Alexander Seyf, CEO of Autolomous, explains how collaboration—not competition—is the key to overcoming bottlenecks in CGT development.

Autolomous, a leading software provider for cell and gene therapy (CGT) manufacturing, is focused on streamlining operations and digitizing traditionally manual processes. At the helm is CEO Alexander Seyf, who has observed that many of the challenges CGT developers face today have already been tackled elsewhere in the industry. Yet progress is too often stalled by a reluctance to share knowledge.

Seyf argues that the current siloed approach wastes time and resources, as companies repeatedly “reinvent the wheel.” Through increased cooperation and responsible data sharing, he believes the sector could unlock significant efficiencies, enabling faster access to therapies and delivering greater value to patients. In this interview, he outlines the practical, technical, and cultural shifts needed to make that vision a reality.

The company says many development hurdles have been solved before—how do you quantify the time and cost lost when firms choose not to share data?

Quantifying the precise time and cost lost due to a lack of data sharing is difficult to calculate for each company, but industry-wide patterns paint a clear picture. Seyf notes that many developers independently tackle the same manufacturing issues—such as integrating with bioreactors, optimising cell culture workflows, or handling regulatory submissions. In many of these cases, data already exists that could offer solutions, but it’s simply not accessible.

He estimates that each of these common challenges can add three to six months to a development timeline when tackled in isolation. The resulting financial waste can stretch from hundreds of thousands to millions of dollars, depending on the phase of development. Importantly, he emphasises that these delays don’t just affect bottom lines—they also mean patients are left waiting longer for vital treatments.

Seyf also highlights the increased likelihood of project failure when developers lack access to prior learnings. Without visibility into known process variables or pitfalls, companies risk making costly mistakes that could otherwise be avoided. Cumulatively, he believes these inefficiencies are shaving years off industry-wide development timelines and costing billions in avoidable expenditure.

You’ve noted a reluctance to collaborate—what are the main reasons you’ve heard for that hesitation, and how does the company address them?

According to Seyf, the most common reason for withholding data is the belief that proprietary information—particularly in manufacturing—provides a competitive edge. Many companies fear that by sharing, they might lose their market position. However, he points out that structured platforms can enable selective data sharing, allowing companies to control exactly what is shared and with whom. This makes it possible to collaborate meaningfully in pre-competitive areas without exposing core IP.

Another recurring concern is around intellectual property. Companies worry that sharing even anonymised or partial data could inadvertently compromise sensitive knowledge. To mitigate this, Autolomous has developed strong data governance systems that include secure storage, access controls, and audit trails. These systems are complemented by clear legal frameworks and sharing agreements that protect contributors’ rights.

Trust is the final barrier. Seyf acknowledges that companies need to feel confident that shared data will be handled responsibly. That’s why Autolomous prioritises transparency and invests in security measures like encryption and compliance protocols. He believes that by demonstrating ethical stewardship of data, long-term trust can be built across the ecosystem.

The company argues that reinventing solutions wastes resources—can you give an example of a past project where shared data would have prevented a setback?

While specific client stories remain confidential, Seyf offers a generalised example that reflects a common pattern. A biotech company working on an autologous CAR-T therapy experienced major delays during scale-up due to poor transduction efficiency when using a particular viral vector in combination with a bioreactor. The team spent months troubleshooting the issue, incurring high costs and missing key clinical trial milestones.

Had this company had access to anonymised data from other developers using the same vector-bioreactor setup, the outcome could have been very different. They might have uncovered optimal process parameters, such as temperature, mixing speed, or cell density thresholds that were known to influence outcomes. Likewise, they could have avoided pitfalls already documented by others and implemented proven solutions much sooner.

According to Seyf, access to even this kind of targeted, de-identified insight could have cut the troubleshooting timeline dramatically, saving time, money, and ultimately, lives.

You believe increased cooperation speeds up patient access—what specific steps is the company taking to facilitate that cooperation?
To translate its vision into action, Autolomous has launched a sector-wide initiative called Act for Hope. This collaborative movement aims to drive large-scale change by connecting leaders across the cell and gene therapy ecosystem. The goal is to make CGT not only more accessible, but also more widely understood and seamlessly integrated into global healthcare systems.

Seyf explains that any successful therapy must navigate the so-called “3 P’s” equation: securing the alignment of Physicians, Payers, and Patients. With that in mind, Act for Hope is currently focused on four strategic workstreams: educating physicians, informing payers, optimising manufacturing, and fostering knowledge sharing.

Through this initiative, Autolomous is building trusted partnerships across the value chain—from academia and CDMOs to biotechs and technology providers. The company is also working to surface success stories and quantify the impact of collaboration, showing others what’s possible when data is shared responsibly.

The company works with partners across the value chain—how do you ensure all collaborators trust the data they receive and use?

Trust, says Seyf, starts with transparency and continues with rigorous process. Autolomous ensures that data integrity is maintained by verifying provenance and providing full traceability. Data is standardised, clearly defined, and structured in a way that makes it easy to interpret and apply across different use cases.

On the technical side, the company employs strong encryption protocols, granular access controls, and well-defined user roles to ensure that data is only accessible to authorised users. Legal agreements further reinforce expectations around confidentiality and permissible use. Seyf believes that combining technological safeguards with open communication is essential to maintaining trust in a data-sharing environment.

What governance or legal frameworks does the company recommend to other developers to make data-sharing safe and efficient?

Seyf advocates for a strong legal foundation as the starting point for any data-sharing initiative. This begins with comprehensive data sharing agreements that clearly outline what data is being shared, how it can be used, who owns it, and what happens in the event of termination or breach.

He also underscores the importance of regulatory compliance, particularly in jurisdictions governed by laws like the EU’s GDPR. Techniques such as pseudonymisation, data aggregation, and differential privacy can help extract meaningful insights without compromising individual privacy.

On the governance front, Seyf recommends using platforms that support detailed access control and audit trails, allowing companies to assign permissions and track usage. These capabilities are essential for managing risk and encouraging wider participation in collaborative ecosystems.

The company supports open communication among peers—what forums or platforms have you found most effective for frank data exchange?

According to Seyf, there are still relatively few forums that allow for open and meaningful data exchange in CGT. This gap is one of the main drivers behind the Act for Hope initiative. However, he identifies several formats that have shown promise.

Virtual workshops and webinars—particularly those focused on technical or regulatory challenges—can be powerful platforms for knowledge exchange. These events provide opportunities for peer-to-peer discussion and problem-solving, especially when paired with open Q&A.

He also sees value in consortium-led efforts, such as those by the Alliance for Regenerative Medicine, which facilitate collaboration in pre-competitive areas. In addition, the Autolomous platform itself enables peer-to-peer connections between users facing similar challenges. These targeted exchanges, Seyf believes, often lead to the most candid and constructive conversations.

Looking ahead, which areas of drug development do you see as most in need of cross-company collaboration, and why?

Seyf identifies three key areas where greater collaboration could accelerate progress across the board. The first is manufacturing process optimisation. As CGT manufacturing remains a major bottleneck, he believes that sharing insights on core steps like vector production, cell culture, and fill-finish could help standardise operations and improve scalability.

The second is analytical testing and quality control. Standardised methods would reduce variability, improve data comparability, and simplify regulatory submissions—ultimately making therapies easier to validate and approve.

The third is regulatory strategy itself. Seyf argues that companies developing novel therapies can benefit greatly from sharing anonymised case studies and best practices when engaging with regulators. By working together to define clearer pathways, the industry as a whole can reduce friction and speed time to market.

Across all these areas, Seyf believes the benefits of collaboration are no longer just theoretical—they are practical, measurable, and essential for progress.