Jessica Zdinak, Applied Research & Analysis Company - Behavioral Science Research Firm | LSI USA '24

Jessica Zdinak  0:03  
All right, good afternoon. So as drew, I believe I mentioned, my name is Dr. Jessica    Zdinak. And I am founder and Chief Research Officer of ARAC (Applied Research and Analysis Company). I'm going to just talk briefly to you all today about behavioral science, and using behavioral science expertise to really drive regulatory applications with a focus of the consumer and the regulator at hand. Before we get into a brief agenda, because I only have five minutes, I wanted to get kind of a survey of the room. How many of you all have actually met face to face with your end user, your end consumer, whoever that might be? Has anyone sat down face to face and had conversations with them? Okay, great. So we're really going to speak today about how important that is to do. So we'll go ahead and just get started first about what a wreck is. We are a growing and leading social and behavioral science research firm. We have a team of psychologists, statisticians, who focus on conducting the behavioral science research needed to support applications to the FDA, we really focus on providing a boutique level of this service, we come to clients or clients come to us and we really want to know, what is their business question, what is their business strategy. And we use that coupled with our experience, our background working in public health, as well as the expertise in the behavioral sciences. We also have a medical monitoring team. So we conduct a lot of the clinical research that is needed as you progress along the FDA pathway. Also here at a rec partners very closely with a regulatory solutions firm, a Korto and which we have some folks in the room who are representing. And they really provide this service from the beginning to the end as a regular regulatory consulting firm. And we come in and we play the role, as you'll see in just a few minutes of some specific studies to support that application. And so, if you look a little bit here about our background, we have the FDA application support in which we're partnering with, for example, acordo regulatory solutions. And then the regulatory studies, the statistical analysis, and the quantitative and qualitative research is, that is our bread and butter. That is our expertise. I'm an experimental psychologist and statistician, and so are all my other scientists on the team. So we come into play for Human Factors studies, usability testing, label development, label comprehension, right? FDA wants to know, are your consumers going to know how to use your end product, and that consumer can be physicians, other medical professionals, patients. So that's where we come into play, as well as being able to kind of on a longer term, be able to provide the feasibility and the clinical testing that's required to get your application is approved. So this is just a variety of different areas that we have expertise and experience in, we really bring over 30 years of experience in the FDA, my team of scientists has a lot of academic experience, public health experience, as well as the applied industry experience. And we have many different success stories when it comes to conducting studies applying to the FDA and getting authorization of product. So why are we here? Why are you guys all here? You know, you might be at the beginning stage of developing a product, we work with people from the beginning, when they say I have this idea, I had this concept that typically then turns into the startup, the startup can then turn into a real life actionable product. And we go along the pathway for those individuals, those startups, those ideas all the way from the beginning, all the way through them to getting them on market through the FDA. We all have that in common. We have a product in mind. We want it to see it be successful. And we're here to help you do that when it comes to the behavioral sciences and being able to answer the question whether it's human factors label or your clinical testing. And I know I'm getting short on time, this is the quickest presentation ever. Why a rack is different, because there's a lot of other CEOs out there that maybe have been more well established longer periods of time than our firm. But what sets us apart, and we've been told this over and over again by our clients is what we call the success triangle. We leverage our expertise in science and the regulator, we have a very close relationship with the FDA. We also then focus not on our business strategy, but your business strategy. In addition to that, our focus is on the consumer, your end user, what do they went today? And what are they telling you that they maybe don't want, but who knows what they're going to want six months, a year and two years and we consider all those factors. I know I think these slides will be up for being able for you guys to view them. We've really just given an overview of how our firm might be able to assist you as a startup, maybe as someone who's a little farther along on the pathway to getting FDA authorization, or have you received authorization, and now you have to continue your post market assessment and surveillance, we're also there for that. And so because I know my time is ticking, a quick summary, you know, the bread and butter again of what we do, it's building relationships. Whether that relationship was with your regulator, your future regulator, your current regulator, whether that's the relationships with your end user and your consumer, or that's a relationship with you as a client. We leverage trust, we leverage, accountability, and dependability. And we really consider everyone to be a partner who we work with. And so it's not my har phrases. It's not just research that's going to drive success for you. It's going to be doing the right research at the right time with the right research partner, and that is a wreck. So with that, I want to thank you all right.