A careful AI lab that happens to work in clinical research safety.

Burna AI is the safety and data quality platform for clinical research, from early phase trials through postmarket surveillance. Burna AI performs automated adverse event grading and attribution in real time, providing clear rationale and audit-ready evidence, including generation of IRB, sponsor and FDA reports. Burna AI delivers CTCAE v5 and v6 grades and MedDRA LLT codes on every encounter; enabling standardization, cross-site consistency and accuracy of clinical research data.

What exists today.

What exists today is working software. A grading engine that reads the note, retrieves the criterion, scores attribution per drug, and writes the reports, with every output carrying the evidence it rests on.

INDPostmarket
the engine, constant
Ph IPh IIPh IIIApproval

clinical trials through postmarket surveillance

Figure 1. One engine, the whole lifecycle.

grading engine · attribution · real-time infrastructure · Healthnotes

Who built this.

A platform-engineering founder, a chief medical officer who has run cancer centres and led leukemia programmes, and a lead engineer who owns the infrastructure that has to hold.

Portrait of Nnenna John, Founder and CEO of Burna AI

Nnenna John

Founder and CEO

Nineteen years in platform engineering, six of them at Airbnb building infrastructure for 150 million users across 220 countries, and earlier at JP Morgan Chase, Roku and Expedia. A domain outsider to clinical trials with an insider’s advisory network. She architected the grading workflow and the twelve-agent cascading constraint pipeline behind every suggested grade.

Portrait of Jonathan Gerber, MD, Chief Medical Officer of Burna AI

Jonathan Gerber, MD

Chief Medical Officer

Trained in internal medicine and hematology/oncology at Johns Hopkins and served on the hematology faculty there. He founded and led the Leukemia Program at Levine Cancer Institute, and was Chief of the Division of Hematology and Oncology and Director of the UMass Cancer Center at UMass Chan. His research covers early-phase clinical investigation with novel agents, leukemia stem cell biology, and minimal residual disease.

Portrait of Paschal Ezeugwu, Lead Engineer and Co-Founder of Burna AI

Paschal Ezeugwu

Lead Engineer and Co-Founder

EHR integration and the quiet infrastructure that has to hold. SMART on FHIR across Epic, Oracle Health and regional systems, HL7 and FHIR pipelines, real-time architecture. The platform side of every deployment ships under his ownership.

“My daughter had one kidney taken out. We went to ten doctors. She was on the wait list for three years. I don’t remember any of those conversations. When we moved hospital they gave me piles of paper. I wish I’d had a way to capture what was said.”

Nnenna John · Founder and CEO, Burna AI

The people who read the work before you do.

Five councils meet on a weekly rotation: practising oncologists, pharmaceutical executives, regulatory scientists, informaticists and operators. They are why a domain outsider could build this, and they read the work before you do.

Clinical

  • Dr. Stefan Gluck

    Formerly VP at Celgene; former CMO at RNA Diagnostics. Presenting Burna at AI in Oncology Germany, ESMO Breast Cancer and ASCO 2026.

  • Dr. Andrea Pirzkall

    Formerly CMO at Replimune and Asher Biotherapeutics; ED Clinical Development at BeiGene; Principal Medical Director at Genentech.

  • Dr. Michel Azoulay

    Strategic advisor to the CEO and exec lead for Protocol Safe. Former CMO at IFLI; formerly leadership at Sanofi, Amgen and IQVIA.

  • Dr. Usman Shah

    Medical Director, GI Oncology and Phase 1 Trials, Atlantic Health System.

  • Dr. John Hayslip

    CMO at Verastem Oncology; NCI cancer center network.

  • Dr. Oliver Overheu

    Senior Associate, Duke Capital Partners. Board-certified medical oncologist and hematologist, formerly Katholisches Klinikum Bochum. Duke Fuqua MBA.

  • Dr. Manuj Agarwal

    Radiation Oncology, Hospital of the University of Pennsylvania. American Brachytherapy Society.

  • Jide Sotunbo, MPH, PharmD

    Clinical Development Trial Lead, Eli Lilly.

  • Dr. Islam Sadek

    Executive Director, US Product Strategy Lead, Hematology, Novartis; formerly Gilead Sciences and Janssen.

Regulatory and standards

  • Dr. Howard Fingert

    Former Head, Pfizer Clinical Safety; VP ONO Pharma. Member FDA ODAC and NCI advisory committees including CTCAE updates.

  • Sophia Scott Goodison, MPH

    Twenty-five years in pharmacovigilance and benefit-risk. Formerly SERM Senior Director and Group Leader for early phase oncology, immunology and cell and gene therapy at GSK; earlier Janssen and Novartis.

  • Dr. Mary Morison Saltz

    Chief Clinical Integration Officer, Stony Brook Medicine. Led the N3C national data initiative.

  • Milad Bahrami

    President, Concept Plus; formerly NIH, FDA CDER and Leidos Health.

  • Dr. Mark Schweitzer

    Dean, Wayne State University School of Medicine. Federal study sections and FDA advisory experience.

Technology and product

  • Dr. Joel Saltz

    SUNY Distinguished Professor; founding chair of Biomedical Informatics at Stony Brook. Clinical informatics governance across N3C and CI4CC.

  • Kira Sentrenko

    Market Access, Promomed Group; formerly Roche, Merck and J&J.

  • Dan Storms

    Formerly CPO at The Rounds and CookUnity.

  • Rebecca Greene

    Co-founder and CTO, Regal.ai; formerly CPO at Handy.

Commercial

  • Carl Kennedy

    Formerly Global Chief of Strategy, Medidata.

  • Kevin Li

    Finance and operations. Early career in investment banking, corporate finance at Facebook, CFO of Athena Capital through a public listing, and CEO of HomeOptions.

  • David Malinosky

    Commercial strategy, paired with Carl on enterprise market access.

  • Ryan Joswick

    Formerly SVP Sales, Heartland Payment Systems.

  • Laurence Girard

    CEO, FruitStreet and HealthcareShares. Lead investor in the physician-led seed round.

  • Njideka “Deka” Dike

    CEO, Omatochi. EY Entrepreneur of the Year.

Brand and adoption

  • Dr. Azita Hamedani

    Former President and CEO, UNC Health Faculty Physicians, and former Chair of Emergency Medicine.

  • Chirag Lodhia

    Director of Digital Health Training and Adoption, Monash Health. Author of the 12-pillar Implementation Playbook.

  • Rilwan Lawal

    Founder and CEO, GigEasy.

  • Dr. Anu Orebiyi, PsyD

    Assistant Executive Director, Wright Institute. Behavioral health and health equity.

Advisors are listed in their personal capacity. Affiliations are given for context, not to imply institutional endorsement. A few advisors sit on more than one council.

Between visits, patients tell Healthnotes what actually happened. The clinical record improves at the source.

Healthnotes

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