Expert-quality SAPs at AI speed
Purpose-built regulatory intelligence for clinical-trial biostatistics, combining evidence-grounded AI systems with expert human review.
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Purpose-built regulatory intelligence for clinical-trial biostatistics, combining evidence-grounded AI systems with expert human review.
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.
Software engineer with a background in data infrastructure, distributed systems, and ML tooling. She has worked on large-scale data interoperability frameworks, performance optimization across analytical pipelines, and integrating LLM capabilities into data workflows across verticals including healthcare, finance, and developer tooling. She has also been involved in community building aimed at broadening access to tech.
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.
