Článek
RAPS Convergence 2025: Transparency, Trust, and Resilience in Regulatory Science
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Michael Day, Ph.D
Takeaways from RAPS Convergence 2025
RAPS Convergence 2025 highlighted an important transition across the regulatory landscape. Regulators and sponsors are expected to operate with greater visibility—communicating decisions, sharing data, and adapting plans in real time. Across plenary and technical sessions, the focus was on how to maintain scientific integrity and consistency while managing growing public scrutiny and complex product development.
My session — “Regulatory Agility in Action: Avoiding FDA CRLs with the Strategic VDC (Virtual Development Center) Approach” — addressed one clear example of this shift: FDA’s public release of Complete Response Letters (CRLs). This topic was also part of a much broader discussion, with several sessions highlighting trends that are shaping how development programs should be designed and managed.
My session — “Regulatory Agility in Action: Avoiding FDA CRLs with the Strategic VDC (Virtual Development Center) Approach” — addressed one clear example of this shift: FDA’s public release of Complete Response Letters (CRLs). This topic was also part of a much broader discussion, with several sessions highlighting trends that are shaping how development programs should be designed and managed.
1. Transparency Is Changing Regulatory Practice
Transparency and public trust were central topics throughout the meeting. The FDA’s decision to publish more than 200 historical CRLs and begin real-time release of future letters represents a significant change in how regulatory outcomes are communicated.1
This shift reinforces that regulatory feedback will increasingly enter the public domain. Sponsors will need to plan submissions that are internally consistent, clearly justified, and defensible against public and scientific review. The transparency theme was also reflected in:
The consistent message: transparency is now a baseline expectation. Clear scientific rationale, well-documented decision-making, and consistent communication will define quality as much as technical precision.
This shift reinforces that regulatory feedback will increasingly enter the public domain. Sponsors will need to plan submissions that are internally consistent, clearly justified, and defensible against public and scientific review. The transparency theme was also reflected in:
- Public trust sessions, which addressed how agencies explain their decisions and communicate uncertainty.
- Workshops on data sharing and digital review, highlighting that reviewers need access to structured, interpretable data rather than static reports.
- Discussions on global harmonization, where regulators and sponsors recognized the value of aligned expectations and consistent information exchange.
The consistent message: transparency is now a baseline expectation. Clear scientific rationale, well-documented decision-making, and consistent communication will define quality as much as technical precision.
2. Agility With Defined Controls
Speakers repeatedly emphasized that agility must be systematic, not improvised. Effective organizations plan for uncertainty by defining project decision gates, establishing clear review points, and documenting how data changes will be managed.
This structured flexibility mirrors the lessons from many recent CRLs. Sponsors who had defined contingency plans and pre-aligned cross-functional communication were better able to respond to regulatory questions without major disruption. Examples discussed included:
The clear takeaway: flexibility is essential, but it must exist within a controlled framework.
This structured flexibility mirrors the lessons from many recent CRLs. Sponsors who had defined contingency plans and pre-aligned cross-functional communication were better able to respond to regulatory questions without major disruption. Examples discussed included:
- Adaptive trial and submission models that allow updates without undermining prior work.
- Advanced therapy and mRNA programs, where scientific uncertainty requires flexible planning and continuous data reassessment.
- Case studies on program pivots, showing that early scenario mapping prevents reactive, high-cost corrections later.
The clear takeaway: flexibility is essential, but it must exist within a controlled framework.
3. Data and Evidence as a Cohesive Scientific Narrative
Many technical sessions emphasized that the strength of data depends on how well it is integrated and interpreted. Regulators expect not only valid results, but also a coherent explanation of how each dataset supports product quality, safety, and efficacy. Key insights included:
In the context of CRL transparency, this principle is critical. Many public CRLs cite incomplete or disconnected data narratives rather than outright technical failures. The meeting reinforced that clarity of explanation is as important as the underlying data itself.
- Real-world and digital evidence discussions, showing how new data sources are reshaping regulatory confidence in traditional endpoints.
- Workshops on endpoint and assay integration, demonstrating that inconsistencies between CMC and clinical narratives can undermine overall credibility.
- Panels on digital review tools, where agencies outlined their move toward structured data formats and automated consistency checks.
In the context of CRL transparency, this principle is critical. Many public CRLs cite incomplete or disconnected data narratives rather than outright technical failures. The meeting reinforced that clarity of explanation is as important as the underlying data itself.
4. Integration Across Disciplines Prevents Avoidable Risk
Several sessions examined how communication breakdowns between CMC, clinical, and quality functions contribute to regulatory setbacks. Cross-functional alignment was repeatedly identified as a leading indicator of submission quality. Key points discussed included:
In this context, the VDC approach discussed in my session aligns closely with the meeting’s emphasis on integration and accountability.
- Speakers highlighted situations where teams that maintained structured handovers and shared narrative continuity were able to manage regulatory questions more effectively.
- Internal “joint review” meetings across CMC, nonclinical, statistics, and regulatory functions were cited as best practice.
- The most effective sponsors viewed regulatory compliance as a shared responsibility across development, not a downstream task.
In this context, the VDC approach discussed in my session aligns closely with the meeting’s emphasis on integration and accountability.
5. Increasing Modality Complexity Requires Strong Fundamentals
Sessions on cell and gene therapies, mRNA platforms, and novel biologics highlighted that as product complexity increases, the importance of scientific fundamentals becomes even more critical.
The message was consistent: innovation cannot replace control. Robust data, validated methods, and sound documentation remain the cornerstone of regulatory reliability.
- Manufacturing scalability, assay robustness, and comparability were recurring themes.
- Several talks emphasized lifecycle control and validation strategies as determinants of long-term regulatory success.
- Across modalities, stability, potency, and control strategy remain the foundation for credibility with health authorities.
The message was consistent: innovation cannot replace control. Robust data, validated methods, and sound documentation remain the cornerstone of regulatory reliability.
Take-Home Messages
The sessions underscore the importance of transparency, trust, and resilience across the product development lifecycle. The emphasis needs to be on designing submissions that can stand up to both regulatory and public examination.
Resilience in design is key, with outcomes from regulators and sponsors alike showing that structured planning and decision architecture can reduce late-stage surprises. As important is to ensure data is gathered and connected across disciplines, and not presented as isolated results, so that it tells a coherent story about the product. Moreover, cross-collaboration and integration help to mitigate many of the regulatory issues encountered when functions fail to communicate. And programs that are internally consistent, traceable, and defensible will be most likely to succeed.
Ultimately, evidence about a product’s potential requires scientific rigor and a commitment to the fundamentals of R&D.
Resilience in design is key, with outcomes from regulators and sponsors alike showing that structured planning and decision architecture can reduce late-stage surprises. As important is to ensure data is gathered and connected across disciplines, and not presented as isolated results, so that it tells a coherent story about the product. Moreover, cross-collaboration and integration help to mitigate many of the regulatory issues encountered when functions fail to communicate. And programs that are internally consistent, traceable, and defensible will be most likely to succeed.
Ultimately, evidence about a product’s potential requires scientific rigor and a commitment to the fundamentals of R&D.
About the author:
Michael Day, Ph.D., is Senior Director of Regulatory Strategy and CMC at Cencora. Mike brings more than 25 years of regulatory, CMC, and quality experience, including direct interactions with FDA on CRLs and BLA submissions in cell and gene therapies.
Disclaimer:
The opinions expressed in this article are solely those of the author and does not constitute legal advice. Cencora, Inc., strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.
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Source:
1. https://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters
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