Zhaohui Su, VP, Strategic Consulting at Veristat, shared a post on LinkedIn:
“Cell based therapies are revolutionizing the treatment landscape for cancer and rare diseases. Despite the FDA‘s emphasis on flexibility, sponsors often encounter uncertainty regarding the practical application of these principles. The 2026 issue brief from Friends of Cancer Research and Parker Institute for Cancer Immunotherapy identifies key areas where increased clarity could facilitate more efficient development:
1. Early-phase clinical development
Unclear expectations during IND preparation frequently result in repeated revisions and duplicated efforts. A clearer framework is necessary to balance consistency with product-specific flexibility, ultimately reducing uncertainty and enhancing early-phase efficiency.
2. CMC & lifecycle management
The manufacturing processes for cell therapies evolve rapidly, yet regulatory expectations do not always keep pace. Sponsors often adopt conservative strategies, which can lead to increased costs and complexity. A lifecycle-based approach that includes staged specifications and flexible comparability could better align regulatory expectations with development realities while ensuring quality.
3. Clinical trial design and evidence expectations
As therapies like CAR-T are introduced in earlier treatment lines, the expectation for randomized trials presents feasibility, ethical, and operational challenges. There is a pressing need for clearer guidance on when alternative designs or novel endpoints may be suitable to support more predictable and efficient late-stage development.
Ongoing collaboration among regulators, sponsors, clinicians, and the broader ecosystem is important to effectively translate flexibility into practice and ensure that innovation reaches patients without unnecessary delays.”
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