Faster Programs, Cleaner Evidence — Without Betting the Company on Wishful Thinking
We help sponsors pursue FDA acceleration mechanisms (Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, RMAT) with disciplined eligibility framing, meeting strategy, and evidence roadmaps that anticipate post-market commitments and keep the program defensible under scrutiny.
Why “Accelerated” Programs Still Fail
Acceleration is not a shortcut—it’s a contract: you earn speed with strong rationale, credible endpoints, and a plan for confirmatory evidence and lifecycle obligations. Programs stall when surrogate endpoints aren’t defensible, CMC isn’t ready to scale, or meeting asks are vague. We build a coherent strategy that links eligibility → evidence → regulatory commitments.
- Eligibility must be precise: “serious condition” and “unmet need” must be argued with real comparators.
- Endpoints must be defensible: accelerated approval hinges on surrogate/intermediate endpoints with justification.
- CMC can make or break timelines: scaling and comparability planning are often the hidden delay.
- Post-market obligations are real: confirmatory trials, labeling, REMS/pharmacovigilance planning may be required.
Accelerated Pathway Programs
Programs designed to unlock speed while keeping the overall program defensible.
Acceleration Strategy Sprint (Eligibility + Plan)
Typical range: $12,000–$30,000 (scope-dependent)
For sponsors deciding which acceleration mechanisms apply and what evidence is required to earn them.
- Eligibility assessment across Fast Track / BTD / AA / Priority / RMAT
- Endpoint strategy (surrogate vs clinical) + confirmatory evidence concept
- High-level CMC and lifecycle risk assessment (comparability, scale, commitments)
Designation Request Package (Fast Track / BTD / RMAT)
Typical range: $12,000–$30,000 (scope-dependent)
For sponsors pursuing designation with a disciplined narrative and evidence framing that survives review.
- Request drafting: disease context, unmet need, current standard of care, meaningful advantage
- Evidence summary integration (clinical, nonclinical, mechanistic) + risk framing
- Submission packaging + follow-up response support
FDA Meeting Strategy & Briefing Package
Typical range: $12,000–$30,000 (scope-dependent)
For sponsors needing alignment on endpoints, confirmatory strategy, CMC readiness, or safety monitoring plans.
- Meeting question strategy + briefing package authoring
- Endpoint/confirmatory plan framing and alternative scenarios
- Meeting prep + minutes + action plan after feedback
Lifecycle Execution & Commitments Support
Typical range: $12,000–$30,000 (scope-dependent)
For programs moving fast that need controlled execution: submissions, labeling, PV planning, and confirmatory commitments.
- Support for IND/BLA/NDA-related authoring and submission execution (scope-dependent)
- Confirmatory study planning artifacts + timeline control
- Labeling strategy + risk management planning (PV/REMS as applicable)
Who We Help
Serious Conditions / High Unmet Need
Programs where speed matters, but only if eligibility and evidence are framed with discipline.
Surrogate Endpoint Programs
Teams pursuing accelerated approval where endpoint justification and confirmatory strategy must be explicit.
Advanced Therapies (RMAT)
CGT/advanced therapy sponsors needing a coherent plan that integrates CMC realities with clinical timelines.
CMC-Limited Sponsors
Teams with promising data but manufacturing/comparability constraints that can derail acceleration if ignored.
Investor-Driven Timelines
Programs needing credible acceleration strategy that withstands diligence and avoids “fake speed.”
Programs Under Scrutiny
Sponsors who need defensible plans for commitments, labeling, and confirmatory evidence under modern FDA expectations.
How We Run Accelerated Pathway Engagements
Speed comes from clarity, not shortcuts.
Eligibility & Comparators
We define the condition context, unmet need, current standard of care, and the “meaningful advantage” rationale.
Endpoints & Commitments
We map primary endpoints, surrogate justification, confirmatory trial concepts, and lifecycle obligations.
FDA Meetings & Evidence
We package clear questions and briefing materials to secure alignment and reduce late-stage surprises.
Submit + Maintain
We support submission execution and post-market commitments so accelerated timelines don’t collapse later.
Accelerated Pathway FAQs
What’s the difference between Accelerated Approval and Priority Review?
Accelerated Approval relates to the basis for approval (often surrogate/intermediate endpoints with confirmatory commitments). Priority Review relates to FDA’s review timeline once a submission is accepted. Many programs pursue multiple mechanisms together.
Can we pursue Fast Track, Breakthrough Therapy, and Accelerated Approval together?
Potentially, depending on the program. We map which mechanisms apply, what each one requires, and how they affect your evidence and meeting strategy.
What’s the biggest risk to “accelerated” timelines?
Overpromising on endpoints or underestimating CMC/comparability constraints. We focus early on the areas that most often trigger late-stage delays.
Are these pricing ranges fixed?
No—these are typical working bands. After a short triage call we can provide a fixed or milestone quote based on modality, endpoint strategy, meeting cadence, and how much documentation and execution support you need.
Talk Through Your Acceleration Strategy
Share your product type, indication, current data package, target endpoints, and timeline constraints. We’ll outline a sequenced plan (eligibility → endpoints → meetings → execution) with clear deliverables and a quote aligned to your goals.
Based in Charleston, SC • With Worldwide Support
Prefer direct email? info@verusfda.com