In this article, we shine the spotlight on Amy Blawas. Amy joined NDA in 2020, and has over 18 years of experience in the pharmaceutical and regulatory industry, primarily in biologics and cell therapy. She applies her skills & knowledge to a broad range of therapeutic areas and has successfully helped clients prepare & interact with Health Authorities throughout the stages of drug development.

Paving the way for new knowledge

The space in-between is where the magic happens. For Amy Blawas, principal consultant at NDA, that space is right in-between the forefront of science and the regulatory foresight, transforming innovation to new therapies. With over 20 years of experience in the pharmaceutical industry, she easily bridges any gap in understanding between scientists and regulators, making the interactions smooth and uncomplicated.

Amy Blawas joined the pharmaceutical industry with an undergraduate degree in chemical engineering. Working for a British company in their pharmaceutical section she enrolled in the management training program. Through this experience, she concluded that she wanted to pursue a career in pharmaceutical development and went back to school for a PhD in Biomedical Engineering.

“ I had my heart set on pharmaceuticals and since both maths and science come very naturally to me, engineering was a good place for me to be ” Amy explains

With a fresh degree from Duke University, Amy came back to industry where she started working in the pharmaceutical development area. The company she joined provided such a good teaching environment, flexibility, and possibilities to grow that Amy stayed for 17 years. 

“ There was a lot of focus on training”, Amy remembers. “On Fridays we met and discussed different regulations and how to handle them. It was a good experience, as I developed a solid foundation in regulatory affairs ”.  


The promises of uncharted territory

Eventually, Amy was up for some new challenges and felt like moving into biotech.  She joined a company working with autologous cell therapy for cancer, which was new and at the time rather unexplored.

“This was right on the cutting edge of technology”, Amy says, “and it was enlightening. At that time, we didn't have all of the language or guidelines to follow. By working together with the Agencies, I was instrumental in taking this highly technical information and establishing precedents for these new type of products”.

The advancements in the pharmaceutical industry create a sea of change in the regulatory environment and Amy was bridging the gap between the innovation and the mechanisms intended to regulate them. Making sure that the regulators would understand the science and that the new treatments would be safe once they reached the patients.

“’ The edge’ is a highly collaborative interface with the agency”, Amy explains. “And I think it's really interesting to be in that space because things are developing as you're developing so it's very challenging ”


Getting the story straight

Amy enjoys helping pharmaceutical companies to prepare for agency interactions. To assist them, by determining what their data package must look like and ensuring that the technical information is clear so the agency can understand the message and provide the most useful feedback. Digging into all the information and data can be hard work, but for Amy, the most rewarding part of her job is when she can facilitate the understanding between the sponsor and the agency. It becomes easier for everyone involved if the Agency does not have to come back and ask more questions.

“ There is no better feeling than when you see it all come together and you realise that - Yes, that was exactly what we needed to do here ”.

Challenges come and go but Amy handles uncertainties by always going back to the existing guidelines and regulations to find the best practice for a similar product or issue. By being an exceptionally optimistic person, she never backs down when it comes to mining through the information that can be relevant or helpful. However, when things don’t work out, Amy has a clear strategy:

“ If I get frustrated, I try to approach the questions in a new way. And if that doesn’t help move the project forward, I go for a run, come back, and start over again ”.


The facilitator

The scientific space where Amy works is the front line of new technology where it is important to communicate highly technical information in an accurate and efficient way.

“ In my experience, it can be reassuring for the client to know that they have someone to assist them with extracting the precise message for the question they need to be answered. ”

Amy has supported many agency meetings and is very comfortable in her role facilitating the questions and representing the agency’s potential position for the sponsor during preparation. Her mission is to keep everyone on the same page, to get to the end goal which is for the sponsor to have their questions answered.



Amy Blawas

Principal Consultant

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