Epidemiology Consulting
Northeast Epi partners with pharmaceutical companies, CROs, and biotech firms to deliver epidemiological research that holds up under scrutiny, from FDA submissions to peer-reviewed publication.
Explore Our ServicesPrecision. Clarity. Results.
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What We Do
We bring academic rigor and real-world pragmatism together, giving pharmaceutical companies, CROs, and biotech firms the epidemiological support they need, scoped to the project and not a retainer.
Prevalence, incidence, and natural history analyses, including rare disease population sizing, designed to support regulatory submissions and market access strategy.
FDA submissions · Market accessObservational study design, retrospective chart review protocols, and healthcare claims data analysis, supporting RWE strategies for regulatory and commercial purposes.
Observational · Claims · RWEBottoms-up patient funnel modeling, from diagnosed prevalence to addressable trial populations, with explicit epidemiological assumptions and sensitivity analyses.
Rare disease · Gene therapy · OrphanIndependent scientific review of study endpoints, statistical assumptions, and patient selection criteria, providing an external epidemiological lens before submission or publication.
Protocol · Endpoints · PowerChart review design, site-level enrollment gap analysis, and patient identification strategies for rare and ultra-rare disease trials, with a focus on improving recruitment efficiency.
Enrollment · Recruitment · Chart reviewMethods sections, epidemiological background, and results interpretation for peer-reviewed publications and regulatory briefing documents, with a track record of published RWE research.
Publications · Regulatory · MethodsStatistical analysis plan development, survival analysis, time-varying covariate modeling, and competing risks methods, with hands-on SAS programming for clinical and real-world datasets.
SAS · Survival analysis · Competing risksSelected Research
Peer-reviewed and conference-presented research conducted in partnership with pharmaceutical sponsors and academic medical centers.
Selected Engagements
The following engagements are illustrative of our consulting practice. All client details are confidential.
Retained by a biotech acquirer to independently validate epidemiological estimates and addressable market assumptions presented by multiple acquisition target companies across seven rare disease indications, including X-linked retinitis pigmentosa (XLRP), fungal keratitis, cold agglutinin disease, myasthenia gravis, nephrotic syndrome, CDKL5 Deficiency Disorder, tuberous sclerosis complex, and refractory status epilepticus. Work involved critically assessing disease prevalence, incidence, and patient population sizing claims against published literature and real-world benchmarks, providing the buyer with an objective scientific basis for evaluating target credibility and informing acquisition decision-making.
Evaluated disease indications best aligned to a novel autoimmune target, incorporating epidemiological burden analysis, patient population sizing, and competitive pipeline assessment. Deliverables included a slide deck supporting target selection and external stakeholder engagement. The recommended target was selected for advancement.
Analyzed potential new orphan disease indications for a commercial-stage cardiovascular asset, evaluating whether the epidemiology supported FDA orphan designation eligibility. Deliverables included a quantitative epidemiological model and summary slide deck to support internal indication prioritization and regulatory strategy discussions.
Developed an epidemiology-based methodological framework for clinical trial diversity planning in alignment with FDA diversity guidance. Included an analysis of ClinicalTrials.gov data to identify enrollment shortfalls across high-impact disease indications including diabetes, hypertension, and NASH. Work informed published thought leadership produced by the client organization.
Executed full systematic literature reviews across two disease areas, atopic dermatitis and a rare genetic disorder, encompassing literature search, retrieval, screening, data abstraction, and abstraction workbook development for downstream biostatistical modeling. Delivered final evidence synthesis reports to support health technology assessment submissions.
Conducted a forward-looking epidemiological analysis of infectious disease burden to support vaccine pipeline development and business development strategy. Included systematic literature review, disease-level ranking by prevalence, geographic distribution, and severity, and a prioritized target assessment to facilitate internal strategic decision-making.
About Northeast Epi
Northeast Epi was founded by Regina Grebla, PhD to bring together two worlds that rarely meet: the methodological rigor of academic epidemiology and the pragmatism of drug development. The result is research that holds up under peer review and delivers in clinical operations.
"Good epidemiology doesn't just answer the question you asked — it tells you whether you asked the right question."Our guiding principle
We work as an embedded scientific partner, not a vendor. Engagements are scoped collaboratively, delivered with full methodological transparency, and sized to your actual needs.
How We Work
We keep our process simple and transparent, because your timeline matters.
We start by understanding what you actually need, not what sounds right in an RFP. Most projects take shape in a single conversation.
You receive a clear written proposal: deliverables, methods, timeline, and fees. No surprises, no scope creep without a conversation first.
Every analysis is documented with explicit assumptions, data sources, and limitations. You should be able to defend the methodology to an FDA reviewer or a scientific advisory board.
We're available for questions, revisions, and extensions, on your schedule and not a retainer clock.
Therapeutic Expertise
Our experience spans rare and ultra-rare diseases, neuromuscular conditions, oncology-adjacent indications, and infectious disease, with fluency in the regulatory and commercial landscape for each.
Get In Touch
We work with pharmaceutical companies, CROs, and biotech firms on a project basis, from targeted population analyses to full observational study design. Reach out to start a conversation about your needs.
Tell us about your project and we'll be in touch within one business day.