Marina Daineko on exploring femtech and other understudied populations

RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Marina Daineko, senior manager, compliance assurance at EPAM Systems. 

What’s your current role and what does it entail?

Currently I play the role of compliance and regulatory senior manager at EPAM Systems. EPAM is a leading AI and digital transformation services and product engineering company, and I serve as a bridge between different regulatory bodies and our customers, helping them to develop and sell safe products. I call myself a liaison or a bridge between these two very important parts because the world can't live without medical devices, pharmaceuticals and combination products, and they must be regulated, so we need to understand these different languages.

How did you get there?

I started my medtech career as an R&D engineer. I progressed to R&D scientist, which eventually led me to biological evaluation. Now, I work in compliance, regulatory, and also biological evaluation of medical devices. When I was working as R&D scientist, I thought, "I do understand how to do this evaluation, but I want to know more about where these rules and requirements are coming from.”

Kim Young, who is now RAPS’ regional director of engagement, actually opened my mind to the world of regulatory affairs when we were both working at the same company. I decided to go into this area to be able not only to fulfill the requirements or follow the regulations and standards, but also to understand how they come to be.

What inspired your session, FemTech and Beyond: Addressing Sex-Based Disparities in Medical Devices and Pharmaceuticals?

I'm doing risk analysis and risk management on a daily basis, and I’ve noticed how many understudied populations there are. I’ve noticed, for instance when I'm doing biological evaluation, there are just a few clinical studies on reproductive and development toxicity that can help me understand toxicity to very specific chemicals. On the other side, because I also work with software, I notice that when we are considering UI, again there are populations that are not considered.

You write that there are gaps in how women are underrepresented in clinical research and that these gaps directly impact the quality of regulatory decision making and ultimately patient outcomes. How did that influence your session?

We want to start with femtech but extend it to their understudied patient populations in general. Why we want to start with femtech? Because historically, all the clinical studies and investigations were focused on male populations. The data that we can see right now that relates to different outcomes from these clinical studies is mainly male-focused.

Women, in general, we’re trying to catch men when it comes to state of the art. The physiology is more or less studied. We know what to expect for outcomes on males, but what about women?

Still, we want to extend this beyond just femtech and talk about other understudied patient populations.

For instance, there may be software applications that are intended to be used by wide patient populations such as pediatrics, or adults. That makes sense, right? But what about products that are not dedicated exclusively to elder people, but can be used by elder people? This mobile application should make it easy for elder people who may have eye problems or tremors to use, because they should benefit as well. We know many people in the industry share this feeling, so why not talk about it loudly?

What advice would you give someone attending RAPS Convergence?

I’m looking forward to all the wonderful sessions, but the networking at RAPS Convergence is my favorite part. Some amazing people are coming to this conference, and I’m really looking forward to seeing everyone. 

What's one piece of advice you'd give someone who's attending this event for the first time? 

Don't be afraid, and network. What I really like about RAPS Convergence, and RAPS Euro Convergence, is that you get to be with so many people who share the same passion as you. There are no stupid questions. People are very open and friendly, and they help you as much as they can.

Network. Communicate. Ask questions.

Also, don’t try to cover everything. It's simply impossible because RAPS Convergence is huge. It's impossible to be everywhere. Pick the sessions you feel are critical for you right now. And book time in advance to meet people that you want to speak with. It's better just to book time in advance because it gets busy while you’re there.

I also recommend making notes while you’re there. I find it really useful, whether it's for posting on LinkedIn, for my personal usage knowledge, or just for reaching out to people. Communication is our everything, as I like saying. Just be yourself and communicate with others. You’ll have a great time.