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This week’s Making Rounds spotlights Sean McNiff, director of clinical programming for gene therapy pioneer Bluebird Bio.
McNiff, who is also a Bluebird shareholder, spoke with Healthcare Brew at eClinical Solutions’s November biopharma conference in Boston about how new technologies and capabilities, like artificial intelligence (AI), are shaping the life science industry.
This interview has been lightly edited for length and clarity.
Tell me about yourself and your work at Bluebird.
My primary job is to work with their technology. I bring in all of our clinical data from all our clinical trials and transform it into something that our monitors can use, our data cleaning people can use. Then we can make decisions on patient care, like what to do, what to tell the investigator to do—this is working, this is not working.
I started in this industry about 30 years ago: My first casebook was about an AIDS trial. I knew what I wanted to do with my life and this was to dedicate it to biotech pharma. I’m a solutions guy; I’m not a visionary. I make things work. Through the partnership that Bluebird has with eClinical, we’re able to exchange ideas, and then I’m able to offer solutions.
How is new technology changing Bluebird’s work when it comes to clinical trials?
Having one platform like eClinical’s [Elluminate cloud platform] really makes a big difference. We made an early investment with them, we’re early adopters, and we’ve been working with them for seven years now. I don’t have to reinvent the wheel. These are designed specifically for clinical trials.
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My company is seeing that, because we’re able to get the data so early as patients continue to come into the system, we can start processing their results as soon as they’re done with their assessments and they’ve reached milestones. We’re able to look at this data constantly and have it at a much higher level of clean before it’s time to actually cut the data to submit it.
There’s also an aggregation feature that allows the data manager and medical data reviewers to see the data differently than in the past. They can see trends among patients, subgroups of patients. It can also influence future designs of protocols.
What do you expect for the future of clinical trials?
A lot of this stuff is just going to be expedited. In the trials that I’ve done in my current job for the past seven years, the subject has to come in to see the investigator, or they’re in the hospital for an extended period of time. We can’t do decentralized trials.
But the new technology would have been very effective on some of the trials I’ve worked on in the past. All my past companies are working on the medical record and also the streamlining of the collections using different electronic tools. If we merge that then with AI, we’re able to—if the models are trained right—interpret that stuff quicker and easier. But also, we’d be able to create data that can simulate bigger populations and more diverse populations.