Everyone in pharma is racing to launch generative AI tools, even the FDA. However, some things in life take time to flourish… 📈⚕️ As journalist Natalia Mesa outlines in her recent take for BioSpace the FDA’s recent rollout of Elsa, a large language model designed to help with clinical protocol reviews and scientific evaluations, raised some red flags ⚠️. According to Mesa’s reporting, FDA insiders described the implementation as rushed, lacking proper oversight, and prone to incorrect or partially accurate outputs. Some said Elsa wasn’t ready. Others questioned how decisions made with its help could hold up under legal or scientific scrutiny. I don’t know for sure, won’t speculate on FDA’s moves. But I can say one thing clearly: it took a decade for Insilico Medicine, to get to the most advanced and well-validated AI platform in the industry, PharmaAI. Steadily building, testing, and validating…it takes time to grow organically 🌿. For those curious, here is a brief historic note: 🧬 2014 – Founded to bring AI into aging and medicine. 📄 2016–2019 – Published foundational work; GENTRL, their early generative model, created viable molecules in under a month. 🧪 2020–2021 – Launched PharmaAI, combining tools for target discovery (PandaOmics), molecule generation (Chemistry42), and trial prediction (InClinico). 💊 2022 – AI-designed anti-fibrotic drug ISM001-055 entered Phase I trials. 📈 2023–2025 – That same drug, now named Rentosertib, reached Phase II trials—with results published in Nature Medicine in June 2025 confirming safety and initial efficacy in patients. 🚀 Over just a span of several years, PharmaAI platform enabled discovery and design of more than 30 preclinical and clinical drug candidates, and multiple new targets (see image). The lesson here is this: Insilico didn’t skip steps. It published results and AI platform mechanics relentlessly, validated with its own pipeline and client’s projects, and iterated, it took time and patience. Their tools evolved from basic algorithms to a trusted enterprise platform used by major pharma players across the globe… I think Alex Zhavoronkov and Alex Aliper could one day write a book about this roller coaster ride! Meanwhile, I feel like the FDA’s experiment with Elsa shows what happens when there is a push for a quick win in a complex area like medical AI, something Mesa’s reporting hints to… I hope they figure things out fast, the FDA is one of the most important organizations in the world, IMO. We all need them to be doing great, because the health and lives of many-many people depend on that 🙏🩺 Image credit: Insilico Medicine
Alex Zhavoronkov
4mo
Wow, thank you for these thoughts and history recap, Garri Zmudze 🙏
Original reporting: https://www.biospace.com/fda/fdas-ai-rollout-raises-questions-around-readiness-legality Insilico pipeline: https://insilico.com/pipeline