By Benjamin Ross

August 16, 2018 | TransCelerate and its subsidiary BioCelerate have announced a new technology platform, DataCelerate, which will allow multiple de-identified research and development (R&D) data types to be submitted, uploaded, converted, harmonized, and downloaded through an access controlled, secured environment.

Mike Graziano, Vice President of Drug Safety Evaluation at Bristol-Myers Squibb and project leader of the BioCelerate Toxicology Data Sharing Initiative, told Clinical Informatics News the concept behind the platform is fairly simple.

“By sharing data among member companies, we can learn from each other and increase the overall efficiency of the drug development process,” Graziano said. “The real value of this project is going to be based on the amount of data that’s entered into the system. The more data in the system, the more value we generate.”

DataCelerate’s technology can support both structured and unstructured data and is built on the Accenture Insights Platform (AIP) by Accenture Applied Intelligence to provide dynamic search, analytics, visualization, and reporting.

The platform’s first data set—preclinical toxicology data—is live and accessible to participating BioCelerate Member Companies. In a press release, TransCelerate stated their Placebo and Standard of Care (PSoC) data repository will be migrated into DataCelerate, expanding the volume of data to include over 85,000 patients and in excess of 130 studies in nearly 20 therapeutic areas ranging from diabetes to rare conditions such as Duchenne muscular dystrophy.

Preclinical toxicology was a high priority project, Graziano said, because the system technology and regulatory format (SEND data) could be used as the basis for other types of CDISC data.

“When we designed the platform, we did so with the intent that we would in fact be able to expand the types of data that you could collect through this system and actually link it and include it to clinical data,” he said. In fact, Graziano went on to say that TransCelerate is currently working on getting their placebo-control database linked to the toxicology data sharing platform.

It’s About Working Together

Graziano sees DataCelerate as representing a shift in mindset for the clinical trial industry saying that, as far as he’s aware, this is the first time within the pharmaceutical industry that companies have come together and agreed to share individual animal data from pre-clinical toxicology studies on a large scale using a standard regulatory format.

“I think companies are realizing that drug development is extremely difficult,” said Graziano. “Anything we can do to help ourselves and help each other really benefits all of us.”

He says that, historically, companies have taken an introverted approach to research.

“I can remember the perspective that I had several years ago where I didn’t want to participate in forums like this,” Graziano recalled. “I always felt I knew what I was doing and I had a better approach and strategy than everybody else, and I didn’t want to share what I had learned. But I came to realize that everyone feels the same way and that we could all learn from each other.”

Since DataCelerate’s went live earlier this summer, Graziano says he’s seen participating companies start to overcome their reluctance to share more information on their assets. To help alleviate these fears, he says the data sharing agreement is being modified to include structures on a voluntary basis. “If a company feels comfortable releasing the structure they can do that,” said Graziano. “But it’s not obligated.”

“If two or more companies are working on a particular target in growth development, they could see that in the database,” he continued. “They could see whether or not the toxicity they’re seeing with their compound are similar to what other companies are seeing with their compounds of the same target. This gives companies a better understanding of on- vs. off-target toxicity.”

The shared platform also assists in defined decision making, according to Graziano. As a toxicologist, he’s seen a lot of programs where toxicology issues pop up, and when asked if those same issues were observed by other companies, the answer is usually, “We don’t know.”

“It would be great to be able to use the toxicology data set to see that Company X saw this [toxicology issue] as well and was able to move their asset forward, so it looks like we can overcome this liability,” he said.

Five companies are currently utilizing DataCelerate, Graziano said, with the plan being to expand in the coming months.

“Now that the system is up and developed, we’re getting a lot of interest from other TransCelerate Member Companies who are considering joining [DataCelerate],” said Graziano. “So the more Member Companies we have, the more studies that go in, and the greater value we’ll have.”