Four things a chemotherapy playbook gets wrong
Toxicity is organ-specific, not diffuse
Ocular surface toxicity, interstitial lung disease, and hepatic effects appear in patterns a chemotherapy-shaped monitoring plan under-weights or misses entirely.
The payload — not the antibody — drives the signal
Payload class and linker stability determine which organs are at risk; the antibody target alone doesn't tell you what to watch for.
Specialist referral pathways need to exist before dosing
Ophthalmology, pulmonology, or hepatology referral triggers built into the protocol catch signals early — added after the first event, they catch them late.
Off-target delivery is a distinct failure mode
Linker instability releasing payload systemically is a different safety question from on-target, off-tumor effects — and needs its own signal definition.
Four recurring failure points
Monitoring schedules borrowed from a prior chemotherapy program instead of built around this ADC's specific payload and linker chemistry.
Organ-specific signals — ocular, pulmonary, hepatic — adjudicated by a generalist reviewer without the modality-specific map the molecule requires.
Labeling and REMS strategy for organ-specific toxicity started too late to shape the monitoring plan it was meant to inform.
Sites without the specialist referral network the protocol assumes — an ophthalmology consult that takes three weeks when the signal needs three days.
Where the judgment sits, stage by stage
Organ-aware signal definitions and specialist referral triggers, set from the payload's known toxicity profile.
Site readiness review — confirming the ophthalmology, pulmonology, or hepatology referral pathway actually exists.
Named physician adjudicates organ-specific signals against the payload-aware criteria set at study start.
Label-relevant organ toxicity surveillance and signal management as real-world exposure accumulates.
Named, credentialed, and on the record
Dr. Ashok Srivastava, MD, Ph.D., MBA
President & Chief Medical Officer
Board-certified oncologist with immuno-oncology drug development experience across 27 INDs, 9 NDAs, and 3 BLAs. 135 oncology & hematology trials across 20 countries — the base of judgment organ-specific ADC toxicity review draws on.
Educate · Evaluate · Execute for ADCs
ADC safety briefing
Organ-specific toxicity patterns, specialist referral design, and labeling implications — for your board and clinical team.
IHASG Readiness Assessment
A graded review of your safety governance against an ADC-specific standard, with a roadmap to Level 4.
Continuous Medical Oversight
A named physician reviewer on the Workbench, adjudicating organ-specific signals against payload-aware criteria.
Clinical briefing on ADC safety
Questions ADC programs ask us
Is ADC toxicity really different enough from chemotherapy to need a different monitoring plan?
Yes — ADC toxicity is frequently organ-specific and payload-driven (ocular surface, interstitial lung disease, hepatic effects) rather than the diffuse myelosuppressive pattern of classical chemotherapy. A monitoring plan built for chemotherapy can under-weight or miss these signals entirely.
Do you help design the specialist referral pathways, not just the safety monitoring plan?
Yes — organ-aware ADC monitoring means the ophthalmology, pulmonology, or hepatology referral triggers are built into the protocol from the start, not added after the first event.
Is your ADC experience specific to one payload class?
Our named reviewer's oncology drug development experience spans multiple payload classes; the specific monitoring plan and referral pathways are scoped to your ADC's payload and linker chemistry on a call.
Talk to an ADC safety expert.
Bring us the monitoring plan, the referral pathway design, or the safety review you're building.
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