Two Regulatory Gears. One Field.
Regulatory strategy for vaccines and anti-infectives — running at emergency-use tempo one year and full-BLA rigor the next.
No Field Swings Between Extremes Like Infectious Disease.
In a pandemic, the FDA can authorize under Emergency Use in weeks and review under rolling submission. Between pandemics, the same product class faces one of the most demanding evidence bars in medicine — large field-efficacy trials, correlates of protection, and lot-to-lot consistency. Both realities have to live in one development plan.
Add the CBER–CDER split — vaccines and biologic antitoxins on one side, antivirals and antibacterials on the other — plus a global patchwork of WHO prequalification and national authorities, and infectious disease becomes an exercise in regulatory range. We build programs that can shift gears without breaking.
From containment lab to commercial lot, infectious-disease programs carry biosafety, potency, and consistency questions unique to the field.
The Same Product Class Is Reviewed Two Completely Different Ways.
Knowing which gear you are in — and building a plan that can pivot between them — is the core discipline of infectious-disease regulatory strategy.
Pandemic Speed
- Emergency Use Authorization on a lower, evolving evidence standard
- Rolling review with data submitted as it matures
- Platform and prototype-pathogen approaches that pre-position the science
- Manufacturing scale-up and comparability running in parallel with the clinic
Full-BLA Rigor
- Large field-efficacy trials, or an accepted correlate of protection
- Lot-to-lot consistency, potency assays, and stability across the shelf life
- Transition from EUA to a full BLA or NDA once the emergency ends
- Post-marketing safety at population scale, including rare-event surveillance
When an immune marker predicts efficacy, it can stand in for a field trial — the surrogate that makes fast vaccine approval possible.
A Validated Correlate of Protection Changes What a Trial Has to Prove.
When an antibody titer or other immune marker reliably predicts clinical protection, immunogenicity can substitute for a massive field-efficacy trial — enabling strain changes, pediatric extrapolation, and faster approval. The influenza strain-update model works precisely because the correlate is accepted.
Establishing and defending that correlate — the assay, the threshold, the bridging strategy — is where vaccine programs are made or lost. We build the immunogenicity and bridging case the way CBER evaluates it, and we manage the assay comparability that keeps it valid across manufacturing changes.
Infectious Disease Spans the Widest Modality Range in Medicine.
Each modality answers to a different center, evidence standard, and incentive program. The regulatory strategy is inseparable from what you are building.
Prophylactic Vaccines
Prevention in healthy populations, where the safety bar is highest, the correlate of protection is central, and manufacturing consistency is a review discipline of its own.
Therapeutic Vaccines
Immunization against established infection or cancer, blending vaccine science with a treatment benefit–risk and endpoint framework.
Antivirals
Small molecules and biologics against viral disease, with viral-load and clinical endpoints, resistance monitoring, and drug-interaction depth.
Antibacterials & AMR
Antibiotics fighting resistance and a broken market — where QIDP designation, GAIN exclusivity, and the limited-population LPAD pathway are the tools.
Prophylactic Antibodies
Long-acting monoclonals for prevention — RSV and beyond — where a single injection protects and the endpoint is prevented infection.
Platform Technologies
mRNA and vector platforms where prior approvals de-risk the technology, letting a new construct move faster — if the platform comparability case is built.
Antibiotics Are a Regulatory Problem the FDA Built Pathways to Solve.
New antibiotics face a broken economic model: succeed clinically, then be held in reserve and barely sold. Congress and the FDA responded with QIDP designation and its priority review and five extra years of exclusivity under GAIN, and the Limited Population Pathway for antibacterial and antifungal drugs targeting resistant infection in small populations.
These pathways change trial size, endpoint, and labeling — a narrower population, a non-inferiority design, a specific resistance indication. We build antibacterial programs to use them fully, and to line up with the reimbursement reforms the field still needs.
QIDP, GAIN, and the LPAD pathway reshape the trial and the label for drugs targeting resistant infection.
Pandemic Preparedness Is a Regulatory Strategy, Not a Fire Drill.
The programs that moved fastest in the last emergency were the ones whose platforms, assays, and regulatory relationships were already in place. Preparedness is designed years ahead of the outbreak.
from sequence to clinic is achievable on a validated platform with a pre-agreed regulatory approach — but only if the groundwork was laid before the emergency.
Every emergency authorization eventually has to convert to a full license — plan the pivotal evidence and CMC for the endemic file from day one.
WHO prequalification and national authorities decide worldwide access — align the dossier for the FDA, the EMA, and PQ in parallel.
Six Failure Modes We Are Brought In to Prevent.
Most trace back to a program built for one gear that had to run in the other.
An EUA with no path to a BLA
Emergency authorization built without the pivotal evidence and CMC package needed to convert to a full license once the emergency ends.
A correlate of protection assumed, not established
Relying on an immune marker as a surrogate without the validation and assay data CBER needs to accept it in place of efficacy.
Lot consistency and potency underbuilt
Underestimating the manufacturing-consistency and potency-assay expectations that dominate a vaccine BLA review.
AMR incentives left unused
Failing to secure QIDP and GAIN, or to design for the LPAD pathway, and forfeiting exclusivity, priority review, and a feasible trial.
Resistance and interactions surfaced late
Antiviral and antibacterial programs that underinvested in resistance monitoring and drug-interaction data the division expects.
Global access planned after approval
Missing WHO prequalification and ex-US requirements until after the FDA file, delaying the populations that need the product most.
Infectious-Disease Regulatory Leadership That Can Shift Tempo.
Our ID and vaccine leads have run emergency-use submissions and full BLAs, defended correlates of protection, and secured the AMR incentives that make an antibiotic program viable.
"Infectious disease rewards range. The best programs are built to run at pandemic speed and survive full-BLA scrutiny — because sooner or later they have to do both."
The discipline we bring across vaccines, antivirals, antibacterials, and prophylactic antibodies.
Developing a Vaccine or Anti-Infective? Build a Program That Can Change Gears.
Bring senior infectious-disease regulatory leadership in early — while the pathway, correlate, and incentive strategy are still open.
Senior-led. Embedded in your team. No junior hand-offs.