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Burna AI is a clinical infrastructure company for oncology safety. Built by Nnenna John, Founder and CEO, with nineteen years in platform engineering and six years at Airbnb building infrastructure for 150 million users. Paired with Paschal Ezeugwu, Lead Engineer and Co-Founder, who carries EHR integration and the quiet infrastructure that must never fail. Advised by 25 oncologists, pharmaceutical executives, regulatory scientists, informaticists, and operators across 5 councils.
Twelve specialized agents in a patented cascading constraint pipeline. Two patents filed. CancerX member, HHS Cancer Moonshot Initiative. Eligible for the CDER Emerging Drug Safety Technology Program. Validation studies in flight at a US NCI-designated comprehensive cancer center.
Across 5 councils. Council leads include a former VP at Celgene, a former CMO at Replimune and BeiGene, a former SVP Medical Affairs at Taiho Oncology, and the founding chair of biomedical informatics at a leading US academic medical center.
Twelve specialized agents in a patented cascading constraint pipeline. Every grade ships with a source sentence and a CTCAE criterion attached.
Of the HHS Cancer Moonshot Initiative. Eligible for the CDER Emerging Drug Safety Technology Program; application in review.
Every adverse event in an oncology trial is a clinical decision. Every clinical decision deserves to be defensible.
Inter-rater agreement on adverse event grading today, kappa 0.59 to 0.68 (Hong et al., 2020). Independent investigator-assigned attributions are changed by central review 31 to 36 percent of the time (Hillman et al., Journal of Clinical Oncology, 2010). The 2019 FDA-NCI workshop characterized the current state of oncology adverse event attribution as sub-optimal, unreliable, inefficient.
The standard the field deserves is real-time, citation-bound, and defensible. Burna is building that standard. A platform that does the grading and citation work a person would do with unlimited time, and hands the finished, cited, attributed, audit-ready result to a clinician for review and signature. The work is compressed. The clinician is preserved. Human-in-the-loop, always.
Burna AI is the safety and data quality platform for oncology drug development, from clinical trials through postmarket surveillance. Two product lines on one engine. CTCAE AI for cancer centers, academic medical centers, and CROs running oncology trials. Protocol Safe for pharma sponsors who need an isolated AI environment for protocol-aware adverse event attribution inside their own cloud. Same engine, two deployment shapes, one evidence spine.
A platform-engineering founder. A Lead Engineer who owns the quiet infrastructure that must never fail. An Operating Partner with the capital discipline to fund what is being built.
Founder and CEO
Nineteen years in platform engineering. Six years at Airbnb building infrastructure for 150 million users across 220 countries. Earlier career platform engineering at JP Morgan Chase, Roku, and Expedia. A domain outsider to clinical trials with an insider’s advisory network. Architect of the Burna grading workflow, the twelve-agent cascading constraint pipeline that produces every suggested grade with its citation and attribution.
Lead Engineer and Co-Founder
EHR integration and the quiet infrastructure that must never fail. SMART on FHIR across Epic, Oracle Health, and regional EHRs, HL7 and FHIR pipelines, real-time architecture. The platform side of every design partner deployment ships under his ownership.
Operating Partner
Finance and operations expert. Early career in investment banking, corporate finance at Facebook, CFO of Athena Capital taken public via SPAC, and CEO of HomeOptions. Responsible for operations and financing at Burna AI.
The team beyond the founders is a small, senior group today, growing to 12 to 18 people over the next 18 months. Burna hires clinically literate engineers, engineering-literate clinicians, and people who have survived at least one regulated enterprise rollout. Open roles at careers@burna.ai.
Burna is advised by 25+ advisors organized into five councils that meet on a weekly rotation. The composition of the bench is itself a piece of the moat: senior pharma CMOs, former Celgene and Takeda executives, founding chairs of biomedical informatics, and CRO operators do not join early-stage healthcare AI cap tables without architectural and evidence-base conviction.
Formerly VP at Celgene; former CMO at RNA Diagnostics. Presenting Burna at AI in Oncology Germany, ESMO Breast Cancer, and ASCO 2026.
Formerly CMO at Replimune and Asher Biotherapeutics; ED Clinical Development at BeiGene; Principal Medical Director at Genentech.
Strategic Advisor to the CEO; Exec Lead for Protocol Safe. Former CMO at IFLI; formerly leadership at Sanofi, Amgen, and IQVIA.
