What if blockchain could be used to actually save lives?
That’s the thinking ongoing at pharmaceutical heavyweights Pfizer, Amgen and Sanofi. The three companies – typically black boxes when it comes to their work – are now eyeing blockchain as a means of streamlining the process of developing and testing new drugs. Speaking exclusively to CoinDesk, representatives from the companies shed light on how they are combining efforts to develop a blockchain framework that can address current logjams in the clinical trials process.
But while it might seem strange that these fierce competitors are interested in working together, according to Jaydev Thakkar, product innovation lead for digital health at Amgen, there is growing momentum to collaborate on foundational issues of industry-wide importance.
Thakkar said:
“[The focus is] to help each other so that running the engine of clinical research is as optimized as possible for each of us.”
In recent years, pharmaceutical companies have been put under more pressure to bring new, more personalized drugs to market faster and at more affordable prices and in a personalized fashion.
But because of government regulations, the growing complexity of the studies undertaken and stringent standards, the current research and development process is highly cumbersome – with studies typically lasting between six and seven years. And about 90 percent of the drugs that enter clinical testing fail, according to Ken Getz of the Center for the Study of Drug Development at Tufts University, making the average cost of successfully developing a single drug about $2.6 billion.
“The likelihood of recouping that $2.6 billion investment is much lower today than it was five years ago,” Getz said.
Yet, Pfizer, Amgen and Sanofi believe blockchain can help.
“This is about execution and operations models,” said Munther Baara, senior director of development business technology at Pfizer. “It’s all about collaboration.”
All about data
Ultimately, reducing the length and cost of clinical trials and improving their success rate is dependent on one thing in particular: improved data management and movement.
On that front, the pharmaceutical industry faces the same problem as does the rest of the U.S. healthcare system, the fact that most data is stored in proprietary data silos with limited interoperability and transferability.
“The issue that we all struggle with in pharma is … the fact that data is fragmented. If you see five different physicians, you end up with data stored in five different systems,” said Baara.
And for pharma, the limited access to and portability of patient data means that locating and recruiting individuals who meet the eligibility criteria for a given trial is challenging.
The current recruiting process involves hiring research organizations and investigators to beat the bushes, so to speak, by visiting physicians’ offices to find patients who qualify and are interested in participating in a study. The inverse is also frequently true, in that patients with diseases who want to participate in research often have difficulty being matched to an appropriate study.
To bridge these gaps, a blockchain-based system could be used that allows individuals who want to participate in trials to aggregate their health data and make it visible to recruiters, according to the pharma executives.
While the data on the ledger wouldn’t immediately be connected to a particular identity, recruiters could prompt an anonymous eligible candidate, and once the individual consented, their identity would be revealed.
Baara added:
“The beauty with the blockchain is the control is with the individual.”
Circling back
Yet, the individual is sometimes difficult to keep around.
Because clinical studies typically span several years, retaining patients has also become a problem for the industry, particularly since entire studies can be invalidated if enough patients don’t show up within the required time window.
As such, a blockchain-based conduit for patient interaction could offer immediate utility.
“Today doctors and nurses running clinical trial programs are still having to resort to calls or post to remind patients about their appointments, which in this setting are particularly time-sensitive,” said Dany DeGrave, senior director of innovation programs and external networks at Sanofi. “In the future, we envisage automation will make the whole process a lot more efficient.”
Not only do the executives think a blockchain system could automate communication between pharma company and patient, but they also think such a system would ensure the integrity of data. The latter is particularly important as regulatory approval for new drugs hinges on accurate data, and public trust in the pharma industry has ebbed and flowed over the years as stories of fabricated results make headlines.
According to DeGrave, the immutable nature of blockchains could play a critical role in guarding against the falsification of data, and allow the public and other researchers better trust in the systems being used to track data.
Currently, the three companies are working with the IEEE Standards Association, the standards body of the world’s largest technology association, to develop testbeds for implementing the technology and addressing the challenges.
Regulators, for their part, also appear to be warming up to the concept. Representatives from the Food and Drug Administration, the primary agency overseeing the U.S. industry, will share their thoughts on the topic at an industry symposium in February.
Getting it right
But as many industries flirting with blockchain are discovering, finding a sweet spot for implementing the technology is never quite as simple as it may sound.
Specifically in the healthcare setting, firmly entrenched legacy electronic health records vendors, like Epic and Cerner, could stand in the way, much to the chagrin of blockchain startups in the space.
“We need to overcome any barriers to the conversion of health care data into blockchain by providing the right incentives to the incumbents, in order to fully and quickly realize the potential we see in this new technology,” DeGrave said.
That said, though, Pfizer’s Baara expressed optimism that the trend of consumers demanding more control of their personal health data will, over time, incent the current data custodians to relax their stranglehold.
Yet, costs associated with innovating in the space and the risk-averse nature of the heavily-regulated sector also means there’s an additional imperative to make sure things go smoothly the first time around.
“Like in any industry, we need to make sure the technology is mature enough before making sweeping changes to minimize any potential disruption,” said DeGrave, concluding:
“The costs associated with change in our industry are enormous, so we’d better get it right early on.”
Pharmaceutical production line image via Shutterstock