Accelerated
Pathways

Leaders in Expedited Program Strategy

Why Expedited Programs Matter

An Expedited Program Can Move Approval Forward by Years.

For a serious condition with unmet need, the right FDA designation buys earlier and more frequent agency engagement, rolling review, a surrogate-endpoint pathway, and months off the review clock. But the wrong request, filed with the wrong data at the wrong time, burns a cycle and signals weakness to the division. We help sponsors qualify for the programs they can actually win, sequence the requests correctly, and carry the obligations that come attached long after the designation is granted.

Wondering which expedited program your asset actually qualifies for? Let's find out.

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Capabilities

Every Expedited Program. One Coherent Strategy.

The designations overlap, stack, and sometimes work against each other. We help you pick the ones that fit your data and your timeline, win them, and manage what they commit you to.

Pathway Selection Strategy

Mapping your asset against every FDA and EMA expedited program to decide which to pursue, in what order, and when.
Breakthrough Therapy & Fast Track

Eligibility assessment and designation request authoring for the two most-used FDA expedited designations.
Accelerated Approval

Surrogate endpoint justification, confirmatory trial design, and the post-marketing commitments that follow approval.
RMAT & Regenerative Medicine

Regenerative Medicine Advanced Therapy designation strategy for cell, gene, and tissue-engineered products.
Orphan Drug & Rare Disease

Orphan Drug Designation, rare pediatric disease priority review vouchers, and the rare-disease development toolkit.
Global Expedited Programs

EMA PRIME, accelerated assessment, MHRA ILAP, and Project Orbis, aligned so one program reinforces the next.
Pathway Selection Strategy

Five FDA Programs, Overlapping Rules, One Right Answer for You.

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, and RMAT each carry different evidence bars, benefits, and timing. Some stack; some make others redundant. We assess your indication, modality, and current data package against every program, model how each one changes your timeline and confirmatory obligations, and give you a sequenced plan that tells you which designation to request, when, and with what supporting data.

What We Assess

  • Serious condition and unmet medical need positioning
  • Program-by-program eligibility scoring against your data
  • Optimal timing and sequencing of each request
  • Interaction between FDA and EMA expedited programs
  • Impact on trial design, endpoints, and CMC timelines
  • Downstream confirmatory and post-marketing obligations
  • Board- and investor-ready expedited strategy memos
Breakthrough Therapy & Fast Track

The Difference Is the Data You Bring, and the Story You Tell With It.

Fast Track turns on nonclinical or preliminary clinical evidence and opens early, frequent FDA engagement and rolling review. Breakthrough Therapy demands preliminary clinical evidence of substantial improvement over available therapy, and in return brings intensive senior-staff guidance. We assess which bar you clear today, position your evidence to meet it, and author designation requests that read the way the division expects them to.

Included Capabilities

  • Fast Track eligibility assessment and request authoring
  • Breakthrough Therapy Designation (BTD) strategy and requests
  • Clinical evidence positioning against available therapy
  • Rolling review planning and coordination
  • Designation timing relative to Phase 1/2 readouts
  • Response strategy for FDA requests for information
  • Resubmission strategy after a denied request
Accelerated Approval

Approval on a Surrogate Endpoint Is a Promise, Not a Finish Line.

Accelerated Approval lets you reach the market on a surrogate or intermediate endpoint reasonably likely to predict clinical benefit, then obligates you to confirm that benefit after approval. Recent withdrawals have made FDA far more demanding about the surrogate you choose and the confirmatory trial you commit to. We build the endpoint justification, design a confirmatory trial the agency will accept as already underway, and manage the post-marketing requirements so the approval holds.

Included Capabilities

  • Surrogate and intermediate endpoint justification
  • Confirmatory trial design and enrollment timing
  • Accelerated Approval eligibility and precedent analysis
  • Post-marketing requirement (PMR) negotiation and planning
  • Withdrawal-risk assessment and mitigation strategy
  • Alignment of accelerated approval with Priority Review
  • FDA meeting strategy to secure endpoint agreement

Preparing a designation request? A senior review can be the difference between grant and denial.

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RMAT & Regenerative Medicine

The Designation Built for Cell and Gene Therapy.

Regenerative Medicine Advanced Therapy designation is the expedited program written specifically for cell therapies, gene therapies, and tissue-engineered products treating serious conditions. Like Breakthrough Therapy it opens intensive FDA engagement, but it adds flexibility that matters for advanced therapies: surrogate-endpoint routes and tailored, sometimes real-world, post-approval evidence strategies. We position your preliminary clinical evidence, author the request, and connect RMAT to the CMC and comparability planning these products live or die by.

Included Capabilities

  • RMAT eligibility assessment and designation request authoring
  • Preliminary clinical evidence positioning for advanced therapies
  • Surrogate and intermediate endpoint strategy for RMAT
  • Post-approval evidence and real-world data planning
  • Integration with CMC comparability and potency strategy
  • Coordination with Orphan Drug and Breakthrough designations
  • INTERACT and pre-IND strategy for novel modalities
Orphan Drug & Rare Disease

Rare Disease Is Its Own Regulatory Discipline.