Medical Director, GI Oncology and Phase 1 Trials, Atlantic Health System.
CMO at Verastem Oncology; NCI cancer center network.
Radiation Oncology, Hospital of the University of Pennsylvania. American Brachytherapy Society.
Clinical Development Trial Lead, Eli Lilly
Advisor and investor. Strategy.
Global CMO at Fresenius Medical Care; formerly SVP Medical Affairs at Taiho Oncology.
Principal at OncAdios; formerly VP Medical Oncology at ONO Pharma USA; Senior Medical Director at Takeda. Trained at Dana-Farber and MGH. FDA pathway co-lead.
Chief Clinical Integration Officer, Stony Brook Medicine. Led the N3C national data initiative. SAFE-Onc and standards co-lead.
President, Concept Plus; former NIH, FDA CDER, Leidos Health.
Dean, Wayne State University School of Medicine. Federal study sections, FDA advisory experience.
SUNY Distinguished Professor; founding chair of Biomedical Informatics at Stony Brook. Deep clinical informatics governance (N3C, CI4CC) and hands-on technical fluency.
Market Access, Promomed Group; formerly Roche, Merck, J&J.
Formerly CPO at The Rounds and CookUnity. Product roadmap and prioritization.
Co-Founder and CTO, Regal.ai; formerly CPO, Handy (acquired by Angi/NASDAQ: ANGI)
Formerly Global Chief of Strategy, Medidata. Enterprise market access lead.
Commercial strategy. Paired with Carl on enterprise market access.
Formerly SVP Sales, Heartland Payment Systems.
CEO, FruitStreet and HealthcareShares. Lead investor in the physician-led seed round.
CEO, Omatochi. EY Entrepreneur of the Year.
President, UNC Health Faculty Physicians. Institutional adoption co-lead.
Director of Digital Health Training and Adoption, Monash Health. Author of the 12-pillar Implementation Playbook that ships with every Burna engagement.
Founder and CEO, GigEasy. Partner, Dria Ventures.
Assistant Executive Director, Wright Institute. Behavioral health, health equity.
Market Access, Promomed Group; formerly Roche, Merck, J&J. Voice for cross-market positioning.
Traction, compliance, and architecture, current as of May 2026.
Member of CancerX, the HHS Cancer Moonshot Initiative public-private partnership focused on accelerating innovation in oncology. Eligible for the CDER Emerging Drug Safety Technology Program; application in review. Accepted into a top-tier cancer center accelerator program.
A prospective workflow study at a US NCI-designated comprehensive cancer center, co-designed with Dr. Andrea Pirzkall. A 1,200-chart retrospective accuracy study at a US NCI-designated comprehensive cancer center, with Bio-IT World 2026 poster output. A second-site prospective workflow pilot in scoping inside an active GI oncology and Phase 1 trials program. A postmarket pharmacovigilance pilot launching 2027. Methodology and kappa numbers available under NDA. Publication target venues include JCO, JAMIA, JCO Clinical Cancer Informatics, and Annals of Oncology.
Active design partner conversations at NCI-designated cancer centers in the United States, with qualification underway in EU, APAC, and MENA. The 2026 design partner cohort accepts pilot scoping conversations through the end of Q3 2026.
21 CFR Part 11 aligned, with a validation package that ships with every engagement. HIPAA aligned, BAA executed per engagement. GDPR, UK GDPR, PIPEDA, APPI, PIPA, and Australian Privacy Act aligned, with regional deployment options in the US, UK, EU, Canada, Australia, Japan, Korea, Singapore, and UAE and KSA at launch. SMART on FHIR across Epic, Oracle Health, Athenahealth, Allscripts, eClinicalWorks, MEDITECH, Dedalus, and regional systems. SOC 2 Type II audit kicked off Q2 2026; Type I attestation available now.
The engine is a twelve-agent cascading constraint pipeline. Every suggested grade requires a source sentence and a CTCAE criterion. Every attribution cites its WHO-UMC or Kramer reasoning path. Two patents filed on the architecture. Citation-bound by design, not by runtime filter.
Six principles. Each one is non-negotiable. Each one has been tested by a feature request Burna turned down.
Burna will never ship a feature that removes human review from the grading loop. Every grade, every attribution, every signed record passes through a clinician’s hands before it becomes a record. We have turned down feature requests that would have violated this principle. We will keep turning them down.
