Connecting The FDA And Pharma / Biotech Industry
By Rob Wright
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