Formation Bio, in collaboration with Sanofi and OpenAI, has introduced Muse, an AI tool designed to accelerate and improve patient recruitment for clinical trials. This collaboration aims to combine pharmaceutical expertise with advanced AI models to expedite the delivery of breakthrough therapies to patients.
Addressing Recruitment Bottlenecks
Patient recruitment is a critical and often time-consuming and expensive aspect of clinical development. It is estimated that less than 10% of patients participate in clinical trials, often due to lack of awareness or access. This low participation rate can significantly delay the availability of new medicines. Muse aims to address this bottleneck by accelerating recruitment strategy and content creation, reducing timelines from months to minutes.
How Muse Works
Muse analyzes extensive scientific literature, real-world evidence, and insights on diseases and patient populations. It delivers comprehensive research, strategic opportunities, and faster preparation of patient recruitment strategies. The AI tool compiles in-depth research on diseases and patient demographics, identifies optimal patient profiles and recruitment strategies, and auto-generates high-quality recruitment materials and pre-screening questionnaires tailored to specific patient subgroups.
Ben Liu, Co-Founder & CEO of Formation Bio, stated, "AI presents a tremendous opportunity to transform drug development, ultimately enhancing both efficiency and outcomes... Muse is just the start—one of the many AI innovations we're building for drug development."
Initial Deployment in Multiple Sclerosis Trials
Developed jointly by the three companies leveraging multiple OpenAI models, Muse is designed for use across a wide range of therapeutic areas. Sanofi plans to implement Muse in upcoming Phase 3 studies for multiple sclerosis (MS). For this rollout, Sanofi will provide data and expertise on MS, leveraging its experience in delivering innovative treatments to support patients affected by this condition.
Emmanuel Frenehard, Chief Digital Officer, Sanofi, said, "By leveraging advanced AI capabilities, we can not only enhance recruitment efficiency but also potentially bring new treatments to patients faster... represents another proof point in Sanofi's journey to becoming the first pharma company powered by AI at scale."
Enhancing Inclusivity and Compliance
Muse develops tailored strategies and materials designed for diverse patient populations, including historically underrepresented groups, to enhance inclusiveness and representation in clinical trials. This approach aims to expand participation and capture broader trial data, contributing to more reliable, generalizable insights that better reflect the needs of all patients.
Additionally, Muse includes an LLM agent that incorporates Institutional Review Board (IRB) and regulatory guidelines, aiming to automatically generate high-quality materials that keep compliance best practices in mind. This feature, combined with human experts, reduces the risk of regulatory setbacks, promoting smoother, more efficient trial progression.
Commitment to AI Safety and Data Privacy
AI safety and data privacy are embedded throughout Muse's development and deployment. Muse relies on research publications and other public and proprietary data sources, none of which contain personally identifiable information (PII).
Brad Lightcap, COO, OpenAI, commented, "We believe AI can accelerate drug development, bringing new treatments to patients more quickly... This first product from our collaboration with Sanofi and Formation Bio is just the beginning, and we can't wait to see the impact it will have."
