Bluenote Raises $10Million from Lux Capital & Elad Gil to Transform Life Sciences Workflows with AI

Bluenote’s mission is to bring life-saving medicines, medical devices, and diagnostics to patients & clinicians sooner by streamlining regulatory and compliance workflows.

Bluenote announced $10M in financing for its generative AI platform for life sciences companies. Co-founders Fatima Sabar and Katsuya Noguchi were early executives at Color Health. The team brings more than a decade of experience building AI tools for life sciences and healthcare.

The round is led by Lux Capital, with participation from Elad Gil, Anthropic & Menlo Ventures Anthology Fund, McKesson Ventures, Avichal Garg/Electric Capital, Moxxie Ventures, Carbon Silicon Ventures, and leaders in AI and life sciences – Othman Laraki (CEO Color Health), Fidji Simo (CEO Instacart, Co-founder Metrodora Institute, OpenAI Board), Mike Nohaile (CEO Prellis Biologics, previously Amgen & Novartis Executive), Kristen Fortney (CEO BioAge), Eric Morgen (COO BioAge), Qasar Younis (CEO Applied Intuition), Linus Upson (Verily), and Jeffrey Low (Life sciences investor).

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“At Lux, we fund businesses that turn science fiction into fact. Bluenote is enabling exactly that type of breakthrough innovation—leveraging cutting edge AI to radically reduce the overhead and manual workflows to bring pharmaceutical products into the hands of patients sooner,” said Deena Shakir, General Partner at Lux Capital. “The team represents inimitable industry expertise and technical sophistication, and their traction and high praise from customers speak for itself.”

Bluenote’s Generative AI Technology Platform Streamlines Regulatory & Compliance Workflows

Companies in the life sciences industry are heavily regulated, and need to invest significant time and resources to fulfill their regulatory and compliance obligations. While the regulatory framework is in place to ensure patient safety, clinical efficacy, and consistent product quality, the work required to produce compliance documentation is time-consuming and largely manual. Following a clinical trial’s completion, companies typically spend 8-9 months preparing regulatory submissions¹. Across the industry, thousands of scientists, engineers, and development professionals spanning multiple functions – research, clinical, manufacturing, regulatory and quality – dedicate significant time to produce thousands of pages for regulatory filings and manage complex interdependencies between protocols, technical reports and compliance requirements. This time could instead be redirected towards scientific research and product development to bring new breakthroughs to patients.

Bluenote has developed a generative AI technology platform for life sciences companies to streamline regulatory workflows and bring their breakthroughs to patients sooner. Today, the platform’s most widely used applications focus on producing regulatory filings, technical reports, protocols, Standard Operating Procedures (SOPs), validation reports, risk analyses, manufacturing documentation and more. Bluenote has deployed 15+ applications for scientists, engineers, quality, regulatory and manufacturing teams. Bluenote has developed fine-tuned models that are 90% preferred over off-the-shelf models. The company is rapidly expanding the number of applications on its platform.

Bluenote is Increasing the Accuracy, Reliability & Timeliness of Regulatory Filings, and Helping Companies Accelerate Time to Market

“Within the healthcare industry, we face extensive regulatory requirements and documentation that must adhere to numerous guidelines and regional laws. At Guardant Health, we have been pleased with Bluenote’s generative AI capabilities to streamline these time-intensive and complex tasks—ranging from scientific research papers, study reports, and software development documentation critical to regulatory filings,” said Kenny Speer, Vice President, Bioinformatics and Software Engineering at Guardant Health. “Bluenote’s technology not only helps the accuracy, reliability, and timeliness of our documentation, but also flags areas that need human-in-the-loop review. This heightened confidence in our submissions ultimately improves completeness, reduces time-to-market, and supports better patient care outcomes.”

“Companies spend an inordinate amount of time and resources producing thousands of pages for regulatory filings. Hundreds of people are involved across R&D, clinical, manufacturing, regulatory,” said Mike Nohaile, CEO of Prellis Biologics, and previously executive at Amgen and Novartis. “Every week a process development scientist spends on documentation is a week they are not optimizing the drug product. You want your clinical teams focused on opening study sites, not filling in regulatory filings. Now companies can automate this time-intensive work with Bluenote, and focus on critical development activities.”

“Life sciences leaders are moving quickly to deploy generative AI across dozens of workflows. In this industry, every day counts. Each day a breakthrough therapy or device is not in the hands of clinicians and patients is a lost opportunity to save lives,” said Fatima Sabar, Bluenote Co-founder & CEO. “Bluenote’s AI agents are being integrated into laborious workflows to accelerate time to market and increase operational excellence.”

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Bluenote has Developed a Secure Generative AI Platform that is Tailored to the Life Sciences Industry:

• Accuracy and verifiability of AI outputs
  • Bluenote’s product is engineered to include only factual details from traceable primary sources, combining guardrails with custom Large Language Models (LLMs), and inserting call-to-action placeholders for human reviewers to provide details where additional context is needed.
• Customized outputs via proprietary datasets, connectivity to data lakes & a multi-model approach
  • Bluenote developed domain-optimized Retrieval-Augmented Generation (RAG) that ingests data from various data lakes and third party applications, accurately processes the datasets, including industry-specific edge cases, and indexes them to support unique application requirements.
  • Bluenote finds that there is no one-size-fits-all model, and instead, combines the best models from Anthropic, OpenAI, Google, and its own fine-tuned models based on proprietary datasets. With new models regularly entering the market, Bluenote continuously evaluates and updates model configurations to ensure that customers are among the first to benefit from the latest advances.
• Single, secure platform that powers multiple workflows and functions
  • There are compounding benefits to having a single platform running AI applications instead of multiple vendors for each. The same proprietary knowledge base is used for multiple applications. The outputs from one workflow become inputs into another, enabling the propagation of changes. In addition, customers prefer to consolidate their proprietary data within a single, secure environment for simplicity.

With the new financing, Bluenote is rapidly expanding its platform to support additional mission-critical, time-intensive workflows, and enabling life sciences companies to bring their breakthroughs to patients sooner.

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