When I was a surgical oncology fellow at the National Cancer Institute, every in-the-moment decision during surgery had a direct result for my patient. Physicians are trained to make life and death decisions in split seconds, and in my opinion, there is no greater responsibility.
Though I enjoyed my time as a physician in clinical care, I was always pulled back to research, to the science, to the deep understanding of how and why. I wanted to help more patients and felt the best way to do that was to better understand the underlying diseases and work to translate that science into medicine. As the head of our Global Clinical Development team at Regeneron, I get to do just that. Our development organization is directly responsible for translating our tremendous pipeline of research candidates into medicines for patients.
After years at a lab bench investigating a potential medicine, once we get to the development step in the process, it can be tempting to try the latest innovation in an effort to increase your chances at success. But it’s critical to bring it back to our core responsibility and ask ourselves: “Is this going to help our patients?”
Innovation for the sake of innovation is not innovative. It must directly benefit our patients or improve how efficiently we move from research candidates to medicines.
With that in mind, our development team focuses on getting it right from the beginning, working closely with our research colleagues, learning from and observing the latest trends and making sure there is a direct benefit for our patients. At Regeneron, innovation is in our approach – it’s a mindset we apply to developing our medicines.
Investing in the early science
It’s critical to bring it back to our core responsibility and ask ourselves: “Is this going to help our patients?”
We know a trial and error approach to drug development doesn’t work. It costs more and is less effective in the long run. Instead, we invest heavily in understanding basic biology to build a strong foundation before jumping to the next step in the development process. We analyze novel findings thoughtfully with help from our colleagues in Research, which includes our Regeneron Genetics Center (RGC) and a host of specialty research groups that dive deep into the disease area, disease target and investigational compound. By developing an innovative process to understand the biology from the start, we aim to reduce questions in the clinical research process and make more informed decisions that ideally accelerate our drug development timelines.
Strategically pulling from our data analysis toolbox
After establishing a solid biologic understanding, we enlist a diverse portfolio of data analysis methods. Similar to the buzz around the term “innovation,” different kinds of analyses go in and out of style. One example, Bayesian analysis, which is an alternative statistical approach to evaluating hypotheses, is very popular these days. However, we’ve found that another commonly used method of statistical analysis, the frequentist methodology, is a better fit for the data we’re seeking to understand. The old adage that “if you’re a hammer, all the world is a nail,” is something we strive to avoid. Instead, we need a full toolbox of approaches and use the best tool for the job at hand. Innovation is in the thinking – not in the tool.
Data collection is not our sole purpose
As new technologies are rapidly adopted and change the way we do medicine, we must ask: “Does it work?” “Is it best for patients?”
When it comes to clinical trials, even the most popular devices may not collect the right data to benefit the trial participants. “Could they support the endpoints?” “Is it validated?” “Does it need to be validated for this particular application?” “Does the information actually help us make better decisions that ultimately help our patients?” To us, you have to answer these questions for each individual application. It’s not one answer fits all.
A recent example is the use of wrist wearables in pain management trials to measure activity level. These wearable devices have been a hot topic in clinical development circles, and initially we thought they might be effective for one of our clinical trials. But after extensive testing, we realized it would not provide the information we needed – for our patient population or to help advance our understanding of our candidate medicine. Knowing we still needed a way to capture valuable information, our team went back to the drawing board and ultimately saw an opportunity to gather more exact information through a shoe sole device that was both comfortable for the patient and analytically effective. Patients involved in the clinical trial simply insert the sensor into the sole of their shoe, and with every step they generate real-time kinetic data to measure stride, pressure, cadence and more. This specialized sensor will help us capture difficult-to-measure data points that will help us better understand the effect of the investigational medicine.
The power of science to change patients’ lives inspires our development team to think innovatively, to ask the tough questions and to never give up on being able to do our work better. In the end, this mindset is itself the best kind of innovation.