🚀 Big shout-out to our Principal Biostatistician, Run Zhuang, for presenting "Machine Learning Generated Digital Twins as External Controls” at the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop. Run showed how AI-generated #digitaltwins serve as external controls in non-randomized #trials to improve efficiency and reduce bias to establish causal effects. Thank you to everyone who stopped by! #RISW2026

4️⃣ days out from our webinar: More Drugs, Faster: Can Clinical Development Keep Up? Dr. Jon Walsh (Unlearn), Dr. Tala Fakhouri (Parexel, formerly FDA/CDER), and Dr. Barbara Bierer (Harvard, MRCT Center) on what faster discovery demands of sponsors, regulators, and the people running trials. 📅 Monday, September 28, 11 AM PT / 2 PM ET. Can't attend live? Register and we'll send the recording. ➡️ Register: na2.hubs.ly/H07_k1z0

#UnlearnerSpotlight 🚀 “My favorite part about working at Unlearn is the ‘lightbulb moment’ when customers see how our offerings can improve their day-to-day work.”

🕚 Time change: our Sept 28 webinar with Dr. Jon Walsh, Dr. Tala Fakhouri, and Dr. Barbara Bierer now runs 11 AM PT / 2 PM ET. Same day, same panel. Registered? Update your calendar. Not yet? na2.hubs.ly/H07WcrY0

💭 Everyone says @FDA review needs to modernize for the #AI era. What does that actually require over the next three to five years? Dr. Tala Fakhouri led development of FDA's first draft AI guidance from inside CDER. Dr. Barbara Bierer leads the MRCT Center's work on standards for international #trials. Dr. Jon Walsh took AI-generated #digitaltwins through EMA qualification. 📅 Monday, September 28, 8 AM PT. Live Q&A included. 🔗 Register: na2.hubs.ly/H07Sm820

💊 A #clinicaltrial is a long chain of decisions, and each one shapes the next. In his latest reflection, our CEO Steve Herne looks back on a busy few months at Unlearn: ➡️ Three new papers from our science team ➡️ New collaborations with Acumen and VectorY ➡️ FRESH, our oncology modeling approach, starting to prove useful beyond oncology ➡️ Being named the 2026 Fierce AI Innovation Award for Clinical Trial Design All of it driving our work heading into Q4. Read his full reflection here: na2.hubs.ly/H07R0tP0

Dario Amodei argues #AI will generate more #drugcandidates than the system built to test and approve them can handle. If he's right, the bottleneck moves downstream, to how quickly and how credibly #trials can be run and reviewed. 📅 On September 28, Dr. Tala Fakhouri (Parexel; authored FDA's first AI guidance at CDER), Dr. Barbara Bierer (Harvard Medical School, MRCT Center), and Dr. Jon Walsh (Unlearn) get into which uses of AI in trials are defensible today and what #regulatory review needs to become. 45 minutes of discussion, then your questions live. 🚀 Register: na2.hubs.ly/H07K0Y70

🎉 Unlearn has been named a winner in the first-ever Fierce AI Innovation Awards, in the Clinical Trial Design category! Every #clinicaltrial is a chain of high-stakes decisions made across fragmented data, tools, and institutional memory. We built Unlearn to be the scientific intelligence layer for #clinicaldevelopment: integrating the evidence, modeling, and reasoning behind those decisions so trial teams can commit with confidence. Thank you to @LifeSciEvents and the judges, and congratulations to the other honorees. Most of all, thank you to the sponsors who have trusted us as a partner in getting treatments to patients faster. #FierceAIInnovationAwards

🎉 Please join us in congratulating Andrew Stelzer, who has been promoted to Chief Commercial Officer at Unlearn. Since joining as Head of Business Development five years ago, Andrew has been instrumental in building the partnerships that bring digital twins of patients into clinical development. He leads with both strategic vision and genuine care for the people around him, and that combination has meaningfully shaped our momentum as a company. Congratulations, Andrew. We are excited for what comes next. 🚀

🖥️ Our webinar is a month away. If #AI makes #drugdiscovery much faster, can #clinicaldevelopment and #regulatory review keep up? Dr. Jon Walsh, Dr. Tala Fakhouri, and Dr. Barbara Bierer get into it on Monday, September 28, followed by a live audience Q&A. ➡️ Register now: na2.hubs.ly/H07ttrc0

#UnlearnerSpotlight 🚀 “My favorite part of working at Unlearn is being surrounded by coworkers who are exceptionally talented and committed to mastering their craft, while sharing a common purpose of improving the efficiency of clinical trials.”

