Establish an oncology presence in the US
Bridge the gap between discovery and commercialization
Built for solid tumor innovators going global. Senior oncology leaders help you take an asset to the US yourself, or find a partner whose portfolio gap makes it a priority.
Where promising programs get stuck on the way to the US
From asset to approved US drug: very few make it
compounds ever screened becomes an approved medicine
oncology drugs entering Phase 1 reaches FDA approval (5.3%)
oncology programs clears Phase 2 into Phase 3 (24.6%)
from Phase 1 to approval, at about $2.6B per new medicine once failures are counted
The molecule is rarely the problemThese are the four hurdles that most often slow or stop an approval.
Data
Clinical data generated outside the US doesn't always carry over. FDA increasingly expects trials that reflect US patients and US standards of care, and a data package built for another market can mean running a new trial late in development.
CMC
Manufacturing can sink an approval as easily as the clinical results can. Process validation, comparability, and inspection readiness need to meet FDA standards well before filing, because plant inspection findings can delay or block approval even when the efficacy data is strong.
Dose
Under FDA's Project Optimus, oncology programs are expected to optimize the dose before registration trials. Programs that move straight to the maximum tolerated dose risk being sent back to do the work, which adds time and cost.
Scientific network
A successful US program needs US relationships. Pivotal trials depend on US investigators and sites, and guideline inclusion and scientific advocacy depend on US key opinion leaders who know the data.
Your path to the US market, on your terms
Most biotechs license away US rights early, because the US path looks too costly and too uncertain to walk alone. That is when the rights are cheapest to buy. We give you more options, and the platform to run your US business once you are there.
Take it to the US yourself
We design the regulatory and commercial plan to bring your asset into the US. Selling to Big Pharma becomes a choice, not the only way in.
See how it works ↓Find the right partner
We match your asset to the US and EU partners whose portfolio gap makes it a priority, and we open the door where decisions get made.
See how it works ↓Know where your asset stands
xOne scores your asset against the criteria US partners and FDA weigh: clinical and pre-clinical data, regulatory path, market access, competition and manufacturing. You see the strengths and gaps before a buyer does.
See how it works ↓From your data package to a US launch plan
One team takes you from the first readiness review to launch.
- Step 1
US readiness review
We test your clinical, CMC and IP package against what FDA will ask for, and rank the gaps by cost and risk.
- Step 2
Regulatory plan
FDA meeting strategy, bridging or global trial design, dose optimization, and US sites and investigators.
- Step 3
Commercial plan
US market model, pricing and access, launch sequence, forecast, and build-versus-partner economics side by side.
- Step 4
Build and launch
Interim leadership, US team build, and launch infrastructure: field design, targeting, incentives and reporting.
What you walk away with
A US development plan your board can fund
A data package built for FDA
A launch or license decision made on real numbers
A partnering process built from the buy side
We have sat where your buyers sit. We know what they screen for and what moves an asset to the top of the pile.
- 1
Position the asset
A target product profile and a data story buyers recognize. Not first, but better: tolerability, dosing and payer coverage versus standard of care.
- 2
Map the partners
A ranked list of US and EU buyers by portfolio gap, recent deals, therapeutic focus and development capacity.
- 3
Open the doors
Senior introductions into BD, R&D and commercial leadership through our network.
- 4
Shape the deal
License, co-develop, US NewCo or regional split, with terms anchored on comparable deals.
- 5
Support diligence
Data room, FDA questions and CMC diligence, handled by people who have run them.
More than one credible partner at the table, and terms built on real comparables.
Evaluate your asset the way a US buyer will
Every US buyer runs the same checklist before taking a meeting, and most of it happens out of view. We are building that checklist into xOne. Our advisors’ evaluation frameworks become a scoring model that ranks oncology assets on their US development and commercial potential.
Science
Modality, target and payload, and pre-clinical activity and safety in validated models.
Clinical
Single-agent activity, dose-limiting toxicity, and proof of concept for the asset or close analogs.
Regulatory
Orphan, breakthrough and accelerated approval potential, plus the size and enrollment risk of the pivotal trial.
Market
Unmet need in the core indication, competitive intensity, and comparable deals.
Access
How the drug will be covered, bought and dispensed: Part B or D, buy and bill, or specialty pharmacy.
Manufacturing and supply
Complexity and cost, from process to supply chain.
How it works
- 1Frameworks from the buy side.The criteria come from advisors who have run these evaluations.
- 2Grounded in evidence.Each criterion is tied to published evidence and comparable deals.
- 3Explained, not just scored.Every score shows its reasons, and our advisors review the result with you.
What you get
- A clear read on your asset’s strengths and gaps before you meet FDA or partners
- Evidence behind the choice to build it yourself or partner
- Your data and spend focused on the gaps that move value most
Know your asset’s score before the buyer calculates it.
Senior leadership across every function your asset needs
Deep oncology roots across big pharma, biotech, start-ups and tech ventures.
Clinical development
The journey from Phase I or proof of concept to pivotal trials enabling US approval.
Product development
Manufacturing harmonization and validation, and product compliance.
Regulatory
FDA interactions, trial design, labeling and PDUFA.
Commercial strategy
Marketing, market access, sales, customer engagement planning, and revenue forecasting.
Medical affairs
Connect with the US scientific community for clinical trial planning and execution, and medical education.
years of combined experience on this team, bringing assets like yours to US patients.