Are You Post-Approval Ready? What the FDA’s New Guidance Means for CGT Enabling Technology Providers
Earlier this month, the FDA released its draft guidance on post-approval methods for collecting safety and efficacy data for cell and gene therapies. For many in the field, this felt like an incremental regulatory update. But for those who have followed our recent Lonrú Lens analyses, the shift fits a pattern we have been tracing for months. Our Evidence and Access Navigator mapped how post-approval data expectations in Europe and the United States are tightening. Our CRISPR Clinical Trials Dashboard highlighted the growing need for long term durability data across emerging gene editing programs. Our insights on the evolving UK ATTC and point-of-care manufacturing ecosystem showed how identity and batch data must persist across years of follow-up. And our Investment Signal Heatmap made clear that capital is flowing toward platforms that can prove durability and long term safety, not just early clinical success. The new FDA draft guidance brings all of these threads together. It elevates the importance of long term evidence and makes clear that enabling technology providers will be central to generating, structuring, and sustaining that evidence over the full lifecycle of a CGT product.
Most early reactions to the guidance focused on what it means for sponsors, but a more important shift is happening underneath the surface. Enabling technologies are becoming central to how long term evidence is shaped and maintained. At Lonrú, we see this guidance as the moment when enabling technology providers begin to play a more strategic role in defining the durability, safety, and comparability narrative that accompanies a therapy well beyond initial approval.
FDA’s message is clear: For CGTs, post-approval evidence is part of the product itself. Sponsors must be able to demonstrate ongoing safety, durability, manufacturing comparability, and patient level follow-up for as long as the therapy is on the market. For many products, this extends out 5, 10, even 15 years. No sponsor can maintain this level of data integrity alone. They depend on the platforms, orchestration systems, QC and potency tools, analytics technologies, registry-compatible datasets, and patient outcome solutions built by enabling technology providers.
This shift changes how companies in this space can differentiate. Enabling technologies have traditionally been seen as the infrastructure that keeps cell and gene therapy programmes moving. They manage the workflow, the scheduling, the identity, the metadata, the QC, the batch analytics, or the data capture. They remain essential in those roles. But the FDA guidance adds a new dimension. A platform is no longer judged only on the efficiency it brings to development or manufacturing. It is also judged on how well it contributes to the evidence the sponsor must ultimately defend.
Many enabling technologies already sit close to these evidence streams without framing themselves that way. Orchestration platforms hold identity events that can support long term data linkage. QC and CMC technologies maintain structured batch histories that help correlate changes in process with changes in clinical outcomes. Analytics engines convert raw clinical and real world data into harmonised datasets that align with regulatory expectations. Patient outcome tools become natural anchors for long term follow-up. Even companies whose tools sit entirely on the manufacturing or data layer still contribute critical information that supports evidence continuity.
The FDA has not asked enabling technology providers to reinvent themselves. It has simply clarified the importance of the capabilities they already provide. What is missing is a structured way for these companies to understand how their technology aligns with this new evidence environment and where further development or integration would create commercial advantage.
To help with this, we created the VantagePoint™ Post-Approval Evidence Readiness Scorecard. It is designed specifically for enabling technology companies and reflects the evidence domains highlighted in the new guidance. Instead of assuming all companies operate in the same space, the Scorecard begins by asking users to identify the archetype that best describes their technology. A manufacturing or CMC platform will naturally be strongest in different areas than a patient data system or an analytics engine. The Scorecard accounts for that by adjusting how each domain is weighted and how the overall readiness score is calculated.
The output is clear and practical. Users receive a weighted score that reflects what they can realistically influence, an assessment that highlights their strongest areas, and targeted recommendations for where strengthening or partnering could create the most strategic uplift. The aim is not to present a standard that all companies must match. Instead, it offers a realistic and forward-looking view of how each company already contributes to the evidence landscape and where new value can be created as expectations grow.
From Lonrú’s perspective, this is the moment for enabling technology providers to step into a more strategic role in the CGT ecosystem. Companies that understand how they support post-approval evidence will be the ones sponsors rely on as therapies progress from early trials into long term real world use. Their technologies will not only support operations, but will help secure the long term success of the therapies themselves.
You can explore the VantagePoint™ Post-Approval Evidence Readiness Scorecard below. It only takes a few minutes and provides a clear perspective on how your technology aligns with the evidence needs that will define CGT development in the years ahead. If you would like to discuss your results or explore how your platform can strengthen its position in this evolving environment, Lonrú would be glad to help.
