Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy developers that is reinforcing fragmentation, stalling innovation and delaying access to treatments.
Despite major scientific breakthroughs and recent regulatory streamlining in cell and gene therapy, a number of industry leaders are sounding the alarm over a systemic problem they say threatens both the pace of innovation and patient access: the field’s persistent failure to share data.
While the cell and gene therapy (CGT) sector has long operated under a culture of protection, experts warn that the lack of transparent, structured data-sharing is no longer just an academic debate—it’s contributing to repeated mistakes, wasted investment and companies going under before their therapies ever reach patients.
The CGT space still largely resists open sharing and collaboration, experts told BioSpace. “There is little to no data-sharing occurring today,” Trenchant Bio CEO Jon Ellis said.
While there are various reasons for this, the problem is clear: Sharing learnings collectively is essential for creating a prosperous, thriving ecosystem, rather than one limited by isolated company silos, argued Alexander Seyf, CEO of manufacturing platform provider Autolomous.
In interviews with BioSpace, experts spoke about how the current lack of data-sharing is slowing commercialization across the field. Industry reluctance to share data spans regulatory, clinical and operational domains, Seyf said, reinforcing barriers to market access, payer engagement, pricing and outcomes-based reimbursement that CGT leaders have long struggled to overcome.
A 2019 article examining the risks and delays associated with translating CGT innovations into regulated products highlights how limited data sharing transparency—whether from proprietary raw materials or poorly managed tech transfer—can both delay CGT development and compromise quality control.
Additionally, the authors found that without early standardization and open information exchange, developers risk repeating work—including failures—misinterpreting test results and selecting suboptimal materials. These setbacks compound over time, leading to clinical and commercial delays that drive up costs throughout the CGT pipeline.
Stephen Majors, head of communications at the Alliance for Regenerative Medicine (ARM), agreed that this ingrained reluctance to share data limits commercialization. “The more data that developers share, the more the field overall can advance,” he told BioSpace.
Hurdles to Open Data Sharing
For years, many researchers in cell and gene therapy have championed the value of scientific data-sharing, especially in areas like genomics and rare diseases, where collaboration can directly accelerate patient access to new treatments. Yet a persistent gap remains between intention and execution.
While government agencies like the National Institutes of Health have pushed for transparency through policies including the 2023 NIH Data Management and Sharing Policy requiring data sharing plans, researchers still face practical, ethical and proprietary barriers. Concerns about patient privacy, restrictive consent language and intellectual property protections continue to limit access to datasets.
Ellis argued that this harsh reality is rooted in how the industry’s regulatory framework evolved early on. Specifically, he pointed to an FDA position that emphasized process control, often summarized as “the process is the product,” which inadvertently reinforced secrecy. A developer’s mentality is, “If my process is my product, I’m going to tell no one anything about my process,” he said. “That is not particularly helpful to data-sharing because data-sharing is typically around the process.”
As a result, many companies still view data as a competitive asset, and internal legal teams act accordingly, he continued. “The legal team says: ‘Why are we doing this? Why share anything? What’s in it for us?’ All they care about is protecting our assets.”
Ali Pashazadeh, CEO of investment banking firm Treehill Partners, echoed the description of this dynamic on the commercial side. “Once I generate that data . . . I will publish about 11% of the data, typically when it’s positive,” Pashazadeh told BioSpace of the overall approach to data of researchers, developers and sponsors in CGT. “If it’s a larger player, that goes up to maybe 20%–30% of data that’s published.”
As a result, clinical development teams operate with limited visibility into what’s already been tried, often designing studies that repeat avoidable mistakes. “We’re making the same mistakes over and over,” Pashazadeh said. “Patients will be subjecting themselves to clinical studies when actually . . . they could have been in a better study design.”
Seyf also pointed to a lack of proper digital foundation at the root of the industry-wide failure to share data. “From a digitization perspective, we are at Industry 1.0, at best,” he said. “Right now, capsules of knowledge are in people’s minds, on paper, in chest drawers and filing cabinets.”
The cost of this immaturity is not theoretical. Outcome-based payments, where insurance payments are tied to the quality of care provided rather than the quantity of services, “will be the only viable model for the foreseeable future, but you cannot implement them without real data capture,” Seyf said.
As commercial pressures mount, many developers are now feeling the consequences of this siloed approach—but lack the funds or infrastructure to make the necessary changes. “There’s so many challenges in the industry right now: lack of money, lack of resources,” Ellis said. “Digitization comes toward the back of the queue when you’ve got clinical trials to fund.”
Dan Strange, CTO and co-founder of Cellular Origins, an automated CGT manufacturing technology company, agreed. “Some companies are starting to adopt standards . . . but it’s a matter of time and development over the next few years.”
According to Pashazadeh, this fractured development environment is directly tied to the financial fragility faced by many companies. Early-stage developers in particular often “struggle to design the best study based on the limitations of the available data,” he said, while noting that improved real-world evidence sharing could shave tens of millions of dollars in the development timelines of new therapies.
Particularly frustrating to experts are the setbacks that could have been avoided if companies were more willing to share not just their successes, but also their failures. Seyf pointed to more mature industries like aviation, where critical information is routinely shared. For example, he said, flight data from a black box is made available to all airlines after a crash to help prevent future failures across the entire industry.
“As much as [CGT companies] think they’re all unique, they’re not,” Ellis said. “You’d be shocked how similar some aspects are between them. . . . Divulging what they know doesn’t work would at least be helpful.”
Unlocking CGT’s Comeback
Despite these frustrations, the experts emphasized that meaningful solutions are within reach—if stakeholders across the ecosystem step up.
“There’s significant appetite from our members to solve these sorts of challenges together,” Majors added. He noted that ARM has been actively convening developers on this front through pre-competitive initiatives like its A-Gene and A-Cell manufacturing best practices guides.
Disease registries may be one part of the answer, according to Majors. “Randomized controlled trials are often unethical and/or implausible for rare disease therapies, but regulators still need a comparator to evaluate clinical benefit,” Majors said. “Disease registries can provide this comparator data.”
Both Ellis and Pashazadeh argue that even modest clearinghouse models—focused on anonymized, pre-competitive operational data—could help. “If everybody takes a step back . . . can we as a collective get to the market quicker, easier, with lower manufacturing costs?” Pashazadeh asked. This way, “we grow the size of the pie” for everyone.
This has the potential to “be the rising tide lifting all boats,” Ellis said.
Several experts argue that while industry collaboration is critical, regulators are uniquely positioned to catalyze action. “I’d love to see an FDA workshop: everyone gets together, everyone is there, everyone agrees on what we’re going to deliver,” Ellis said. “We don’t need 500-page documents—we need deliverables, real milestones.”
American Society of Gene and Cell Therapy (ASGCT) CEO David Barrett emphasized the importance of ongoing collaboration with regulators. ASGCT was among the founding partners of the Standards Coordinating Body for Regenerative Medicine developing industry standards specific to this field.
Barrett also voiced optimism regarding the FDA’s evolving leadership. “There is a continued and increased focus on transparency, which will have a very positive impact on the field,” he told BioSpace, pointing to recent remarks by Nicole Verdun, former super director of the FDA’s Office of Therapeutic Products (OTP), encouraging CGT sponsors to share data, particularly in rare diseases. Notably, Verdun was placed on administrative leave, along with her deputy, Rachael Anatol, last month.
The stakes are high—not just for companies, but for patients waiting on these therapies.
“Collaboration is absolutely going to help us thrive,” Ellis said. “Otherwise,” he cautioned, “I’m scared this industry really is in trouble. And that’s a tragedy because it’s so powerful.”
