Cytel

Animal toxicology often fails to predict human response. To address this long-standing scientific limitation, the FDA’s newly published roadmap outlines a pivotal shift in how safety data for biologics will be generated and assessed. Join Cytel’s Mike Fossler and Nelia Padilla along with Mammoth Preclinical Consulting, LLC’s Founder C. Edwin Garner, PhD, for an insightful webinar that will unpack the implications of this shift and explore how sponsors can adapt their strategies to align with evolving regulatory expectations. Register today! https://hubs.ly/Q03VhwyQ0 #FDA #biologics #drugdevelopment

Investing in women’s health could not only extend and improve lives but also boost the global economy by $1 trillion annually by 2040. Grammati Sarri, Lilia Leisle, PhD, and Jeff Muir discuss the gender health gap and their investigation into the economic impact of investments to address this global health crisis. Read the post to learn more: https://hubs.ly/Q03Vg8xb0

What an incredible final day of PHUSE EU Connect 2025! Thank you to all the incredible presenters and all those we connected with for your thought-provoking and engaging conversations! 🎉 And a special shout out to Marie Poupelin and Hugo Signol for your insightful presentations and sharing your internship experiences! Thanks to: Luke Hilliard, Macarena Pazos Maidana, Dr. Alexander Schacht, Angelo Tinazzi, Geoff King, Luis Alejandro González, Cedric Marchand, Sebastià Barceló Bauçà, Nolwenn Juhel, Cyril Sombrin, John T., Eswara Gunisetti, Christopher Oelkrug, Jackie Dowell, MBA, Gareth Hughes-Jones, Camila Pazos Maidana, Ph. D., Steven Thacker, and Corey Dunham Didn’t get a chance to speak with our experts? Contact us! https://lnkd.in/eic65R6k We look forward to seeing you next year!

We’re proud to announce that Cytel is a finalist for the Scrip Award for Best CRO Specialist Providers! Learn more about how Cytel’s East Horizon™ — a cloud-native platform integrating trial design, simulation, and AI-assisted tools — enables robust scenario testing, risk mitigation, and faster, more informed decision-making: https://hubs.ly/Q03TXmSG0 #ScripAwards #Cytel #ClinicalResearch #software #EastHorizon

Cytel is at PHUSE EU Connect 2025! Day 2 has been amazing with more insightful conversations, workshops, and presentations! 📍Head over to Booth 9 to meet with our experts and learn more about our innovative solutions! See you there! Congrats to our presenters today, including Cedric Marchand and Marie Poupelin! https://lnkd.in/e4PQKJFv

Animal toxicity often does not predict human toxicity. For a number of years, the FDA and other regulatory agencies have been concerned about the use of animals in toxicology studies and the increasing realization that animal toxicology data does not always predict human toxicity. Mike Fossler discusses the FDA’s ambitious long-term strategy for reducing or even eliminating animal testing in preclinical safety studies. Read the post to learn more: https://hubs.ly/Q03TJlGq0

🌟 Webinar alert! Last chance to register! The rise of targeted- and immune-therapies has shifted the focus in early-phase dose-finding studies away from finding the Maximum Tolerated Dose (MTD) and toward identifying the Optimal Biological Dose (OBD). The PKBOIN-12 method, developed by Dr. Hao Sun, Biostatistician at Bristol Myers Squibb, and colleagues, enhances the established BOIN12 algorithm by incorporating Pharmacokinetic (PK) information into the OBD determination process. In this webinar, Kevin Trimm and Hao Sun will cover the motivations for developing this new method, its implementation in advanced statistical software, as well as its statistical underpinnings. The conversation will be framed within the context of the shifting regulatory assessments of biologics in Phase II clinical trials, encapsulated in the FDA’s Project Optimus. Please join us for a fascinating conversation. Register today! https://hubs.ly/Q03Ttq5S0 #ProjectOptimus #PBPK

Cytel is making waves at PHUSE EU Connect 2025! We’re excited to connect with industry leaders and share insights that are shaping the future of clinical data science. 📍Meet us at Booth 9 to learn more about our innovative solutions and how we can help accelerate your journey from data to decision. See you there! Luke HilliardMacarena Pazos MaidanaDr. Alexander SchachtAngelo TinazziGeoff KingLuis Alejandro González Cedric MarchandSebastià Barceló BauçàNolwenn JuhelHugo SignolCyril Sombrin #PHUSEEU #ClinicalDataScience #Cytel #Innovation #DataDriven

Patient and public involvement in HTA has progressed from best practice to policy requirement, yet communication barriers persist. Cytel’s Manuel Cossio and co-author Ramiro E. Gilardino explore how plain language summaries (PLSs) and summaries of information for patients (SIPs) — supported by AI — can enhance equity and transparency in HTA. Read the full article here: https://hubs.ly/Q03TnNJn0

Data Monitoring Committees (DMCs) are empaneled to safeguard trial participants and uphold the scientific integrity of a trial. But when it comes to assessing risk-benefit, are DMCs typically provided with benefit summaries by default or upon request? Join us for an insightful webinar where our experts, Rebecca Gatesman and Emily Woolley, will examine real-world scenarios and explore how appropriate data summaries can best support DMCs to assess risk-benefit. Key topics will include: • How DMCs consider alternative therapies and trials available to participants when making a recommendation • Which data summaries reflect participant benefit • How sponsors can best support DMCs • Planning for risk-benefit assessments Register today! https://hubs.ly/Q03TkjVF0