In a podcast recorded early March (just before AVA6103 started dosing, published mid April) CC was asked about accelerated approval for AVA6000. She smiled and said “stay tuned.” Referencing alignment with FDA #ProjectOptimus. 7/12

ICON’s experts examine the challenges of ADC development and why early scientific advice, dose optimisation and accelerated designations are vital for efficient approval. ow.ly/oPVf50YnYEX #DrugDevelopment #RegAffairs #ProjectOptimus #OncologyResearch

AE management probably has always been underrated but with CAR T and TCEs it’s become the “x” factor for clinical, regulatory, and commercial success. Hat tip to ProjectOptimus.

📹 WATCH: Harpreet Singh, MD, former #FDA director, discusses the FDA's new draft guidance on radiopharmaceutical dosing and its relation to #ProjectOptimus. hubs.li/Q03M9gK00

👏 Congrats @VivekSubbiah & team on their important study in @JCOOA_asco 👉 how @US_FDA Project Optimus is transforming early-phase oncology trials — shifting focus from “maximum tolerated dose” to smarter, patient-centered designs👉huge step forward for cancer research! 💪#ClinicalTrials #ProjectOptimus

Important insights! 📊 Despite FDA Project Optimus, many early-phase oncology trials still rely on toxicity-driven dose selection. Flat efficacy–toxicity curves highlight the urgent need for biologically driven dose optimization. #OncologyTrials #ProjectOptimus

💫🌟🚨 New in @JCO_ASCO 2025 📄 Impact of FDA Project Optimus Guidance on Design of Early-Phase Oncology Trials 👨‍⚕️ @DavidRSpigel @VivekSubbiah @OncoAlert @MedicalwatchFTW 📊 Key Results from 248 US Trials (2015–2023): ✅ 40% included multiple dose arms ✅ Use of model-based designs ↑ after guidance ✅ 1 in 3 trials had flat dose-efficacy relationship ⚠️ 18% of phase 2/3 trials used non-recommended doses 🔬 Toxicity-driven decisions still dominate dose selection 💡 Take-home: Despite Optimus guidance, flat efficacy-toxicity curves & single-arm designs persist. Stronger regulatory & academic push needed to shift paradigms toward biologically driven dose optimization. #OncoTwitter #ClinicalTrials #DoseOptimization #FDA #ProjectOptimus #CancerResearch ascopubs.org/doi/10.1200/OA-…

🚨 Hot off the press in @ASCO journal @JCOOA_ASCO 👉Pleased to share our study 👉 "Impact of FDA Project Optimus Guidance on Design of Early-Phase Clinical Trials" 📊 Analysis of 367 phase I #oncology trials (2021-2024) reveals Project Optimus is transforming cancer drug development: 📈 Bayesian designs surged 48% → 75% 🎯 30% now include dose-optimization plans ⚖️ Moving beyond max tolerated dose approach 👉This shift toward smarter, more patient-centered trial design marks a pivotal moment in early-phase cancer research @OncoAlert @JCO_ASCO @PamelaKunzMD #ClinicalTrials #CancerResearch #ProjectOptimus #PrecisionMedicine #FDAGuidance Open access Link: ascopubs.org/doi/10.1200/OA-…

3/ At @ASCO 2021 annual meeting, Anne’s data & voice spearheaded a shift in the field - laying the groundwork for paradigm shifts by @FDAOncology - #ProjectOptimus & #ProjectRenewal 👉🏻 mbcalliance.org/news/in-memo…

Excited to see momentum building for right dosing in #oncology & see @The_Right_Dose cited 1st in this publication. 🙌 to Anne Loeser, whose bold, patient-1st vision sparked a movement now echoed in @FDAOncology #ProjectOptimus & #ProjectRenewal. ascopubs.org/doi/10.1200/JCO… #bcsm

#PlusTherapeutics announces the treatment of its initial patients in the Company’s ReSPECT-LM dose optimization trial for REYOBIQ™ (rhenium Re 186 obisbemeda) for the treatment of #leptomeningealmetastases (LM). This #clinicaltrial builds on promising results from $PSTV’s completed Phase 1 single-dose escalation study, which demonstrated the feasibility of REYOBIQ for treating LM. The trial is designed in alignment with the @US_FDA's #ProjectOptimus to identify the optimal dosing regimen that maximizes efficacy and safety. The substantial clinical need is expected to facilitate rapid overall trial enrollment. Read the full press release here: bit.ly/4nIlPDw Learn more about the ReSPECT-LM trial here: bit.ly/45OBc6O @UTHealthSA #clinicaltrials

🎤 New Podcast Alert from Fortrea! 🎧 Tune in to Fortrea’s new podcast series: Project Optimus. Episode 1: "Rethinking Dose Optimization in #Oncology," delves into what #ProjectOptimus is and its key advantages for sponsors, regulators and patients. fortrea.com/insights/launchi…

Missed our oncology webinar: "Beyond Project Optimus: Challenges, Lessons Learned, and Protocol Design Considerations in Today’s Oncology Programs"? You can still register and view it! eventsonlineregister.com/eve… #oncology #projectoptimus #FDA #oncologytrials #drugdevelopment

Great workshop and talk #YingYuan @MDAndersonNews on 🔧 backfill strategies in early phase trials including novel BARD covariate-adaptive randomisation strategies allowing dose escalation, backfill and randomisation data to ⏫ efficiency of 🧬 trials #ProjectOptimus #AACR25

Don't miss tomorrow's #oncology webinar: A new dose selection paradigm is here in oncology. How can we optimise it? Register: arena-international.com/even… #projectoptimus #FDA #doseselection #oncologytrials #drugdevelopment

🎤 Processa Pharmaceuticals $PCSA to Present at World Orphan Drug Congress 2025 Dr. David Young, Founder & President of R&D, will speak on applying FDA’s Project Optimus to rare diseases—showcasing $PCSA's approach to designing safer, more effective therapies. 💡 Why It Matters • Aligns $PCSA with FDA-backed innovation • Highlights leadership in rare disease drug design • Reinforces focus on high-value orphan markets 📍Full details: redchip.com/stocks/pcsa/news… $PCSA $MRNA $BNTX $NUVB $GPCR #PCSA #Biotech #RareDiseases #Oncology #FDA #ProjectOptimus #BiotechInvesting

There is still time to sign up for the April 16 #oncology webinar: A new dose selection paradigm is here in oncology. How can we optimise it? Register: arena-international.com/even… #projectoptimus #FDA #doseselection #oncologytrials #drugdevelopment

A new dose selection paradigm is here in oncology. How can we optimise it? Join this insightful oncology webinar on 16 April. Register today: arena-international.com/even… #oncology #projectoptimus #FDA #doseselection #oncologytrials #drugdevelopment

The FDA’s #ProjectOptimus is reshaping dose optimization in #oncology to a #patientcentric approach, resulting in significant effects on trial timelines & costs. Join us for a #paneldiscussion & learn how to adapt your clinical strategies early. Register: arena-international.com/even…

Got email from student enrolled in Honors Science Research program in HS in NY. He read a paper with Sotorasib in PDAC and reached out with a great question re balance toxicities vs efficacy. Spot on! #projectoptimus Impressed with his drive to learn. 🙌 for his teachers