Every suggested grade requires a source sentence and a CTCAE criterion. Every attribution requires a named WHO-UMC or Kramer reasoning path. Citation is the shape of the product. Architectural constraint, not runtime filter. Two patents filed.
Cross-site grading consistency and attribution drift surface while a trial is running. Real-time infrastructure is a safety and data quality requirement, not a dashboard preference.
The 12-pillar Implementation Playbook ships with every engagement: stakeholder mapping, SOP updates, LMS-compatible training modules, coordinator workflow walkthroughs, executive sponsor briefings, continuity-of-care protocols. The playbook is part of the product. Burna arrives ready, alongside your team.
Burna is pursuing a regulated market. Conservative is the strategy. Phrases like "strong agreement with expert clinicians in ongoing internal testing" appear in public copy because the specific accuracy numbers belong in peer-reviewed papers and under NDA with pilot partners. When a claim rests on a single study, we say so. When we do not know, we say so.
Every enterprise relationship starts with a co-authored paper or poster. The paper is the procurement asset. The relationship is scientific before it is commercial. This is slower than a transactional sales motion. It is the standard a clinical safety platform earns the trust to live inside a regulated workflow.
The narrowness is the moat. The platform expands to adjacent surfaces only when they sit on the same evidence spine.
CTCAE coding, including TERM and CATEGORY, coupled with intelligence to support determination of Severity GRADE, with mandatory citation to source text. Multi-drug causality attribution using WHO-UMC and Kramer algorithms across 42 oncology regimen profiles. Audit-ready e-signature workflows. Sponsor-tenant deployments for pharma and CRO engagements. Postmarket ICSR processing. PRO-CTCAE patient portals. CareVid video documentation. The 12-pillar Implementation Playbook that makes all of it land in a clinical workflow. The engine is a twelve-agent cascading constraint pipeline with two patents filed.
Burna does not diagnose. Burna does not prescribe. Burna does not modify dose. Burna does not adjust radiation plans. Burna does not match patients to trials. Burna does not do broad oncology decision support. For any of those, we can often point you to friends and partners.
The platform expands to adjacent surfaces only when they sit on the same evidence spine.
Every piece of product, every pilot, and every page of the site traces back to one of these audiences.
Headquartered in the United States. Team distributed internationally. US validation and design-partner conversations are in progress, with additional MENA and APAC qualification underway.
International-first is a strategic commitment. Sixty percent of Phase 3 oncology sites are outside the United States. Forty percent of the global lung cancer burden is in Asia. A platform that lives inside regulated clinical workflows is built from day one for more than one jurisdiction.
Regional residency at launch includes the US, UK, EU (Frankfurt, Dublin, Paris), Canada, Australia, Japan, Korea, Singapore, UAE, and KSA. Clinical notes are supported in English, French, German, Spanish, Portuguese, Italian, Japanese, Korean, and Arabic at launch.
Burna hires clinically literate engineers, engineering-literate clinicians, and people who have survived at least one regulated enterprise rollout. The team is small and senior today, growing to 12 to 18 people over the next 18 months. Roles are remote-first with a US headquarters and an internationally distributed team.
Email careers@burna.ai →For engineers who have shipped in a regulated environment: HIPAA, 21 CFR Part 11, SMART on FHIR, EHR integration, EDC writeback. You will own platform surfaces that clinicians sign records against.
For clinicians who read code, write SQL, and want to design the next generation of clinical decision support. You will sit at the table with engineering, with the authority that comes with the clinical lens.
For someone who has led at least one regulated enterprise rollout. You will be named in design partner contracts and on-site for the pilot window. Clinical change management is the job.
Burna routes internally. For a faster turnaround, note it in the subject line.
A 30-minute conversation with Nnenna John, Founder and CEO: - schedule a conversation.
One for prospective design partners, candidate hires, advisors, and strategic partners. One for journalists, evaluators, and anyone tracking the field.
A 30-minute conversation with Nnenna covers the platform, the validation roadmap, the advisor bench, and where Burna fits in your world.
For commercial pharma or CRO conversations, the Protocol Safe team often joins.
Subscribe to the quarterly safety and data quality briefing. Validation readouts, design partner cohort updates, and conference timing only.
No tracking beacons, no marketing email cadence.
Read the engine page for the twelve-agent cascading constraint pipeline in full, or the FAQ for cross-site questions.