CGT Industry Must Adopt 'Aviation-Style' Data Sharing to Avoid Systemic Failure

The cell and gene therapy (CGT) industry is operating in a state of data isolation that threatens the viability of the entire sector. Alexander Seyf, CEO of Autolomous, warns that the field is in a "pre-black box" stage, where a culture of data hoarding and silos prevents the industry from learning from collective failures.

Writing for BioSpace, Seyf compares the current state of CGT to early aviation, a period where the absence of shared safety data hindered progress and cost lives. He argues that the industry must transition to a model of transparency—specifically sharing non-IP data and failures—to prevent systemic setbacks. As an example of the fragility of the current ecosystem, Seyf cites 2025 deaths from acute liver failure following treatment with Sarepta Therapeutics’ AAV-based gene therapies. He notes that such safety events in a single program can reset the risk conversation for all AAV programs across the entire field, regardless of the specific company involved.

The Data Gap

According to Seyf, the industry is attempting to apply traditional pharmaceutical processes to live-cell therapies, a mismatch he describes as using "flat-head screwdrivers on star-shaped screws." To move beyond this, he proposes a "three-legged stool" of essential integrated data: scientific data, manufacturing data, and post-treatment data.

However, Seyf contends that even this framework is incomplete. He identifies a "fourth leg" of data—genetic elements that manifest before a disease occurs—which he argues is currently being ignored. Without this preemptive genetic data, he warns that AI models are left with only half the necessary picture to truly optimize patient outcomes.

The Role of AI

To bridge these gaps, Seyf proposes using artificial intelligence as the "connective tissue" capable of integrating these disparate data silos. By synthesizing scientific, manufacturing, and clinical data, AI can help the industry identify patterns of failure and success that are currently invisible to individual companies.

"We must stop operating in silos and obsessively protecting our intellectual property (IP) while often ignoring the common failures that could teach us how to survive as an industry," Seyf stated. He emphasizes that the specialized nature of autologous, patient-specific treatments means that a failure in one program can damage public and regulatory trust in the entire modality.

The Path Forward

The shift toward a collaborative, pre-competitive data-sharing ecosystem is becoming a necessity as the FDA pushes for more standardized data. Transitioning away from a zero-sum competitive mindset could significantly reduce wasted research years and accelerate the delivery of life-saving treatments.

As the industry evolves, the primary challenge remains the willingness of firms to prioritize collective safety over absolute secrecy. Seyf concludes that the stakes are too high for continued isolation: "If we guard our secrets, patients suffer. Only through a commitment to transparency and data sharing—and artificial intelligence—can we make cell and gene therapies safer and more effective."