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Mark Levi, PhD, Consumer Safety Officer

Mark Levi, PhD, Consumer Safety Officer

"[At FDA] you get to see the kind of science that few others in my field ever see, which is the whole package; the results of a decade of R&D, the clinical trials, and the validated manufacturing process."
-- Dr. Mark Levi, Consumer Safety Officer

Mark Levi

Q: In choosing a career path, why should a scientist consider FDA?

Mark Levi: FDA is an ideal place to apply your scientific knowledge to the wide range of novel products that FDA regulates. You also get to work with and help scientists and physicians whose drugs and biologics are close to or are in clinical trials. And with a regularly paid salary, a scientist can focus on science and not perpetual grant writing!

Q: What keeps you at FDA?

ML: In addition to the above, I’ve done my own proprietary drug discovery, pre-clinical evaluation of molecules in rodents, and was on a medical school faculty where clinical significance was of the utmost importance. At FDA, I put all this knowledge to use. I also enjoy the collaborative, not hypercompetitive, culture that FDA fosters where scientists and physicians work alongside each other and any needed experts, even neurovirologists, are just down the hall (and the lawyers are upstairs). You get to see the kind of science that few others in my field ever see which is the whole package; the results of a decade of R&D, the clinical trials, and the validated manufacturing process. Continuing education occurs here daily.

Q: How do you use your science degree at FDA?

ML: At FDA’s Center for Biologics Evaluation and Research, where I work, I use my PhD in medicinal chemistry indirectly. My dissertation and post-doc both focused on the design, synthesis, purification, and identification of small molecules and the development of the structure-activity relationships between molecules. This meant that I could work in the pharm/tox area both at the University of Arkansas for Medical Sciences as a faculty member and at FDA’s National Center for Toxicological Research examining approved drugs used to treat ADD/ADHD.

The labs at CBER perform work to facilitate the availability of seasonal and pandemic influenza vaccines.  This work is often time-sensitive, and my background with small molecules proves quite useful in these efforts. Interestingly, during my post-doc, which focused on the robotic synthesis of peptides, I was asked to draft my mentor’s expert testimony on pesticides for a Parliamentary committee and on the most likely result of a synthesis (methamphetamine) for the Crown prosecutor. Knowing how to write about science for non-scientists has helped me greatly. Today, as a Regulatory Project Manager, I manage the reviews of multiple submissions and talk to our experts as well as the sponsor’s regulatory managers. Even when talking science, diplomacy is a very useful skill.

Q: How is the science conducted at FDA different from science conducted at NIH, academia, or industry?

ML: The science behind reviewing is heavily applied and involves a very thorough examination of everything that has been submitted. Every process, chromatogram, and method is scrutinized since no commercially available standards exist for the novel products we review.

The physicians often review every case study report since the clinical trial may have only enrolled 20 people. FDA frequently develops its own analytical methodology (which can be validated) and analyzes samples from different lots of biologics for purity and excipient levels before approval to ensure they meet specifications and can use these results to recommend changes to the manufacturing process. At this stage, the recipient of the biologic in the vial is not a rodent but may be a trauma patient who is hemorrhaging or a perfectly-healthy infant.

Science at FDA doesn’t depend on the whims of a peer reviewer who could have a conflict of interest. At FDA, all scientists are here for the same purpose, that is, ensuring efficacy and safety and not competing against each other. And FDA scientists are not required to publish like they are at other institutions, although FDA scientists do have an impressive track record in peer-reviewed journals.