Un equipo excepcionalmente sólido.
BioThera Solutions opera con experiencia multidisciplinar que abarca biología de EV, biofabricación, medicina clínica, asuntos regulatorios y desarrollo comercial.
Liderazgo
Frédéric St-Denis-Bissonnette
PhD — Fundador y Director Ejecutivo
Perfil
Científico con doctorado y emprendedor en serie con profunda experiencia en biofabricación de vesículas extracelulares (EV/exosomas). Múltiples publicaciones revisadas por pares como primer autor en revistas internacionales de primer nivel, incluyendo contribuyente nombrado en las directrices MISEV2023 de ISEV.
Es contribuyente nombrado en las directrices ISEV MISEV2023 y cofundador de la Sociedad Canadiense de Vesículas Extracelulares (CanSEV). Fuera del laboratorio, tiene una trayectoria comprobada en la creación — habiendo fundado y liderado múltiples iniciativas en contextos científicos, comunitarios y comerciales. BioThera es donde converge esa amplitud.
Liderazgo en la comunidad EV
Cofundó la Sociedad Canadiense de Vesículas Extracelulares (CanSEV) junto a investigadores líderes en EV de todo Canadá. Sirve como miembro permanente del consejo — impulsando la coordinación nacional de la investigación en EV.
Contribuyente nombrado al proceso de directrices MISEV2023 de la Sociedad Internacional de Vesículas Extracelulares — el estándar de oro del campo para la caracterización, fabricación y reporte de datos sobre EV en todo el mundo.
From a uOttawa Side-Project to MIT & Fulbright
BioThera Solutions was born from a conviction formed during doctoral research at the University of Ottawa — that the EV field needed a dedicated vehicle to accelerate its path to commercial reality. It is now crossing borders, powered by a Fulbright Canada Entrepreneurship Award and hosted at MIT.
“Too many anti-aging products make claims science cannot support. We are building the science that changes that. Extracellular vesicles are not just another ingredient — they are a fundamental biological communication system the body already uses, and one of the most compelling platforms science has uncovered for extending human healthspan. The goal was never simply to live longer. Medicine 3.0 asks a harder question: how do we add healthy, functional years — not just years? How do we delay the onset of the chronic diseases that quietly erode quality of life decades before they kill? That is the question BioThera is built around.”
Doctoral research at the University of Ottawa and Health Canada's Centre for Oncology, Radiopharmaceuticals and Research — supervised by Drs. Jessie R. Lavoie and Lisheng Wang. The focus: developing clinically relevant, scalable biomanufacturing workflows for EV-based cancer biotherapeutics — specifically natural killer cell-derived EVs for cancer immunotherapy. What began as rigorous academic science became the technical foundation of BioThera Solutions.
That conviction took its first commercial form through the uOttawa eHub Startup Garage — first the RevUp Circuit bootcamp, then the Exploration Circuit for tailored, one-on-one venture development. The mentorship provided through both programs was instrumental in shaping BioThera into a commercially grounded venture. BioThera took first place at the annual Rally Day pitch competition, marking the transition from research concept to investable company. Lab2Market — a national STEM commercialization program — further deepened go-to-market strategy and regulatory positioning through an equally exceptional mentorship experience. Along the way, BioThera joined forces with Momentum A.I.R., an innovation hub bridging academia and industry to de-risk and validate STEM ventures for investment readiness.
Selected as a 2025–2026 Fulbright Canada Short-Term Entrepreneurship Award recipient — a binational distinction recognizing outstanding innovators who demonstrate both exceptional scientific promise and the entrepreneurial vision to bring their work to market. Hosted at MIT in April 2026, the residency focuses on advancing BioThera's North American commercialization pathway: regulatory positioning, manufacturing scale-up strategy, and U.S. market entry.
Fulbright Canada is a binational, treaty-based organization supported by Global Affairs Canada and the United States Department of State — identifying outstanding innovators across both countries for residential academic and entrepreneurial exchange.
Investigación que da forma al campo. Ciencia que define la plataforma.
