5 Questions with Alison Demarest, Principal,
“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features Alison Demarest of Meridian BioGroup in Frederick, MD.
Alison Demarest has more than 30 years of experience in biotechnology and FDA-regulated industries under GMP and GLP in both consulting and operating companies, including contract manufacturing and contract testing. She is the co-founder of Meridian BioGroup, a compliance, regulatory and validation service-provider to the Maryland biopharm community in its 14th year. She has developed and taught graduate courses at Johns Hopkins’ Center for Biotechnology Education and has been a frequent lecturer on compliance topics at ASME and ISPE conferences, Hood College and UMBC. She holds an MS in nutritional biochemistry from the University of Arizona and an MBA in finance from Johns Hopkins.
1. What was your first job/role in biotech?
My first job after graduate school in Arizona was at Advanced Biotechnologies (ABI) in Silver Spring, testing cell culture products, sera, and concentrated virus stocks that we sold to labs at NIH and commercial customers. ABI provided purified HTLV-III (now called HIV) to Abbott for the first FDA-licensed test to screen the US blood supply. As a result, I was fortunate to be introduced to cGMP compliance by senior Abbott professionals and found my niche.
2. What can you tell us about your current role and company?
My business partner Tom Blake and I founded Meridian BioGroup in 2007, after having managed the Maryland office of a similar firm that was sold and ultimately closed. We quickly recognized the on-going need in Maryland for high quality services in QA/QC, compliance, and validation. We added regulatory services in 2018 and since 2007 we have assisted more than 100 clients, most of them within Maryland. Meridian’s office is in the Frederick Innovative Technology Incubator (FITCI) where we serve as a resource to the Incubator’s start-ups. Right now, we have 30 employees and 10 long-term subcontractors engaged in projects throughout Maryland, and we are always interested in receiving resumes for consideration. We are fortunate to be in a thriving state and, these days, to be serving an “essential industry.”
3. What is the biggest misconception in this industry when it comes to “validation, regulatory and compliance” and why?
I am sure I speak for our entire staff in answering this question. There is actually no such thing as cGMP-light. Compliance can be approached as a continuum and FDA guidance for Phase 1 is very helpful. But cGMP is, by FDA definition, a minimum standard.
4. What advice would you give to a previous boss if you could, and why?
Surround yourself with people who are smarter than you are and let them excel.
This old adage is particularly apt in biopharm, where many functional groups must contribute and collaborate to move drug development forward. A good leader depends on her/his SMEs and stays out of the weeds. I probably couldn’t do most of the projects our QA professionals are doing right now; I wouldn’t know how.
5. If you could have any superhero power, what power would you have, and why?
This is the easiest question of them all: My best recurring dreams are ones where I can fly. I have said many times, I hope I come back as a bird. In the meantime, skiing is as close as I can come to that feeling of flight.
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