Founded on Urgency.
Built for Impact.
RapiGenes was founded by a team of drug–device engineers, regulatory scientists, and emergency medicine clinicians who share a single conviction: that the gap between life-saving drugs and the people who need them most is an engineering problem — one we intend to solve.
Patient First
Every design decision begins and ends with the patient in extremis — lives depend on our getting it right.
Regulatory Rigor
We design for approval from day one. Regulatory strategy is embedded in our engineering culture, not added after.
Mission Alignment
Our work supports warfighters, first responders, and civilian communities facing the world’s most dangerous threats.
Scientific Integrity
Data-driven decisions, transparent communication, and a commitment to reproducible science guide our development process.
Why RapiGenes Exists
The autoinjector is not a new technology. But despite decades of commercial availability, the platform has never been systematically applied to the full breadth of emergency medicine needs — particularly in military and CBRN applications where existing products are aging, supply-constrained, or simply absent.
RapiGenes was established to change that. By combining modern drug–device combination product regulatory science with advanced autoinjector engineering, we are building a pipeline of products that can enter government stockpiles, combat medical kits, and civilian emergency response systems within this decade.
RapiGenes, Inc. Incorporated
Company established with seed capital. Founding team assembled from FDA regulatory, DoD medical research, and pharmaceutical device industry backgrounds.
Platform Feasibility & Market Assessment
Comprehensive analysis of unmet needs in trauma and CBRN drug delivery. Target product profiles (TPPs) defined for lead autoinjector candidates.
FDA OCP Pre-RFD Meeting
Confirmed combination product designation and drug-led regulatory pathway. CDER as lead center established for lead programs.
DoD SBIR Phase I Award
Phase I Small Business Innovation Research grant awarded to advance nerve agent antidote autoinjector. Design freeze for lead device achieved.
IND-Enabling Studies & CMO Partnership
Contract manufacturing organization (CMO) partner selected. IND-enabling preclinical studies initiated. Human factors formative studies underway.
Expertise at the Intersection of Drug, Device, and Defense
Chief Executive Officer
15+ years in pharmaceutical and medical device commercialization. Former regulatory affairs executive with FDA drug–device combination product submission experience.
Chief Technology Officer
Lead engineer with 20 years in autoinjector and drug delivery device design. Expert in human factors engineering, ISO 11608 compliance, and design V&V for prefilled injection systems.
Chief Medical Officer
Emergency medicine physician and military medical officer. Former U.S. Army Combat Casualty Care researcher. Expert in CBRN decontamination and prehospital emergency medicine.
VP, Regulatory Affairs
RAC-certified regulatory professional with deep FDA combination product experience. Led multiple successful NDA and BLA submissions integrating device constituents.
VP, Quality & Compliance
QMS architect with experience implementing 21 CFR Part 820, ISO 13485, and ICH Q10 pharmaceutical quality systems at combination product companies.
Director, Government Affairs
Former DoD program manager with BARDA and JPEO CBRND acquisition experience. Manages SBIR/STTR grant portfolio and DoD medical countermeasure procurement relationships.