Note: Not all of the following publications are directly related to BioThera's current technology. Many originate from doctoral research in cancer immunotherapy and NK cell-derived EVs. The scientific methods, manufacturing rigor, and characterization expertise developed across these studies directly inform BioThera's approach — even where the biological context differs.
F. St-Denis-Bissonnette et al. A clinically relevant large-scale biomanufacturing workflow to produce natural killer cells and natural killer cell-derived extracellular vesicles for cancer immunotherapy. Journal of Extracellular Vesicles.
Por qué importa:Establishes the knowledge and expertise behind BioThera's biomanufacturing approach. Demonstrates a GMP-compliant, serum-free hollow-fibre bioreactor workflow with extensive particle characterization — the foundation for a clinically relevant, fully scalable production system.
DOIWelsh JA, Goberdhan DCI, O'Driscoll L, Buzas EI, St-Denis-Bissonnette F, et al.; Théry C, Witwer KW. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. Journal of Extracellular Vesicles.
Por qué importa:The field-defining global consensus standard for EV research (3,043+ citations). BioThera's CEO helped write the rulebook that governs acceptable EV characterization worldwide — we do not merely comply with MISEV2023, we helped establish it.
DOIF. St-Denis-Bissonnette et al. Evaluation of resazurin phenoxazine dye as a highly sensitive cell viability potency assay for natural killer cell-derived extracellular vesicle-based cancer biotherapeutics. Journal of Extracellular Biology.
Por qué importa:Validated potency assays are a regulatory requirement (Health Canada, FDA) for IND filing and clinical-grade lot release — directly addressing a key CMC gap and reducing regulatory risk.
DOIF. St-Denis-Bissonnette et al. Ultracentrifugation and Ultrafiltration Differentially Alter the Composition and Functionality of the Biomolecular Corona of Extracellular Vesicles. Journal of Extracellular Biology.
Por qué importa:Demonstrates how isolation method shapes EV surface composition and bioactive corona — directly informing BioThera's process design and batch-to-batch consistency standards.
DOIM. Kirkby, F. St-Denis-Bissonnette et al. Natural Killer Cell-Derived Extracellular Vesicles Exhibit Cytotoxicity Against Bulk Tumor Cells and Cancer Stem Cells in Triple-Negative Breast Cancer. Nanomaterials (MDPI).
Por qué importa:Functional preclinical evidence that NK cell-derived EVs exert direct cytotoxic activity against both bulk triple-negative breast cancer cells and the cancer stem cell subpopulation associated with tumour recurrence — reinforcing the scientific case for BioThera's longer-term immuno-oncotherapeutic EV roadmap.
DOIF. St-Denis-Bissonnette et al. Scalable Biomanufacturing Workflow to Produce and Isolate Natural Killer Cell-derived Extracellular Vesicle-based Cancer Biotherapeutics. Journal of Visualized Experiments (JoVE).
Por qué importa:Published, reproducible step-by-step protocol for NK-EV manufacturing — confirms that the production process is documented, validated, and ready for tech transfer and partnership.
DOIF. St-Denis-Bissonnette et al. An Optimized Positive Staining Protocol for Clear Visualization of Extracellular Vesicles by TEM Using Uranyless and Lead Citrate. Langmuir.
Por qué importa:TEM imaging is a mandatory MISEV2023 characterization requirement. This uranium-free protocol addresses a key reproducibility gap and positions the founder at the frontier of EV characterization methodology.
DOIPersonal clave
Complementando al fundador, el equipo principal de BioThera aporta profundidad científica, disciplina financiera y experiencia traslacional.
Karan MedirattaPhD Candidate
Chief Scientific Officer
Doctoral-level scientist specializing in extracellular vesicle (EV/exosome) biology. Brings deep experimental expertise to BioThera's scientific strategy, characterization protocols, and platform development. Leads R&D execution, manufacturing validation, and product optimization across BioThera's EV biomanufacturing pipeline.
Perfil de LinkedIn
Michael KingCPA
Financial Controller
Experienced financial professional with a track record across early-stage life sciences and biotech ventures in the Ottawa ecosystem. Ensures BioThera's financial operations, reporting, and compliance infrastructure are built to scale.
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