BlackCat Bio's therapeutic-area AI agents cut statistical analysis plan (SAP) drafting from weeks to days, catch indication-specific issues in protocols before they become amendments, and deliver fully sourced outputs grounded in FDA guidance for your exact study type.
Unlike generic AI, BlackCat Bio deploys therapeutic-area agents trained on the specific statistical conventions, FDA precedent, and operational realities of your indication.
Former FDA statistical reviewer with 20+ years in pharma and biotech. Barbara has reviewed hundreds of protocols and SAPs across pulmonary, autoimmune, metabolic, cardiovascular, dermatology, and analgesia. She has a proven track record of successful regulatory submissions including NDAs, PMAs, 510(k)s, and BLAs. She brings 20+ years of FDA and industry expertise to every engagement.
Software engineer and data engineering leader with a decade of experience building scalable systems across biotech, healthcare, and venture. Skilled in full-stack development, data infrastructure, and AI-powered tools that support scientists, clinicians, and investors—spanning high-throughput experimentation, therapeutic discovery, and portfolio strategy.
Product Manager with 5+ years of experience building AI-focused healthtech and biotech products, backed by a Master's in Human-Computer Interaction. Passionate about crafting products that are both intuitive and impactful — eliminating friction for end users while solving real problems in the life sciences space.
Built production systems used by investors, scientists, and internal teams — often collaborating across functions to translate real-world needs into scalable, user-focused software. Background spans both biotech and fintech, with a strong focus on end-to-end development, performance optimization, and delivering real impact through thoughtful engineering.
BlackCat Bio's AI tool is poised to be a game-changer for our network of consulting statisticians. By ingesting complex study protocols, FDA interactions, and more, it will allow our biostatisticians to move straight to the high-level strategic refinement that matters most. We won't just save dozens of hours. We will ensure a higher baseline of consistency and quality across every project.
