly, but it all depends on the company’s parameter
The Steps & Challenges
of Getting a Drug to Market
Claravant creates a 175-point rating system for drug development
n By Meg Snyder, Editor