It’s been a few years since Frank Nogueira watched pallets of hard copy documents being loaded onto a truck from a loading dock so that data could be transferred from the developer to anyone else along the pipeline who needed the crucial data, including health care agencies.
But remember it he does, and those are days he doesn’t miss. Even in the past 10 years as the hard copies of data have transformed into pdfs or some other virtual format, Nogueira, the CEO of Accumulus Synergy Inc., is moving forward with what he and 10 other big players think of as more efficient methods of doing business.
Busting a logjam of inadequate data sharing methods and communications between pharmas and health authorities around the world is the impetus behind the creation of nonprofit Accumulus, whose common, cloud-based platform is designed to make the regulatory process easier for everyone involved.
The coalition’s initial membership is a Who’s Who of big pharma: Amgen Inc., Astellas Pharma Inc., Bristol Myers Squibb Co., Glaxosmithkline plc, the Janssen Pharmaceutical Cos. of Johnson & Johnson, Eli Lilly and Co., Pfizer Inc., Roche Holding AG, Sanofi SA and Takeda Pharmaceutical Co. Ltd.
An industry often plagued by unnecessary complexities and inefficiencies in communications and data transfer needs an alternative, the consortium said, in order to ultimately lower the costs of innovating and getting medicines more quickly to the market.
“The time is right if you think about where technology has evolved,” Nogueira, who is also vice president of regulatory affairs at Roche, told BioWorld.
COVID-19 has accelerated the thinking that the industry needs to be more fluid in its communication methods, he said.
Does each of the coalition members see this new path in exactly the same way? No, Nogueira said, they often see things differently but the common touchstone, he added, is doing “the right thing for patients.”
Efficiencies in the regulatory process can be made. The consortium said those include leveraging advanced technology such as data science and artificial intelligence. Over the past 30 years, terabyte upon terabyte of information has been logged and shipped by developers to their partners or to health care agencies and often it’s all on a pdf. It’s not quite like loading pallets of hard copies onto a truck so it can hit the road, but Nogueira said he sees the day the pdf data is no longer trapped there and can stand alone with the proper algorithms.
“I would love to have the data and the narrative exist in harmony,” he added.
The goal of the platform is to meet regulatory, cybersecurity and privacy requirements from development to manufacturing to submissions to regulatory agencies. The consortium, formed in 2020, said it plans to collaborate with health care authorities, including the FDA, the EMA and the U.K. Medicines and Healthcare products Regulatory Agency.
“We’ve talked to the FDA,” Nogueira said. “They are equally interested and, as of December 2020, we signed a public-private partnership with the FDA and said we will work in an open way and collaborate on a common goal in exchanging data in a better way.”
The only other industry with similar cost and complexity issues is the airline manufacturing industry, Nogueira said. The pharmaceutical industry, he added, is in the more unique position in terms of how long it monitors patients over time and the lengths of its studies.
Accumulus is preceded in the effort to streamline drug development by Transcelerate Biopharma Inc., a nonprofit that launched in 2012 with 10 of the industry’s big pharmas focused on improving the speed and quality of clinical trials by finding and resolving common bottlenecks in study design and execution.
Transcelerate’s original lineup included many that are on Accumulus’ roster, such as BMS, Lilly, Glaxosmithkline, Pfizer, Roche and Sanofi. But it also had Abbot , Astrazeneca plc, Boehringer Ingelheim GmbH and Genentech Inc. on board. The collaboration’s initial projects included developing a shared user interface for investigator site portals, joint recognition of study site qualification and training, developing risk-based site monitoring standards, developing clinical data standards and establishing a comparator drug supply model.
Transcelerate’s most recent initiatives came in October 2020, when it launched four new projects. One of the four was the creation of a new module in its data-sharing platform enabling patient-level data sharing of both the investigational product and control arms of COVID-19 clinical trials, including the supporting documentation.