What happens when #AI can generate more drug candidates than the system built to test and approve them was ever designed to handle? That's the question we're taking on. Dr. Jon Walsh (Co-founder & Chief Scientific Officer, Unlearn), Dr. Tala Fakhouri (Chief AI & Regulatory Strategy Officer, Parexel, and former FDA/CDER AI policy lead), and Dr. Barbara Bierer (Harvard Medical School, MRCT Center) discuss where AI is already making #clinicaltrials more efficient, and what it will take for #regulatory review to keep pace. 45 minutes of discussion, plus live Q&A. 📍 Monday, September 28, 8 AM PT ➡️ Register: na2.hubs.ly/H0772Nb0 ——— @Parexel, @harvardmed, @MRCTCenter

🚀 Our team had a great time at #JSM2026 in Boston last week, where we brought two talks to the stage on AI-generated digital twins. Run Zhuang shared how our AI-generated #digitaltwins extend across #trial designs, including support for #regulatory decisions. Daniele Bertolini showed how digital twins enable rigorous trials where a control group isn't feasible — across ALS, Huntington's, and oncology. Every conversation this week reinforced why we do this work — bringing better evidence to trials, faster.

Unlearn's Co-Founder and CSO, @AnotherJonWalsh, will present "Digital Twins in Nephrology Clinical Trials" at #GlomCon2026 in Maui this week — a look at how AI-generated #digitaltwins can make #nephrology trials leaner without compromising rigor. 📅 Thursday, August 6 · 1:30 PM HST

🚀 Unlearn is bringing two talks to #JSM2026 in Boston on Wednesday, August 5: Run Zhuang — "Digital Twins and Causal Machine Learning in Drug Development," 8:35 AM ET Daniele Bertolini — "Machine Learning–Generated Digital Twins as External Controls for Non-Randomized Trials," 10:35 AM ET Run will cover how our AI-generated #digitaltwins extend across #trial designs, including to support #regulatory decisions. Daniele will show how digital twins enable rigorous trials where a control group isn't feasible — across ALS, Huntington's, and oncology.

"Can we trust AI in a clinical trial?" is the wrong question. The @FDA's guidance doesn't assess #AI. It assesses a specific use of a specific model, weighed on two axes: how much the model influences the result, and what it costs if that result is wrong. We ran three real uses through that lens. ➡️ na2.hubs.ly/H06YKq-0

#UnlearnerSpotlight 🚀 “I enjoy working at the intersection of AI, software engineering, and clinical research, where every project offers an opportunity to learn something new. Knowing that the tools we build and validate can help researchers design more efficient clinical trials—and ultimately accelerate the development of new treatments—makes the work especially rewarding.”

Every trial is a chain of key decisions, and the evidence behind them sits in tools that were never built to talk to each other. So teams rebuild the same reasoning at every stage. Unlearn integrates the evidence, modeling, and reasoning behind those decisions, so trial teams can commit with confidence and each decision builds on the last. That is why we have been named a finalist in the 2026 Fierce AI Innovation Awards for AI Innovation in Clinical Trial Design. 🚀 Credit to our team and to the sponsors running active studies with us today. Thank you to @LifeSciEvents. #FierceAIInnovationAwards

That's a wrap on #AAIC2026! Our team presented "Using Digital Twins to Improve Statistical Efficiency in Alzheimer's Disease Trials with p-tau217", announced our collaboration with Acumen Pharmaceuticals on their sabirnetug program, and had many great conversations about what smarter AD trial design can look like. Thanks to everyone who connected with us! 🚀

Alzheimer's is one of the hardest places to run a #clinicaltrial, and it's exactly where #digitaltwins can help most. We're proud to be working with @AcumenPharm to apply ours across their sabirnetug program, spanning Phase 1 and Phase 2 studies. More here: na2.hubs.ly/H06yNMw0