Expert SpotlightJuly 2016 - Q&A with Sophia Fuerst, President, Nonproprietary Names Division
Ms. Sophia Fuerst first joined Drug Safety Institute’s Nonproprietary Names Division as Managing Director in 2005, and was promoted to President in 2007. She was formerly Director of the USAN Program at the American Medical Association (AMA) and served in various positions during her 18-year tenure with the program, including AMA Senior Staff Scientist in the area of Drug Nomenclature.
Before her career at the AMA and BI, Sophia earned a B.S. in Biology/Chemistry (pre-med) from St. Joseph’s College, an M.S. in Medicinal Chemistry from the University of Chicago and an M.B.A. from Governor’s State University, Illinois. We asked Ms. Fuerst a few questions about her experience at those regulatory agencies, and what it’s like working for Brand Institute.
BI: What do you like most about working for Brand Institute/Drug Safety Institute?
SF: I love being able to speak with and get to know our clients. I especially like that every new project brings a learning opportunity. There’s always something in the drug industry that’s innovative and new. There are a lot of biologics out there; now virtually 50 – 60 percent of what we work on are biologic type submissions. These include things like gene therapy, cell therapy, and fusion proteins…to me it’s just fascinating.
BI: What does your typical day at BI look like?
SF: Well, I’m an early riser…I like to go through my emails that come in from Tokyo and our Korean team…I’m on the phone a lot, emailing a lot, and reviewing my team’s work before it goes out. And then of course my own project work which is the strategy recommendation work—this includes coming up with stems with all the science behind it.
BI: What are stems? Why do you have to be so careful of which ones you include in your proposed names?
SF: INN and USAN have a list of stems and their definitions. If you belong with an existing stem group, INN will tell you that you belong there and can’t go anywhere else. As with most things there are grey areas with innovative drugs. There are clients that come to us looking for a new stem when that proposition will be very challenging based on their drug’s chemistry. So it’s our job in the strategy recommendation to do an in-depth search to explain why they are going to fit with an existing group so they can be approved. Many clients want a new stem to suggest or communicate that they’re drug is truly novel, so that’s always a plus.
BI: How might the nonproprietary name development process be improved?
SF: It always seems that when the INN deadline is announced all these companies want to make the deadline and it becomes so pressed for time. I think it would make sense to do four meetings a year; I think it would move much more smoothly.
BI: Tell us something you think people don’t know about nonproprietary naming but think they should:
SF: It takes a long time. If there is no pushback from either committee and everything goes through very smoothly with no glitches, it’s 18 months minimum. That’s where our expertise comes into play. A lot of companies don’t know the process or the different aspects that can lead to committee acceptance or denial. A lot of people go in and make submissions on their own, and that’s why rejection rates are so high when they don’t come through us where we know all the rules and guidelines. I hate to admit it but I made a lot of those rules and guidelines when I was there!
BI: That’s pretty impressive! How did your background qualify you for your positions at USAN and INN?
SF: I developed an interest in chemistry and became really interested in the pharmaceutical industry as a result. What’s really helped me was getting my master’s in business…That is why I’m able to do the work I do! I’ve also always enjoyed puzzles, which I compare to a nonproprietary name and the way you can break it down. Making up words for a living…there can’t be anything better to do!