The average pharmaceutical company clinical trial lasts about seven years, according to the U.S. Food and Drug Administration.
While many factors affect how quickly a trial can progress, utilizing new digital technology can help a pharmaceutical company save both time and money. But there’s a lot more involved than simply strapping smartwatches onto trial participants to help gather data, said Jordan Brayanov, R&D Digital Strategy Lead at Takeda.
Brayanov, who earned a Ph.D. in biomedical engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences and Graduate School of Arts and Sciences in 2012, navigates a maze of challenges as he works to incorporate digital technologies into the clinical trial process.
“Digital technologies evolve so quickly and then fall off the radar so quickly,” he said. “But pharmaceutical companies tend to have a slow rate of technology adoption, so it is difficult to ever adopt anything new. We are trying to educate the organization and shorten some of the timelines, and also support external vendors to extend the lifespan of these devices so they could be adopted.”
Take a smartwatch, for instance. It could be a useful tool to continuously monitor a patient’s heartrate during a clinical trial. But not all smartwatches are created equal. Some record heartrate measurements every minute, some track heartrate continuously for every heartbeat, while others take measurements that are first averaged then sampled, Brayanov explained.
“At the end of the day, if we want to run a trial in 10 different countries, at 50 different clinical sites, on 3,000 patients, and we want to have these patients wear a wristwatch to collect heartrate continuously, we can’t have data streams that are disjointed,” he said.
And even if a pharmaceutical company is able to use a standardized product across different sites—a particular series of Apple Watch, for instance—if a new model is released while the clinical trial is ongoing, the data from the new smartwatches may not be compatible. Even pre-purchasing thousands of devices may not be a solution, since there’s no guarantee the device manufacturer won’t push an update that will change the internal algorithm.
Those challenges might be enough to make the average person’s head spin, but Brayanov has always found he works best when he has difficult problems to tackle.
His father was an engineer and his mother was a scientist, so even from a young age Brayanov understood that science could answer tough questions. He was initially interested in studying computer science as an MIT undergrad, but gravitated toward areas where two fields intersect, like biology and engineering.
“I was always fascinated by the idea that the human body is one of the most complex machines that we don’t really understand, but we are trying to model, design, and build around it,” he said.
After earning a master’s degree in mechanical engineering from MIT, Brayanov decided to pursue a Ph.D. in the lab of Maurice Smith, Gordon McKay Professor of Bioengineering, so he could dive deeper into the complex world of bioengineering.
At Harvard, Brayanov focused on modeling the motor system. He built instruments to solve specific problems and applied his work to better understand patients suffering from Alzheimer’s and Parkinson’s disease.
After earning his Ph.D., Brayanov joined Respiratory Motion, Inc., an early-stage startup that was designing a new measurement modality for respiratory volume monitoring. He focused on data analysis and algorithm development, as well as the usability of the instrument the team was designing.
“In the beginning, almost every day I would face problems and I would have no idea whether they would be solvable. That is exciting,” he said. “And the pace at a startup is also very different than the pace in academia.”
Brayanov brought his problem-solving skills to Takeda two years ago, where he joined the company in what was then a brand new position.
Almost since day-one, the biggest challenge Brayanov has faced has been educating others within the organization. Changing people’s mindsets and communicating to colleagues that there may be other ways to do things requires a delicate balance of technical and soft skills.
For Brayanov, it is easy to get immersed in technical details, but what drives him is designing solutions that could ultimately improve patients’ lives.
“If I can come up with a way to simplify a clinical trial such that patients don’t have to go to the hospital as many times, or can get their medicine just when they need it instead of every day, or develop a new way to monitor the effectiveness of a medicine so we can more efficiently adjust dosing for patients, that’s a success I can be proud of,” he said.
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