Kelly Gelinne, our Associate Director of Marketing, sat down with Mary Barecki-Roach, Nuventra’s Vice President of Quality Assurance to learn more about her career path into quality assurance, her predictions on major drug development changes in the next couple decades, and more.
Mary has more than 23 years of experience in the GLP-regulated pharmaceutical industry and 7 years of experience under GCP regulations. She has extensive experience in QC and QA as well as pre-clinical DMPK, nonclinical and clinical PK data analysis and interpretation, and report writing. At Nuventra, her main focuses are managing the QA unit, staying abreast of regulatory requirements, and maintaining compliance with the regulations, training, SOP development, and software validation activities.
Kelly: Welcome, Mary. We’re excited to chat with you today!
Mary: Thank you, Kelly.
Kelly: Let’s jump into our five questions to learn more about you…
How did you end up at Nuventra in a Quality Assurance role?
Mary: Well, after my undergrad work, I started out as a pharmacy tech, then I decided that I wanted to pursue a Masters degree in Biological Sciences where I ended up focusing most of my work in Microbiology. After I graduated from grad school, I started working with the Animal Tox unit at Pharmacia & Upjohn doing DMPK GLP work. After that, I took a job at Schering-Plough, also in the DMPK group. There, I was working mostly on animal safety studies and was involved with preparing microsomes and running transporter studies.
After I left Schering-Plough, I did some independent consulting work prior to starting at ClinPharm Consulting, aka Nuventra, in May of 2011. I started out working on mostly TK and PK analyses studies at that point, and started gaining experience in the clinical study analyses and writing world, and then about 5 years ago I helped to bring in the QA services in-house and grow the QA group here at Nuventra.
Kelly: That’s great, so you’ll be celebrating a decade with Nuventra within a year.
Mary: I will, yes!
What major changes do you predict in drug development in the next 1 or 2 decades?
Mary: So, I’m thinking that Artificial Intelligence (AI) will probably become a bigger part of drug development over the next 10-20 years. AI has been used already in developing COVID treatments, and big pharma companies have been using AI for quite some time to help develop drugs even before the COVID pandemic occurred.
I also expect to see more work in virology and vaccine development and ways to safely develop vaccines in a shorter amount of time.
Kelly: Certainly, there has been a lot of focus on vaccine development in the past 7 or 8 months.
What do you enjoy about working in QA?
Mary: In working in QA, I am exposed to and involved with many different processes within Nuventra which makes my job very interesting. It is also interesting to watch the new developments that are coming from the FDA and other regulatory authorities around the world.
Kelly: Certainly always changing. It seems like a lot to keep up with.
Mary: Yes. I would say, on a daily basis, I’m always checking.
Is there a certain therapeutic area that you’re particularly passionate about?
Mary: Yeah, so since my background is in microbiology, I am very interested in antibiotic and vaccine development. I have to say that it has been very interesting following all the different developments and research that’s gone on around the SARS-CoV-2 virus.
Kelly: Definitely an interesting time to be in this field.
How do you think COVID-19 will impact the future of drug development?
Mary: I think in the arena of drug development, COVID-19 has already pushed the boundaries of the development timelines. Drugs may come to the market faster than we’ve seen in the past, and I think focus on already approved therapies may take a bigger role in finding a way to repurpose these drugs for another therapy. These drugs have already been shown to be safe, so the development timeline can in some cases be shortened.
Kelly: That’s great. So, switching to our final question—we always like to throw in a bonus question to get to know you on a personal level. What do you like to do in your free time when you’re not working at Nuventra?
Mary: So, when I do find free time, I try to work on stained glass. I took a class a long time ago and I have all the equipments, and I recently obtained a bunch of free glass from one of my neighbors who has been doing this for years and he just doesn’t want to do it anymore. So, I have this corner in my garage with a bunch of glass and my equipment sitting there. So, that’s something I really want to get started back into because it’s very enjoyable work and you get a very nice product at the end.
Kelly: Well, what better time to pick up that hobby than during in a global pandemic. Thank you so much for your insights today, Mary. We really appreciate it.
Mary: Absolutely. Thank you, Kelly.
If you have any questions for Mary or for any of our other scientists, please don’t hesitate to contact us.