Bluenote announced $10 million in funding for its generative AI platform for life sciences companies. The funding round was 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).
Companies in the life sciences industry are very regulated and must invest time and resources to fulfill their regulatory and compliance obligations. Even though 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 usually spend 8-9 months preparing regulatory submissions. Thousands of scientists, engineers, and development professionals spanning functions like research, clinical, manufacturing, regulatory, and quality spend significant time producing thousands of pages for regulatory filings and managing complex interdependencies between protocols, technical reports, and compliance requirements. This time should be redirected towards scientific research and product development to bring breakthroughs to patients.
Bluenote has created a generative AI technology platform for life sciences companies to streamline regulatory workflows and bring their breakthroughs to patients sooner. Now, 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, etc. 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. And the company is rapidly expanding the number of applications on its platform.
The company co-founders Fatima Sabar and Katsuya Noguchi were early executives at Color Health. And the team brings more than a decade of experience building AI tools for life sciences and healthcare. With the new funding, Bluenote is rapidly expanding its platform to support additional mission-critical, time-intensive workflows and enable life sciences companies to bring their breakthroughs to patients sooner.
KEY QUOTES:
“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. The team represents inimitable industry expertise and technical sophistication, and their traction and high praise from customers speak for itself.”
– Deena Shakir, General Partner at Lux Capital
“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. 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.”
– Kenny Speer, Vice President, Bioinformatics and Software Engineering at Guardant Health
“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. 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.”
– Mike Nohaile, CEO of Prellis Biologics, and previously executive at Amgen and Novartis
“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. Bluenote’s AI agents are being integrated into laborious workflows to accelerate time to market and increase operational excellence.”
– Fatima Sabar, Bluenote Co-founder & CEO