Orphan Drug Designation brings seven years of market exclusivity, fee waivers, and tax credits, and it stacks with the expedited programs that speed a rare-disease product to approval. But small, heterogeneous populations force hard choices on endpoints, natural history, and trial size. We prepare Orphan Drug applications, build the rare-disease development strategy around them, and pursue the pediatric priority review vouchers that can be worth more than the program itself.

Included Capabilities

  • Orphan Drug Designation (ODD) request preparation
  • Prevalence and orphan-subset justification
  • Rare Pediatric Disease Designation and priority review vouchers
  • Natural history study strategy and endpoint selection
  • Small-population trial design and statistical approaches
  • EU Orphan Medicinal Product designation coordination
  • Integration with Breakthrough, Fast Track, and RMAT
Global Expedited Programs

Speed in One Region Should Buy Speed in the Next.

The US programs have counterparts abroad: EMA's PRIME and accelerated assessment, the MHRA Innovative Licensing and Access Pathway, and Project Orbis for oncology. Pursued in isolation they generate conflicting advice and duplicated work. We plan expedited designations across regions as one campaign, so a Breakthrough grant strengthens a PRIME request and a single evidence package carries as far as possible.

Programs Supported

  • EMA PRIME (PRIority MEdicines) eligibility and application
  • EMA accelerated assessment and conditional marketing authorization
  • MHRA Innovative Licensing and Access Pathway (ILAP)
  • Project Orbis for oncology products
  • Health Canada and other national expedited routes
  • Cross-region designation sequencing and reuse of evidence
  • Alignment of US and EU orphan and expedited strategies
The Full Lifecycle

Winning the Designation Is Half the Work.

A designation is only as valuable as the request that earns it and the obligations you carry afterward. We handle both ends: authoring the request and executing what comes next.

Designation Request Authoring

The Request Is a Persuasion Document, Not a Form.

A designation request is a tightly argued case that your product meets a specific statutory standard, backed by exactly the right evidence and no noise. We assemble the clinical, nonclinical, and mechanistic support, write the narrative the review division needs to say yes, and pressure-test it against the reasons these requests usually get denied.

Included Capabilities

  • Full designation request authoring across all programs
  • Evidence gap analysis before submission
  • Available-therapy and unmet-need argumentation
  • Senior mock review against denial rationales
  • Supporting data package assembly and formatting
  • Response strategy for FDA information requests
Post-Designation Execution

The Obligations Outlast the Press Release.

Designations create commitments: confirmatory trials, post-marketing requirements, intensified FDA interaction, and the risk of losing a designation if the data does not hold. We help sponsors capture the benefits they were granted and stay ahead of the obligations attached, so an expedited program accelerates the program instead of quietly destabilizing it.

Included Capabilities

  • Confirmatory trial and post-marketing requirement management
  • Intensive FDA engagement planning after designation
  • Designation maintenance and rescission-risk monitoring
  • Rolling review coordination across modules
  • Breakthrough and RMAT benefit realization tracking
  • Lifecycle strategy connecting designation to filing
Who You're Working With

People Who Have Granted These Designations, and Won Them.

Our team includes former FDA reviewers who evaluated expedited program requests from inside the agency, and industry regulatory leaders who have secured Breakthrough, Fast Track, RMAT, and Orphan designations as sponsors. You get the senior practitioner writing the request, not a junior team under a partner's name.

Former FDA Reviewers

Consultants who have reviewed designation requests and expedited-program submissions from inside FDA, and know exactly why the ones that fail get denied.

A Track Record of Granted Designations

Practitioners who have secured Breakthrough Therapy, Fast Track, RMAT, Accelerated Approval, and Orphan Drug outcomes across real programs, not just advised on them in theory.

Advanced Therapy Depth

Direct experience with cell, gene, and regenerative medicine products, where RMAT strategy and CMC comparability decide whether the expedited timeline is real.

Modality and Therapeutic Breadth

Small molecule, biologic, cell & gene, device, diagnostic, and digital health programs across oncology, rare disease, neuroscience, immunology, and beyond.

Work With Us

Find the Fastest Credible Path to Approval.

Tell us about your asset, your indication, and where your data stands. We'll assess which expedited programs you qualify for and match you with a senior regulatory lead, with a response within one business day. All inquiries are strictly confidential.

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Insights & News

Thought Leadership on Expedited Programs.

Our team's perspectives on FDA designations, accelerated approval, and rare-disease strategy: coming soon. In the meantime, reach out directly with a question you'd like to see addressed.

Coming Soon

Fast Track vs. Breakthrough: Which, and When

How to read your own data to choose the designation you can actually win.

Coming Soon

Surviving Accelerated Approval After the Withdrawals

What FDA now expects from your surrogate endpoint and confirmatory trial.

Coming Soon

Stacking Orphan Drug With Expedited Designations

How rare-disease programs combine exclusivity, vouchers, and speed.