Kayla Tausche CNBC

QUALITY AS A CRITICAL PLANNING CRITERION
Commonly held knowledge says that it takes years, combined
with skilled expertise in handling regulatory red tape, to get a
new medical drug or device out of development and into the
marketplace. To say it is a tremendous amount of work is an
obvious understatement.
Yet, headway is being made toward reducing time
frames as well as in adding product value during
the complicated regulatory process. A 20-yearold
Hayward, Calif.. company called Pharmatech
Associates specializes in solutions and processes that can
move products envisioned by biotech firms, medical device
and diagnostic companies and pharmaceutical laboratories
out of the mere idea and concept stage, turning them
into market-ready products and services evaluated and
approved by the Federal Food and Drug Administration.
“Our work is considerably different from what a lot of
others in this industry do since they deal primarily with
theory during the developmental stages,” Warren Baker,
CEO of Pharmatech, said. He notes that instead, his firm
takes an evidence-based approach from the beginning of
a new product’s life cycle, ultimately reducing the amount
of time and testing needed to bring a product into compliance.
“Everything done on the front end will be of benefit
to a company when it goes to file the applications. We have
been able to show our clients how to expedite their development
and approval processes.”
Baker and Pharmatech use a system called “Quality by
Design” – or QbD – to expedite this process. QbD was first
introduced by Joseph M. Juran in the late 1970s and was
later embraced by the U.S. auto industry during its labor
crisis in the 1980s. The FDA gave its nod of acceptance to
QbD in 2004, noting its basic premise that quality can be
planned and could have time and cost-saving implications
for both pharmaceutical and medical device development.
Baker sees plenty of potential for startup success, even
though the economic recovery from the Great Recession
from 2007 to 2009 remains slow and tepid at best.
“Despite our current economy, with the biotech industry
exploding the way it is regarding targeted therapies for
specific diseases, and with products advancing through
the approval process, there is plenty of room for startups
to find success,” Baker said. “The regulatory side is getting
more complex, but we have the insight to help startups understand
the opportunities and what it will take to get a
product through the process and to market.”
www.pharmatechassociates.com