The Most Competitive Review Space in Medicine.
Senior regulatory and CMC leadership for cancer therapeutics — built around the Oncology Center of Excellence and Project Optimus.
Oncology Is Not Reviewed Like the Rest of the Pipeline.
The Oncology Center of Excellence runs its own operating model. Real-Time Oncology Review dismantles the dossier into components the FDA reads as they are ready. Project Orbis puts your file in front of the FDA, the EMA, Health Canada, the MHRA, the TGA, and Swissmedic at the same time. Project Optimus rewrote how you justify a dose.
The upside is real: cancer drugs reach patients faster than any other class. The cost is a review that scrutinizes dose, endpoint, diagnostic, and confirmatory design as one connected argument — and penalizes any weak link. We build that argument before it is tested.
Every targeted therapy carries a diagnostic, a dose question, and a surrogate endpoint. They stand or fall together.
The Oncology Center of Excellence Toolkit.
Six expedited instruments shape almost every modern cancer filing. Sequenced well, they compress years. Requested at the wrong stage — or with the wrong evidence — they stall the program instead.
Breakthrough Therapy
Preliminary clinical evidence of a substantial improvement on a clinically significant endpoint unlocks intensive FDA guidance and a senior review team. The workhorse designation for immuno-oncology.
Fast Track
Rolling review and more frequent interactions from early development. Often the first designation secured — the on-ramp that makes later Breakthrough and Accelerated Approval requests credible.
Accelerated Approval
Approval on a surrogate reasonably likely to predict benefit — ORR, pCR, MRD — in exchange for a confirmatory trial already underway at the time of approval. The bargain that defines oncology.
Real-Time Oncology Review
The FDA reviews data as it is submitted rather than waiting for a complete application. Datasets flow in near-final form; approvals have landed weeks after submission. Requires flawless data readiness.
Project Orbis
One submission reviewed in parallel by the FDA and international partners. Demands a single dossier engineered to satisfy divergent evidentiary standards — and an ICH E17 multi-regional trial to feed it.
RMAT
For CAR-T and other regenerative oncology therapies: Breakthrough-level benefits plus early, structured engagement on the CMC and comparability questions that decide cell-and-gene timelines.
The Race to the Maximum Tolerated Dose Is Over.
For decades, oncology borrowed a dosing paradigm from cytotoxic chemotherapy: push to the highest tolerated dose and register it. For targeted and immuno-oncology agents, more is not better — and the FDA now expects a dose justified by data, not by toxicity alone.
Maximum Tolerated Dose
- 3+3 escalation to the highest dose patients can tolerate
- Single dose carried into registration untested against alternatives
- Chronic toxicity surfaces post-approval, forcing dose reductions in the real world
- No characterization of the exposure–response relationship for efficacy
Optimized Dose
- Randomized comparison of two or more doses before registration
- Dose selected on safety, tolerability, PK/PD, and efficacy together
- Long-term tolerability and dose intensity built into the design
- An exposure–response story the review division can defend
The dose-finding strategy now has to be designed into Phase 1 — not repaired in a post-marketing requirement.
Choose the Endpoint, and You Have Chosen the Pathway.
Overall survival is the standard the agency trusts most and the slowest to read out. Every surrogate above it trades certainty for speed — and dictates whether you are filing for full or accelerated approval.
Overall Survival
The gold-standard clinical benefit. Unambiguous, but slow, expensive, and easily confounded by crossover and subsequent therapy.
Progression-Free Survival
Time to progression or death. A validated endpoint in many tumor types, sensitive to assessment schedule and blinded independent review.
Overall Response Rate + Duration
Tumor shrinkage and how long it lasts. Readable from single-arm trials — the classic basis for accelerated approval in refractory disease.
Pathologic Complete Response
The neoadjuvant surrogate. Supports accelerated approval when paired with an event-free-survival confirmatory readout.
Minimal Residual Disease
The emerging molecular surrogate in hematologic malignancies. Powerful, evolving, and negotiated endpoint-by-endpoint with the review division.
The therapy and the test that selects for it are one regulatory program with two submissions.
A Targeted Therapy Is Only as Approvable as Its Companion Diagnostic.
If your label names a biomarker, the FDA expects an FDA-approved or -cleared test to identify the patients who receive the drug. The diagnostic's PMA and the therapy's BLA or NDA have to arrive aligned, validated on the same assay used in the pivotal trial.
Our companion diagnostic strategy practice coordinates the drug and device tracks as one plan — bridging studies, assay lock, CDx labeling concordance, and the tumor-agnostic case when the biomarker, not the organ, defines the indication.
The Accelerated Approval Reckoning.
Accelerated approval is a promise, not a finish line. The FDA's Project Confirm made the confirmatory record public, ODAC has grown pointed about dangling indications, and the 2023 statutory reforms let the agency require the confirmatory trial to be underway before approval.
of oncology accelerated approvals have faced a confirmatory trial that failed, was delayed, or converted late — the risk the review division is pricing into your file.
Under current law the confirmatory trial should already be enrolling at the time of accelerated approval — design it in parallel, not after the win.
The Oncologic Drugs Advisory Committee increasingly decides borderline cases in public. A file that anticipates the panel's questions is a file that survives them.
Six Failure Modes We Are Brought In to Prevent.
None of these are surprises to a reviewer. They are surprises to sponsors who did not have oncology-specific regulatory leadership at the table early enough.
An un-optimized dose
Carrying a single MTD-derived dose into registration without the randomized comparison Project Optimus now expects — the most common complete-response-letter theme in modern oncology.
A single-arm trial asked to do too much
ORR data marshaled toward full approval, or a confirmatory trial designed too late to convert an accelerated approval before the indication is questioned.
A companion diagnostic that lags the drug
The therapy is ready; the FDA-approved test is not, or was validated on a different assay than the pivotal trial used. The label stalls on the diagnostic.
Biologic CMC comparability gaps
For antibodies, ADCs, and bispecifics: a process change between clinical and commercial material without the comparability package to bridge it.
Orbis data that does not travel
A pivotal trial that satisfies the FDA but not the multi-regional and ICH E17 expectations of the other Orbis partners — collapsing the concurrent-review advantage.
A diversity and enrollment plan bolted on late
Missing a credible Diversity Action Plan and representative enrollment strategy that the OCE now expects to see designed into the pivotal, not appended to the submission.
Not Read About Them. Filed Them.
Our oncology leads have sat on the sponsor side of Breakthrough meetings, Optimus dose discussions, ODAC preparations, and Orbis submissions — and on review teams that granted and refused them.
"An accelerated approval is only worth the confirmatory trial you designed alongside it. We build both at once, and we build them to survive ODAC."
The posture we bring to every cancer program — from first-in-human dose strategy through label negotiation and lifecycle.
Building a Cancer Therapy? Design the Regulatory Argument Before the Dose Locks.
Bring senior oncology regulatory and CMC leadership in early — while dose, endpoint, and diagnostic are still choices, not commitments.
Senior-led. Embedded in your team. No junior hand-offs.