http://www.lifescienceleader.com/magazine/current-issue-3/item/4077-fda-connects-with-pharmaceutical-biotechnology-industries
Even with more than 8,800 employees and an annual budget of around
$3.2 billion, the FDA’s task of protecting the public health seems
daunting, considering the complexity of products being developed by
industry. Factor in other issues such as counterfeiting, terrorism, drug
reimportation, and the globalization of drug discovery, development,
and manufacturing, and you soon realize that working at the FDA is
indeed quite a challenge.
Jeffrey Baker, Ph.D., is learning how true that statement is. Baker,
who was hired in 2011, is the deputy director, office of biotechnology
products at the FDA’s Center for Drug Evaluation and Research (CDER).
His hiring is an example of how the FDA, in an effort to learn more
about the industry it governs, brought in someone with extensive
industry experience.
Having spent 20 years working for the likes of Eli Lilly and MedImmune,
Baker arrived at the FDA with what he describes as his “industry
toolbox,” which includes a Lean Six Sigma Black Belt — indicating
significant competency with a variety of tools and techniques that
represent the best practices for quality in process improvement. Perhaps
more importantly, he brought a willingness to learn. “I am trying to
share my relevant experiences and be an active listener, a student of
folks who have been doing this for years.” With that mindset, Baker’s
goal is to help develop a shared vocabulary and shared expectations
between the FDA and industry, thereby making it not just a governing
body, but an enabling body.
Developing A Shared Vocabulary
When Baker first joined FDA, one of the first things he wanted to do
was to meet as many people as he could to gain a greater understanding
of the organization...
No comments:
Post a Comment