Aktis Oncology’s Post

Absolutely great meeting and productive exchange around trends and needs in today's pharma world - Tanja Obradovic Why Summits https://lnkd.in/gkMtSaua #oncodaily #oncology #cancer #pharmaceuticals #medicalaffairs #clinicaldevelopment #regulatorypathways #medicalcommunication #marketaccess #conference #networking

Happy to share our recent review in Drug Metabolism and Pharmacokinetics! In this review, we've summarized published case examples and our experience at Astellas in the oncology area with a particular focus on the application of QSP in the preclinical stage. "Practical QSP application from the preclinical phase to enhance the probability of clinical success: Insights from case studies in oncology" https://lnkd.in/g6sXhdJ4

This is getting murkier and intriguing case in Oncology It will be worthwhile to follow this interesting market case study that can have profound impact on all future generics and Biosimilars launches in India. Opinion welcomed https://lnkd.in/gMyP5PSK

Post-marketing studies are critical in filling evidence gaps following drug approvals in oncology. At an upcoming Endpoints News webinar on May 22, I'll be discussing the landscape of post-marketing commitments/requirements, and how pragmatically-designed studies in routine practice settings can accelerate critical evidence generation. I'll be joining Carla V. Rodriguez-Watson, PhD, MPH of Reagan-Udall Foundation for the FDA, Ashita Batavia, MD, MS of Johnson & Johnson, and our moderator Matthew Reynolds. Register here: https://lnkd.in/e_aPiq-B #Pragmaticstudies #PostMarketingCommitments #PostMarketingRequirements #ProspectiveRealWorldStudies

🌟 #Webinar This Thursday: Mastering Project Optimus in Oncology Drug Development Join us for a must-attend webinar on the FDA's Project Optimus and its implications for oncology drug development. 👉 Secure your spot: https://lnkd.in/eGhgEFSx Covering: 🔹 An introductory overview of Project Optimus 🔹 Its impact on oncology trials and drug development 🔹 Practical strategies for navigating the new regulatory framework The Experts: 🎙️ Giles Partington, Principal Statistician, Phastar 🎙️ Sam Hinsley, Principal Statistician, Phastar (Moderator) Don't miss out on this crucial opportunity to stay ahead in oncology drug development. Register today! #Oncology #DrugDevelopment #ProjectOptimus #FDA #ClinicalTrials #Webinar #Phastar

More exciting news coming out of Treadwell Therapeutics!

🎗 Explore our robust library of oncology learning content. Pharmaceutical companies rely on our trusted Oncology: Treatment and Management and Oncology Business Acumen curriculums to train their teams. In response to the rise of precision medicine, we've also introduced three new eModules on Precision Medicine. Equip your client-facing teams with the latest knowledge and skills needed to excel in the evolving field of oncology. Chat with our training experts to learn more. https://lnkd.in/dZmk7bbP #CMRInstitute #yourCMR #lifesciences #healthcare #lifescienceindustry #healthcareindustry #healthcareeducation #oncology #precisionmedicine

DID YOU KNOW? Drug development programs with clinical trials employing patient preselection biomarkers have a two-fold higher likelihood of approvals (15.9%), driven by a Phase II success rate of nearly one-in-two.[1] Learn more about how CertisAI™ Predictive Oncology Intelligence can be used to develop stratification strategies for clinical trial patient selection: https://hubs.la/Q01-jZQ90. #AI #ArtificialIntelligence #MachineLearning #PredictiveAnalytics #DigitalDrugDevelopment #PersonalizedMedicine #CancerResearch #TranslationalScience #FightCancer #EndCancer #CertaintyisPriceless [1] Clinical Development Success Rates and Contributing Factors 2011–2020. BIO. Feb. 2021:17-18. Figure: Chart of phase transition success rates and LOA from Phase I.

Want to learn more about RNAseq as a predictive biomarker in oncology trials, especially our #OPTICRCC trial in #kidneycancer? Great team with Brian Rini, Katy Beckermann, and Anupama Reddy. Register for this webinar: https://lnkd.in/e7EJN83t

Oncology experts : Rayone 19 years. Our people are the key to the success of your next clinical trial. Oncology is one of the fastest growing therapeutic areas of clinical research. Our very own oncology expert, Rayone, with 19 years of experience, shares a valuable insight from her journey in oncology clinical trials. She emphasizes the importance of thorough protocol reviews, especially in Phase I studies, where overlooking this step can lead to swift amendments and potential waivers jeopardizing the integrity of the study data. Her key piece of advice? "Prioritise collaboration and thoroughness to efficiently gather the data you need. Involve clinical operations professionals early on to help create a practical protocol that benefits both the study and the patients involved." HiRO - Harvest Integrated Research Organization is proud to have Rayone as part of our team, our teams extensive experience continues to drive our commitment to excellence in oncology clinical trials. #OncologyExperts #ClinicalTrials #Clinicalresearch #drugdevelopment #biotech #pharma