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SCS Home  >  Graduate Programs  >  Master of Science in Quality Assurance and Regulatory Science  >  Faculty Profiles

Faculty Profiles

Neal Siegel

Neal Siegel is chief scientist for Sword Diagnostics, a Chicago area biotechnology company. He worked in the diagnostics division of Abbott Laboratories for 19 years and holds six foreign and U.S. patents related to blood separation technologies. Siegel, who earned a PhD in biochemistry, lives on an 11-acre farm in Morris, Illinois, where he tends to 10 donkeys, 4 horses, and roosters Moe, Larry, and Curly.

Q: What is quality?

NS: It means making sure that things work correctly the first time and every time you use them. How do you know that the first aspirin in the bottle - or the last - is safe? How do you know a beverage is safe to drink? It's because of safeguards put into place by industry and regulated by the FDA.

Q: Is the MQARS program the first of its kind?

NS: Engineers have studied quality, but not life scientists. Because of the variability of biological components, quality in the life sciences is different from quality in engineering. Even the statistical methods they use may be different: linear for engineering, nonlinear for biology.

Q: How did this program get started?

NS: I taught an undergraduate course, Quality in Science, in Northwestern's chemistry department for five years. Faculty, grad students, and post-docs heard about it and asked what they needed to know to work in industry. This program fills a critical need, and SCS deserves accolades for breaking ground with it.

Q: What's it like to deal with the FDA?

NS: I have a great deal of respect for the FDA. The Food, Drug, and Cosmetic Act of 1938 grew out of a therapeutic disaster: more than 100 people, most of them children, died after taking an untested sulfa wonder drug that used a toxic chemical as a solvent. That couldn't happen today, and although our system may not be perfect, we have controls in place to respond rapidly to problems and fix them.


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