The cell and gene therapy (CGT) field stands at a pivotal moment. Scientific breakthroughs are outpacing the infrastructure designed to deliver them. While innovation in discovery continues to accelerate, manufacturing, data systems, and operational practices often lag. The result is a patchwork of disconnected processes that slow the pace of bringing therapies to patients. The path forward is not just about new technology; it's about shared commitment to digital transformation, interoperability, and standardization.
This message resonated throughout both the Medicine Maker Sharing is Caring: The Secrets of CGT roundtable and the inaugural Title21 Advisory Council meeting. In the former, CGT manufacturing industry leaders assembled to address how secrecy is hindering the progress of cell and gene therapy. The council also brought together leaders across the advanced therapies ecosystem, including Stella Vnook, Jeff Liter, Elena Maryamchik, Robert Richards, and Caitlin Cahill, alongside Title21 senior leadership. Together, these discussions reveal a growing consensus: data must move as freely as the science itself if the industry is to unlock the full potential of advanced therapies.
The digital foundation for standardization
In both conversations, experts from across the industry highlighted the importance of standardization and pointed to digitalization as its essential foundation. At the Medicine Maker roundtable, panelists noted that data cannot be standardized if it remains trapped in silos, spreadsheets, or paper binders. The group emphasized that the first step toward meaningful collaboration is to ensure that information exists in a digital, accessible format.
The Advisory Council echoed this view, identifying interoperability between systems as one of the sector's most pressing challenges, particularly as manufacturing models become increasingly decentralized. Academic centers, hospitals, and manufacturing partners each operate under unique data frameworks and workflows. Without digital tools capable of bridging these systems, even the most advanced therapies risk delay at every handoff.
Council participants highlighted that progress requires both technological and linguistic alignment. It is not enough to digitize processes; organizations must also share common definitions and data standards. Standardizing nomenclature, forms, and chain-of-custody documentation across institutions allows digital systems to exchange information seamlessly, reducing the potential for errors and lost time.
Moving from proprietary to collaborative thinking
Both the roundtable and Advisory Council challenged one of the industry's enduring barriers: the instinct to protect too much data as proprietary. Participants agreed that while intellectual property must be safeguarded, many process insights could be shared without risk, especially those related to operational best practices. Doing so is critical for allowing the broader community to avoid unnecessary duplication and accelerate learning across programs.
Council members discussed the importance of developing secure digital frameworks that encourage collaboration while maintaining privacy. They explored established methods such as role-based data access, anonymized sandboxes, and blockchain to allow secure data exchange without exposing sensitive information. These approaches enable institutions to share key process insights, such as standardized collection or manufacturing parameters, while protecting patient confidentiality and competitive advantage.
This digital transformation is more than a technical initiative. It requires a cultural shift that promotes collective learning and shared progress across the field.
Predictive analytics and the power of shared data
Across both meetings, a consensus formed on the importance of analytics as the bridge between scientific insight and operational performance. Predictive analytics can transform reactive decision-making into proactive control, improving both quality and scalability. The right predictive models will depend on consistent, comparable data drawn from across the value chain.
The group emphasized that interoperability is not simply a technology issue; it directly affects patients. When clinical and manufacturing data flow seamlessly, it allows teams to anticipate risks, optimize scheduling, and reduce variability. These efficiencies translate directly into improved outcomes and safety for patients waiting for the development of critical therapies.
Participants also discussed how organizations can better communicate the return on investment from digitalization. Predictive tools not only support regulatory compliance but also deliver measurable gains in cost efficiency, throughput, and product quality. For smaller developers, analytics that integrate scientific and operational data can make the difference between a promising therapy and a sustainable business model.
Building shared infrastructure for the future
A recurring theme in both discussions was the need for neutral ground, shared platforms, standards, and data structures that transcend competitive boundaries. Roundtable participants called for neutral third parties and scientific societies to steward industry-wide data sets, ensuring transparency and trust. Advisory Council members agreed that regular cross-sector dialogue is vital to sustaining progress and preventing fragmentation as more organizations build their own manufacturing capabilities.
Specifically, the Council noted that collaboration between hospitals, academia, and manufacturers should reflect the continuum of care itself. Each entity contributes critical data from different steps throughout the patient journey, from cell collection through product infusion. Digital systems that can unify this lifecycle view are essential for long-term scalability and global access.
The risks of failing to build shared infrastructure are tangible, participants warned. Without it, isolated digital solutions were likely to proliferate and could create new bottlenecks rather than removing existing ones. Establishing interoperable, standards-based frameworks will ensure that innovations developed in one institution can be effectively replicated and scaled across others.
The human imperative behind digital transformation
Both groups called attention to the underlying motivation for collaboration: digital transformation is about people as much as systems. Standardization creates predictability, but it also fosters trust. Clinicians can act with confidence knowing that the data before them is accurate and complete. Patients benefit from therapies delivered with greater consistency and safety.
Council members observed that digital tools amplify human expertise, not replace it. When designed well, technology makes data more actionable and processes more transparent, enabling healthcare professionals to focus on what matters most: patient care.
From insight to implementation
The insights shared across both the Medicine Maker roundtable and the Advisory Council meeting reflect a growing alignment throughout the industry. Stakeholders from across the CGT ecosystem, including clinicians, manufacturers, academic centers and technology leaders, are recognizing that digital transformation is not a competitive advantage but a shared responsibility.
As the sector moves toward more decentralized and personalized care models, collaboration on data standards, interoperability, and analytics will be essential. Consistent, connected data can shorten manufacturing timelines, reduce variability and improve safety monitoring, all of which translate directly into better patient access and outcomes. Predictive insights built on shared data will help identify risks earlier, optimize production, and ensure that therapies reach patients faster and more reliably.
The industry's challenge now is to move beyond imagining what digital transformation could achieve to collective execution. Sustained progress will depend on aligning around common frameworks and governance models that support both innovation and trust.
As Jonathan Wofford, Chief Commercial Officer at Title21 Health Solutions, has notes, this kind of collaboration is critical to advancing CGTs. That sentiment captures the shared mission of the entire field: to ensure that the promise of advanced therapies becomes a reliable, safe, and scalable reality for every patient who needs them.