Four things that don't behave like a small molecule
The toxicity window is measured in hours
CRS and ICANS can escalate within hours of infusion — a review cadence built for weekly safety batches misses the window entirely.
Chain of identity never stops mattering
From leukapheresis through manufacturing to infusion, the product is the patient's own cells — an identity error is a patient-safety event, not a paperwork error.
Follow-up runs for years
Long-term follow-up for genetically modified cell products extends well past the trial's primary endpoint — the safety obligation doesn't end at database lock.
Site readiness is part of the safety plan
Sites need ICU-level escalation pathways in place before the first patient is dosed — not discovered during the first CRS event.
Four recurring failure points
Dose-escalation designs borrowed from small-molecule oncology don't fit a product with a delayed, evolving exposure curve.
CRS/ICANS grading criteria left ambiguous until the first event forces an inconsistent, retrospective call.
RMAT and expedited-pathway strategy started too late to shape the pivotal trial design it was meant to inform.
Site activation outpaces site readiness — a center added for enrollment speed without the escalation pathway a CRS event requires.
Where the judgment sits, stage by stage
Dose-escalation design and CRS/ICANS signal definitions, set before protocol lock.
Site readiness review — escalation pathway and ICU access confirmed before activation.
Named physician adjudicates every CRS/ICANS-graded event, on the clock the toxicity actually runs on.
Long-term follow-up design and signal management across the multi-year observation period.
Named, credentialed, and on the record
Dr. Ashok Srivastava, MD, Ph.D., MBA
President & Chief Medical Officer
Board-certified oncologist with direct clinical development and BLA filing experience in CAR-T cell therapy, including playing a key role in the approval of AUCATZYL® (obe-cel). 135 oncology & hematology trials across 20 countries.
Educate · Evaluate · Execute for CAR-T
CAR-T safety briefing
CRS/ICANS grading, site-readiness expectations, and RMAT strategy — for your board and clinical team.
IHASG Readiness Assessment
A graded review of your safety governance against a CAR-T-specific standard, with a roadmap to Level 4.
Continuous Medical Oversight
A named physician reviewer on the Workbench, adjudicating every CRS/ICANS-graded event as it happens.
Questions CAR-T programs ask us
Do you review CRS/ICANS events on the clock they actually happen on?
Yes — Continuous Medical Oversight is built for same-day, not same-week, adjudication, with the named reviewer's decision documented as it happens.
Can you help with site readiness, not just protocol design?
Yes — site-readiness review, including escalation-pathway confirmation, is part of our start-up-phase expert-in-the-loop role.
Is this specific to CD19 CAR-T, or does it extend to other targets?
Our named CAR-T experience is CD19-specific; the underlying safety-governance discipline — signal definitions, documented adjudication, audit trail — applies across CAR-T targets and is scoped to your program on a call.
Talk to a cell therapy expert.
Bring us the dose-escalation design, the signal definitions, or the safety review you're building.
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