Women in Science: Kathryn Starzyk on the power and complexities of real-world evidence

She takes us through her journey from an early interest in math and science to recognizing the power and complexities of RWE. 

Could you give us an overview of your work?​

OM1 is the leader in real-world data, evidence generation, and artificial intelligence (AI) solutions for chronic conditions, such as rheumatoid arthritis, inflammatory bowel disease, heart failure, major depressive disorder, and others. The mission of OM1, which I joined close to its founding in 2015, is to unlock the power of healthcare data to measure and predict outcomes, accelerate medical research, and improve clinical decision-making. We combine high-quality data and provider networks, proprietary technologies, and cutting-edge AI, and wrap-around services to deliver innovative solutions for life sciences companies, clinicians, and other healthcare stakeholders. We believe data has the potential to transform how treatments are developed, diseases are diagnosed, and healthcare is delivered. 

As an epidemiologist, it’s an exciting place to be, as the technological advances in handling high volumes of increasingly varied and complex real-world data opens up so many possibilities on the patient-centric research side. Our patented AI technology, for example, coupled with clinical and epidemiological expertise, can tackle some of the most challenging questions with insights, including finding patients with mis- or undiagnosed conditions, accelerating (and diversifying) clinical trial recruitment, understanding disease subtypes, and predicting outcomes, and driving personalized treatments and care. In my role, I work with teams of scientists that are both at the forefront of solution generation, so understanding what our stakeholders are trying to do and helping them craft innovative approaches, on the execution side of RWE generation and dissemination.

Could you describe your personal journey bringing us to where you are now? ​

I realized I was interested in math and science from very early on and started college as a mathematics major. I soon realized the world of pure mathematics as a career path was not for me, so I set out to find something that would meld many of my interests. Had I been more aware of the applications of epidemiology at the time, it might have seemed an obvious choice earlier on, but I think the professional experiences and exposures I had prior to pursuing it at the graduate level were key to my journey. 

I have now spent the last 30 years in observational research in a variety of roles, including as an immunohistochemist and research scientist at the National Institute of Child Health and Human Development (NICHD) and as a clinical development and risk management scientist at Genzyme, a biotechnology company focused on rare diseases that is now part of Sanofi. I started working directly in the RWE generation space about 17 years ago, initially more focused on the design and conduct of large, global, prospective disease registries then morphing into more technology and big data-driven approaches.

I am amazed how far we have come, from my early days at NICHD where we had to cobble together clinical, pathological, imaging, and genetic data in the most cumbersome (and often manual) ways to now, where we can corral such diverse data, including clinical, socioeconomic, and patient-generated, quickly and efficiently. 

What ignites your passion in your current role? ​

Being part of multidisciplinary teams that are transforming how research is conducted is exciting. The FDA and other stakeholders are increasingly recognizing the power (and complexities) of RWE, and there is a real impetus to find ways to optimize our approaches to ensure data quality and utility. There is a lot of talk about personalized treatment decisions and how they impact actual care and the outcomes that truly matter, so to be part of moving towards that goal, and not just in oncology but across therapeutic areas, is inspiring. Many chronic diseases, particularly those with an autoimmune component, are complex and continue to have unmet needs despite the volume of clinical development being done – there are so many questions that are left for RWD to solve. 

What is your current work ethos/style? ​

My style is to lead by example. I am a big believer in being intellectually engaged and strive to have those around me similarly inspired to do their best and be mission driven. 

Could you share some advice for young women starting to develop an interest in science or wanting to pursue a career like yours? ​

My advice for young women starting to develop an interest in science (and more specifically biomedical fields) would be to keep an open mind when opportunities come up – there are so many different paths to take, whether it be bench science or epidemiology or bioengineering or medicine, or a mixture of them all. Talk to people. Ask questions. And for those who love the language of math, go for it! Carve your own path.